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 .

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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

AI/ML Overview

This document describes the 510(k) summary for the Kevo NPWT-αHemo30 Foam Dressing Kit. This is a medical device submission, and the "acceptance criteria" and "device performance" here refer to demonstrating substantial equivalence to a predicate device, not typical AI model performance metrics. The information is extracted and presented as requested, adapted to the nature of this submission.

Analysis of the Kevo NPWT-αHemo30 Foam Dressing Kit (K113199) Submission

The provided document describes a 510(k) submission for the Kevo NPWT-αHemo30 Foam Dressing Kit, which is a medical device and not an AI/software device. Therefore, the questions related to AI model performance, AI-assisted human reading, training sets, and expert adjudication are not directly applicable in the context of this submission.

The "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence to a predicate device, the Genadyne A4-XLR8 Foam Dressing Kit (K092992), through a series of bench tests and comparisons of physical and material properties.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrating Substantial Equivalence to Predicate)	Reported Device Performance (Kevo NPWT-αHemo30 Foam Dressing Kit)
Dimensions unchanged after 72 hours of suction pressure	Dressings appeared unchanged after undergoing long periods of suction pressures.
Variation in suction pressures to be < +/- 5mmHg compared to predicate	Difference in suction pressures between the two dressings is < +/- 5mmHg. Pressure distribution appeared uniform across both dressings.
Fluid removal rate substantially equivalent to predicate	Fluid removal rate was found to be substantially equivalent (using plasma to simulate wound exudate).
Biocompatibility compliance	Passed ISO 10993-5 L929 MEM Elution, ISO 10993-10 Intracutaneous Injection, ASTM F756-08 Hemolysis, ISO 10993-10 Kligman Maximization Tests.
Sterilization compliance	Passed ISO 10993-7 ETO residuals, USP 32 NF 27 <85> Bacterial Endotoxins, ISO 10993 -1 Rabbit Pyrogen, ISO11137-1:2006 (Radiation Sterilization), ISO 11737-1 2006 (Microorganism Population), ANSI/AAMI/ISO 11737-2:1998 (Sterility Test), USP 32 NF <71> Sterility Tests, ISO 17025:2005 (Testing/Calibration Labs), ASTM F1980-07 (Accelerated Aging).
Foam composition	Reticulated flexible polyether-based polyurethane foam (Identical to predicate).
Foam code	Identical (A30M) to predicate.
Foam manufacturer	Crest Foam Industries (Identical to predicate).
Foam converter/kitter	Keystone Solutions Group (Identical to predicate).
Processing and Sterilization methods	Identical to predicate.
Hydrophobic property	Yes (Identical to predicate).
Sizes available	Small, Medium, Large (Identical to predicate).
Use with negative pressure wound therapy (NPWT)	Yes (Identical to predicate).
Sterility	Yes (Identical to predicate).
Prescription only	Yes (Identical to predicate).
Use environment	Acute, Extended, and Home Care Settings by Healthcare Professionals (Identical to predicate).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify a precise numerical "sample size" for the foam dressings tested in the bench studies. It refers to "3 different conditions" for the core bench tests but doesn't quantify the number of dressings per condition.
Data Provenance: The data comes from prospective bench tests conducted specifically for this 510(k) submission. The country of origin for the data collection is implied to be within the US, given the submission is to the FDA from a US company (Ann Arbor, MI).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable as the ground truth for this medical device (a foam dressing) is established through objective physical and chemical bench testing, not expert interpretation of outputs like in AI/imaging studies. The "ground truth" is adherence to predefined engineering specifications and performance benchmarks compared to the predicate device.

4. Adjudication Method for the Test Set

Not applicable. As there are no human interpretations or subjective assessments requiring adjudication in these bench tests, no adjudication method was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a foam dressing, not an AI-assisted diagnostic tool. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence is based on objective physical and chemical measurements from bench testing (e.g., dimensional stability, pressure variation, fluid removal rates, biocompatibility, sterilization parameters) and direct comparison of material properties and manufacturing processes to the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for a physical device, ground truth establishment for such a set is irrelevant.

Summary

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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 FoamDressing	K092992

DEVICE DESCRIPTION

807.92(a)(4)

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

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K113199

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.	GenadyneBiotechnologies, Inc.K092992
510(k)
Foam DressingComposition	Reticulated flexible polyetherbased polyurethane foam	Reticulated flexible polyetherbased 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 andSterilization Methods	Identical	Identical
Hydrophobic	Yes	Yes
Sizes	Small, Medium, Large	Small, Medium, Large
For use with negativepressure wound therapy(NPWT)	Yes	Yes
Sterile	Yes	Yes
By Prescription Only	Yes	Yes
Use Environment	Acute, Extended and HomeCare Settings by HealthcareProfessionals	Acute, Extended and HomeCare Settings by HealthcareProfessionals

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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:

1. 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.
1. 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 <+/-5mmHg. It was also noted that the pressure distribution appeared to be uniform across both dressings.
1. Fluid removal rates were recorded to determine the wound exudate removal rate between the Kevo NPWT- αHemo30 Foam Dressing Kit and the Genadyne A4-XLR8 Foam Dressing Kit using plasma to simulate wound exudate. Suction was continuous for the entire 72 hour study. Fluid removal rate was found to be substantially equivalent.

Additional tests were performed to further validate the substantial equivalence of the Kevo NPWT- «Hemo30 Foam and the predicated Genadyne A4-XLR8 Foam during its intended use *:

1. Foam Comparisons under constant negative pressure (125mmHg) using the Genadyne A4 wound Vacuum over 72 hours.
1. Foam Comparisons under variable negative pressure (150mmHg, 0mmHg) using the Genadyne A4 wound Vacuum over 72 hours.
1. Foam Comparisons using optical measurement of cell size.

Synthetic blood O+ (code 70-016) from Carolina Biological was used as a replacement for wound exudate.

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Summary of Biocompatibility Compliance Tests 807.92(b)(2) ·

ISO 10993-5 L929 MEM Elution Test .
ISO 10993-10 Intracutaneous Injection Test .
. ASTM F756-08 Hemolysis - Rabbit Blood - ASTM Indirect Contact
ISO 10993-10 Kligman Maximization Test .

Summary of Sterilization Compliance Tests 807.92(b)(2)

ISO 10993-7 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
USP 32 NF 27, 2009 <85> 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 <71> 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.

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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

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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

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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 - 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

Regulation Number and Section

§ 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.