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.

Device Description

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.

AI/ML Overview

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.

Summary

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May 12, 2023

SOMAVAC Medical Solutions, Inc. % Dawn Norman Partner MRC Global LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112

RE: K231063

Trade/Device Name: SOMAVAC® 100 Sustained Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: April 13, 2023 Received: April 14, 2023

Dear Ms. Norman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Digitally signed by Mark Mark Trumbore -S Trumbore -S -S -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231063

Device Name SOMAVAC® 100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) K231063 May 10, 2023

Company:	SOMAVAC Medical Solutions, Inc.3144 Stage Post Rd Suite 101Bartlett, TN 38133
Primary Contact:	Ms. Dawn N. Norman, MSPartner, MRC Global9085 E. Mineral CircleCentennial CO 80112Phone: 618-604-3064Dawn.Norman@askmrcglobal.com
Company/SecondaryContact:	Mr. Phil RyanCOOSOMAVAC Medical Solutions, Inc.Phone: 901-212-2198phil.ryan@somavac.com
Trade Name:	SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100)
Common Name:	Pump, Portable, Aspiration (Manual Or Powered)
Classification:	Class II
Regulation Number:	21 CFR 878.4780
Panel:	General and Plastic Surgery
Product Code:	BTA
Primary Predicate:	SOMAVAC® 100 (K222856),Manufacturer: SOMAVAC Medical Solutions, Inc.

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SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) SOMAVAC® Medical Solutions, Inc.

Device Description:

Indications for Use:

Substantial Equivalence:

The SOMAVAC® 100 uses the same fundamental technology as the predicate device. The indications for use of the subject device is identical to the predicate device. The additional sterilization method for the drain connector accessories for the SOMAVAC® 100 does not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and validation testing has demonstrated that no adverse effects have been introduced by these changes and that the device performs as intended.

From the results of nonclinical testing described, SOMAVAC Medical Solutions concludes that the SOMAVAC® 100 is substantially equivalent to the legally marketed predicate devices. The table below summarizes the key differences between the SOMAVAC® 100 and the predicate device.

	SubjectSOMAVAC® 100Sustained VacuumSystem (SOMAVAC® 100)	Primary PredicateK222856: SOMAVAC®100 Sustained VacuumSystem (SOMAVAC® 100)	Assessment ofDifferences
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
	SubjectSOMAVAC® 100	Primary PredicateK222856: SOMAVAC®	Assessment ofDifferences
	Sustained VacuumSystem (SOMAVAC® 100)	100 Sustained VacuumSystem (SOMAVAC® 100)
Vacuumpressure	-60 to -350 mmHg	-60 to -350 mmHg	Identical
Use setting	Home and health careenvironment	Home and health careenvironment	Identical
Indicationfor use	The SOMAVAC® 100Sustained VacuumSystem (SOMAVAC® 100)is a portable batterypowered vacuum source/ waste containerintended for the removalof surgical and bodilyfluids from a closedwound following plasticsurgery and othergeneral surgery forminglarge flaps for hematomaand seroma prophylaxis.It is intended for use inhomecare and healthcareenvironments.	The SOMAVAC® 100Sustained VacuumSystem (SOMAVAC® 100)is a portable batterypowered vacuum source/ waste containerintended for the removalof surgical and bodilyfluids from a closedwound following plasticsurgery and othergeneral surgery forminglarge flaps for hematomaand seroma prophylaxis.It is intended for use inhomecare and healthcareenvironments.	Identical
WasteCollectionCapacity	50mL/drain100 mL total(disposable wastecollection units)	50mL/drain100 mL total(disposable wastecollection units)	Identical
Flow @ MaxVacuum	1.0 mL/min	1.0 mL/min	Identical
Electrical	3VDC2xAA batteries (seriesconnection)	3VDC2xAA batteries (seriesconnection)	Identical
Weight	300 gram w/batteries	300 gram w/batteries	Identical
ElectricalEquipmentClassification	Class IIType BFIP (22)	Class IIType BFIP (22)	Identical
Transport	Portable, wearableDelivered in a belt to beworn by the patient	Portable, wearableDelivered in a belt to beworn by the patient	Identical
Mode ofoperation	Non-continuous,intermittent, controlledby vacuum pressure andthe amount of exudatecollected	Non-continuous,intermittent, controlledby vacuum pressure andthe amount of exudatecollected	Identical
	SubjectSOMAVAC® 100Sustained VacuumSystem (SOMAVAC® 100)	Primary PredicateK222856: SOMAVAC®100 Sustained VacuumSystem (SOMAVAC® 100)	Assessment ofDifferences
Accessories	drain connectors,sterile via ethyleneoxide or gammaradiation waste collectionunits belt AA batteries	drain connectors,sterile via gammaradiation waste collectionunits belt AA batteries	SubstantiallyEquivalent

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Performance Testing:

The SOMAVAC® 100 continues to comply with voluntary standards for software, electrical safety, electromagnetic compatibility, and powered suction pumps which has not changed since the original clearance. The additional sterilization method for the drain connector accessories does not affect the substantial equivalence to the predicate device SOMAVAC® 100. Therefore, the previous functional performance testing for verification is applicable to the subject device. and that previous is applicable.

In the predicate submission (SOMAVAC® 100, K222856), the drain connector accessories are provided sterile via gamma irradiation. A secondary sterilization method, ethylene oxide (EO), has been validated for the drain connector accessories per the following standards:

. ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide . sterilization residuals

Packaging evaluations to confirm seal strength were conducted post sterilization to confirm the additional sterilization method, ethylene oxide, does not impact the packaging or shelf life:

Standard	Description	Results
ASTM F88/F88M(at T=0 & T=3 years)	Standard Test Method for Seal Strength of Flexible BarrierMaterials	Pass
ASTM 1886(at T=0 & T=3 years)	Determining Integrity of Seals for Flexible Packaging by VisualInspection	Pass

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SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) SOMAVAC® Medical Solutions, Inc.

Conclusion:

The intended use and indications for use of the SOMAVAC® 100 subject device are identical to the predicate device. The additional sterilization method for the drain connector accessories of the SOMAVAC® 100 does not introduce a new intended use and does not raise new issues of safety and effectiveness. Verification and validation rationales have demonstrated that no adverse effects have been introduced by the ethylene oxide sterilization method and that the device continues to perform as intended.

From the results of nonclinical testing described, the SOMAVAC® 100 subject device is substantially equivalent to the predicate, SOMAVAC® 100 (K222856).

Regulation Number and Section

§ 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.