(28 days)
The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) 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 SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery-powered vacuum pump/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 homecare and healthcare environments. The SOMAVAC® 100 may be used for most instances a surgeon determines a closed suction drain device is applicable. The SOMAVAC® 100 is compatible with drains commonly used after surgeries and is intended to be used by a single patient. The SOMAVAC® 100 is to be installed by trained medical personnel. Post-installation (in patient setting or at home), the SOMAVAC® 100 is intended to be operated by patients or their caregivers.
This document details a 510(k) premarket notification for the SOMAVAC® 100 Sustained Vacuum System. It establishes substantial equivalence to a predicate device, K180606.
Here’s an breakdown of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of "acceptance criteria" against which a clinical performance study would be evaluated in terms of sensitivity, specificity, accuracy, or similar metrics. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SOMAVAC® Device, K180606) through non-clinical performance testing and direct comparison of specifications.
The "performance" described refers to the device's functional characteristics and compliance with standards, rather than diagnostic or treatment efficacy from a clinical study. The table below summarizes the key comparisons made to demonstrate substantial equivalence, which serves as the "acceptance criteria" for this type of regulatory submission in the absence of a new clinical claim.
| Characteristic | Acceptance Criteria (Predicate K180606) | Reported Device Performance (Subject K222856) | Assessment of Differences |
|---|---|---|---|
| Regulatory status | Class II | Class II | Identical |
| Classification name | Pump, portable, aspiration. | Pump, portable, aspiration. | Identical |
| Regulation | 878.4780 | 878.4780 | Identical |
| Product Code | BTA | BTA | Identical |
| Vacuum pressure | -60 to -350 mmHg | -60 to -350 mmHg | Identical |
| Use setting | Home and health care environment | Home and health care environment | Identical |
| Indication for use | 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. Intended for use in homecare and healthcare environments. | 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. Intended for use in homecare and healthcare environments. | Identical |
| Waste Collection Capacity | 50mL/drain, 100 mL total (disposable waste collection units) | 50mL/drain, 100 mL total (disposable waste collection units) | Identical |
| Flow @ Max Vacuum | 1.0 mL/min | 1.0 mL/min | Identical |
| Electrical | 3VDC, 2xAA alkaline batteries (series connection) | 3VDC, 2xAA batteries (series connection) | Substantially Equivalent (Alkaline or lithium-ion batteries are appropriate) |
| Weight | 300 gram w/batteries | 300 gram w/batteries | Identical |
| Electrical Equipment Classification | Class II, Type BF, IP (22) | Class II, Type BF, IP (22) | Identical |
| Transport | Portable, wearable; delivered in a belt to be worn by the patient | Portable, wearable; delivered in a belt to be worn by the patient | Identical |
| Mode of operation | Non-continuous, intermittent, controlled by vacuum pressure and amount of exudate collected | Non-continuous, intermittent, controlled by vacuum pressure and amount of exudate collected | Identical |
| Accessories | drain connectors, non-sterile waste collection units belt AA batteries | drain connectors, sterile waste collection units belt AA batteries | Substantially Equivalent (Offering of sterile drain connectors does not affect substantial equivalence) |
Study Information
The document describes non-clinical testing rather than a traditional “study” with patient data.
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical performance verification and validation. The "test set" would refer to the physical devices and components tested. The provenance is not explicitly stated in terms of country of origin of "data," but it implicitly comes from the manufacturer's internal testing. The testing is prospective in the sense that the new device was built and then tested.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For non-clinical performance testing of a physical device like this, "ground truth" is established by engineering specifications, validated measurement equipment, and industry standards (e.g., electrical safety, EMC). Expert review would be part of the design and verification processes but not as a formal "ground truth" for a test set in the clinical sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This type of adjudication is typically used in clinical studies for interpretation of imaging or clinical outcomes, not for engineering performance testing.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or cases in an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware product. While it contains software, the performance listed is for the complete system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical testing is based on:
- Engineering specifications: The defined parameters for vacuum, flow, electrical characteristics, and physical properties.
- Regulatory standards: Compliance with voluntary standards for electrical safety (e.g., IEC 60601-1), electromagnetic compatibility (e.g., IEC 60601-1-2), and powered suction pumps (e.g., ISO 10079-1).
- Previous device performance: The performance of the predicate device (K180606) served as a benchmark for equivalence.
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The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The software changes were validated in accordance with FDA guidances for software in medical devices, but this is distinct from training an AI model.
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How the ground truth for the training set was established: Not applicable. (See answer to point 7).
§ 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.