(85 days)
No
The description focuses on mechanical vacuum generation and maintenance, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive control beyond simple pressure regulation.
Yes
The device is described as 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." This function directly addresses a medical condition (hematoma and seroma prophylaxis) and aids in the healing process post-surgery, which aligns with the definition of a therapeutic device.
No
The device is described as a vacuum source/waste container for removing surgical and bodily fluids from a closed wound. Its purpose is fluid removal and prophylaxis, not to provide diagnostic information about a patient's condition.
No
The device description clearly outlines hardware components including a battery-powered pump assembly, disposable collection units, drain connectors, and a belt. It also mentions electrical safety and electromagnetic compatibility testing, which are relevant to hardware.
Based on the provided information, the SOMAVAC™ Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the removal of surgical and bodily fluids from a closed wound. This is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description focuses on generating vacuum and collecting fluids. There is no mention of analyzing the collected fluids or using them for diagnostic purposes.
- Lack of Diagnostic Elements: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SOMAVAC™ Device does not perform any such analysis.
The SOMAVAC™ Device is a surgical drainage device, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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 surger for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.
Product codes
BTA, GCY
Device Description
The single-patient use SOMAVAC™ Device is capable of generating sustained vacuum at the end two surgical drains to effectively remove bodily fluids after plastic or general surgeries. The SOMAVAC™ Device has a battery-powered SOMAVAC™ Pump assembly to generate vacuum with accessories, including disposable collection units, two drain connectors, and one belt. All products are non-sterile. Surgical drains are not included. The SOMAVAC™ device is compatible with non-collapsible, open channel (proximal), smooth bore drains with a distal inner diameter of 3mm - 4.5mm (commonly 15 – 19 Fr.). Up to two drains can be attached to the SOMAVAC™ Device. Each disposable waste collection units collects up to 100 mL of fluid. Versions of the device will be marketed with factory-set single, vacuum pressure levels ranging from 60 to 350mmHg. The device maintains suction throughout its use in a manner analogous to a thermostat by selectively running the pump motors to maintain the preset pressure. The device stops when the collection units are full or if the collection units are detached from the device. SOMAVAC™ Pump assembly has light and sound indicators to help users identify when the collection unit is full and ready to be exchanged, the battery is ready to be changed, or if there is a malfunction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
closed wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Homecare and healthcare environments.
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
Non-clinical tests: Risk Analysis was developed in accordance with ISO 14971:2012. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain or engorgement. Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 with US deviations per ANSI/AAMI ES60601-1:2005 + A1:2012, C1:2009 and A2:2010, IEC 60601-1-2:2014, EN 60601-1-11 (First Edition): 2010, and IEC/EN 60529: 2013, (IP22) standards. Biocompatibility has been evaluated per ISO 10993:2009. Vacuum and flow measurements: Performance testing to determine the vacuum levels and flow of the pump as compared to its specifications. Verification of operating times: The operating times were checked with different pump loads with the recommended battery type. The dependency was checked at worst-case fluid output and fluid-viscosity setting. The correct function of the battery-low indication was also confirmed. Confirmation of the endurance runtime of the SOMAVAC™ Device was performed based on the lifetime of the mechanical pump and the fatigue life of components subject to repeated loading, and supported with the average number of hours needed clinically.
Clinical testing: Clinical testing was not required to demonstrate the substantial equivalence of the SOMAVAC™ Device to its predicate device(s). Clinical literature has been evaluated to support the range of vacuum pressures available for clinicians to prescribe.
Key results: The intended use and indications for use of the subject devices are substantially equivalent to the predicate devices. The differences between the SOMAVAC™ Device and its predicate 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 differences and that the device performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
May 31, 2018
SOMAVAC Medical Solutions, Inc. % Ms. Dawn Norman Regulatory Consultant MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119
Re: K180606
Trade/Device Name: SOMAVAC Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA, GCY Dated: March 6, 2018 Received: March 7, 2018
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. 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SOMAVAC™ Device
Indications for Use (Describe)
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 surger 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) Notification Summary
| Name | SOMAVAC Medical Solutions, Inc. |
|---|---|
| Address | 20 South Dudley Street, Suite 100 |
| Memphis, TN 38103 | |
| Phone Number | (901) 664 6370 |
| Establishment | |
| Registration | |
| Number | N/A |
| Name of Contact | |
| Person | Dawn N. Norman, Regulatory Consultant |
| MRC-X, LLC | |
| Name of the Device | |
| Trade Proprietary | |
| Name | SOMAVAC™ Device |
| Common name | Pump, Portable, Aspiration (Manual Or Powered) |
| Classification | |
| name | Powered suction pump |
| Apparatus, suction, single patient use, portable | |
| Classification | |
| Panel | General and Plastic Surgery |
| Regulation | 878.4780, 878.4680 |
| Product Code(s) | BTA, GCY |
| Predicate Devices | Primary Predicate: Easy Go Vac (K140179) |
| Reference Predicate: RedyRob Closed Wound Drainage System | |
| (K972703) | |
| Device | |
| Description | The single-patient use SOMAVAC™ Device is capable of generating |
| sustained vacuum at the end two surgical drains to effectively remove | |
| bodily fluids after plastic or general surgeries. The SOMAVAC™ Device | |
| has a battery-powered SOMAVAC™ Pump assembly to generate | |
| vacuum with accessories, including disposable collection units, two drain | |
| connectors, and one belt. All products are non-sterile. Surgical drains are | |
| not included. The SOMAVAC™ device is compatible with non- | |
| collapsible, open channel (proximal), smooth bore drains with a distal | |
| inner diameter of 3mm - 4.5mm (commonly 15 – 19 Fr.). Up to two drains | |
| can be attached to the SOMAVAC™ Device. Each disposable waste | |
| collection units collects up to 100 mL of fluid. Versions of the device will | |
| be marketed with factory-set single, vacuum pressure levels ranging from | |
| 60 to 350mmHg. |
4
| | The device maintains suction throughout its use in a manner analogous
to a thermostat by selectively running the pump motors to maintain the
preset pressure. The device stops when the collection units are full or if
the collection units are detached from the device. SOMAVAC™ Pump
assembly has light and sound indicators to help users identify when the
collection unit is full and ready to be exchanged, the battery is ready to be
changed, or if there is a malfunction. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 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. |
Comparison of the technological characteristics with the predicate device
The SOMAVAC™ Device uses the same fundamental technology as the predicate and reference pumps. The indications for use of the subject device is a subset of and substantially equivalent to the predicate and reference devices. The differences between the SOMAVAC™ Device and its predicate and reference devices 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 differences and that the device performs as intended.
From the results of nonclinical testing described, SOMAVAC™ Medical concludes that the SOMAVAC™ Device is substantially equivalent to the legally marketed predicate devices. The table below summarizes the key differences between the SOMAVAC™ Device and the predicate devices.
| | SOMAVAC™ Device | Primary Predicate
Easy Go Vac
Aspirator (K140179) | Reference
Predicate
Redyrob, Closed
Wound Drainage
System
(K972703) |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory status | Class II | Class II | Class I |
| Classification name | Pump, portable, aspiration. | Pump, portable, aspiration. | Non powered, single patient, suction apparatus. |
| Regulation | 878.4780 | 878.4780 | 878.4680 |
| Product Code | BTA | BTA | GCY |
| Vacuum pressure | -60 to -350 mmHg | -51 to -483 mmHg | 0 to -675mmHg |
| Use setting | Home and health care environment | Homecare and healthcare environments | Home and in-patient (based on literature) |
| | | | |
| Indication for
use | 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.
lt is intended for use
in homecare and
healthcare
environments. | The Easy Go
Aspirator provides a
portable, AC/DC
powered medical
vacuum source. It is
intended for use in
the home
care/healthcare
environments. | The intended use for
Redyrob is a vacuum
source/waste
container utilized for
post-operative
wound drainage. The
indications for use
for the device are to
drain blood and
secretions from
wounds and body
cavities for
hematoma and
seroma prophylaxis
and for the removal
of serosanguineous
fluid and other
harmful liquids. |
| Waste
Collection
Capacity | 50mL/drain
100 mL total
(disposable waste
collection units) | 800mL | 600mL |
| Flow @ Max
Vacuum | 1.0 mL/min | 13 L/min | Unknown |
| Electrical | 3VDC
2xAA alkaline
batteries (series
connection) | 100-240VAC
13.7VDC | Not Powered |
| Weight | 300 gram w/batteries | 11lbs (shipping) | Unknown |
| Electrical
Equipment
Classification | Class II
Type BF
IP(22) | Class II
Type BF
IP(unknown) | Not Applicable |
| Transport | Portable, wearable
Delivered in a belt to
be worn by the
patient | Portable
Too large to be
attached to the body | Portable
Fastening strap
provided for
attachment |
| Mode of
operation | Non-continuous,
intermittent,
controlled by vacuum
pressure and the
amount of exudate | Non-continuous
(15 minute intervals) | Non Continuous
(waste collection
portion must be
emptied and
replaced) |
5
Summary of non-clinical tests conducted for determination of substantial equivalence
6
The SOMAVAC™ Device complies with voluntary standards for electrical safety, electromagnetic compatibility, and powered suction pumps. The following data were provided in support of the substantial equivalence determination:
- Risk Analysis was developed in accordance with ISO 14971:2012. o
- Software verification and validation testing were conducted and documentation was provided as o recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain or engorgement.
- Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (Third Edition) o + CORR. 1:2006 + CORR. 2:2007 + A1:2012 with US deviations per ANSI/AAMI ES60601-1:2005 + A1:2012, C1:2009 and A2:2010, IEC 60601-1-2:2014, EN 60601-1-11 (First Edition): 2010, and IEC/EN 60529: 2013, (IP22) standards.
- Biocompatibility has been evaluated per ISO 10993:2009. o
- Vacuum and flow measurements: Performance testing to determine the vacuum levels and flow о of the pump as compared to its specifications.
- Verification of operating times: The operating times were checked with different pump loads with o the recommended battery type. The dependency was checked at worst-case fluid output and fluid-viscosity setting. The correct function of the battery-low indication was also confirmed.
- Confirmation of the endurance runtime of the SOMAVAC™ Device was performed based on the o lifetime of the mechanical pump and the fatigue life of components subject to repeated loading, and supported with the average number of hours needed clinically.
Summary of tests conducted for determination of substantial equivalence
Clinical testing was not required to demonstrate the substantial equivalence of the SOMAVAC™ Device to its predicate device(s). Clinical literature has been evaluated to support the range of vacuum pressures available for clinicians to prescribe.
Conclusions Drawn
The intended use and indications for use of the subject devices are substantially equivalent to the predicate devices. The differences between the SOMAVAC™ Device and its predicate 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 differences and that the device performs as intended.
From the results of nonclinical testing described, SOMAVAC™ Medical concludes that the SOMAVAC™ Device is substantially equivalent to the legally marketed predicate devices.