(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, batterypowered 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.
The provided text is related to the FDA 510(k) clearance for the SOMAVAC® 100 Sustained Vacuum System. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's clinical performance against specific acceptance criteria for a novel AI or diagnostic system.
Therefore, many of the requested categories in your prompt cannot be fully addressed from the provided text. The document describes changes to a previously cleared device (SOMAVAC® 100, K222856) specifically regarding an additional sterilization method (ethylene oxide) for its drain connector accessories. The performance testing section focuses on validating this new sterilization method and its impact on packaging.
Here's an attempt to answer your questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are not presented in a table format for a clinical outcome or diagnostic accuracy in this document. Instead, the "performance testing" focuses on validating the sterilization method and its effects on packaging integrity, referencing existing standards. The acceptance criteria essentially reflect compliance with these standards.
| Acceptance Criteria (Related to new sterilization method) | Reported Device Performance |
|---|---|
| Sterilization: Compliance with ISO 11135:2014 (Ethylene oxide sterilization requirements) | Demonstrated compliance with ISO 11135:2014 |
| Residuals: Compliance with ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Demonstrated compliance with ISO 10993-7:2008 |
| Packaging Seal Strength: Pass ASTM F88/F88M at T=0 & T=3 years (post-sterilization) | Pass |
| Packaging Integrity: Pass ASTM 1886 at T=0 & T=3 years (post-sterilization) | Pass |
| Overall: No adverse effects introduced by the additional sterilization method and device continues to perform as intended. | Verification and validation rationales demonstrated no adverse effects, device performs as intended. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of patient data or algorithm performance. The testing mentioned relates to the physical and chemical properties associated with the new sterilization method and packaging. Therefore, no information on sample size for a "test set" for device performance (e.g., fluid removal efficiency in patients) or data provenance (country, retrospective/prospective) is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a test set requiring expert-established ground truth for clinical or diagnostic performance. The validation of sterilization and packaging integrity would typically involve laboratory testing by qualified personnel, but not "experts" in the sense of clinicians establishing ground truth from patient data.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as the testing concerns physical and chemical properties of the device components/packaging, not clinical or diagnostic outcomes requiring expert consensus.
5. 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 or diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (suction pump), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing related to the new sterilization method, the "ground truth" is established by adherence to recognized international standards (ISO 11135, ISO 10993-7, ASTM F88/F88M, ASTM 1886). These standards define acceptable parameters for sterilization efficacy, residuals, and packaging integrity.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.
Summary of Device Performance (from the document):
The SOMAVAC® 100 Sustained Vacuum System, in this submission (K231063), is essentially the same device as its predicate (K222856). The only change covered by this 510(k) is the addition of Ethylene Oxide (EO) as a sterilization method for the drain connector accessories, alongside the existing gamma radiation method.
The study presented here focuses on validating this new sterilization method and confirming that it does not negatively impact the device's safety or effectiveness. This was achieved by demonstrating compliance with ISO standards for EO sterilization and biological evaluation, and by conducting packaging evaluations (seal strength and integrity) post-sterilization, which all "Passed". The conclusion is that the device remains substantially equivalent to the predicate.
§ 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.