(28 days)
Not Found
No
The summary describes a mechanical vacuum system for fluid removal and does not mention any AI/ML components or functionalities.
No.
The SOMAVAC® 100 System is intended for the removal of surgical and bodily fluids from a closed wound (i.e. wound drainage), which is a supportive rather than a therapeutic function.
No
The device is a portable vacuum source/waste container intended for the removal of surgical and bodily fluids from a closed wound. It does not perform any diagnostic functions.
No
The device description explicitly states it is a "portable battery-powered vacuum pump/waste container," indicating it is a physical hardware device with a vacuum pump and container, not solely software.
Based on the provided information, the SOMAVAC® 100 Sustained Vacuum System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery". This is a therapeutic and post-surgical management function, not a diagnostic one.
- Device Description: The description reinforces its function as a "portable battery-powered vacuum pump/waste container" for fluid removal.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition. IVD devices are specifically designed for such in vitro examination of specimens.
Therefore, the SOMAVAC® 100 falls under the category of a surgical or post-surgical device for fluid management, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BTA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended for use in homecare and healthcare environments. 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in a smaller font.
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
1
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,
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
2
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| K222856: SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) | October 17, 2022 |
|---|---|
| -------------------------------------------------------------- | ------------------ |
| Company: | SOMAVAC Medical Solutions, Inc.
3144 Stage Post Rd Suite 101
Bartlett, TN 38133 |
| ---------- | --------------------------------------------------------------------------------------- |
|---|
-
Primary Contact: Ms. Dawn Norman, MS Partner; MRC Global, LLC 9085 E. Mineral Circle Centennial, CO 80112 Phone: 618-604-3064 Dawn.Norman@askmrcglobal.com
Company/Secondary Mr. Phil Ryan Contact: COO SOMAVAC Medical Solutions, Inc. Phone: 901-212-2198 phil.ryan@somavac.com -
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.
4
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:
SOMAVAC® 100 Sustained
Vacuum System
(SOMAVAC® 100) | Predicate K180606:
SOMAVAC® Device | 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 |
| SOMAVAC® Medical Solutions, Inc. | Subject K222856:
SOMAVAC® 100 Sustained
Vacuum System
(SOMAVAC® 100) | Predicate K180606:
SOMAVAC® Device | Assessment of
Differences |
| Indication for use | The SOMAVAC® 100
Sustained Vacuum System 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® Device 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. | 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 batteries (series
connection) | 3VDC
2xAA alkaline 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 the
amount of exudate collected | Non-continuous,
intermittent, controlled by
vacuum pressure and the
amount of exudate
collected | Identical |
| | Subject K222856:
SOMAVAC® 100 Sustained
Vacuum System
(SOMAVAC® 100) | Predicate K180606:
SOMAVAC® Device | Assessment of
Differences |
| Accessories | drain connectors,
sterile waste collection units belt AA batteries | drain connectors,
non-sterile waste collection units belt AA batteries | Substantially
Equivalent;
The offering of
sterile drain
connectors does
not affect the
substantial
equivalence
between the
predicate and
subject device. |
5
6
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).