Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

A4-XLR8 Foam Dressing 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 flap and grafts

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

Device Description

Genadyne A4-XLR8 Foam Dressing 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.

Genadyne A4-XLR8 Foam Dressing is available in three sizes; 1) small, 2) medium and 3) large.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Genadyne A4-XLR8 Foam Dressing:

The document provided is a 510(k) Summary for a medical device called the "A4-XLR8 Foam Dressing." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy from scratch. Therefore, the "acceptance criteria" and "study" described are often focused on showing that the new device performs comparably to the predicate device, especially in terms of safety and basic functionality relevant to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance (Results)
L929 MEM Elution Test (ISO 10993-5)	Non-cytotoxic, meets ISO 10993-5 requirements.
L929 MEM Elution Test (ISO 10993-10)	Non-cytotoxic, meets ISO 10993-5 (likely a typo, should be ISO 10993-10) requirements.
Kligman Maximization Test (ISO 10993-10)	Grade I sensitization rate (not significant), meets ISO 10993-10 requirements.
Intracutaneous Injection Test (ISO 10993-10)	Negligible irritant, meets ISO 10993-10 requirements.
Kinetic Limulus Amebocyte Lysate Test (LAL) (USP 32, NF 27:2009)	Contains 0.00689 EU/mL. Correlation coefficient for linear regression was -0.999.
Inhibition and Enhancement Testing, LAL Kinetic Method (USP 32, NF 27:2009)	No inhibition or enhancement present. Correlation coefficient for linear regression was -0.999 (standard), -0.996 (sample 1), -0.997 (sample 2), -0.998 (sample 3).
Bacteriostasis & Fungistasis / Direct Transfer (USP 32, NF 27:2009)	Non-bacteriostatic and non-fungistatic.
Bioburden Validation – Exhaustive Recovery (ANSI/AAMI/ISO 11737-1:2006)	100% recovery, recovery factor 1.
Accelerated Aging (ASTM F1980-07)	4-months of real-time testing completed (at time of filing).
Residual EtO, ECh, and EG (ISO 10993-10)	Ethylene Oxide: Not Detected. Ethylene Chlorohydrin: Not Detected. Ethylene Glycol: 1.18mg, 1.71mg, 1.43mg, 1.65mg, 1.34mg, 1.31mg.
Comparative Bench Test: Dimensions (before/after 72h suction)	Both dressings (subject & predicate) appeared unchanged.
Comparative Bench Test: Suction Pressures	Difference in suction pressures between devices: ± 5mmHg. Pressure distribution uniform across both dressings.
Comparative Bench Test: Fluid Removal Rates (using plasma over 72h continuous suction)	Fluid removal rate found to be substantially equivalent.

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

The provided text describes bench testing rather than clinical testing with human subjects.

Sample Size for Bench Testing:
- For the comparative bench test, the exact number of units of each dressing (Genadyne A4-XLR8 Foam Dressing and Smith & Nephew Renasys F NPWT Foam Dressing) tested is not explicitly stated. It mentions "Genadyne collected data on 3 different conditions," which likely implies multiple measurements or samples for each condition. Without a specific number, it is inferred to be a sufficient sample size for engineering bench testing.
Data Provenance: The comparative bench test was an in-house study conducted by Genadyne Biotechnologies, Inc. This indicates it was done by the manufacturer, likely in a controlled laboratory setting. No specific country of origin for the data is mentioned beyond "in-house," but the company is located in Great Neck, NY, USA. The nature of the tests (bench tests) means they are prospective experiments designed to evaluate specific physical and chemical properties.

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

This section is not applicable to this submission. The tests performed are primarily laboratory-based (biocompatibility, chemical residues, physical performance under vacuum). These types of tests establish "ground truth" through adherence to recognized standards (ISO, USP, ASTM) and objective measurements, not through expert human interpretation of medical data (like imaging or pathology).

4. Adjudication Method for the Test Set

This section is not applicable. Since the tests are objective measurements against defined standards or direct comparisons of physical properties (e.g., measuring dimensions, pressure, fluid volume), there is no need for expert adjudication in the way it would be used for clinical interpretations or subjective assessments.

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

This section is not applicable. The device being reviewed is a foam dressing for negative pressure wound therapy, not an AI or imaging diagnostic or assistive device. Therefore, an MRMC study is irrelevant to this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical medical dressing, not an algorithm or an AI system. "Standalone performance" in this context would refer to the dressing's intrinsic properties and performance characteristics as measured in bench tests, which are covered extensively in item 1.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed can be categorized as:

Objective Measurement against Standards: For biocompatibility tests (L929 MEM Elution, Kligman Maximization, Intracutaneous Injection), endotoxin tests (LAL), sterility-related tests (Bacteriostasis & Fungistasis, Bioburden Validation), and material property tests (Residual EtO/ECh/EG), the ground truth is established by adherence to specified international (ISO) and national (USP, ANSI/AAMI) standards, with results being quantitative measurements or qualitative assessments of compliance.
Direct Comparative Measurement: For the "Comparative Bench Test," the ground truth is the directly measured performance of the predicate device (Smith & Nephew Renasys F NPWT Foam Dressing Kit). The subject device's performance is then compared to this benchmark to demonstrate "substantial equivalence." This involves objective measurements of dimensions, suction pressures, and fluid removal rates.

8. The Sample Size for the Training Set

This section is not applicable. The device is a passive medical device, not an AI or machine learning system that requires a "training set."

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

This section is not applicable, as there is no training set for this type of device.

Summary

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092992
pg. 1 of 4

510(k) Summary 807.92(c)

JUN 2 9 2010

SPONSOR

807.92(a)(1) Genadyne Biotechnologies, Inc.

Company Name:

Company Address

65 Watermill Lane Great Neck, NY 11021

Telephone: Fax:

800.208.2025 516.487.7878

Contact Person:

Chien-Ming Goh

Summary Preparation Date: June 17, 2010

DEVICE NAME

807.92(a)(2)

Trade Name:	A4-XLR8 Foam Dressing
Common/Usual Name:	Foam Dressing
Classification Name:	Negative Pressure Wound Therapy Powered
	Suction Pump and Accessories
Regulation Number:	21 CFR 878.4780
Product Code:	OMP
Device Class:	Class II
Panel:	General & Plastic Surgery

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device 510(k) # Company Product RenasysTM-F NPWT Foam Dressing K082211 Smith & Nephew, Inc.

DEVICE DESCRIPTION

807.92(a)(4)

Genadyne A4-XLR8 Foam Dressing is available in three sizes; 1) small, 2) medium and 3) large.

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DEVICE INTENDED USE

807.92(a)(5)

A4-XLR8 Foam Dressing is appropriate for use on the following wounds:

Pressure ulcers .
Diabetic/Neuropathic Ulcers .
Venous insufficiency ulcers ●
Traumatic wounds ●
Post-operative and dehisced surgical wounds ●
Comparative Bench ●

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

NONCLINICAL AND CLINICAL TEST

807.92(b)

Test	Standard	Results
L929 MEM Elution Test- ISO	ISO 10993-5	Reticulated PE/PU, isconsidered non-cytotoxicand meets the requirementsof the Elution Test definedin ISO 10993-5 guidelines.
L929 MEM Elution Test- ISO	ISO 10993-5	Reticulated PE/PU, isconsidered non-cytotoxicand meets the requirementsof the Elution Test definedin ISO 10993-5 guidelines.
L929 MEM Elution Test- ISO	ISO 10993-10	Reticulated PE/PU, isconsidered non-cytotoxicand meets the requirementsof the Elution Test definedin ISO 10993-5 guidelines.
Kligman MaximizationTest - ISO	ISO 10993-10	Based on the criteria of theprotocol, a Grade Isensitization rate is notconsidered significant andthe test article meets therequirements of the ISO10993-10 guidelines.
Intracutaneous InjectionTest - ISO	ISO 10993-10	Based on the criteria of theprotocol, the test article isconsidered a negligibleirritant and meets the
Kinetic LimulusAmebocyte Lysate Test(LAL)	USP 32, NF 27:2009	requirements of the ISO 10993-10 guidelines.The test article contains 0.00689 EU/mL. The correlation coefficient for the linear regression was calculated to be -0.999.
Inhibition andEnhancement Testing,LAL Kinetic Method	USP 32, NF 27:2009	The correlation coefficient for the linear regression was calculated to be -0.999 for standard curve, -0.996 for sample 1 and -0.997 for sample 2 and -0.998 for sample 3. There was no inhibition or enhancement present in the test article.
Bacteriostasis &Fungistasis / DirectTransfer	USP 32, NF 27:2009	The test article is considered non-bacteriostatic and non-fungistatic, according to the USP guidelines.
Bioburden Validation –Exhaustive Recovery	ANSI/AAMI/ISO 11737-1:2006	The percent recovery was 100% and the recovery factor was 1 using the exhaustive recovery method.
Accelerated Aging	ASTM F1980-07	At the time of this filing 4-months of real-time testing has been completed
Residual EtO, ECh, andEG	ISO 10993-10	Ethylene Oxide – Not Detected Ethylene Chlorohydrin - Not Detected Ethylene Glycol - 1.18 mg, 1.71 mg, 1.43 mg, 1,65 mg, 1.34 mg, 1.31 mg
Comparative BenchTesting of Subject DeviceVs Predicate Device	In-house	Based on the comparative bench test it was established that the A4-XLR8 Foam Dressing Kit is substantially equivalent to the Renasys F NPWT Dressing Kit *

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*OVERVIEW OF COMPARATIVE BENCH TEST

To ensure that the Genadyne A4-XLR8 Foam Dressing Kit is substantially equivalent to the Smith and Nephew Renasys F NPWT Foam Dressing Kit, Genadyne collected data on 3 different conditions during the bench test to demonstrate that under a vacuum environment and at different set levels of vacuum pressure, the foam performed exactly as expected and there were no unexpected outcomes during the tests.

The following tests were conducted:

1. Dimensions were recorded before and after the 72 hours bench test. The results demonstrated after undergoing long periods of suction pressures both dressings appeared unchanged.
1. Suction pressures were recorded to determine the variation in suction pressures between the Genadyne A4Foam Dressing and the Smith & Nephew Foam. It was determined that the difference in suction pressures between the two dressings is ± 5mmHg. It was also noted that pressure distribution appeared to be uniform across both dressings.
1. Fluid removal rates were recorded to determine the wound exudate removal rate between the Genadyne A4 Foam Dressing and the Smith & Nephew Foam Dressing using plasma to simulate wound exudate. Suction was continuous for the entire 72 hour study. Fluid removal rate was found to be substantially equivalent.

SUBSTANTIAL EQUIVALENCE

807.92(b)(3)

In establishing substantial equivalence to the predicate device, Genadyne Biotechnologies evaluated the indications for use, material, technology, and product specifications of the product. Performance testing has been completed to demonstrate the substantial equivalence of the Genadyne A4-XLR8 Foam Dressing 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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Genadyne Biotechnologies, Inc. % Smith Associates E.J. Smith 1468 Harwell Avenue Crofton, Maryland 21114

JUN 2 9 2010

Re: K092992

Trade/Device Name: A4-XLR8 Foam Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: A4-XLR8 Foam Dressing Regulatory Class: II Product Code: OMP Dated: June 1, 2010 Received: June 1, 2010

Dear E.J. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

{5}------------------------------------------------

Page 2 - E.J. Smith

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/ReportaProblem/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.

Sincerely yours.

Mark N. Melkerson Director

Enclosure

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: A4-XLR8 Foam Dressing

Indications for Use:

Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote would healing by the removal of excess exudates, infectious material and tissue debris.

A4-XLR8 Foam Dressing 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 flap and grafts .

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

(Check appropriate designation below)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Consurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kraaffer MxM
(Division Sign-Off)

Division of Surgical, Orthopedic. and Restorative Devices

Page of

510(k) Number KD92992

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.