Genadyne XLR8 White Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound therapy to the wound. Genadyne A4-XLR8 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.

XLR8 White 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

The Genadyne XLR8 White Foam Dressing Kit is a Rx only device.

Device Description

The Genadyne XLR8 White Foam Kit consists of a XLR8 Port, XLR8 Transparent Film and a XLR8 White Foam. Each component are packaged, sealed and sterilized individually and then bagged.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device and includes summaries of non-clinical tests. However, it does not contain the kind of detailed information typically found in a study proving a device meets specific clinical acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and biocompatibility/bench testing. It does not describe a study involving human patients or AI algorithms in the ways requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

Acceptance Criteria and Study Details

A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or reported device performance in terms of clinical outcomes (e.g., wound healing rates, infection reduction) against specific numerical targets. The "Acceptance Criteria" mentioned for non-clinical tests are qualitative (e.g., "not considered to have a cytotoxic effect," "meets the requirements of the ISO 10993-10 guidelines," "performs up to the acceptability criteria").

Acceptance Criterion (Non-Clinical)	Reported Device Performance (Non-Clinical)
ISO 10993-5 Cytotoxicity Test	"not considered to have a cytotoxic effect."
ISO 10993-10 Kligman Maximization	"Grade 1 reaction" and "classified as having weak allergenic potential." "Grade 1 sensitization rate is not considered significant and the test article meets the requirements of the ISO 10993-10 guidelines."
ISO 10993-10 Intracutaneous	"test article sites did not show a significantly greater biological reaction than the sites injected with the control article." "the test article meets the requirements of the ISO 10993-10 guidelines."
Bench Tests for Performance	"dressing kit components are all compatible and performs up to the acceptability criteria." (Specific numerical criteria not provided)
Stability Test	"Devices has passed and met all expectations of the stability tests in terms of bioburden, packaging, seal integrity and performance." (Specific numerical criteria/results for "expectations" not provided)

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The tests described are non-clinical (biocompatibility and bench tests), not a clinical 'test set' in the context of AI or diagnostic performance studies. The specific number of test items (e.g., foam samples) used for each non-clinical test is not provided.
- Data Provenance: Not applicable for clinical data. For the non-clinical tests, the provenance is a laboratory setting. No country of origin for clinical data is relevant here.
- Retrospective or Prospective: Not applicable as no clinical study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No clinical test set or ground truth established by experts is described. The non-clinical tests are evaluated against established laboratory protocols and standards (e.g., ISO 10993 guidelines).
Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication is described.
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

No MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. This document pertains to a wound dressing kit, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical wound dressing kit, not an algorithm, so a standalone algorithm performance study is irrelevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" or reference for passing is established by adherence to recognized international standards (e.g., ISO 10993) and pre-defined acceptance criteria within those standards.
The sample size for the training set

Not applicable. There is no AI model or algorithm described that would require a training set.
How the ground truth for the training set was established

Not applicable. As there is no AI model or training set, this question is not relevant to the provided text.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

April 30, 2015

Genadyne Biotechnologies Incorporated Mr. Chien-Ming (Andrew) Goh Vice President 16 Midland Avenue Hicksville, New York 11801

Re: K142646

Trade/Device Name: Genadyne XLR8 White Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 27, 2015 Received: March 30, 2015

Dear Mr. Goh:

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 (reporting of medical

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

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) K142646

Device Name Genadyne XLR8 White Foam Dressing Kit

Indications for Use (Describe)

Genadyne XLR8 White Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound. Genadyne A4-XLR8 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.

XLR8 White 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

Type of Use (Select one or both, as applicable)
-------------------------------------------------

For use in connection with a FEE-Only Retirement Plan	For use in connection with a FEE-Only Retirement Plan	For use in connection with a FEE-Based Retirement Plan	For use in connection with a FEE-Based Retirement Plan
For use in connection with a FEE-Only Retirement Plan
For use in connection with a FEE-Based Retirement Plan

|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510k Summary

General Information	Date: 4/29/2015
1.	Applicant	Genadyne Biotechnologies, Inc.16 Midland Ave,Hicksville, NY 11801(t) 516.487.8787(f) 516.977-8974
2.	Contact Person	Mr. Chien-Ming GOH (Andrew)Vice PresidentGenadyne Biotechnologies Inc.16 Midland Ave,Hicksville, NY 11801(t) 516.217.0101(f) 516.977.8974
3.	Trade Name	Genadyne XLR8 White Foam Dressing Kit(Ref:PVA-FOAM1)
4.	Common Name	Foam Dressing
5.	Classification Name	Negative Pressure Wound Therapy PoweredSuction Pump and Accessories
6.	Regulation Number	21 CFR 878.4780
7.	Product Code	OMP
8.	Class in which Device hasbeen placed	Class II
9.	Panel	General & Plastic Surgery
10.	Reason for PremarketNotification	New Device
11.	Identification of LegallyMarketed Device Which WeCan Claim SubstantialEquivalence (PredicateDevice)	A4-XLR8 Foam Dressing K092992
12.	Brief Description of Device	The Genadyne XLR8 White Foam Kit consists of aXLR8 Port, XLR8 Transparent Film and a XLR8White Foam. Each component are packaged,sealed and sterilized individually and then bagged

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Indications for use 13. [21 CFR 807.92(a)(5)]

XLR8 White 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

The Genadyne XLR8 White Foam Dressing Kit is a Rx only device.

14. Technological Characteristics

No.		Foam	Port Tubing	Film
1.	MaterialsUsed:	Polyvinyl AlcoholDressing	Silicone	Polyurethane
2.	Size:	20 cm x 15 cm x 1 cm15 cm x 10 cm x 1 cm7.5 cm x 10 cm x 1 cm	31 inches	26 x 30 cm

Table of Comparison to Predicate Devices:

Parameters	Predicate	New
Parameters	GenadyneA4-XLR8 Foam Dressing	GenadyneXLR8 White Foam Dressing Kit
510(k) Number	K092992	TBD
Indications for Use	Genadyne A4-XLR8 Foam Dressing isintended to be used in conjunction withthe Genadyne A4 Wound VacuumSystem (K082676) to deliver negativepressure wound therapy to the wound.	Genadyne XLR8 White Foam DressingKit is intended to be used in conjunctionwith the Genadyne A4-XLR8 WoundVacuum System (K090638) to delivernegative pressure wound therapy to the

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	Genadyne A4 Wound Vacuum System isindicated for patients who would benefitfrom a suction device, particularly as thedevice may promote wound healing bythe removal of excess exudates,infectious material and tissue debris.A4-XLR8 Foam Dressing is appropriatefor use on the followingwounds:Pressure ulcers Diabetic/Neuropathic Ulcers Venous insufficiency ulcers Traumatic wounds Post-operative and dehisced surgical wounds Skin flap and graft	wound. Genadyne A4-XLR8 WoundVacuum System is indicated for patientswho would benefit from a suction deviceparticularly as the device may promotewound healing by the removal of excessexudates, infectious material and tissuedebris.XLR8 White Foam Dressing isappropriate for use on the followingwounds: Pressure ulcers Diabetic/Neuropathic Ulcers Venous insufficiency ulcers Traumatic wounds Post-operative and dehisced surgical wounds Skin flap and grafts
Foam DressingMaterial	Flexible Polyether and PolyesterPolyurethane Foam	Polyvinyl Alcohol Dressing
Hydrophobic	Yes	Yes
Sizes:	7.5 cm X 10 cm x 3.3cm12.5 cm x 18 cm x 3.3 cm15 cm x 26 cm x 3.3 cm	20 cm x 15 cm x 1 cm15 cm x 10 cm x 1 cm7.5 cm x 10 cm x 1 cm
For use with NegativePressure WoundTherapy Systems	Yes	Yes
Sterile	Yes	Yes
Sterilization Method	EO	Gamma Radiation for White Foam, EOfor Silicone Port and Transparent Film
Kit Content	Silicone TubingTransparent Adhesive Film	Silicone PortTransparent Adhesive Film

15. Summary of Non clinical Tests

Device	Tests	Rationale
XLR8 White FoamKit	ISO 10993-5L929 Neutral RedUptakeCytotoxicity Test	Based on the criteria of the protocol and the ISO10993-5 Guidelines, the test article meets therequirements of the tests and s not considered tohave a cytotoxic effect.
	ISO 10993-10KligmanMaximization Test	Based on the defined scoring system of Kligman,this is a Grade 1 reaction and the test article isclassified as having weak allergenic potential. AGrade 1 sensitization rate is not consideredsignificant and the test article meets therequirements of the ISO 10993-10 guidelines.
	ISO 10993-10IntracutaneousInjection Test	The test article sites did not show a significantlygreater biological reaction than the sites injectedwith the control article. Based on the criteria of theprotocol, the test article meets the requirementsof the ISO 10993-10 guidelines.
	Bench Tests forPerformance	Results from the bench test shows that thedressing kit components are all compatible and

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Evaluation	performs up to the acceptability criteria.
Stability Test	Stability tests was performed on our foams andcomponents with 2 year accelerated aging andcontinuous real time. Devices has passed and metall expectations of the stability tests in terms ofbioburden, packaging, seal integrity andperformance.

Conclusion & 16. Determination of Substantial Equivalence
Based on the information presented above, it is concluded that the XLR8 White Foam Dressing Kit is substantially equivalent to the predicate devices and is safe and effective to be used together with a negative pressure wound therapy device.

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.