(85 days)
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.
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.
The SOMAVAC™ Device, a portable battery-powered vacuum source/waste container for surgical and bodily fluid removal, underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly provide a table of acceptance criteria with corresponding reported device performance values in a side-by-side format. However, it lists several non-clinical tests conducted, implying that the device met the specifications and standards targeted by these tests. Based on the "Summary of non-clinical tests conducted for determination of substantial equivalence" section (page 6), the following can be inferred:
| Acceptance Criterion (Inferred from Test) | Reported Device Performance |
|---|---|
| Compliance with ISO 14971:2012 for Risk Analysis | Risk Analysis was developed in accordance with ISO 14971:2012. |
| Software Verification and Validation (moderate level of concern) | Software verification and validation testing were conducted; compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern. |
| Electrical Safety (IEC 60601-1:2005, ANSI/AAMI ES60601-1:2005, etc.) | 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 (ISO 10993:2009) | Biocompatibility has been evaluated per ISO 10993:2009. |
| Vacuum and Flow Measurements | Performance testing to determine the vacuum levels (-60 to -350 mmHg) and flow (1.0 mL/min @ Max Vacuum) of the pump as compared to its specifications was performed. |
| Verification of Operating Times with various pump loads and battery | Operating times were checked with different pump loads and the recommended battery type. Dependency was checked at worst-case fluid output and fluid-viscosity. Correct function of battery-low indication was confirmed. |
| Endurance Runtime (mechanical pump lifetime, component fatigue life) | Endurance runtime was performed based on the lifetime of the mechanical pump and fatigue life of components subject to repeated loading, supported by average clinical hours. |
| Manufacturing Quality Standards | Not explicitly detailed in performance but referred to as general controls provisions, including good manufacturing practice requirements (21 CFR Part 820). |
2. Sample Size Used for the Test Set and Data Provenance:
The study relies primarily on non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or samples from a typical clinical study is not applicable. The samples used would be:
- Physical units of the SOMAVAC™ Device and its components for performance, electrical safety, and endurance testing.
- Materials used in the device for biocompatibility testing.
- Software code for verification and validation.
Data Provenance: The tests are described as non-clinical tests. The country of origin for these tests is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. regulatory standards and potentially U.S. or internationally accredited testing laboratories. All tests are inherently retrospective in the sense that they evaluate manufactured device units against established specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable as the determination of substantial equivalence was based on non-clinical engineering and bench testing, not on clinical assessment requiring expert interpretation of patient data or images to establish a "ground truth."
4. Adjudication Method for the Test Set:
This information is not applicable as there was no clinical study involving human judgment or interpretation of data that would require an adjudication method. Test results are compared against predetermined engineering specifications and industry standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the SOMAVAC™ Device to its predicate device(s)." This type of study would involve human readers (e.g., clinicians) evaluating cases with and without AI assistance, which is not relevant for this device.
6. Standalone Performance Study:
A standalone performance study in the context of typical AI device evaluation (algorithm only without human-in-the-loop performance using patient data) was not performed. The device is a physical medical device, not an AI diagnostic algorithm. The "standalone" performance described here relates to the device's technical specifications and functionality (e.g., vacuum, flow, battery life) as measured in a lab setting without human intervention beyond operating the test equipment.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests constitutes:
- Engineering Specifications: The design specifications the device was intended to meet (e.g., target vacuum pressure range, flow rate, battery operating times).
- Voluntary Standards: Established international and national standards for medical devices (e.g., ISO 14971, IEC 60601-1, ISO 10993).
- FDA Guidance Documents: Recommendations from FDA for software and other aspects.
8. Sample Size for the Training Set:
This information is not applicable. The SOMAVAC™ Device is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable because there is no training set for this device.
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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
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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
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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) |
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Traditional 510(k) Notification Summary
| Name | SOMAVAC Medical Solutions, Inc. |
|---|---|
| Address | 20 South Dudley Street, Suite 100Memphis, TN 38103 |
| Phone Number | (901) 664 6370 |
| EstablishmentRegistrationNumber | N/A |
| Name of ContactPerson | Dawn N. Norman, Regulatory ConsultantMRC-X, LLC |
| Name of the Device | |
| Trade ProprietaryName | SOMAVAC™ Device |
| Common name | Pump, Portable, Aspiration (Manual Or Powered) |
| Classificationname | Powered suction pumpApparatus, suction, single patient use, portable |
| ClassificationPanel | 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) |
| DeviceDescription | The single-patient use SOMAVAC™ Device is capable of generatingsustained vacuum at the end two surgical drains to effectively removebodily fluids after plastic or general surgeries. The SOMAVAC™ Devicehas a battery-powered SOMAVAC™ Pump assembly to generatevacuum with accessories, including disposable collection units, two drainconnectors, and one belt. All products are non-sterile. Surgical drains arenot included. The SOMAVAC™ device is compatible with non-collapsible, open channel (proximal), smooth bore drains with a distalinner diameter of 3mm - 4.5mm (commonly 15 – 19 Fr.). Up to two drainscan be attached to the SOMAVAC™ Device. Each disposable wastecollection units collects up to 100 mL of fluid. Versions of the device willbe marketed with factory-set single, vacuum pressure levels ranging from60 to 350mmHg. |
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| The device maintains suction throughout its use in a manner analogousto a thermostat by selectively running the pump motors to maintain thepreset pressure. The device stops when the collection units are full or ifthe collection units are detached from the device. SOMAVAC™ Pumpassembly has light and sound indicators to help users identify when thecollection unit is full and ready to be exchanged, the battery is ready to bechanged, or if there is a malfunction. | |
|---|---|
| Indications forUse | The SOMAVAC™ Device is a portable battery powered vacuum source /waste container intended for the removal of surgical and bodily fluids froma closed wound following plastic surgery and other general surgeryforming large flaps for hematoma and seroma prophylaxis. It is intendedfor 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 PredicateEasy Go VacAspirator (K140179) | ReferencePredicateRedyrob, ClosedWound DrainageSystem(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 foruse | The SOMAVAC™Device is a portablebattery poweredvacuum source /waste containerintended for theremoval of surgicaland bodily fluids froma closed woundfollowing plasticsurgery and othergeneral surgeryforming large flaps forhematoma andseroma prophylaxis.lt is intended for usein homecare andhealthcareenvironments. | The Easy GoAspirator provides aportable, AC/DCpowered medicalvacuum source. It isintended for use inthe homecare/healthcareenvironments. | The intended use forRedyrob is a vacuumsource/wastecontainer utilized forpost-operativewound drainage. Theindications for usefor the device are todrain blood andsecretions fromwounds and bodycavities forhematoma andseroma prophylaxisand for the removalof serosanguineousfluid and otherharmful liquids. |
| WasteCollectionCapacity | 50mL/drain100 mL total(disposable wastecollection units) | 800mL | 600mL |
| Flow @ MaxVacuum | 1.0 mL/min | 13 L/min | Unknown |
| Electrical | 3VDC2xAA alkalinebatteries (seriesconnection) | 100-240VAC13.7VDC | Not Powered |
| Weight | 300 gram w/batteries | 11lbs (shipping) | Unknown |
| ElectricalEquipmentClassification | Class IIType BFIP(22) | Class IIType BFIP(unknown) | Not Applicable |
| Transport | Portable, wearableDelivered in a belt tobe worn by thepatient | PortableToo large to beattached to the body | PortableFastening strapprovided forattachment |
| Mode ofoperation | Non-continuous,intermittent,controlled by vacuumpressure and theamount of exudate | Non-continuous(15 minute intervals) | Non Continuous(waste collectionportion must beemptied andreplaced) |
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Summary of non-clinical tests conducted for determination of substantial equivalence
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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.
§ 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.