(273 days)
No
The device description and performance studies focus solely on the physical properties and performance of a foam wound dressing kit used in conjunction with a separate wound vacuum system. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
This device is indicated to promote wound healing, which is a therapeutic purpose.
No
The device is a foam dressing kit used for negative pressure wound therapy, which promotes healing by removing exudates and debris. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "Foam Dressing Kit" made of physical materials (reticulated flexible polyether and polyurethane hydrophobic foam) and is a single-use dressing housed in a pouch. This indicates it is a physical medical device, not software-only.
Based on the provided information, the Kevo NPWT- αHemo30 Foam Dressing Kit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in conjunction with a wound vacuum system to deliver negative pressure wound therapy to wounds. This is a therapeutic application, not a diagnostic one.
- Mechanism of Action: The device works by promoting wound healing through the removal of excess exudates, infectious material, and tissue debris. This is a physical process applied to the wound itself, not an analysis of biological samples outside the body.
- Device Description: The description details a foam dressing, which is a physical component applied to the wound.
- Performance Studies: The performance studies focus on the physical properties and function of the dressing in a simulated wound environment (e.g., dimensions, suction pressure, fluid removal rates, foam comparisons). These are not studies related to the analysis of biological samples for diagnostic purposes.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Kevo NPWT- αHemo30 Foam Dressing Kit does not perform this function.
N/A
Intended Use / Indications for Use
Kevo NPWT- αHemo30 Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- αHemo30 Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
Kevo NPWT - αHemo30 Foam Dressing Kit is appropriate for use on the following wounds:
- Pressure Ulcers
- Diabetic/Neuropathic Ulcers .
- Venous Insufficiency Ulcers .
- Traumatic Wounds .
- Post-Operative and Dehisced Surgical Wounds .
- Skin Flaps and Grafts .
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Kevo NPWT- α.Hemo30 Foam Dressing Kit is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO.
The Kevo NPWT- αHemo30 Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large:
Small: 100mm x 80mm x 30mm Medium: 125mm x 190mm x 30mm Large: 150mm x 250mm x 30mm
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
Acute, Extended and Home Care Settings by Healthcare Professionals
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)
Overview Of Comparative Bench Tests
To ensure that the Kevo NPWT- aHemo30 Foam Dressing Kit is substantially equivalent to the Genadyne A4-XLR8 Foam Dressing Kit, Kevo collected data on 3 different conditions during the bench test to demonstrate that under a vacuum environment and at different set levels of negative vacuum pressure, the foam performed exactly as expected and there were no unexpected outcomes during the tests.
The following bench tests were conducted:
- Dimensions were recorded before and after the 72 hour bench test. The results demonstrated after undergoing long periods of suction pressures both predicate and Kevo dressings appeared unchanged.
- Suction pressures were recorded to determine the variation in suction pressures between the Kevo NPWT- αHemo30 Foam Dressing Kit and the Genadyne A4-XLR8 Foam Dressing Kit. It was determined that the difference in suction pressures between the two dressings is Bacterial Endotoxins Test, Guidelines on Validation of the Limulus Amebocyte Lysate Test as an End-Product
- ISO 10993 -1 Rabbit Pyrogen Test .
- ISO11137-1:2006 Sterilization of Health Care Products Radiation Part 1: - Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices with Sponsor Specifications.
- ISO 11737-1 2006: Sterilization of Health Care Products Microbiological ◆ Methods - Part 1: Determination of the Population of Microorganism on Products
- ANSI/AAMI/ISO 11737-2:1998 Sterilization of Medical Devices -Microbiological Methods - Part 2 - Test of Sterility Performed in the Validation of a Sterilization Process.
- USP 32 NF, 2009 Sterility Tests
- ISO 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories
- ASTM F1980-07 Guide for Accelerated Aging of Sterile Medical Devices
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.
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
KII3199
page 1/4
510(k) Summary 807.92(c)
JUL 3 0 2012
SPONSOR
Company Name:
807.92(a)(1)
807.92(a)(2)
Kevo Medical Supplies
Company Address:
Telephone: Fax:
734.274.0020
Dr. John Nanos
3588 Plymouth Rd.
Ann Arbor, MI 48105
734.327.0626
Contact Person:
July 22ND, 2012 Summary Preparation Date:
DEVICE NAME
Trade Name: Common/Usual Name: Classification Name:
Regulation Number: Product Code: Device Class: Panel:
Kevo NPWT- αHemo30 Foam Dressing Kit Foam Dressing Negative Pressure Wound Therapy Powered Suction Pump and Accessories 21 CFR 878.4780 OMP Class II General & Plastic Surgery
PREDICATE DEVICE
| PREDICATE DEVICE | 807.92(a)(3) | |
|---|---|---|
| Company | Brand Name | 510(k) Number |
| Genadyne Biotechnologies, Inc. | A4-XLR8 Foam | |
| Dressing | K092992 |
DEVICE DESCRIPTION
807.92(a)(4)
The Kevo NPWT- α.Hemo30 Foam Dressing Kit is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO.
The Kevo NPWT- αHemo30 Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large:
Small: 100mm x 80mm x 30mm Medium: 125mm x 190mm x 30mm Large: 150mm x 250mm x 30mm
1
DEVICE INTENDED USE
807.92(a)(5)
Kevo NPWT- cHemo30 Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative
pressure wound therapy to the wound. Kevo NPWT- αHemo30 Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
Kevo NPWT - αHemo30 Foam Dressing Kit is appropriate for use on the following wounds:
- · Pressure Ulcers
- Diabetic/Neuropathic Ulcers .
- Venous Insufficiency Ulcers .
- Traumatic Wounds .
- . Post-Operative and Dehisced Surgical Wounds
- · Skin Flaps and Grafts
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
PREDICATE PRODUCT COMPARISON TABLE 807.92(a)(6)
| Parameters | Kevo Medical Supplies,
Inc. | Genadyne
Biotechnologies, Inc.
K092992 |
|-----------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 510(k) | | |
| Foam Dressing
Composition | Reticulated flexible polyether
based polyurethane foam | Reticulated flexible polyether
based polyurethane foam |
| Foam Dressing Code | Identical (A30M) | Identical (A30M) |
| Foam Manufacturer | Crest Foam Industries | Crest Foam Industries |
| Foam Converter/Kitter | Keystone Solutions Group | Keystone Solutions Group |
| Processing and
Sterilization Methods | Identical | Identical |
| Hydrophobic | Yes | Yes |
| Sizes | Small, Medium, Large | Small, Medium, Large |
| For use with negative
pressure wound therapy
(NPWT) | Yes | Yes |
| Sterile | Yes | Yes |
| By Prescription Only | Yes | Yes |
| Use Environment | Acute, Extended and Home
Care Settings by Healthcare
Professionals | Acute, Extended and Home
Care Settings by Healthcare
Professionals |
2
KII3199
CLINICAL AND NONCLINICAL TESTS
807.92(b)
Overview Of Comparative Bench Tests
To ensure that the Kevo NPWT- aHemo30 Foam Dressing Kit is substantially equivalent to the Genadyne A4-XLR8 Foam Dressing Kit, Kevo collected data on 3 different conditions during the bench test to demonstrate that under a vacuum environment and at different set levels of negative vacuum pressure, the foam performed exactly as expected and there were no unexpected outcomes during the tests.
The following bench tests were conducted:
-
- Dimensions were recorded before and after the 72 hour bench test. The results demonstrated after undergoing long periods of suction pressures both predicate and Kevo dressings appeared unchanged.
-
- Suction pressures were recorded to determine the variation in suction pressures between the Kevo NPWT- αHemo30 Foam Dressing Kit and the Genadyne A4-XLR8 Foam Dressing Kit. It was determined that the difference in suction pressures between the two dressings is Bacterial Endotoxins Test, Guidelines on Validation of the Limulus Amebocyte Lysate Test as an End-Product
- ISO 10993 -1 Rabbit Pyrogen Test .
- ISO11137-1:2006 Sterilization of Health Care Products Radiation Part 1: - Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices with Sponsor Specifications.
- ISO 11737-1 2006: Sterilization of Health Care Products Microbiological ◆ Methods - Part 1: Determination of the Population of Microorganism on Products
- ANSI/AAMI/ISO 11737-2:1998 Sterilization of Medical Devices -Microbiological Methods - Part 2 - Test of Sterility Performed in the Validation of a Sterilization Process.
- USP 32 NF, 2009 Sterility Tests
- ISO 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories
- . ASTM F1980-07 Guide for Accelerated Aging of Sterile Medical Devices
SUBSTANTIAL EQUIVALENCE
807.92(b)(3)
In establishing substantial equivalence to the predicate device, Genadyne A4-XLR8 Foam Dressing Kit, Kevo Medical evaluated the indications for use, material, technology, and product specifications for the product. Performance testing has been completed to demonstrate the substantial equivalence of the Kevo NPWT- aHemo30 Foam Dressing Kit for its indications for use.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 30 2012
Kevo Medical Supplies % Smith Associates Mr. E.J. Smith Consultant 1468 Harwell Avenue Crofton, Maryland 21114
Re: K113199
Trade/Device Name: The Kevo NPWT-aHemo30 Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered sunction pump Regulatory Class: Class II Product Code: OMP Dated: June 18, 2012 Received: June 18, 2012
Dear Mr. Smith:
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
5
Page 2 - Mr. E.J. Smith
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
Indications for Use
510(k) Number (if known): K113199
Device Name: The Kevo NPWT- «Hemo30 Foam Dressing Kit
Manufactured For: Kevo Medical Supplies 3588 Plymouth Rd. Ann Arbor, MI 48105
Indications for Use:
Kevo NPWT- αHemo30 Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- αHemo30 Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
Kevo NPWT - aHemo30 Foam Dressing Kit is appropriate for use on the following wounds:
- Pressure Ulcers .
- Diabetic/Neuropathic Ulcers .
- Venous Insufficiency Ulcers .
- Traumatic Wounds .
- Post-Operative and Dehisced Surgical Wounds .
- Skin Flaps and Grafts .
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Prescription Use V (Part 21 CFR 801 Subpart D) 'AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daiel Keene form
(Division Sign-Off)
Page 1 of of
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K113199