The Cardinal Health NPWT PRO HC system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.

Device Description

The Cardinal Health NPWT PRO HC system is an AC-powered, portable suction device with battery backup that provides localized negative pressure when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressings, canister tubing with clamps and connectors, and polyurethane drapes with adhesive. The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO HC system provides care in the acute, extended and home care settings.

The Cardinal Health NPWT PRO HC system functions the Cardinal Health NPWT PRO devices. The Cardinal Health NPWT PRO HC system includes a built-in placement holder for the 300cc or 500cc collection canisters. It has a pushbutton ON/OFF operation with five userselectable pressure settings. The system produces optional negative pressure settings of 50mmHg. 75mmHg. 100mmHg. 125mmHg. and 150mmHg. It has alarms for Low Pressure/Leak. Full Canister, and Low Battery and an alert when the device is due for service. These alarms include both audible and visual indications.

The purpose of this 510(k) submission is to introduce the Cardinal Health NPWT PRO HC system. The Cardinal Health NPWT PRO HC system is identical to the NPWT PRO with the exception of: 1) addition of two motorized pumps for increased air flow volume; (2) one additional battery; and (3) a slightly larger case to accommodate the additional pumps and battery. The user interface for the PRO HC is identical to the PRO.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cardinal Health NPWT PRO HC System, a negative pressure wound therapy device. The submission focuses on demonstrating substantial equivalence to a predicate device (Cardinal Health NPWT PRO Family) rather than proving the device meets new acceptance criteria for clinical efficacy. The device is a powered suction pump, and the "acceptance criteria" discussed are primarily related to its functional performance and safety, ensuring it performs comparably to the predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Functional Performance	Deliver negative pressure at individual pressure settings (50, 75, 100, 125, 150 mmHg)	Verified that the PRO HC provides negative pressure at individual pressure settings, identical to the predicate device.
	Deliver negative pressure wound therapy in continuous and intermittent operating modes	Verified that the device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device.
	Canister Full alarm functionality	Verified using wound fluid designed to simulate real exudate.
	System performance and Leak alarm functionality with high air leaks at the dressing site	Verified.
	System performance in all pressure settings with simulated exudate	Verified.
	System performance with all sizes of disposable foam dressing kits and accessories	Verified.
Electrical Safety and EMC	Compliance with IEC 60601-1 (safety) and IEC 60601-1-11 (home care safety)	Complies with IEC 60601-1 and IEC 60601-1-11 standards.
	Compliance with IEC 60601-1-2 (EMC)	Complies with IEC 60601-1-2 standard.
Software Verification/Validation	Software performs as intended, no significant flaws leading to injury	Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. The device's software was considered "Moderate" level of concern, indicating that a failure or latent flaw could directly result in minor injury.
Clinical Usability	Proper use of the device in a home environment by healthcare providers and patients	33 subjects (17 healthcare providers, 16 patients) participated. All met predetermined acceptance criteria, and no new risks were identified. (Note: This testing was conducted on the predicate device, NPWT PRO, but deemed applicable to PRO HC due to identical user interface).

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical (Bench) Tests: The document does not specify a numerical sample size for the individual bench tests (e.g., how many times each pressure setting was tested, or how many simulated leaks were induced). These are typically engineering verification tests.
Electrical Safety & EMC Tests: No specific sample size is given. These tests are usually conducted on a representative sample of the finished device.
Software Verification & Validation: No specific sample size is given for tests of the software itself beyond the general statement of "testing was conducted."
Clinical Usability Testing:
- Sample Size: 17 healthcare providers and 16 patients (total 33 subjects).
- Data Provenance: The study was conducted in a "home care setting," implying it was conducted domestically (likely USA, given the FDA submission context) and would be considered prospective for the usability aspect. The data relates to the predicate device (NPWT PRO) but is stated to be applicable to the PRO HC due to identical user interfaces.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Functional, Electrical Safety, EMC, Software Tests: The "ground truth" for these tests is based on engineering specifications, recognized national/international standards (e.g., IEC 60601 series), and FDA guidance for software. These are not typically established by human experts in a "ground truth" sense, but rather by objective measurements against predefined criteria.
Clinical Usability Testing: The "ground truth" was whether participants could properly use the device and meet "predetermined acceptance criteria." These criteria would have been established by the device manufacturer, likely with input from clinical experts or human factors engineers. The qualifications of these specific experts are not detailed in the provided text. The participants themselves (17 healthcare providers and 16 patients) were the subjects whose performance was evaluated against these criteria.

4. Adjudication Method for the Test Set

For the functional, electrical safety, EMC, and software tests, adjudication is not explicitly described. These are objective tests where results either meet the specification/standard or they do not.
For the Clinical Usability Testing, the document states, "All 33 subjects met the predetermined acceptance criteria." This implies a clear set of criteria were established beforehand, and subjects' performance was evaluated against these. There is no mention of an "adjudication method" like 2+1 or 3+1, which are typically used for subjective diagnostic interpretations. It was a direct assessment against predefined performance tasks.

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

No MRMC or AI Comparative Effectiveness Study was done. This device is a medical pump for negative pressure wound therapy, not a diagnostic imaging device utilizing AI. The focus of the submission is on physical and software performance and user interaction, not on improving human reader performance with AI.

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

No standalone "algorithm only" performance was done in the context of AI. As mentioned above, this is not an AI-driven diagnostic device. The "standalone" performance closest to this concept would be the device's functional performance (e.g., maintaining negative pressure) as measured in bench testing, independent of direct human interaction other than setting it up.

7. The type of ground truth used

Functional Performance: Engineering specifications and objective measurements (e.g., pressure readings, alarm activation).
Electrical Safety & EMC: Compliance with international standards (IEC 60601 family).
Software Verification & Validation: Adherence to software development lifecycle processes and satisfactory performance during testing against requirements, guided by FDA software guidance.
Clinical Usability Testing: Predetermined acceptance criteria for task performance and absence of new risks, likely established by human factors experts/designers, with patients' and healthcare providers' successful completion of tasks serving as the empirical data.

8. The Sample Size for the Training Set

Not applicable in the context of typical AI/ML model training. The software on this device is stated as "firmware control of the device" in the full 510(k) and is not described as involving a learning algorithm that requires a "training set" in the machine learning sense. The software undergoes traditional verification and validation.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI/ML sense described for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of a stylized human figure in profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circular seal.

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

September 2, 2015

Cardinal Health % Ms. Allison Scott Navigant Consulting Incorporated 9001 Wesleyan Road, Suite 200 Indianapolis. Indiana 46268

Re: K150124

Trade/Device Name: Cardinal Health NPWT PRO HC System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 6, 2015 Received: August 7, 2015

Dear Ms. Scott:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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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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Indications for Use

510(k) Number (if known)

Device Name

Cardinal Health NPWT PRO HC System

Indications for Use (Describe)

The Cardinal Health NPWT PRO HC system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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510(k) Summary

I. Submitter Information

Cardinal Health 1500 S Waukegan Road Waukegan, IL 60085

Judith Harbour, RAC Contact Person: 954-582-7433 Judith.Harbour@cardinalhealth.com

July 14, 2015 Date Prepared:

II. Device Information

Name of Device:	Cardinal Health NPWT PRO HC
Common Name:	Negative Pressure Wound Therapy Powered Suction Pump
Classification Name(s):	Powered Suction Pump (21 CFR 878.4780)
Regulatory Class:	II
Product Code:	OMP

III. Predicate Device

Primary: K143016 Cardinal Health NPWT PRO Family This predicate has not been subject to a design-related recall.
K093564 Innovative Therapies, Inc. Sved® Wound Treatment System Reference: K111333 Innovative Therapies, Inc. Antlia III Wound Treatment System

4. Device Description

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5. Intended Use(s)

6. Comparison of Technological Characteristics

This submission describes a new model to the existing cleared Cardinal Health NPWT PRO family: the Cardinal Health NPWT PRO HC. The subject and predicate devices are based on the following same technical elements:

· Continuous and Intermittent negative pressure treatment modes;
· 50mmHg, 75mmHg, 100mmHg, 125mmHg & 150mmHg negative pressure settings;
· Pressure sensing technology within the pump;
· Available for use with 300cc and 500cc canisters;
· Use AC and Rechargeable battery

The NPWT PRO HC differs from the NPTW PRO in that:

· There are two additional motorized pumps for increased air flow volume;
· There is an additional battery; and
· The exterior case is larger to accommodate the additional pumps and battery.

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7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Tests (Bench)

Testing has been conducted to verify that the modifications to the NPWT PRO HC meet design specifications and demonstrate substantial equivalence to the predicate NPWT

PRO device. The list below summarizes the testing conducted for the Cardinal Health NPWT PRO HC device:

Verification that the PRO HC provides negative pressure at individual pressure settings, . identical to the predicate device;
. Verification that the device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device;
. Verification of Canister Full alarm functionality using wound fluid designed to simulate real exudate;
Verification of system performance and Leak alarm functionality when running with high air leaks at the dressing site;
Verification of system performance in all pressure settings with simulated exudate; and ●
Verification of system performance with all sizes of disposable foam dressing kits and accessories.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the Cardinal Health NPWT PRO HC. The system complies with the IEC 60601-1 and IEC 60601-1-11 standards for safety and the IEC 60601-1-2 standard for EMC.

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, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator.

Clinical Usability Testing

Testing was conducted using the NPWT PRO device in a home care setting to ensure proper use of the device in the home environment. [Testing conducted with PRO device is directly applicable to the PRO HC device as they have the identical user interface.] The testing included 17 healthcare providers and 16 patients. All participants were provided a user guide and quick reference guide for reference during the study and were asked to perform a series of tasks using the NPWT PRO. All 33 subjects met the predetermined acceptance criteria and no new risks were identified as part of this study.

8. Conclusions

The non-clinical tests, electrical safety and EMC, software verification and validation, and clinical usability testing, demonstrate that the Cardinal Health NPWT PRO HC system is equivalent to the predicate device for the intended 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.