Enivo™
Device Facts
| Record ID | K223373 |
|---|---|
| Device Name | Enivo™ |
| Applicant | Aroa Biosurgery , Ltd. |
| Product Code | BTA · General, Plastic Surgery |
| Decision Date | Apr 7, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Device Story
Enivo™ is a portable, battery-powered surgical drainage system for home and healthcare environments. It consists of a vacuum device unit and a removable silicone drainage catheter. The device provides continuous suction to remove surgical and bodily fluids from closed wounds. It is intended for hematoma and seroma prophylaxis following plastic or general surgeries where large flaps are formed. The system operates continuously for up to 30 days. Healthcare providers or patients use the device to manage post-surgical drainage, potentially reducing complications associated with fluid accumulation.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing only, including software verification/validation, electrical safety (IEC 60601-1 series), electromagnetic compatibility, biocompatibility (ISO 10993-1), vacuum pressure/flow rate performance, battery life, endurance runtime, package integrity (ASTM F1929, F2096, ISO 11607-1), seal strength (ASTM F88), bacterial filtration efficiency (ASTM F2101), sterilization (ISO 11135), bacterial endotoxins (ANSI/AAMI ST72), bioburden (ISO 11737-1), mechanical strength, and alarm system functionality.
Technological Characteristics
Powered suction pump; battery-powered vacuum unit with disposable exudate reservoir and silicone drainage catheter. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, AIM 7351731, ISO 10993-1, ISO 20697, ISO 11607-1, ISO 11135, ISO 11737-1. ASTM standards: F1929, F2096, F88/F88M, F2101, D4169. ANSI/AAMI ST72. Sterilization via ethylene oxide (EO).
Indications for Use
Indicated for patients undergoing plastic or general surgery involving large flaps; used for hematoma and seroma prophylaxis by removing surgical and bodily fluids from closed wounds.
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 (K222856)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
April 7, 2023
Aroa Biosurgery Ltd. Tina O'brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, Auckland 2022 New Zealand
# Re: K223373
Trade/Device Name: Enivo™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA, Dated: March 10, 2023 Received: March 10, 2023
# Dear Tina O'brien:
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 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
{1}------------------------------------------------
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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.04.07 13:28:45 -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 Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# K223373
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Expiration Date: 06/30/2023
See PRA Statement below.
| Indications for Use | See PRA Statement below. | | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Submission Number (if known) | K223373 | | |
| Device Name | Enivo™ | | |
| Indications for Use (Describe) | Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed. | | |
| Type of Use (Select one or both, as applicable) | <table><tr><td><span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td><td><span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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}------------------------------------------------
| | K223373 |
|-----------------------------|-----------------------------------------------------------|
| 510(k) #: K223373 | 510(k) Summary |
| | Page 1 of 2 |
| | Prepared on: 2023-04-07 |
| Contact Details | 21 CFR 807.92(a)(1) |
| Applicant Name | Aroa Biosurgery Ltd. |
| Applicant Address | 2 Kingsford Smith Place Airport Oaks AKL 2022 New Zealand |
| Applicant Contact Telephone | +64 098693035 |
| Applicant Contact | Ms. Tina O'Brien |
| Applicant Contact Email | tina.obrien@aroabio.com |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | Enivo™ |
| Common Name | Powered suction pump |
| Classification Name | Pump, Portable, Aspiration (Manual Or Powered) |
| Regulation Number | 878.4780 |
| Product Code | BTA |
Legally Marketed Predicate Devices
| | 21 CFR 807.92(a)(3) |
|-------------|----------------------------------------------------------|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) |
| K222856 | SOMAVAC Device |
| | Product Code |
| | BTA |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|----------------------------|---------------------|
|----------------------------|---------------------|
Enivo™ is a surgical drainage system intended for the removal of surgical and bodily fluids from a closed wound. The system can be used
in both home and healthcare environments.
The system includes two primary components:
- A vacuum device unit that includes a single-use, portable, and battery-powered vacuum device that provides continuous operation for
up to 30 days and a disposable exudate reservoir.
- a removable silicone drainage catheter
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
|----------------------------------|---------------------|
|----------------------------------|---------------------|
Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following
plastic surgery or other general surgeries where large flaps are formed.
| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
|--------------------------------|---------------------|
|--------------------------------|---------------------|
Enivo™ shares the same intended use and indications as the predicate.
| Technological Comparison | 21 CFR 807.92(a)(6) |
|--------------------------|---------------------|
|--------------------------|---------------------|
The predicate device uses the same fundamental technology and use configuration as Enivo™ in that it is required to a Class I drainage catheter. The differences between Enivo™ and the predicate do not introduce a new intended use and do not raise new
{4}------------------------------------------------
issues of safety and effectiveness. Bench testing has demonstrated that no new types of risk to the patent have been introduced by these differences and that the device performs as intended.
#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The Enivo™ system complies with voluntary standards for electromagnetic compatibility, and sterile drainage catheters. The following data was provided in support of the substantial equivalence determination:
- Software verification and validation testing
- Electrical safety and electromagnetic compatibility testing were conducted per IEC 60601 1:2005+AMD1:2012+AMD2:2020 with US deviations per AAM ES60601-1:2005+AMD1:2012+AMD2:2021, IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-8:2006+AMD1:2012 +AMD2:2020, IEC 60601-1-11:2015+AMD1:2020, and AIM 7351731:2017
- Biocompatibility evaluated as per ISO 10993-1:2018
- Vacuum pressure and flow rate performance testing
- Battery life testing
- Endurance runtime via simulated use testing
- Performance and safety assessed according to the applicable parts of ISO 20697:2018
- Package integrity assessed as per ASTM F1929:2015, ASTM F2096:2019, and ISO 11607-1:2019
- Package seal strength assessed as per ASTM F88/F88M:2015
- Bacterial filtration efficiency assessed as per ASTM F2101:2019
- Sterilization confirmed by assessment in accordance with ISO 11135:2018
- Bacterial endotoxins assessed as per ANSI/AAMI ST72:2019
- Bioburden (pre-EO) assessed as per ISO 11737-1:2021
- Connection leak testing
- Quantification of connection forces via uniaxial tensile and compression testing
- Mechanical strength assessed using uniaxial tensile and compression testing
- Alarm system assessed to perform as indicated in the instructions
- System performance assessed following simulated transportation testing as per ASTM D4169:2022
Clinical testing was not required to demonstrate the substantial equivalence of Enivo™ to the predicate device.
The intended use and indications for use of the substantially equivalent to the predicate device. The differences between Enivo™ and the predicate device do not intended use and do not raise new issues of safety and effectiveness. Testing demonstrated that no adverse effects have been introduced by the technological differences and that Enivo™ performs as intended.
From the results of nonclinical testing described, Aroa Biosurgery concludes that Enivo™ is substantially equivalent to the legally marketed predicate device.
