The Cardinal Health NPWT device is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy. The system 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.

Device Description

The Cardinal Health NPWT system consists of a powered suction pump device that provides continuous or intermittent negative pressure (SVED – K142916, PRO/PRO to GO/PRO at HOME – K143016, PRO HC – K150124) with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and fluid collection canisters. The pump devices are AC-powered, portable suction devices with battery backup that provide localized negative pressure to remove fluids and infectious materials from the wound. The devices must be used with the Cardinal Health NPWT dressing kits, which are available in various foam sizes. Each Cardinal Health NPWT dressing kit contains an occlusion detection tubing set. various sizes of polyurethane foam, and a polyurethane drape with adhesive.

The purpose of this submission is to modify 1) the tubing in the dressing kits and 2) the disposable fluid collection canister to allow detection of blockage or an occlusion that may occur in the dressing or within the tubing, which in turn triggers an alarm on the pump. The modification consists of a dual lumen tubing set with a twist and lock port that attaches to a disposable fluid collection canister. The canister is modified with three ports in the cap of the canister. One port accepts the twist and lock end of the tubing set for collection of exudate from the wound, and two ports connects to sensors within the pump device. The modifications to the tubing set and the fluid collection canister cap do not require any software or hardware changes to the NPWT pump devices. There are no changes to the Indications for Use for any of the NPWT devices.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device modification, not a study report detailing performance of an AI/ML algorithm. Therefore, many of the requested criteria regarding AI model performance, training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable.

However, I can extract the relevant information from the provided text regarding the device modification and its acceptance criteria as presented in a regulatory context.

The device in question is a Cardinal Health NPWT Occlusion Detection Dressing Kit and Canister, a modification of an existing Negative Pressure Wound Therapy (NPWT) system. The modification aims to allow the detection of blockages or occlusions in the dressing or tubing, triggering an alarm on the NPWT pump.

Here's a breakdown of the information based on your request, focusing on what can be gleaned from a 510(k) submission for a physical device modification:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it lists the types of bench testing conducted to verify the intended performance of the physical modifications. The "acceptance criteria" are implied to be "proper functioning as intended" for each test.

Acceptance Criteria (Implied)	Reported Device Performance
Proper functioning of device features and alarms	Verified to function as intended (Conclusion Statement)
Pressure stability	Verified to function as intended (Conclusion Statement)
Exudate removal	Verified to function as intended (Conclusion Statement)
Usability	Verified to function as intended (Conclusion Statement)
Detection of blockage or occlusion leading to alarm	Verified to function as intended (Conclusion Statement)
No change in safety or effectiveness of the system	Verified, leading to substantial equivalence determination (Conclusion Statement)

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

Sample Size: The document refers to "Bench Testing" but does not specify the sample sizes (e.g., number of dressing kits, canisters, or test runs) for each type of test.
Data Provenance: The document does not provide details on data provenance like country of origin or whether the data was retrospective or prospective. Given it's bench testing for a physical device, this level of detail is typically not reported in a 510(k) summary for such modifications.

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

Not applicable. This is a physical device modification, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the controlled experimental conditions and the direct measurement of the device's functional response.

4. Adjudication method for the test set

Not applicable. As this is not a study requiring human interpretation or labeling, there would be no adjudication method.

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 is not an AI/ML study.

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

Not applicable. This is not an AI/ML algorithm. The device itself (the tubing and canister modification) performs the "detection" of the occlusion, which then triggers an existing alarm system on the pump. It's a mechanical/sensor-based function, not an algorithm.

7. The type of ground truth used

For this physical device modification, the "ground truth" for the bench testing would be the controlled experimental conditions designed to simulate blockages, measure pressure, and evaluate exudate removal. The success or failure is determined by whether the device functions within pre-defined engineering specifications for detecting blockages and triggering alarms, maintaining pressure, and removing exudate. This is not established by expert consensus, pathology, or outcomes data in the way an AI/ML model for diagnosis would be.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable. As there is no training set mentioned or implied for an AI/ML model, this question is not relevant.

Summary of what the document does tell us about proving the device meets criteria:

The study done was bench testing.
The purpose of the testing was to verify that the modifications (dual lumen tubing, modified canister with three ports) perform as intended by allowing the detection of blockages/occlusions and triggering an alarm on the pump.
The specific tests included:
- Proper functioning of device features and alarms (specifically the new occlusion detection alarm).
- Pressure stability testing.
- Exudate removal testing.
- Usability testing.
The conclusion was that the performance data demonstrated the modifications function as intended with no change in safety or effectiveness compared to the predicate device, leading to a determination of substantial equivalence.
No clinical or animal performance studies were required for this specific substantial equivalence determination for the modification.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.

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

September 22, 2017

Cardinal Health Beth Foster Regulatory Affairs Manager 1500 S Waukegan Rd Waukegan, Illinois 60085

Re: K171499

Trade/Device Name: Occlusion Detection Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: August 29, 2017 Received: August 30, 2017

Dear Beth Foster:

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 (reporting of medical device

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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 (DICE) 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. 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

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 (DICE) 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,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K171499

Device Name

Cardinal Health NPWT Occlusion Detection Dressing Kit and Canister

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)

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Image /page/3/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic element above the company name. The graphic element is composed of three curved lines that converge at a point. The text "CardinalHealth" is written in a sans-serif font, with "Cardinal" in a darker shade than "Health".

Cardinal Health NPWT Dressing Kit and Canister Modification Traditional 510(k)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Cardinal Health NPWT Occlusion Detection Dressing Set and Canister

(A summary of safety and effectiveness information in accordance with the requirements of 21

510(k) Number:	K171499
Applicant:	Cardinal Health1500 S Waukegan RoadWaukegan, IL 60085
EstablishmentRegistration Number:	3006367520
Regulatory AffairsContact:	Beth Foster
Telephone:	954-585-5145
Fax:	N/A
E-mail:	beth.foster@cardinalhealth.com
Date Summary Prepared:	May 22, 2017
Trade Name:	Cardinal Health NPWT Occlusion Detection Dressing Kit and Canister
Common Name:	Negative Pressure Wound Therapy Dressing Kit and Canister
Classification Name:	Powered Suction Pump (21 CFR 878.4780)
Classification Panel:	General & Plastic Surgery
Regulatory Class:	Class II
Product Code(s):	OMP
Legally marketed device(s) to which equivalence is claimed:	K150124 Cardinal Health NPWT PRO HC
Reason for 510(k) Submission:	Modification of the tubing and fluid canister to allow detection of blockage or an occlusion that may occur in the dressing or within the tubing, which in turn triggers an alarm on the pump.
Device Description:	The Cardinal Health NPWT system consists of a powered suction pump device that provides continuous or intermittent negative pressure (SVED – K142916, PRO/PRO to GO/PRO at HOME – K143016, PRO HC – K150124) with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and fluid collection

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Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a sans-serif font, with the first letter capitalized and the rest in lowercase.

Cardinal Health NPWT Dressing Kit and Canister Modification Traditional 510(k)

canisters. The pump devices are AC-powered, portable suction devices with battery backup that provide localized negative pressure to remove fluids and infectious materials from the wound. The devices must be used with the Cardinal Health NPWT dressing kits, which are available in various foam sizes. Each Cardinal Health NPWT dressing kit contains an occlusion detection tubing set. various sizes of polyurethane foam, and a polyurethane drape with adhesive.

The Cardinal Health NPWT device is an integrated wound Indications for Use: management system, indicated for the application of continual or intermittent negative pressure wound therapy. The system 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.

Characteristics
Feature	Cardinal Health NPWT Dressing Kitwith Occlusion Detection	Cardinal NPWT PRO HC DressingKit without Occlusion DetectionK150124
Indications for Use	Same as predicate	The Cardinal Health NPWT SVEDPRO Family and PRO HC areintegrated wound managementsystems, indicated for theapplication of continual orintermittent negative pressurewound therapy to the wound as thedevice may promote wound healingby the removal of fluids, including
		wound exudates, irrigation fluids,body fluids and infectious materials.The system is intended for patientswith chronic, acute, traumatic,subacute and dehisced wounds,partial-thickness burns, ulcers (suchas diabetic pressure), flaps andgrafts. The system is intended foruse in acute, extended and homecare settings.
Product Code	OMP	OMP
Patient Population	Same as predicate	Adult single patient
Environment of Use	Same as predicate	Hospitals, Clinics, Long Term Careand Home Care settings
Used in conjunction with CardinalHealth NPWT pump devices	Same as predicate	Yes
Alarms	• Low Pressure/Leak• Canister Full/Blockage• Low Battery	• Low Pressure/Leak• Canister Full• Low Battery
Drape	Same as predicate	Polyurethane film with gentleacrylic adhesive
Foam Dressings	Same as predicate	• Black foam (Polyurethane),Hydrophobic, Open pore structure(400-600 microns) with multiplefoam sizes:Sm: 10x8x3 cmMed: 20x12.5x3cmLg: 25x15x3cmXLg: 58.5x33x3cm• White foam hydrophilic, highdensity, smaller pore size, flexiblewet or dry• Black foam (Polyurethane),Hydrophobic, Open pore structure(600-900 microns)Strips -25x3.8 x1.3 cm
Tubing	• Polyurethane tubing with ABSplastic port• Dual lumen tubing withSpeedConnect• Twist and lock port forattachment to canister	• Polyvinyl chloride tubing withFrench connect port• Single lumen tubing withSpeedConnect• French connect port to attach forattachment to canister
Canister	• Twist and lock port forattachment to tubing• Porous hydrophobic filter toprevent fluid ingress• 300cc and 500cc canister volume	• Grommet port for attachment totubing• Porous hydrophobic filter toprevent fluid ingress• 300cc and 500cc canister volume
Biocompatibility	Non-cytotoxicNon-sensitizingNon-irritating	Non-cytotoxicNon-sensitizingNon-irritating
Sterilization	Same as predicate	EtO Sterilization

Comparison of Technological otomiation

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Image /page/5/Picture/0 description: The image contains the Cardinal Health logo. The logo consists of a stylized red graphic above the text "CardinalHealth". The graphic is composed of several curved lines that converge at a point, resembling a stylized bird in flight or a medical symbol. The text is in a sans-serif font, with "Cardinal" in a slightly larger and bolder font than "Health".

Cardinal Health NPWT Dressing Kit and Canister Modification Traditional 510(k)

Performance Data

The following performance data were provided in support of the substantial equivalence determination. There were no Clinical or

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CardinalHealth	Cardinal Health NPWT Dressing Kit and Canister ModificationTraditional 510(k)
	Animal Performance Studies required for substantial equivalencedetermination.
	Bench TestingThe following testing has been conducted to verify that themodifications of the Dressing Kit and Canister, allowing thedetection of a blockage or occlusion, will perform as intended withthe Cardinal Health NPWT devices:
	Proper functioning of device features and alarms●Pressure stability testing●Exudate removal testing●Usability testing●
Conclusions	The performance data demonstrate that the modifications to theNPWT Dressing Kit and Canister function as intended with nochange in safety or effectiveness of the system and are considered

substantially equivalent to the predicate device.

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.