(85 days)
The SOMAVAC™ Device is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.
The single-patient use SOMAVAC™ Device is capable of generating sustained vacuum at the end two surgical drains to effectively remove bodily fluids after plastic or general surgeries. The SOMAVAC™ Device has a battery-powered SOMAVAC™ Pump assembly to generate vacuum with accessories, including disposable collection units, two drain connectors, and one belt. All products are non-sterile. Surgical drains are not included. The SOMAVAC™ device is compatible with non-collapsible, open channel (proximal), smooth bore drains with a distal inner diameter of 3mm - 4.5mm (commonly 15 – 19 Fr.). Up to two drains can be attached to the SOMAVAC™ Device. Each disposable waste collection units collects up to 100 mL of fluid. Versions of the device will be marketed with factory-set single, vacuum pressure levels ranging from 60 to 350mmHg. The device maintains suction throughout its use in a manner analogous to a thermostat by selectively running the pump motors to maintain the preset pressure. The device stops when the collection units are full or if the collection units are detached from the device. SOMAVAC™ Pump assembly has light and sound indicators to help users identify when the collection unit is full and ready to be exchanged, the battery is ready to be changed, or if there is a malfunction.
The SOMAVAC™ Device, a portable battery-powered vacuum source/waste container for surgical and bodily fluid removal, underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly provide a table of acceptance criteria with corresponding reported device performance values in a side-by-side format. However, it lists several non-clinical tests conducted, implying that the device met the specifications and standards targeted by these tests. Based on the "Summary of non-clinical tests conducted for determination of substantial equivalence" section (page 6), the following can be inferred:
| Acceptance Criterion (Inferred from Test) | Reported Device Performance |
|---|---|
| Compliance with ISO 14971:2012 for Risk Analysis | Risk Analysis was developed in accordance with ISO 14971:2012. |
| Software Verification and Validation (moderate level of concern) | Software verification and validation testing were conducted; compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern. |
| Electrical Safety (IEC 60601-1:2005, ANSI/AAMI ES60601-1:2005, etc.) | Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 with US deviations per ANSI/AAMI ES60601-1:2005 + A1:2012, C1:2009 and A2:2010, IEC 60601-1-2:2014, EN 60601-1-11 (First Edition): 2010, and IEC/EN 60529: 2013, (IP22) standards. |
| Biocompatibility (ISO 10993:2009) | Biocompatibility has been evaluated per ISO 10993:2009. |
| Vacuum and Flow Measurements | Performance testing to determine the vacuum levels (-60 to -350 mmHg) and flow (1.0 mL/min @ Max Vacuum) of the pump as compared to its specifications was performed. |
| Verification of Operating Times with various pump loads and battery | Operating times were checked with different pump loads and the recommended battery type. Dependency was checked at worst-case fluid output and fluid-viscosity. Correct function of battery-low indication was confirmed. |
| Endurance Runtime (mechanical pump lifetime, component fatigue life) | Endurance runtime was performed based on the lifetime of the mechanical pump and fatigue life of components subject to repeated loading, supported by average clinical hours. |
| Manufacturing Quality Standards | Not explicitly detailed in performance but referred to as general controls provisions, including good manufacturing practice requirements (21 CFR Part 820). |
2. Sample Size Used for the Test Set and Data Provenance:
The study relies primarily on non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or samples from a typical clinical study is not applicable. The samples used would be:
- Physical units of the SOMAVAC™ Device and its components for performance, electrical safety, and endurance testing.
- Materials used in the device for biocompatibility testing.
- Software code for verification and validation.
Data Provenance: The tests are described as non-clinical tests. The country of origin for these tests is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. regulatory standards and potentially U.S. or internationally accredited testing laboratories. All tests are inherently retrospective in the sense that they evaluate manufactured device units against established specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable as the determination of substantial equivalence was based on non-clinical engineering and bench testing, not on clinical assessment requiring expert interpretation of patient data or images to establish a "ground truth."
4. Adjudication Method for the Test Set:
This information is not applicable as there was no clinical study involving human judgment or interpretation of data that would require an adjudication method. Test results are compared against predetermined engineering specifications and industry standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the SOMAVAC™ Device to its predicate device(s)." This type of study would involve human readers (e.g., clinicians) evaluating cases with and without AI assistance, which is not relevant for this device.
6. Standalone Performance Study:
A standalone performance study in the context of typical AI device evaluation (algorithm only without human-in-the-loop performance using patient data) was not performed. The device is a physical medical device, not an AI diagnostic algorithm. The "standalone" performance described here relates to the device's technical specifications and functionality (e.g., vacuum, flow, battery life) as measured in a lab setting without human intervention beyond operating the test equipment.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests constitutes:
- Engineering Specifications: The design specifications the device was intended to meet (e.g., target vacuum pressure range, flow rate, battery operating times).
- Voluntary Standards: Established international and national standards for medical devices (e.g., ISO 14971, IEC 60601-1, ISO 10993).
- FDA Guidance Documents: Recommendations from FDA for software and other aspects.
8. Sample Size for the Training Set:
This information is not applicable. The SOMAVAC™ Device is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable because there is no training set for this device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.