(294 days)
No
The summary describes a standard negative pressure wound therapy system with a pump, canister, and dressing kits. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on pressure delivery, alarms, and aging, which are typical for this type of device and do not indicate AI/ML involvement.
Yes
The device is indicated for promoting wound healing by removing excess exudates, infectious material, and tissue debris, which are therapeutic actions.
No
The device is a negative pressure wound therapy system used for treatment, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a pump, canister, battery charger, and wound dressing kits.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "negative pressure wound therapy" to promote wound healing by removing exudates, infectious material, and tissue debris. This is a therapeutic treatment applied directly to a wound on a patient's body.
- Device Description: The components listed (pump, canister, charger, dressing kits) are all consistent with a system designed for applying negative pressure to a wound.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is a therapeutic medical device used for wound management.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.