SOMAVAC 100 Sustained Vacuum System

K222856 · Somavac Medical Solutions, Inc. · BTA · Oct 19, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222856
• Device Name: SOMAVAC 100 Sustained Vacuum System
• Applicant: Somavac Medical Solutions, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Oct 19, 2022
• 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; used for hematoma/seroma prophylaxis post-plastic or general surgery. System includes vacuum source, waste collection units, and drain connectors. Installed by medical personnel; operated by patients/caregivers in home or healthcare settings. Device provides sustained vacuum (-60 to -350 mmHg) to facilitate fluid drainage. Wearable design (belt-mounted) allows patient mobility. Output is fluid collection; healthcare providers monitor drainage to assess wound healing and recovery progress. Benefits include reduced risk of hematoma/seroma formation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, electromagnetic compatibility, vacuum/flow performance verification, and packaging integrity (peel strength, leak, burst) following gamma sterilization.

Technological Characteristics

Portable battery-powered suction pump; 3VDC (2xAA batteries); vacuum range -60 to -350 mmHg; flow rate 1.0 mL/min; 300g weight. Class II, Type BF, IP22. Wearable form factor with belt. Software safety class B per IEC 62304. Sterilization via gamma irradiation for accessories.

Indications for Use

Indicated for removal of surgical and bodily fluids from closed wounds following plastic or general surgery involving large flaps for hematoma and seroma prophylaxis. Intended for use in homecare and healthcare environments by patients or caregivers after installation by trained medical personnel.

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® Device (K180606)

Submission Summary (Full Text)

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October 19, 2022

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

Re: K222856

Trade/Device Name: SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: September 21, 2022 Received: September 21, 2022

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.

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

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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,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K22856

Device Name

SOMAVAC® 100 Sustained Vacuum System (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) | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| K222856: SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) | October 17, 2022 |
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| Company: | SOMAVAC Medical Solutions, Inc.<br>3144 Stage Post Rd Suite 101<br>Bartlett, TN 38133 |
|----------|---------------------------------------------------------------------------------------|
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- Primary Contact: Ms. Dawn Norman, MS Partner; MRC Global, LLC 9085 E. Mineral Circle Centennial, CO 80112 Phone: [phone] [e-mail]
Company/Secondary Mr. Phil Ryan Contact: COO SOMAVAC Medical Solutions, Inc. Phone: [phone] [e-mail]

- Trade Name: SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100)
- Pump, Portable, Aspiration (Manual Or Powered) Common Name:

Classification: Class II

- Regulation Number: 21 CFR 878.4780
Panel: General and Plastic Surgery

- Product Code: BTA
- Primary Predicate: SOMAVAC® Device (K180606), Manufacturer: SOMAVAC Medical Solutions, Inc.

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K222856: 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:

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 updates to SOMAVAC® 100 do 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 concludes that SOMAVAC® 100 is substantially equivalent to the legally marketed predicate devices. The table below summarizes the key differences between SOMAVAC® 100 and the predicate device.

| | Subject K222856:<br>SOMAVAC® 100 Sustained<br>Vacuum System<br>(SOMAVAC® 100) | Predicate K180606:<br>SOMAVAC® Device | 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 |
| Vacuum 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 |
| SOMAVAC® Medical Solutions, Inc. | Subject K222856:<br>SOMAVAC® 100 Sustained<br>Vacuum System<br>(SOMAVAC® 100) | Predicate K180606:<br>SOMAVAC® Device | Assessment of<br>Differences |
| Indication for use | The SOMAVAC® 100<br>Sustained Vacuum System is<br>a portable battery powered<br>vacuum source / waste<br>container intended for the<br>removal of surgical and<br>bodily fluids from a closed<br>wound following plastic<br>surgery and other general<br>surgery forming large flaps<br>for hematoma and seroma<br>prophylaxis. It is intended<br>for use in homecare and<br>healthcare environments. | The SOMAVAC® Device is<br>a portable battery<br>powered vacuum source /<br>waste container intended<br>for the removal of surgical<br>and bodily fluids from a<br>closed wound following<br>plastic 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 Collection<br>Capacity | 50mL/drain<br>100 mL total<br>(disposable waste collection<br>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 alkaline batteries<br>(series connection) | Substantially<br>Equivalent<br>Alkaline or lithium-<br>ion batteries are<br>appropriate. |
| 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 by<br>vacuum pressure and the<br>amount of exudate collected | Non-continuous,<br>intermittent, controlled by<br>vacuum pressure and the<br>amount of exudate<br>collected | Identical |
| | Subject K222856:<br>SOMAVAC® 100 Sustained<br>Vacuum System<br>(SOMAVAC® 100) | Predicate K180606:<br>SOMAVAC® Device | Assessment of<br>Differences |
| Accessories | drain connectors,<br>sterile waste collection units belt AA batteries | drain connectors,<br>non-sterile waste collection units belt AA batteries | Substantially<br>Equivalent;<br>The offering of<br>sterile drain<br>connectors does<br>not affect the<br>substantial<br>equivalence<br>between the<br>predicate and<br>subject device. |

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K222856: SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) SOMAVAC® Medical Solutions, Inc.

# Performance Testing:

The SOMAVAC® 100 device complies with voluntary standards for electrical safety, electromagnetic compatibility, and powered suction pumps. The materials and mechanical properties have been evaluated to confirm the changes to the SOMAVAC® 100 device do not affect the substantial equivalence to the predicate device:

- The software change was developed and validated in accordance with FDA guidances: Deciding When to Submit a 510(k) for a Software Change to an Existing Device (issued October 25, 2017); General Principles of Software Validation (issued January 11, 2002); and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005). The IEC 62304:2006 Software Safety Class for this device remains Class "B".
- Verification of vacuum and flow measurements to confirm that the vacuum levels and flow of the pump continues to meet the specifications.
- . Packaging evaluations peel strength, gross leaks, and burst strength were performed following gamma irradiation sterilization to confirm appropriate packaging of sterile accessories.

#### Conclusion:

The intended use and indications for use of the SOMAVAC® 100 subject device is identical to the predicate device. The updates to the SOMAVAC® 100 device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and validation testing 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, the SOMAVAC® 100 subject device is substantially equivalent to the predicate, SOMAVAC® Device (K180606).