Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K09063) 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 materials and tissue debris.

Spiral 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

Device Description

Gendayne Spiro Foam Dressing Kit is a single-use dressing is housed in a Tyvek/Mylar Peel Pouch.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically a wound dressing kit. It is a regulatory submission to the FDA, not a study report detailing clinical performance or algorithm metrics. Therefore, most of your requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not present.

However, I can extract information related to non-clinical tests and the device's characteristics:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance metrics in the way you might find for a diagnostic algorithm (e.g., sensitivity/specificity thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device and confirming basic safety and functionality through non-clinical tests.

Acceptance Criteria (Stated as conformance to standards/tests)	Reported Device Performance (Summary of Test Results)
Biocompatibility: Conformance to ISO 10993 standards	Cytotoxicity (ISO 10993-5): Meets requirements, not considered cytotoxic.
	Irritation (ISO 10993-10): Meets requirements, did not show significantly greater biological reaction than control.
	Sensitization (ISO 10993-10): Grade 1 sensitization rate, classified as weak allergenic potential (not considered significant).
	Pyrogenicity (ISO 10993-11): Considered non-pyrogenic, meets requirements.
	Systemic Toxicity (ISO 10993-11): Did not induce significantly greater biological reaction than control extracts, considered negative.
Sterilization Validation: Conformance to ISO 11135	Confirms a $10^{-6}$ sterility assurance level (SAL).
Stability Test: Met protocol requirements for 2-year equivalent aging	No significant degradation of seal, no leaks (bubble test), good microbial resistance, no leaks after ship test.
Colorant Test: Determine extractable amount of chemical compounds	Few elements above reporting limit (sodium in one colorant, also in control solution). No VOCs or SVOCs attributable to test article. No additional peaks in LC chromatogram for NVOC compared to control.

2. Sample size used for the test set and the data provenance:

Not applicable. This document is a regulatory submission for a physical medical device (dressing kit), not an AI/software device that typically has a "test set" in the context of algorithm performance. The "tests" described are non-clinical, laboratory-based evaluations of materials and manufacturing processes.
The provenance of data is from laboratory tests conducted by the manufacturer or their designated testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the context of clinical expert consensus is not relevant here. The ground truth for the non-clinical tests is established by industry standards (e.g., ISO guidelines) and the objective measurements of the laboratory equipment and methods.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human reviewers assess cases. The tests performed here are objective laboratory evaluations against predefined criteria in standards.

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 device is a wound dressing kit, not an AI system. Therefore, no MRMC study or AI assistance evaluation 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, so this type of performance evaluation is irrelevant.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the established standards and protocols (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization) and the objective measurements obtained from these validated test methods.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI algorithm for this device.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

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 human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

March 26, 2015

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

Re: K141961

Trade/Device Name: Spiro Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 23, 2015 Received: February 25, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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.

Sincerely yours.

Jennifer R. Stevenson -S

For 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) K141961

Device Name Spiro Foam Dressing Kit

Indications for Use (Describe)

Spiral 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)	Transactional, Identified in a PPE Vehicle Category FilingOne-Time, Non-Transactional, PPE Vehicle Category Filing		Transactional, Identified in a PPE Vehicle Category Filing		One-Time, Non-Transactional, PPE Vehicle Category Filing
	Transactional, Identified in a PPE Vehicle Category Filing
	One-Time, Non-Transactional, PPE Vehicle Category Filing

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

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

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2014

Traditional 510k Summary

General Information		Date: July 10, 2014
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 Spiro Foam Dressing Kit(Ref: XF-SPMK1)
4.	Common Name	Foam Dressing
5.	Classification Name	Powered Suction Pump
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	Gendayne Spiro Foam Dressing Kit is a single-usedressing is housed in a Tyvek/Mylar Peel Pouch.

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

Genadyne Spiro 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 materials and tissue debris.

Spiro 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 .

No.		Foam	Port Tubing	Film
1.	MaterialsUsed:	Flexible Polyetherand PolyesterPolyurethane Foam	Silicone	Polyurethane
2.	Size:	104 +/- 1.5 cmuncoiled length x 1.9+/- .3 cm width x1.6 +/-0.15 cm height	31 inches	26 x 30 cm

14. Technological Characteristics

Table of Comparison to Predicate Devices:

	Predicate	New
Parameters	GenadyneA4-XLR8 Foam Dressing	GenadyneSpiro Foam Dressing Kit
510(k) Number	K092992
Indications for Use	Genadyne A4-XLR8 Foam DressingKits are intended to be used inconjunction with the Genadyne WoundVacuum System to deliver negativepressure to the wound. GenadyneWound Vacuum System is indicated forpatients who would benefit from asuction device particularly as the devicemay promote wound healing by the	Genadyne Spiro Foam Dressing Kit isintended to be used in conjunction withthe Genadyne A4-XLR8 WoundVacuum System (K090638) to delivernegative pressure wound therapy to thewound. Genadyne A4-XLR8 WoundVacuum System is indicated for patientswho would benefit from a suctiondevice, particularly as the device may

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	removal of excess exudates, infectiousmaterials and tissue debris.	promote wound healing by the removalof excess exudates, infectious materialsand tissue debris.
	A4-XLR8 Foam Dressing is appropriatefor use on the following wounds:• Pressure ulcers• Diabetic/Neuropathic Ulcers• Venous insufficiency ulcers• Traumatic wounds• Post-operative and dehiscedsurgical wounds• Skin flap and grafts	A4-XLR8 Foam Dressing is appropriatefor use on the following wounds:• Pressure ulcers• Diabetic/Neuropathic Ulcers• Venous insufficiency ulcers• Traumatic wounds• Post-operative and dehiscedsurgical woundsSkin flap and grafts
Foam DressingMaterial	Flexible Polyether and PolyesterPolyurethane Foam	Flexible Polyether and PolyesterPolyurethane Foam
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	104 +/- 1.5 cm uncoiled length x 1.9 +/-.3 cm width x1.6 +/-0.15 cm height
For use with NegativePressure WoundTherapy Systems	Yes	Yes
Sterile	Yes	Yes
Kit Content	Silicone TubingTransparent Adhesive Film	Silicone TubingTransparent Adhesive Film

Non Clinical Tests 15.

XLR8 Spiro Dressing Kit	Biocompatibility tests were performed on the dressing kit in accordance to ISO 10993.Report can be found in 013_Attachment_D in the RTA submission.	In Report 13-02487-G1, the green foam dressing kit meets the requirements of the test as per ISO 10993-5, and is not considered to have a cytotoxic effect.In Report 13-02487-G2, the green foam dressing kit meets the requirements of the ISO 10993-10 guidelines. It did not show a significantly greater biological reaction than the sites injected with the control article.In Report 13-02487-G3, the green foam dressing kit displayed a Grade 1 sensitization rate and based on the scoring system of Kligman as per ISO 10993-10 guidelines, it is not considered significant and is classified as having a weak allergenic potential.In Report 13-02487-G4, the green foam dressing kit is considered non-pyrogenic and meets the requirements of the Pyrogen Test, as per ISO 10993-11 guidelines.In Report 13-02487-G5, the green foam kit did not induce a significantly greater biological reaction than the control extracts, when tested in Swiss Albino mice, therefore it is considered negative based on standards set by ISO 10993-11.
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Sterilization validationwas performed inaccordance to ISO11135.Report can be found in016_Attachment I in theoriginal submission.	The sterilization activity confirms a $10^{-6}$ sterilityassurance level (SAL), by utilizing the half-cycleoverkill approach which demonstrated total inactivationof a $10^{-6}$ BI at half exposure time, on a four (4) palletload of wound vacuum dressing sets.
Stability test wasperformed and the reportcan be found in015_Attachment H in theoriginal submission.	In the stability test, we performed:-1. Accelerated aging test2. Peel test3. Bubble test4. Ship test5. Package aerosol spore challenge testAll test results shows that the packages met therequirements of the protocol for 2 year equivalentaging. No significant degradation of seal wasobserved, bubble test showed no leaks at any testpoints, microbial challenge shows good resistance andno significant degradation, and bubble test after shiptest showed no leaks.
Colorant test wasperformed on the blueand yellow colorant thatmakes the green foam.The report can be foundin 015_Attachment F.	In Report 14-04232-N1, a test to determine theextractable amount of chemical compounds fromsponsor test material was performed.In the test against metals, no elements above reportinglimit were detected in any of the colorants except forsodium in Reactint Blue X3LV. However, sodium wasalso observed in the control solution (purified water)this presence of sodium cannot be unequivocallyattributed to blue colorant.In the test against volatile organic compound (VOC),no VOC were observed in any of the colors norsamples.In the SVOC analysis of the purified water extract, noSVOC attributable to the test article were observed. NoSVOC were observed in colorant solutions.In the target NVOC analysis of purified water extracts,no target-NVOC attributable to the test article wereobserved. No NVOC were observed in the colorantsolutions.In the Non-Target NVOC in purified water extracts, noadditional peaks were observed in the LCchromatogram of samples compared to the LCchromatogram of control.

Sterilization validationwas performed inaccordance to ISO11135.Report can be found in016_Attachment I in theoriginal submission.

The sterilization activity confirms a $10^{-6}$ sterilityassurance level (SAL), by utilizing the half-cycleoverkill approach which demonstrated total inactivationof a $10^{-6}$ BI at half exposure time, on a four (4) palletload of wound vacuum dressing sets.

Stability test wasperformed and the reportcan be found in015_Attachment H in theoriginal submission.

In the stability test, we performed:-1. Accelerated aging test2. Peel test3. Bubble test4. Ship test5. Package aerosol spore challenge testAll test results shows that the packages met therequirements of the protocol for 2 year equivalentaging. No significant degradation of seal wasobserved, bubble test showed no leaks at any testpoints, microbial challenge shows good resistance andno significant degradation, and bubble test after shiptest showed no leaks.

Colorant test wasperformed on the blueand yellow colorant thatmakes the green foam.The report can be foundin 015_Attachment F.

In Report 14-04232-N1, a test to determine theextractable amount of chemical compounds fromsponsor test material was performed.In the test against metals, no elements above reportinglimit were detected in any of the colorants except forsodium in Reactint Blue X3LV. However, sodium wasalso observed in the control solution (purified water)this presence of sodium cannot be unequivocallyattributed to blue colorant.In the test against volatile organic compound (VOC),no VOC were observed in any of the colors norsamples.In the SVOC analysis of the purified water extract, noSVOC attributable to the test article were observed. NoSVOC were observed in colorant solutions.In the target NVOC analysis of purified water extracts,no target-NVOC attributable to the test article wereobserved. No NVOC were observed in the colorantsolutions.In the Non-Target NVOC in purified water extracts, noadditional peaks were observed in the LCchromatogram of samples compared to the LCchromatogram of control.

Conclusion & Based on the information presented above, it is 16. Determination of concluded that the Spiro Foam Dressing Kit is Substantial Equivalence substantially equivalent to the predicate 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.