Cork Medical Products NPWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound.

When used in conjunction with a NPWT pump system, Cork Medical Products NPWT Wound Dressing Kit 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.

Device Description

Cork Medical Products NPWT Wound Dressing Kit is comprised of components necessary to dress a wound for negative pressure wound therapy. The kit includes reticulated, 30 pores per inch (PPI), polyether, polyurethane foam; transparent polyurethane film drape with adhesive backing; and port pad assembly comprised of silicone port pad, drainage tubing, luer connector, pinch clamp, and transparent polyurethane film drape with adhesive backing.

The kits are available in two (2) sizes: medium and large based on the size of the foam. The medium foam is: 0.75″ x 5″ x 8″. The large foam is 0.75″ x 6″ x 10″. Each kit is single-use and housed in a Tyvek peel pouch, which is sterilized using ethylene oxide.

AI/ML Overview

The provided 510(k) summary describes the Cork Medical Products NPWT Wound Dressing Kit and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device in terms of performance, biocompatibility, and intended use. The study conducted was primarily a series of nonclinical performance tests and biocompatibility assessments.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Criteria	Reported Device Performance/Conclusion
Performance	Continuous Low Negative Pressure (-40 mmHg) Test	Cork Wound Kit analyzed against predicate device, demonstrating substantial equivalence.
	Continuous Typical Negative Pressure (-125 mmHg) Test	Cork Wound Kit analyzed against predicate device, demonstrating substantial equivalence.
	Continuous High Negative Pressure (-200 mmHg) Test	Cork Wound Kit analyzed against predicate device, demonstrating substantial equivalence.
	Intermittent Mode Test	Cork Wound Kit analyzed against predicate device, demonstrating substantial equivalence.
	Leakage Alarm Test	Cork Wound Kit analyzed against predicate device, demonstrating substantial equivalence.
	Blockage Alarm Test	Cork Wound Kit analyzed against predicate device, demonstrating substantial equivalence.
	Canister Full Alarm Test	Cork Wound Kit analyzed against predicate device, demonstrating substantial equivalence.
Biocompatibility	Cytotoxicity Test (on wound foam and drape)	All biocompatibility test results were negative and passed pre-defined test acceptance criteria.
	Intracutaneous Reactivity Test (on wound foam and drape)	All biocompatibility test results were negative and passed pre-defined test acceptance criteria.
	Sensitization Test (on wound foam and drape)	All biocompatibility test results were negative and passed pre-defined test acceptance criteria.
	Overall Biocompatibility Risk Assessment	Completed by Nelson Laboratories, evaluating the biocompatibility of the entire kit. (Implies satisfactory result for substantial equivalence)
Functional Equivalence	Equivalent Indications for Use	Compared and determined to be substantially equivalent to predicate.
	Similar Materials	Compared and determined to be substantially equivalent to predicate.
	Similar Technology	Compared and determined to be substantially equivalent to predicate.
	Similar Product Specifications	Compared and determined to be substantially equivalent to predicate.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the performance tests. It states "Performance tests used simulated wound exudate. Pressure measurements were taken using a wound test bed fixture." This suggests a laboratory-based testing approach.
- Data Provenance: The data is from laboratory testing of the Cork Medical Products NPWT Wound Dressing Kit, compared against the predicate device. It is prospective in the sense that the tests were designed and conducted to evaluate the device. The data is generated in-house or through contract labs (e.g., Nelson Laboratories for biocompatibility) with no explicit country of origin specified beyond the company's US address.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in this context. The study did not involve human experts establishing ground truth for the device's performance in a diagnostic or clinical setting. Instead, the "ground truth" for the performance tests was defined by the expected operational parameters and alarm functions of a negative pressure wound therapy (NPWT) system, which were quantitatively measured using a test bed fixture. For biocompatibility, the ground truth was defined by passing pre-defined acceptance criteria for standard ISO 10993 tests.
Adjudication method for the test set:
- This is not applicable. There was no need for adjudication as the tests were objective, quantitative measurements (e.g., pressure readings, alarm activation) and standard biological assays (e.g., cytotoxicity, sensitization) with pre-defined pass/fail criteria.
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, an MRMC comparative effectiveness study was not done. This device is a medical dressing kit for negative pressure wound therapy, not an AI-powered diagnostic tool requiring human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance testing was done. The nonclinical tests evaluated the physical and functional performance of the device components (foam, drape, port pad assembly) in conjunction with a pump system against established parameters and the predicate device's expected performance, without direct human intervention in the measurement of performance. The biocompatibility tests were also standalone evaluations of the materials.
The type of ground truth used:
- Objective performance criteria and ISO 10993 standards.
  - For performance tests: The ground truth was based on the functional requirements of a NPWT wound dressing kit and the established performance characteristics of the predicate device (e.g., maintaining specific negative pressure levels, triggering alarms correctly). Measurements were taken using a "wound test bed fixture."
  - For biocompatibility: The ground truth was defined by the pre-defined acceptance criteria set by ISO 10993 biological evaluation standards. All tests had to be "negative" and "passed the pre-defined test acceptance criteria."
The sample size for the training set:
- This concept is not applicable to this type of device submission. This is a 510(k) for a physical medical device (wound dressing kit), not a machine learning or AI-driven algorithm. Therefore, there is no "training set" in the computational sense.
How the ground truth for the training set was established:
- This question is not applicable as there was no training set for an AI/ML model.

Summary

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510(k) Summary

807.92(c)

SPONSOR

Company Name: Company Address:

Telephone:	317-849-2675
Fax:	866-271-2580
Contact Person:	Jon D. Speer
Date Prepared:	April 29, 2014

Cork Medical Products 6406 Castleway Court

Indianapolis, IN 46250

DEVICE NAME

Trade Name: Common / Usual Name: Classification Name:

Regulation Number:
Product Code:
Device Class:
Panel:

PREDICATE DEVICE

Table 1 - Predicate Devices

Company	Brand Name	510(k) Number
GenadyneBiotechnologies, Inc.	A4 Wound Dressing Vacuum System Kit	K082676
GenadyneBiotechnologies, Inc.	A4-XLR8 Foam Dressing	K092992

DEVICE DESCRIPTION

P. 16

807.92(a)(2)

807.92(a)(1)

Cork NPWT Wound Dressing Kit Negative Pressure Wound Therapy Powered Suction Pump and Accessories 21 CFR 878.4780 OMP Class II General & Plastic Surgery

Cork Medical Products NPWT Wound Dressing Kit

807.92(a)(3)

807.92(a)(4)

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DEVICE INTENDED USE

807.92(a)(5)

Cork Medical Products NPWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound.

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)

Component	Cork Medical Products NPWT WoundDressing Kit K132004	Genadyne Biotechnologies, Inc. A4 WoundDressing Vacuum System Kit & A4-XLR8Foam Dressing K082676 & K092992(predicate)
Wound Foam -Material	Reticulated polyether based polyurethanefoam (A30M)	Reticulated polyether based polyurethanefoam (A30M)
Wound Foam -Sizes	Medium: 0.75" x 5" x 8"Larger: 0.75" x 6" x 10"	Small: 2.5-cm x 6-cm x 6-cm (~1" x 2.36" x2.36")Medium: 2-cm x 10-cm x 15-cm (~0.79" x3.94" x 5.91")Large: 2.5-cm x 15-cm x 25-cm (~1 x 5.91"x 9.84")
Wound Foam -Biocompatibility	Yes - data provided by UFP Technologies(foam manufacturer)	Yes
Wound Foam -510(k)	To be determined	K092992
Wound Drape -Material	Transparent polyurethane film withadhesive backing	Transparent film dressing
Wound Drape -Biocompability	Yes - data provided by George Medical forDermaMed medical grade acrylic	None specified
Wound Drape -510(k)	K951842 & K990955 (via George Medical,LLC)	K082676
Port Pad Assembly	Silicone port padDrainage tubingLuer connectorPinch clampPort Pad Skirt (Transparent polyurethanefilm with adhesive backing)	Silicone port padDrainage tubingLuer connectorPinch clampTransparent film with adhesive backing
Port Pad - 510(k)	K132004 (this submission)	K082676
SterilizationMethod	Ethylene Oxide	Individual kit components individuallysterilized by Ethylene Oxide or GammaIrradiation

Table 2 - Predicate Comparisons

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Regulation Number/ Product Code	21 CFR 878.4780 / OMP	21 CFR 878.4780 / OMP
Indications for Use	Cork Medical Products NPWT WoundDressing Kit is intended to be used inconjunction with the Genadyne XLR8 Pumpto deliver negative pressure wound therapyto the wound.When used in conjunction with a NPWTpump system, Cork Medical Products NPWTWound Dressing Kit 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.	K082676: The Genadyne A4 WoundVacuum System is indicated for use inpatients who would benefit from negativepressure wound therapy particularly asthe device may promote wound healingby the removal of excess exudates,infectious material and tissue debris.(NOTE: K082676 includes accessory kitcomprised of gauze, transparent filmdressing, and silicone flat drain.)K092992: Genadyne A4-XLR8 FoamDressing is intended to be used inconjunction with the Genadyne A4Wound Vacuum System (K082676) todeliver negative pressure wound therapyto the wound. Genadyne A4 WoundVacuum System is indicated for patientswho would benefit from a suction device,particularly as the device may promotewound healing by the removal of excessexudates, infectious material and tissuesdebris.

NONCLINICAL TESTS

807.92(b)(1)

To ensure the Cork Medical Products NPWT Wound Dressing Kit is substantially equivalent to the Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing, Cork Medical analyzed the performance of the Cork Wound Kit against the predicate device. The specific head to head performance testing conducted to demonstrate substantial equivalence is:

Continuous Mode Low Negative Pressure (-40-mmHg) Test ◆
Continuous Mode Typical Negative Pressure (-125-mmHg) Test .
Continuous Mode High Negative Pressure (-200-mmHg) Test .
Intermittent Mode Test
. Leakage Alarm Test
Blockage Alarm Test .
Canister Full Alarm Test .

Performance tests used simulated wound exudate. Pressure measurements were taken using a wound test bed fixture.

SUMMARY OF BIOCOMPATIBILITY COMPLIANCE TESTS

807.92(b)(1)

A Biocompatibility Risk Assessment was completed by Nelson Laboratories evaluating the biocompatibility of the entire Cork Medical Products Wound Dressing Kit.

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Additional biocompatibility testing was performed on the wound foam and wound drape components, the patient contacting components, for surface device, breached or compromised surface, with a prolonged (24 hours - 30 day) contact per ISO 10993 testing standards. The specific biocompatibility testing performed on the wound foam and wound drape was:

. Cytotoxicity Test
. Intracuteneous Reactivity Test
. Sensitization Test

All biocompatibility test results were negative and passed the pre-defined test acceptance criteria.

Additional biocompatibility information has been provided for each of the individual components included in the Cork Medical Products Wound Dressing Kit, as follows:

. Wound Foam
- Summary of ISO 10993 biocompatibility tests performed on material by UFP o Technologies listed on A-30M specification.
- Crest Foam A-30M MAF 1837- FDA Registration Certificate. o
Wound Drape & Port Pad Drape .
- Summary of ISO 10993 biocompatibility tests performed on DermaMed medical grade o acrylic adhesive provided.
- NOTE: The port pad drape is not in contact with the patient. Biocompatibility not o required.
. Silicone Port Pad
- This material is not in contact with the patient. Biocompatibility not required. o
- Wacker Silicones Elastosil® R 420/60 S. o
. Port Pad tubing
- This material is not in contact with the patient. Biocompatibility not required. o
- Dow Corning Silastic® RX-50 medical grade tubing. o
Luer connector This material is not in contact with the patient. Biocompatibility not required. .
Pinch Clamp This material is not in contact with the patient. Biocompatibility not required. .

CLINICAL TESTS

No clinical testing provided.

SUBSTANTIAL EQUIVALENCE

The results of the nonclinical tests performed demonstrate the performance of the Cork Medical Products Wound Dressing Kit is substantially equivalent to the performance of the predicate device, Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing. The results of the nonclinical tests and summary of biocompatibility compliance tests demonstrate the Cork Medical Products Wound Dressing Kit is safe.

807.92(b)(3)

807.92(b)(2)

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To further establish substantial equivalence to the predicate device, Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing, Cork Medical Products evaluated the indications for use, materials, technology, and product specifications for the product. As a result of this analysis along with performance testing, Cork Medical has demonstrated substantial equivalence of the Cork Medical Products NPWT Wound Dressing Kit for its indications for use.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 2, 2014

Cork Medical Products LLC % Mr. Jon Speer Creo Quality, LLC P.O. Box 1784 Martinsville, Indianapolis 46151

Re: K132004

Trade/Device Name: Cork Medical Products NPWT Wound Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 7. 2014 Received: March 19, 2014

Dear Mr. Speer:

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 docs 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any reathal the Act is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFR & Far 807), adeimg (21 CFR 803); good manufacturing practice requirements as set

{6}------------------------------------------------

Page 2 - Mr. Jon Speer

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Binita S. Ashars 2014.05.02 16:41:54 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date. January 31, 2017 Soo PRA Statemant below.

510(k) Number (if known) K 132004

Device Name

Cork Medical Products NI WT Wound Dressing Ku

Indications for Use (Describe)

Cork Mcdical Products NYWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound.

When used in conjunction with a NPWT puny system. Cork Medical Products NPWT Wound Dressing Kit 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

please do not write below this line – continue on a separate page if needed.

FOR FDA USE ONLY

Concurrence of Conter for Devices and Radiological Health (CDRH) (Signature)

Peter L. Hudson -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden lime for this collection of information is estimated to average 79 hours per response, industry the processed of a processed of a processed of a processed of a pro The Uurden time in this Collection of information to vees, gather and maintain the data needed and completer as any other aspect ume to review the collection of information. Send comments regarding this burden astimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@ida.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of of conduct of upos it displays a currently valid OMB number "

FORM FDA 3881 (1/14)

Page i of 1

PAC Publishing Group, 510(k) 1445-70 E

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.