(238 days)
No
The description focuses on the addition of a touch screen interface and maintains the same core functionality and mechanical components as the predicate device. There is no mention of AI, ML, or any data-driven decision-making processes.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device "may promote wound healing" by therapeutic actions such as the removal of exudates, infectious material, and tissue debris.
No
The device is a negative pressure wound therapy pump, designed to promote wound healing by removing exudates, infectious material, and tissue debris. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition or provide information for diagnosis.
No
The device description explicitly lists hardware components such as the pump, battery charger, and canister. While it includes software, it is not a software-only device.
Based on the provided text, the Nisus Touch Negative Pressure Wound Therapy Pump is not an In Vitro Diagnostic (IVD) device.
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 application directly on the patient's wound, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a pump, canister, and wound kit components used to apply negative pressure to a wound and collect wound drainage. This aligns with a therapeutic device, not an IVD.
- Mechanism of Action: The device works by applying negative pressure to the wound bed, which is a physical therapy mechanism, not a chemical or biological analysis of a sample.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information about a patient's condition based on sample analysis.
Therefore, the Nisus Touch Negative Pressure Wound Therapy Pump is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nisus Touch Negative Pressure Wound Therapy Pump 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
OMP
Device Description
Cork Medical Products has developed a negative pressure wound therapy pump with the same intended use as its predicate device (K140022) but has the addition of an integrated touch screen. The Nisus Touch and Nisus pumps are nearly identical in appearance and utilize the same buttons to power the device and adjust pump settings; however, the Nisus Touch offers the alternative touch screen to easily maneuver between settings based on operator preference. Visual and audible alarms are consistent with the predicate device K140022 and alert the user when critical battery, pressure leakage, system blockage, and full canister occurs. Additionally, the Nisus Touch mechanical components and therapy application are identical to the Nisus pump. The intent of the new model is to appeal to users who encounter touch screens in daily technology and might feel navigation by touch screen is more simplistic.
The components included within the Cork Nisus Touch NPWT Pump are:
- Nisus Touch Negative Pressure Wound Therapy Pump
- Nisus Touch Pump Battery Charger
Accessory components are required to operate the device. Iniection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The canister design was previously provided clearance within the Nisus NPWT system 510k application (K140022).
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 Touch NPWT Pump is designed for use by licensed healthcare professionals only. The keypad and device menus are locked by the healthcare professional to prevent patient from changing the setting prescribed by the physician.
NOTE: Patient functions are limited to power on/off and respond to any alarm conditions.
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)
The Cork Medical Products Nisus Touch Negative Pressure Wound Therapy Pump underwent bench performance testing to establish basic functionality. The bench performance tests conducted are:
. Continuous Mode Low Pressure (40-mmHg) Test
. Continuous Mode Typical Pressure (125-mmHg) Test
. Continuous Mode High Pressure (200-mmHg) Test
. Intermittent Mode Test
. Low Battery Test
Leakage Alarm Test .
Blockage Alarm Test .
. Canister Full Alarm Test
. Suction Capacity and Maximum Vacuum Pressures
The testing results show the Nisus Touch NPWT pump functioned as expected. Performance tests used simulated wound exudate. Pressure measurements were taken using a wound test bed fixture.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
August 13, 2021
Cork Medical Products, LLC Patrick McGinley Chief Executive Officer 8000 Castleway Drive Indianapolis, Indiana 46250
Re: K203693
Trade/Device Name: Nisus Touch Negative Pressure Wound Therapy Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: June 16, 2021 Received: June 21, 2021
Dear Patrick McGinley:
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 ffor 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (0S) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203693
Device Name
Nisus Touch Negative Pressure Wound Therapy Pump
Indications for Use (Describe)
The Nisus Touch Negative Pressure Wound Therapy Pump 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) |
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3
510(k) Summary
807.92(c)
SPONSOR
807.92(a)(1)
| Company Name: | Cork Medical Products LLC |
|---|---|
| Company Address: | 8000 Castleway Drive |
| Indianapolis, IN 46250 |
Telephone: 866-551-2580 Fax: 844-269-8439 Contact Person: Patrick McGinley Date Prepared: August 6th, 2021
DEVICE NAME
807.92(a)(2)
| Trade Name: | Nisus Touch Negative Pressure Wound Therapy Pump |
|---|---|
| System Common/Usual Name: | Negative Pressure Wound Therapy Powered Suction Pump |
| Classification Name: | Powered Suction Pump |
| 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 |
|---|---|---|
| Cork Medical Products | Nisus Negative Pressure Wound Therapy System | K140022 |
DEVICE DESCRIPTION
807.92(a)(4)
Cork Medical Products has developed a negative pressure wound therapy pump with the same intended use as its predicate device (K140022) but has the addition of an integrated touch screen. The Nisus Touch and Nisus pumps are nearly identical in appearance and utilize the same buttons to power the device and adjust pump settings; however, the Nisus Touch offers the alternative touch screen to easily maneuver between settings based on operator preference. Visual and audible alarms are consistent with the predicate device K140022 and alert the user when critical battery, pressure leakage, system blockage, and full canister occurs. Additionally, the Nisus Touch mechanical components and therapy application are identical to the Nisus pump. The intent of the new model is to appeal to users who encounter touch screens in daily technology and might feel navigation by touch screen is more simplistic.
The components included within the Cork Nisus Touch NPWT Pump are:
- Nisus Touch Negative Pressure Wound Therapy Pump
- Nisus Touch Pump Battery Charger
Accessory components are required to operate the device. Iniection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The canister design was previously provided clearance within the Nisus NPWT system 510k application (K140022).
4
The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. These components are used in coniunction with the pump to ensure safe transfer of the wound debris to the canister. The NPWT Accessories were previously provided clearance on K132004. Our application for the Nisus Touch NPWT system includes no revisions to these previously cleared components.
DEALCE TATEMDED OSE
807.92(a)(5)
Indications for Use
The Nisus Touch Neqative Pressure Wound Therapy Pump 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 Touch NPWT Pump must be prescribed by a physician per the stated indications for use. As a condition of use, the Nisus Touch NPWT Pump 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 Touch NPWT Pump, 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.
User
The Nisus Touch NPWT Pump is designed for use by licensed healthcare professionals only. The keypad and device menus are locked by the healthcare professional to prevent patient from changing the setting prescribed by the physician.
NOTE: Patient functions are limited to power on/off and respond to any alarm conditions.
Use Environment
Cork Medical Products Nisus Touch NPWT Pump 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
5
PREDICATE PRODUCT COMPARISON TABLE
807.92(a)(6)
| Subject Device | Predicate Device | |
|---|---|---|
| Company | Cork Medical Products | Cork Medical Products |
| Device Name | Nisus Touch Negative Pressure | |
| Wound Therapy Pump | Nisus Negative Pressure | |
| Wound Therapy System | ||
| 510(k) Number | K203693 | K140022 |
| Regulation Number / | ||
| Product Code | 21 CFR 878.4780 / OMP | 21 CFR 878.4780 / OMP |
| Indications for Use | The Nisus Touch Negative | |
| Pressure Wound Therapy | ||
| Pump 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 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. | ||
| Features | • Multiple keys for navigation | |
| including: power, menu/select, | ||
| exit, up arrow, down arrow, left | ||
| arrow, right arrow | ||
| • Touch screen capability to | ||
| maneuver between therapy | ||
| modes and device settings | • Multiple keys for navigation | |
| including: power, menu/select, | ||
| exit, up arrow, down arrow, left | ||
| arrow, right arrow | ||
| Suction Capacity | ~8-10 liters / minute | 4 liters / minute |
| Maximum Vacuum | ||
| Pressure | 200-mmHg | 220-mmHg |
| Power Requirements | 18 VDC, 2A | 18 VDC, 2A |
| Battery Type | Li-ion | Li-ion |
| Dimensions | 151 x 117 x 84-mm | |
| (~6 x 4.6 x 3.3-inches) | 151 x 108 x 71-mm | |
| (~6 x 4.3 x 2.8-inches) | ||
| Weight | 0.616-kg (~1.36-lb) | 0.575-kg (~1.27-lb) |
| Reusable | Yes | Yes |
| Sterile | Non-sterile | Non-sterile |
| Compliance | IEC 60601-1, 4th Edition (AAMI | |
| ES 60601-1, CAN/CSA C22.2 | ||
| No. 60601-1-08, EN 60601-1) | ||
| IEC 60601-1-2 | ||
| IEC 60601-1-6/IEC 62366 | ||
| IEC 60601-1-11 | IEC 60601-1, 3rd Edition (AAMI | |
| ES 60601-1, CAN/CSA C22.2 | ||
| No. 60601-1-08, EN 60601-1) | ||
| IEC 60601-1-2 | ||
| IEC 60601-1-6/IEC 62366 | ||
| IEC 60601-1-11 | ||
| Storage & Shipping | ||
| Conditions | -25°C (-13°F) without relative | |
| humidity control to 70°C (158°F) | ||
| up to 93% relative humidity | ||
| (non-condensing) | -25°C (-13°F) without relative | |
| humidity control to 70°C (158°F) | ||
| up to 93% relative humidity | ||
| (non-condensing) | ||
| Environmental Conditions | Operating Temperature: 18°C - | |
| 34°C (65°F - 94°F) | ||
| Operating Relative Humidity: | ||
| 10% - 95% non-condensing | ||
| Operating Pressure: 700-hPA – | ||
| 1060-hPA (10.15-atm - 15.37- | ||
| atm) atmospheric pressure | Operating Temperature: 5°C - | |
| 40°C (41°F - 104°F) | ||
| Operating Relative Humidity: | ||
| 15% - 93% non-condensing | ||
| Operating Pressure: 700-hPA – | ||
| 1060-hPA (10.15-atm - 15.37- | ||
| atm) atmospheric pressure | ||
| Accessories | Canisters: | |
| Two Sizes: 250mL, 500mL | ||
| Features: hydrophobic | ||
| membrane filter, liquid solidifier | ||
| (cleared on K14022) | ||
| Wound Dressing Kit: | ||
| Wound Foam | ||
| Wound Drape | ||
| Port Pad Assembly | ||
| Previously cleared on K132004 | ||
| Provided sterile | ||
| Bench Testing completed | ||
| utilized accessories previously | ||
| cleared on separate 510k | ||
| applications to mimic the | ||
| predicate device setting. | Canisters: | |
| Two Sizes: 250mL, 500mL | ||
| Features: hydrophobic | ||
| membrane filter, liquid solidifier | ||
| (cleared with application) | ||
| Wound Dressing Kit: | ||
| Wound Foam | ||
| Wound Drape | ||
| Port Pad Assembly | ||
| Previously cleared on K132004 | ||
| Provided sterile | ||
| Bench Testing utilized canisters | ||
| in application, and accessories | ||
| cleared on separate application. |
6
NONCLINICAL TESTS
807.92(b)(1)
The Cork Medical Products Nisus Touch Negative Pressure Wound Therapy Pump underwent bench performance testing to establish basic functionality. The bench performance tests conducted are:
- . Continuous Mode Low Pressure (40-mmHg) Test
- . Continuous Mode Typical Pressure (125-mmHg) Test
- . Continuous Mode High Pressure (200-mmHg) Test
- . Intermittent Mode Test
- . Low Battery Test
- Leakage Alarm Test .
- Blockage Alarm Test .
- . Canister Full Alarm Test
- . Suction Capacity and Maximum Vacuum Pressures
The testing results show the Nisus Touch NPWT pump functioned as expected. Performance tests used simulated wound exudate. Pressure measurements were taken using a wound test bed fixture.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. The corresponding software documentation required for a 510(k) submission is included per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as published by the FDA.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Nisus Touch Negative Pressure Wound Therapy Pump. The system complies with the IEC 60601-1: 2005, IEC 60601-1-6: 2010, and IEC 60601-1-11: 2010 standards for safety and the IEC 60601-1-2: ed 4.0 (2014-02) standard for EMC.
Additional non-clinical testing conducted
62366: 2007 - Medical devices - Application of usability engineering to medical devices. IEC
CLINICAL TESTS
No clinical testing required to support this 510(k) submission. No clinical testing has been performed.
CONCLUSIONS
Cork Medical concludes, based on nonclinical testing, that the Nisus Touch Negative Pressure Wound Therapy Pump is as safe, as effective, and performs as well as the predicate device, Cork Medical Products Nisus Neqative Pressure Wound Therapy System (K140022).
807.92(b)(3)
807.92(b)(2)