The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

Device Description

Cork Medical Products has developed a negative pressure wound therapy system. The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

The components included within the Cork NPWT System are:

Nisus Negative Pressure Wound Therapy Pump
Nisus NPWT Canister 250-mL
Nisus Pump Battery Charger
Cork Medical Products NPWT Wound Dressing Kit – Medium
Cork Medical Products NPWT Wound Dressing Kit - Large

AI/ML Overview

This document is a 510(k) premarket notification for the "Cork Medical Products Nisus Negative Pressure Wound Therapy System." It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for each performance test in a tabular format with corresponding reported performance metrics for the Cork Medical Products Nisus NPWT System. Instead, it states that "All biocompatibility test results were negative and passed the pre-defined test acceptance criteria," and that nonclinical tests were conducted "to ensure the Cork Medical Products Nisus Negative Pressure Wound Therapy System is substantially equivalent to the Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing." This implies the acceptance criteria for the nonclinical tests were equivalence to the predicate device's performance characteristics.

The comparison table on pages 5 and 6 provides a direct comparison of technical data between the new device and the predicate device. This essentially serves as the 'performance' of both devices that the FDA used to determine substantial equivalence.

Here's a summarized table based on the provided "Predicate Product Comparison Table" and "Nonclinical Tests" section, inferring acceptance criteria as being substantially equivalent to the predicate:

Acceptance Criteria (Inferred: Substantially equivalent to Predicate Device)	Cork Medical Products Nisus NPWT System Performance	Predicate Device (Genadyne A4 Wound Dressing Vacuum System Kit) Performance	Study Type
PUMP - TECHNICAL DATA			Nonclinical Tests
Suction Capacity	4 liters / minute	5 liters / minute	Head to head performance testing
Maximum Vacuum Pressure	220-mmHg	230-mmHg	Head to head performance testing
Power Requirements	18 VDC, 2A	24 VDC, 1A	Head to head performance testing
Battery Type	Li-ion	Ni-MH	Comparison of specifications
Dimensions	151 x 108 x 71-mm (~6 x 4.3 x 2.8-inches)	200 x 180 x 80-mm (~7.9 x 7.1 x 3.1-inches)	Comparison of specifications
Weight	0.575-kg (~1.27-lb)	1.36-kg (~3-lb)	Comparison of specifications
Reusable	Yes	Yes	Comparison of specifications
Sterile	Non-sterile	Non-sterile	Comparison of specifications
Compliance	IEC 60601-1:2005, 3rd Edition (AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1-08, EN 60601-1)IEC 60601-1-2:2007IEC 60601-1-6:2010 / IEC 62366:2010IEC 60601-1-11:2010	UL 60601-1CAN/CSA C22.2 No. 601-1-M90	Comparison of specifications
Storage & Shipping Conditions	-25°C (-13°F) without relative humidity control to 44°C (111°F) up to 93% relative humidity (non-condensing)	-18°C to +43°C (0°F to 110°F)Relative Humidity 10% to 95%700 – 1060 mbar Atmospheric pressure	Comparison of specifications
Environmental Conditions	Operating Temperature: 18°C to 34°C (65°F to 94°F)Operating Relative Humidity: 10% - 95%Operating Pressure: 700-hPA – 1060-hPA (10.15-atm – 15.37-atm) atmospheric pressure	18°C to 34°C (65°F to 94°F) Relative Humidity 10% to 95%700 – 1060 mbar Atmospheric pressure	Comparison of specifications
ACCESSORIES
Canisters	250-mL disposable canisterCanister includes hydrophobic membrane filter and liquid solidifier	800-mL disposable canister with a built-in hydrophobic shut off filter for overflow protection	Comparison of specifications
Wound Dressing Kit	Wound Foam: Reticulated polyether based polyurethane foam (A30M)Wound Drape: Transparent polyurethane film with adhesive backingPort Pad Assembly: Silicone port pad, Port Pad Skirt (Transparent polyurethane film with adhesive backing), Drainage tubing, Luer connector, Pinch clamp	K082676:Non-adherent gauzeAnti-microbial gauzeTransparent film dressingSilicone flat drainK092992: Polyurethane foam (A30M)	Comparison of specifications
Sterilization	Individual kit components individually sterilized by Ethylene Oxide or Gamma Irradiation	(cleared on K132004) - implied similar sterilization	Comparison of specifications
PERFORMANCE TESTS			Nonclinical Tests
Continuous Mode Low Pressure (40-mmHg) Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Continuous Mode Typical Pressure (125-mmHg) Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Continuous Mode High Pressure (200-mmHg) Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Intermittent Mode Test (high pressure: 125-mmHg, low pressure: 40-mmHg)	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Leakage Alarm Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Canister Full Alarm Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Blockage Alarm Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Operating Parameter Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Storage & Shipping Parameter Test	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Canister Real-Time Aging	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
Wound Dressing Kit Aging	Passed (implied by "substantially equivalent")	(Performance of predicate device)	Head to head performance testing
BIOCOMPATIBILITY
Cytotoxicity Test	Negative/Passed	(Implied standard biocompatibility)	ISO 10993 testing standards
Intracuteneous Reactivity Test	Negative/Passed	(Implied standard biocompatibility)	ISO 10993 testing standards
Sensitization Test	Negative/Passed	(Implied standard biocompatibility)	ISO 10993 testing standards

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

Sample size for nonclinical tests: Not explicitly stated for each test beyond "head to head performance testing," "Canister Real-Time Aging," and "Wound Dressing Kit Aging." For the biocompatibility tests, the sample size refers to the "wound foam and wound drape components" and "individual components included in the Cork Medical Products Wound Dressing Kit." Specific numbers are not provided.
Data provenance: The tests were conducted internally by Cork Medical Products ("Cork Medical conducted head to head performance testing") and a Biocompatibility Risk Assessment was completed by "Nelson Laboratories." The data origin is thus from Cork Medical's testing and a third-party lab. No information about country of origin of the data or whether it was retrospective or prospective is mentioned, which is typical for premarket notifications focus on non-clinical engineering and bench testing.

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

Not applicable. This device is a negative pressure wound therapy system, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for its performance is derived from physical measurements (pressure, flow, alarm functionality) and standardized biocompatibility testing.

4. Adjudication method for the test set

Not applicable. As noted above, this device does not involve expert adjudication for establishing ground truth, as it's a mechanical/electrical device.

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 not an AI-assisted diagnostic or imaging tool.

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

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

7. The type of ground truth used

Nonclinical Performance Tests: The "ground truth" for the nonclinical performance tests (e.g., pressure, alarms) was established through engineering and bench testing protocols using "simulated wound exudate" and a "wound test bed fixture." The implicit ground truth standard for these tests was the demonstrated performance of the legally marketed predicate device.
Biocompatibility Tests: The ground truth was based on international standards, specifically ISO 10993 testing standards, with predefined acceptance criteria for cytotoxicity, intracutaneous reactivity, and sensitization.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore does not have "training sets" in that context. Its performance is based on engineering design and testing, not learned data.

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

Not applicable (as above).

Summary

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

October 24, 2014

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

Re: K140022

Trade/Device Name: Cork Medical Products Nisus Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: September 24, 2014 Received: September 26, 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 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

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Page 2 - Mr. Jon D. Speer

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 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.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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

510(k) Number (if known) K140022

Device Name

Cork Medical Products Nisus Negative Pressure Wound Therapy System

Indications for Use (Describe)

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 Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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510(k) Summary

807.92(c)

SPONSOR		807.92(a)(1)
Company Name:	Cork Medical Products
Company Address:	8050 Castleway DriveIndianapolis, IN 46250
Telephone:	317-537-2000
Fax:	844-269-8439
Contact Person:	Jon D. Speer

September 24, 2014

DEVICE NAME

Date Prepared:

807.92(a)(2)

Trade Name:	Cork Medical Products Nisus Negative Pressure Wound Therapy System
Common / Usual Name:	Cork NPWT System
Classification Name:	Negative Pressure Wound Therapy Powered Suction Pump andAccessories
Regulation Number:	21 CFR 878.4780
Product Code:	OMP
Device Class:	Class II

PREDICATE DEVICE

807.92(a)(3)

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

DEVICE DESCRIPTION

807.92(a)(4)

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may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

The components included within the Cork NPWT System are:

Nisus Negative Pressure Wound Therapy Pump
Nisus NPWT Canister 250-mL
Nisus Pump Battery Charger
Cork Medical Products NPWT Wound Dressing Kit – Medium
Cork Medical Products NPWT Wound Dressing Kit - Large

DEVICE INTENDED USE

807.92(a)(5)

Indications for Use

Physician Orders

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

Use of the Nisus NPWT System must be prescribed by a physician per the stated indications for use. As a condition of use, the Nisus NPWT System should only be used by qualified and authorized personnel. The user must have the necessary knowledge of the specific medical application for which negative pressure wound therapy is being used.

Prior to placement of the Nisus NPWT System, the medical professional treating the wound must assess how to best use the system for an individual wound. It is important to carefully assess the wound and patient to ensure clinical indications for negative pressure wound therapy are met.

All orders should include:

. Wound location, size, and type
. Dressing kit type
Negative pressure settings
Frequency of dressing changes
. Secondary dressings

User

The Nisus NPWT System is designed for use by licensed healthcare professionals only. Patients may be trained to perform some limited functions, but the keypad and device menus are locked by the healthcare professional to prevent patient from changing the setting prescribed by the physician.

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NOTE: Patient functions are limited to power on / off, respond to any alarm conditions, and navigating to troubleshooting (should an alarm occur).

Use Environment

Cork Medical Products Nisus NPWT System is designed for the following environmental conditions:

Operating Temperature: 18°C to 34°C (65°F to 94°F) Operating Relative Humidity: 10% - 95% Operating Pressure: 700-hPA – 1060-hPA (10.15-atm – 15.37-atm) atmospheric pressure

PREDICATE PRODUCT COMPARISON TABLE

807.92(a)(6)

	New Device	Predicate Device
Company	Cork Medical Products	Genadyne Biotechnologies, Inc.
Device Name	Nisus Negative Pressure WoundTherapy System	A4 Wound Dressing Vacuum SystemKit & A4-XLR8 Foam Dressing
510(k) Number	K140022	K082676 K092992
Regulation Number / Product Code	21 CFR 878.4780 / OMP	21 CFR 878.4780 / OMP
Indications for Use	The Cork Medical Products NisusNegative Pressure Wound TherapySystem is indicated for use inpatients who would benefit fromnegative pressure wound therapyparticularly as the device maypromote wound healing by theremoval of excess exudates,infectious material, and tissuedebris.	K082676: The Genadyne A4 WoundVacuum System is indicated for usein patients who would benefit fromnegative pressure wound therapyparticularly as the device maypromote wound healing by theremoval of excess exudates,infectious material and tissuedebris. (NOTE: K082676 includesaccessory kit comprised of gauze,transparent film dressing, andsilicone flat drain.)K092992: Genadyne A4-XLR8 FoamDressing is intended to be used inconjunction with the Genadyne A4Wound Vacuum System (K082676)to deliver negative pressure woundtherapy to the wound. Genadyne A4Wound Vacuum System is indicatedfor patients who would benefit froma suction device, particularly as thedevice may promote wound healingby the removal of excess exudates,infectious material and tissuesdebris.
Contraindications	The Nisus NPWT System iscontraindicated for patients with:• Necrotic tissue with escharpresent	The Genadyne A4 is contraindicatedin the presence of:• Necrotic tissue• Untreated osteomyelitis
	New Device	Predicate Device
	Untreated osteomyelitis Malignancy in the wound Non-enteric and unexplored fistulas Do not place dressing directly in contact with: Exposed blood vessels Anastomotic sites Organs Nerves	(to enhance quality of life) Untreated malnutrition Exposed arteries, veins, or organs
Pump - Technical Data
Suction Capacity	4 liters / minute	5 liters / minute
Maximum Vacuum Pressure	220-mmHg	230-mmHg
Power Requirements	18 VDC, 2A	24 VDC, 1A
Battery Type	Li-ion	Ni-MH
Dimensions	151 x 108 x 71-mm(~6 x 4.3 x 2.8-inches)	200 x 180 x 80-mm(~7.9 x 7.1 x 3.1-inches)
Weight	0.575-kg (~1.27-lb)	1.36-kg (~3-lb)
Reusable	Yes	Yes
Sterile	Non-sterile	Non-sterile
Compliance	IEC 60601-1:2005, 3rd Edition (AAMIES 60601-1, CAN/CSA C22.2 No.60601-1-08, EN 60601-1)IEC 60601-1-2:2007IEC 60601-1-6:2010 / IEC62366:2010IEC 60601-1-11:2010	UL 60601-1CAN/CSA C22.2 No. 601-1-M90
Storage & Shipping Conditions	-25°C (-13°F) without relativehumidity control to 44°C (111°F) upto 93% relative humidity (non-condensing)	-18°C to +43°C (0°F to 110°F)Relative Humidity 10% to 95%700 – 1060 mbar Atmosphericpressure
Environmental Conditions	Operating Temperature: 18°C to34°C (65°F to 94°F)Operating Relative Humidity: 10% -95%Operating Pressure: 700-hPA –1060-hPA (10.15-atm – 15.37-atm)atmospheric pressure	18°C to 34°C (65°F to 94°F) RelativeHumidity 10% to 95%700 – 1060 mbar Atmosphericpressure
Accessories
Canisters	250-mL disposable canisterCanister includes hydrophobicmembrane filter and liquid solidifier	800-mL disposable canister with abuilt-in hydrophobic shut off filterfor overflow protection
Wound Dressing Kit	Wound Foam: Reticulated polyetherbased polyurethane foam (A30M)Wound Drape: Transparentpolyurethane film with adhesivebackingPort Pad Assembly: Silicone portpad, Port Pad Skirt (Transparentpolyurethane film with adhesive	K082676:Non-adherent gauzeAnti-microbial gauzeTransparent film dressingSilicone flat drainK092992
New Device	Predicate Device
backing), Drainage tubing, Luerconnector, Pinch clamp	polyurethane foam (A30M)
Sterilized via Ethylene Oxide	Individual kit componentsindividually sterilized by EthyleneOxide or Gamma Irradiation
(cleared on K132004)

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NONCLINICAL TESTS

807.92(b)(1)

To ensure the Cork Medical Products Nisus Negative Pressure Wound Therapy System is substantially equivalent to the Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing, Cork Medical conducted head to head performance testing. The head to head testing conducted:

Continuous Mode Low Pressure (40-mmHg) Test
Continuous Mode Typical Pressure (125-mmHg) Test
Continuous Mode High Pressure (200-mmHg) Test
Intermittent Mode Test (high pressure: 125-mmHg, low pressure: 40-mmHg)
Leakage Alarm Test
. Canister Full Alarm Test
. Blockage Alarm Test
. Operating Parameter Test
Storage & Shipping Parameter Test
. Canister Real-Time Aging
Wound Dressing Kit Aging

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)

Of the items included within the Nisus NPWT System, biocompatibility is only applicable to the NPWT Wound Dressing Kits.

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

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

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. 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
- o Summary of ISO 10993 biocompatibility tests performed on material by UFP 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.
- o NOTE: The port pad drape is not in contact with the patient. Biocompatibility not 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
- o This material is not in contact with the patient. Biocompatibility not required.
- 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

807.92(b)(2)

No clinical testing required to support this 510(k) submission. No clinical testing has been performed.

SUBSTANTIAL EQUIVALENCE

807.92(b)(3)

The results of the nonclinical tests performed demonstrate the performance of the Cork Medical Products Nisus NPWT System is substantially equivalent to the performance of the predicate device, Genadyne A4 Wound Dressing Vacuum System Kit (K082676) and A4-XLR8 Foam Dressing (K092992). The results of the nonclinical tests and summary of biocompatibility compliance tests demonstrate the Cork Medical Products Wound Dressing Kit is safe.

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 components of the product. As a result of this analysis along with performance testing, Cork Medical has demonstrated substantial equivalence of the Cork Medical Products Nisus NPWT System for its indications for use.

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.