NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT

Q: Who is the manufacturer of NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT?

Cork Medical Products, LLC filed the 510(k) submission for NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT (K140022).

Q: What is the FDA product code for NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT?

Genadyne A4 Wound Dressing Vacuum System Kit (K082676); Genadyne A4-XLR8 Foam Dressing (K092992).

Q: Who can help prepare an FDA 510(k) submission like NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K140022 · Cork Medical Products, LLC · OMP · Oct 24, 2014 · General, Plastic Surgery

Device Facts

Record ID	K140022
Device Name	NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
Applicant	Cork Medical Products, LLC
Product Code	OMP · General, Plastic Surgery
Decision Date	Oct 24, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Nisus Negative Pressure Wound Therapy (NPWT) System is a powered suction pump designed to promote wound healing by removing exudates, infectious material, and tissue debris. System components include a pump, 250-mL disposable canister with hydrophobic filter/solidifier, battery charger, and wound dressing kits (foam, drape, port pad). Used in clinical settings by healthcare professionals; patients may perform limited functions (power on/off, alarm response) but device menus are locked by clinicians to prevent unauthorized setting changes. Pump applies negative pressure to the wound bed via the dressing kit. Healthcare providers prescribe settings based on wound assessment. Benefits include wound healing promotion through exudate management. Device is portable, battery-operated, and intended for professional use.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including continuous/intermittent pressure mode testing, leakage/blockage/canister-full alarm verification, and biocompatibility testing per ISO 10993.

Technological Characteristics

Powered suction pump; 220-mmHg max vacuum; 4 L/min suction capacity. Materials: reticulated polyether-based polyurethane foam (A30M), transparent polyurethane film, silicone port pad. Connectivity: standalone. Power: 18 VDC, Li-ion battery. Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11. Sterilization: Ethylene Oxide or Gamma Irradiation for kit components.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing via removal of excess exudates, infectious material, and tissue debris. Contraindicated for patients with necrotic tissue with eschar, untreated osteomyelitis, malignancy in the wound, or non-enteric and unexplored fistulas. Do not place dressing in contact with exposed blood vessels, anastomotic sites, organs, or nerves.

Regulatory Classification

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.

Predicate Devices

Genadyne A4 Wound Dressing Vacuum System Kit (K082676)
Genadyne A4-XLR8 Foam Dressing (K092992)

Related Devices

K203693 — Nisus Touch Negative Pressure Wound Therapy Pump · Cork Medical Products, LLC · Aug 13, 2021
K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) · Cork Medical · Jun 27, 2025
K221223 — extriCARE® 3000 Negative Wound Pressure Therapy System · Alleva Medical Devices · Feb 9, 2023
K151326 — RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device · Smith & Nephew, Inc. · Jul 16, 2015
K161599 — UNO Negative Pressure Wound Therapy System · Genadyne Biotechnologies, Inc. · Apr 6, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) 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. 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. {3}------------------------------------------------ # 510(k) Summary 807.92(c) | SPONSOR | | 807.92(a)(1) | |------------------|------------------------------------------------|--------------| | Company Name: | Cork Medical Products | | | Company Address: | 8050 Castleway Drive Indianapolis, 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 and Accessories | | 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 | |-----------------------------------|-------------------------------------|-----------------------| | Genadyne Biotechnologies, Inc. | A4 Wound Dressing Vacuum System Kit | K082676 | | | Genadyne Biotechnologies, Inc. | A4-XLR8 Foam Dressing | # DEVICE DESCRIPTION # 807.92(a)(4) 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 {4}------------------------------------------------ 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 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. #### 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. {5}------------------------------------------------ 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 Wound Therapy System | A4 Wound Dressing Vacuum System Kit & 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 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. | K082676: The Genadyne A4 Wound Vacuum 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. (NOTE: K082676 includes accessory kit comprised of gauze, transparent film dressing, and silicone flat drain.) K092992: 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 tissues debris. | | Contraindications | The Nisus NPWT System is contraindicated for patients with: • Necrotic tissue with eschar present | The Genadyne A4 is contraindicated in 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 (AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1-08, EN 60601-1) IEC 60601-1-2:2007 IEC 60601-1-6:2010 / IEC 62366:2010 IEC 60601-1-11:2010 | UL 60601-1 CAN/CSA C22.2 No. 601-1-M90 | | 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 | | 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 | | Accessories | | | | Canisters | 250-mL disposable canister Canister includes hydrophobic membrane filter and liquid solidifier | 800-mL disposable canister with a built-in hydrophobic shut off filter for overflow protection | | Wound Dressing Kit | Wound Foam: Reticulated polyether based polyurethane foam (A30M) Wound Drape: Transparent polyurethane film with adhesive backing Port Pad Assembly: Silicone port pad, Port Pad Skirt (Transparent polyurethane film with adhesive | K082676: Non-adherent gauze Anti-microbial gauze Transparent film dressing Silicone flat drain K092992 | | New Device | Predicate Device | | | backing), Drainage tubing, Luer connector, Pinch clamp | polyurethane foam (A30M) | | | Sterilized via Ethylene Oxide | Individual kit components individually sterilized by Ethylene Oxide or Gamma Irradiation | | | (cleared on K132004) | | | {6}------------------------------------------------ {7}------------------------------------------------ ### 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 {8}------------------------------------------------ - . 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.