SOMAVAC® 100 Sustained Vacuum System

K231063 · Somavac Medical Solutions, Inc. · BTA · May 12, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231063
• Device Name: SOMAVAC® 100 Sustained Vacuum System
• Applicant: Somavac Medical Solutions, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: May 12, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Portable, battery-powered vacuum pump and waste container; removes surgical/bodily fluids from closed wounds post-plastic or general surgery. Used for hematoma/seroma prophylaxis. Installed by medical personnel; operated by patients/caregivers in home or healthcare settings. Device maintains sustained vacuum pressure (-60 to -350 mmHg) to facilitate fluid drainage into disposable collection units. Output allows monitoring of fluid volume; aids clinical decision-making regarding wound healing and drain removal. Benefits patient by providing portable, sustained suction, potentially reducing complications associated with fluid accumulation.

Clinical Evidence

Bench testing only. No clinical data presented. Validation included sterilization process validation (ISO 11135, ISO 10993-7) and packaging integrity testing (ASTM F88/F88M, ASTM F1886) at T=0 and T=3 years, all of which passed.

Technological Characteristics

Portable vacuum pump; 3VDC (2xAA batteries); vacuum range -60 to -350 mmHg; flow rate 1.0 mL/min. Waste capacity 100 mL total (50 mL/drain). Class II, Type BF, IP22. Sterilization: Gamma radiation or Ethylene Oxide (ISO 11135). Packaging standards: ASTM F88/F88M, ASTM F1886.

Indications for Use

Indicated for patients undergoing plastic or general surgery involving large flaps, requiring removal of surgical and bodily fluids from closed wounds for hematoma and seroma prophylaxis. Intended for use in homecare and healthcare settings.

Regulatory Classification

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.

Predicate Devices

• SOMAVAC® 100 (K222856)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| ☑ 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.<br>3144 Stage Post Rd Suite 101<br>Bartlett, TN 38133 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Ms. Dawn N. Norman, MS<br>Partner, MRC Global<br>9085 E. Mineral Circle<br>Centennial CO 80112<br>Phone: [phone]<br>[e-mail] |
| Company/Secondary<br>Contact: | Mr. Phil Ryan<br>COO<br>SOMAVAC Medical Solutions, Inc.<br>Phone: [phone]<br>[e-mail] |
| 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),<br>Manufacturer: SOMAVAC Medical Solutions, Inc. |

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

#### 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.

### Indications for Use:

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.

### 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.

| | Subject<br>SOMAVAC® 100<br>Sustained Vacuum<br>System (SOMAVAC® 100) | Primary Predicate<br>K222856: SOMAVAC®<br>100 Sustained Vacuum<br>System (SOMAVAC® 100) | Assessment of<br>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 |
| | Subject<br>SOMAVAC® 100 | Primary Predicate<br>K222856: SOMAVAC® | Assessment of<br>Differences |
| | Sustained Vacuum<br>System (SOMAVAC® 100) | 100 Sustained Vacuum<br>System (SOMAVAC® 100) | |
| Vacuum<br>pressure | -60 to -350 mmHg | -60 to -350 mmHg | Identical |
| Use setting | Home and health care<br>environment | Home and health care<br>environment | Identical |
| Indication<br>for use | The SOMAVAC® 100<br>Sustained Vacuum<br>System (SOMAVAC® 100)<br>is a portable battery<br>powered vacuum source<br>/ waste container<br>intended for the removal<br>of surgical and bodily<br>fluids from a closed<br>wound following plastic<br>surgery and other<br>general surgery forming<br>large flaps for hematoma<br>and seroma prophylaxis.<br>It is intended for use in<br>homecare and healthcare<br>environments. | The SOMAVAC® 100<br>Sustained Vacuum<br>System (SOMAVAC® 100)<br>is a portable battery<br>powered vacuum source<br>/ waste container<br>intended for the removal<br>of surgical and bodily<br>fluids from a closed<br>wound following plastic<br>surgery and other<br>general surgery forming<br>large flaps for hematoma<br>and seroma prophylaxis.<br>It is intended for use in<br>homecare and healthcare<br>environments. | Identical |
| Waste<br>Collection<br>Capacity | 50mL/drain<br>100 mL total<br>(disposable waste<br>collection units) | 50mL/drain<br>100 mL total<br>(disposable waste<br>collection units) | Identical |
| Flow @ Max<br>Vacuum | 1.0 mL/min | 1.0 mL/min | Identical |
| Electrical | 3VDC<br>2xAA batteries (series<br>connection) | 3VDC<br>2xAA batteries (series<br>connection) | Identical |
| Weight | 300 gram w/batteries | 300 gram w/batteries | Identical |
| Electrical<br>Equipment<br>Classification | Class II<br>Type BF<br>IP (22) | Class II<br>Type BF<br>IP (22) | Identical |
| Transport | Portable, wearable<br>Delivered in a belt to be<br>worn by the patient | Portable, wearable<br>Delivered in a belt to be<br>worn by the patient | Identical |
| Mode of<br>operation | Non-continuous,<br>intermittent, controlled<br>by vacuum pressure and<br>the amount of exudate<br>collected | Non-continuous,<br>intermittent, controlled<br>by vacuum pressure and<br>the amount of exudate<br>collected | Identical |
| | Subject<br>SOMAVAC® 100<br>Sustained Vacuum<br>System (SOMAVAC® 100) | Primary Predicate<br>K222856: SOMAVAC®<br>100 Sustained Vacuum<br>System (SOMAVAC® 100) | Assessment of<br>Differences |
| Accessories | drain connectors,<br>sterile via ethylene<br>oxide or gamma<br>radiation waste collection<br>units belt AA batteries | drain connectors,<br>sterile via gamma<br>radiation waste collection<br>units belt AA batteries | Substantially<br>Equivalent |

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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<br>(at T=0 & T=3 years) | Standard Test Method for Seal Strength of Flexible Barrier<br>Materials | Pass |
| ASTM 1886<br>(at T=0 & T=3 years) | Determining Integrity of Seals for Flexible Packaging by Visual<br>Inspection | 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).