Medical Device News Update - April 2024

Note:?This article is a summary of the original article published in my Let's Talk Risk! newsletter on Substack, a reader-supported publication. Read the full article here.

Each month, I compile a comprehensive list of medical device news from the prior month, focusing on FDA approvals, warning letters and recalls.

As a risk practitioner, it is very important to stay up to date with the latest regulatory developments affecting the medical device industry. A review of latest innovations approved or cleared by the FDA helps in understanding different ways the agency evaluates benefit-risk of medical devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful to study for awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Quick Summary

New device approvals/clearances

1. An AI/ML enabled software device to identify patients at risk for developing or having sepsis (De Novo DEN230036).
2. A spinal fusion device with antibacterial coating (De Novo DEN220015).
3. A limb and joint salvage device with antibacterial coating (De Novo DEN210058).
4. A surgical system for open microsurgery (De Novo DEN230032).
5. A continuous glucose monitoring device (De Novo DEN230052).
6. A radiology software to aid in detecting low bone mineral density (De Novo DEN230023).
7. A breakthrough device to repair the native tricuspid value without open heart surgery (PMA, Original, P230007).
8. A breakthrough device to visualize residual cancerous tissue following lumpectomy (PMA, Original, P230014).
9. A breakthrough drug-coated resorbable stent to open up the infrapopliteal artery diameter and prevent lower limb amputations (PMA, Original, P230036)
10. A total of 252 devices were cleared through the 510(k) process during April 2024. Days to FDA decision ranged from 1 to 1318 days with a median of 172 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Dental (DE) accounting for 65% (164/252) of devices cleared.

Featured Innovation: Sepsis Immunoscore(TM)

Sepsis is a difficult condition to diagnose quickly for timely treatment that is appropriately personalized for each patient. According to the CDC, sepsis contributes to at least 1.7 million adult hospitalizations and at least 350,000 deaths in the United States.

The Sepsis Immunoscore is a first ever AI/ML enabled software device cleared by the FDA. It uses up to 22 predetermined inputs from a patient’s electronic health record (EHR) to generate a risk score for having or developing sepsis. It is intended to be used as a aid in the prediction or diagnosis of sepsis in conjunction with other laboratory results and clinical assessments.

By analyzing a combination of biomarkers and clinical data, the Sepsis Immunoscore provides a risk score and four discrete risk categories. These risk categories correspond to how likely a patient's condition might deteriorate within 24 hours of assessment, ranging from length of hospital stay to escalation to ICU care and in-hospital mortality. It integrates directly into the hospital's electronic medical records which makes it easy for the clinician to access this information.

The AI/ML engine was developed in a decade-long partnership with 10 hospitals across the US, which led to a proprietary biobank of dataset consisting of more than 100,000 blood samples from over 25,000 patients that is combined with clinical data from electronic medical records.

In a peer-reviewed article (see link below), researchers demonstrated that "robust diagnostic performance in the subgroup with vague or confounding presentation is a novel aspect" of this approach.

FDA has classified the Sepsis Immunoscore as a Class II device under the device code SAK, with the following generic description:

Software device to aid in the prediction or diagnosis of sepsis. A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis.

According to the reclassification order (see link below), FDA has identified the following risks and mitigation measures associated with this device type:

FDA has also outlined the following special controls for these types of devices:

1. Clinical performance testing requirements: validation using dataset from representative patient population, establishment of "ground truth", objective performance measures, appropriate sub-group analyses, clinically relevant performance goals, training dataset distinct from generalizability testing, and reporting of adverse events.
2. Non-clinical performance testing requirements: precision/sensitivity range of inputs, reproducibility, missing input analysis, monotonicity of device outputs.
3. Software verification and validation
4. Human factors assessment
5. Labeling requirements
6. Post-market performance management plan: data collection, analysis methods and procedures for monitoring relevant performance and detecting changes in performance, sources of performance variation and assessment of results on safety and performance.

Warning letters

FDA issued 3 warning letters in April 2024:

1. Cardinal Health: Marketing of unauthorized syringes in a kit. Additional quality system violation related to purchasing controls.
2. Pinnacle BioLabs: Marketing of a medical device without FDA approval or clearance. Additional quality system violations in design controls, complaints handling, CAPA and MDR reporting.
3. Bioptimal International: Marketing of medical devices without FDA approval or clearance. Additional quality system violations in design controls, complaints handling, process validation, CAPA and MDR reporting.

Class I recall announcements

There were a total of 15 Class I announcements in April 2024:

1. Teleflex/Arrow International: radial artery and catheterization kits for increased resistance that may cause blood vessel injury, narrowing or blockage.
2. Smiths Medical ASD Inc.: ventilator kit malfunction may cause non-cycling, continuous positive gas flow and improper ventilation.
3. Medos International: cracking of a neurovascular catheter may cause delay in procedure, vascular injury, hemorrhage or embolism in the brain.
4. Abbott/Thoratec Corp.: left ventricular assist system due to long-term build up of biological material may cause obstruction and loss of blood flow.
5. Boston Scientific: embolic agent delivery device for increased risk of bowel ischemia when used to stop lower GI bleeding.
6. Fresenius Kabi USA: infusion pump software issues that may lead to serious injury or death.
7. DeRoyal Industries: convenience kits containing urine meter foley impacted by Nurse Assist recall due to sterility issues.
8. Fresenius Medical Care: catheter extension sets and accessories for risk of exposure to higher than allowable levels of toxic compound NDL-PCBAs.
9. Outset Medical: hemodialysis system for risk of exposure to higher than allowable levels of toxic compound NDL-PCBAs.
10. Draeger Inc.: sudden unexpected shutdown of anesthesia system in battery mode may cause delay/interruption in treatment.
11. InfuTronix LLC: multiple device failure modes of an infusion system may lead to serious injury and death.
12. Elekta Instrument AB: microscopic steel debris inside a disposable biopsy needle used to extract brain tumor sample.
13. SonarMed Inc.: software issue in an airway monitor system resulting in failure to detect partial obstruction in sensor tips.
14. SonarMed Inc.: restriction in acoustic sensors used in an airway monitoring system causing difficulty in using suction catheter during use.
15. BioMerieux Inc.: higher than normal levels of antibiotics in testing well of a diagnostic card used to detect antibiotic resistance to bacteria.

For links to each of these updates, click the link below to access the full article.

Medical Device News Update - April 2024

Let me know in your comments below?? if you find this information useful.

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References:

1. Sepsis Immunoscore Peer Review article - Diagnostic and prognostic capabilities of a biomarker and EMR-based machine learning algorithm for sepsis.
2. DEN230036: FDA De Novo Reclassification Order.