The Kendall NPWT Incision Management Dressing Kit, when used with a Cardinal Health NPWT CATALYST, ALLY or ALLY TO GO Devices, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. The Cardinal Health NPWT CATALYST, ALLY TO GO System is intended for use in acute, extended and home care settings.

Device Description

The Kendall Negative Pressure Wound Therapy Incision Management Dressing Kit is a wound dressing kit to be used with cleared Cardinal Health Negative Pressure Wound Therapy (NPWT) CATALYST, ALLY, and ALLY to GO systems (K171499).

The disposable single-use sterile Kendall NPWT Incision Management Dressing Kit consists of five dressing configurations, tubing, and drape strips. The dressing covers the closed surgical site and forms a seal over the sutured or stapled surgical site. The proximal end of the tubing is attached to the dressing while the distal end of the tubing attaches to an exudate canister. The powered suction pump delivers negative pressure to the dressing to aid in the removal of exudate from the wound into the exudate canister. The drape strips are used to patch any air leaks if necessary.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria, study details, and how the device meets those criteria:

Device: Kendall NPWT Incision Management Dressing Kit

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Prevena Plus Incision Management System) through various non-clinical tests. The reported device performance is presented as successfully meeting the objectives of these tests, implying they are comparable to or within acceptable limits for the predicate.

Acceptance Criteria (Implied by Testing Objectives)	Reported Device Performance
Biocompatibility: Meet ISO 10993-1 for limited contact exposure (>24 hrs to <30 days) on breached/compromised surface (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Subacute/Subchronic Toxicity, 4 Week Full Thickness Wound Healing in Rats)	Met: Testing demonstrated biocompatibility per ISO 10993-1 standards.
Absorbency: Demonstrate absorption of wound exudate in the absence of negative pressure	Met: Demonstrated the dressing can absorb wound exudate.
Alert Testing: Not inhibit NPWT CATALYST/ALLY Systems from detecting leaks, occlusion, or full canister	Met: Dressing Kit does not inhibit the NPWT systems' alert capabilities.
Useful Life Testing: Maintain target pressure and transport simulated exudate over the useful life (7 days maximum)	Met: Confirmed the dressing can maintain target pressure and transport simulated exudate over its useful life (stated as 7 days maximum).

Missing Information Regarding AI/Machine Learning Studies:

The provided text does not contain any information about an AI/Machine Learning device or study. The device described is a medical dressing kit for Negative Pressure Wound Therapy (NPWT), a physical medical device. Therefore, the following sections pertinent to AI/ML device studies cannot be addressed based on the given text:

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

Conclusion Regarding Device Acceptance and Study:

The Kendall NPWT Incision Management Dressing Kit gained FDA clearance (K191101) based on a demonstration of substantial equivalence to a predicate device, the Prevena Plus Incision Management System (K180855). This was achieved through a series of non-clinical tests, including biocompatibility and bench testing:

Biocompatibility Testing: Conducted in accordance with ISO 10993-1 standards to support limited contact exposure.
Bench Testing: Included absorbency tests, alert system compatibility tests, and useful life tests. These tests confirmed the dressing's ability to absorb exudate, not interfere with the compatible NPWT pump's alert functions, and maintain performance (target pressure and exudate transport) over its intended 7-day use life.

The document explicitly states: "There were no Human Clinical or Animal Performance Studies required for substantial equivalence determination." This means the clearance was based entirely on the non-clinical and bench testing, demonstrating that the device functions as intended and is comparable to the predicate regarding safety and effectiveness, despite some technological differences (e.g., presence of silver in predicate dressing, different compatible NPWT devices, varying pressure settings, and a shorter maximum use life for the proposed device). The conclusion is that these differences "are not critical to the intended use of the device" and "do not affect the safety and effectiveness."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

July 31, 2020

Cardinal Health Christine Kuntz-Nassif Regulatory Affairs Manager 777 West Street Mansfield, MA 02048

Re: K191101

Trade/Device Name: Kendall NPWT Incision Management Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: June 29, 2020 Received: July 1, 2020

Dear Christine Kuntz-Nassif:

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. 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/cfpmn/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

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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 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 (OS) 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,

Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191101

Device Name

Kendall NPWT Incision Management Dressing Kit

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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510(k) Summary

1. 510(k) Owner:

Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 Telephone: (954) 585-5145

Contact: Christine Kuntz-Nassif Title: Regulatory Affairs Manager Date Prepared: July 31, 2020

2. Device:

Trade Name: Kendall NPWT Incision Management Dressing Kit Common Name: Negative Pressure Wound Therapy Dressing Kit Classification Panel: General & Plastic Surgery Regulation Number: 21 CFR 878.4780 Product Code: OMP Classification: Class II

3. Predicate Devices:

Prevena Plus Incision Management System (K180855)

4. Device Description:

5. Indications for Use:

The Kendall NPWT Incision Management Dressing Kit, when used with Cardinal Health NPWT CATALYST, ALLY, and ALLY TO GO Devices, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. The Cardinal Health NPWT CATALYST, ALLY, or ALLY TO GO System is intended for use in acute, extended and home care settings.

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6. Technological Characteristics Comparison

Elements of	Proposed Device	Predicate Device
Comparison	Kendall NPWT Incision Management Dressing Kit	Prevena Plus Incision ManagementSystem
Indications for Use	The Kendall NPWT Incision ManagementDressing Kit, when used with a Cardinal HealthCATALYST, ALLY or ALLY TO GO NPWTDevices, is intended to manage the environment ofsurgical incisions that continue to drain followingsutured or stapled closure by maintaining a closedenvironment and removing exudate via theapplication of negative pressure wound therapy.The Cardinal Health NPWT CATALYST, ALLY,or ALLY TO GO System is intended for use inacute, extended and home care settings.	The Prevena Plus Incision ManagementSystem is intended to manage theenvironment of surgical incisions thatcontinue to drain following sutured orstapled closure by maintaining a closedenvironment and removing exudate via theapplication of negative pressure woundtherapy.
Product Code	OMP	OMP
Patient Population	Adult	Adult
Environment of Use	Hospitals, Clinics, Long Term Care and HomeCare settings	Hospitals, Clinics, Long Term Care andHome Care settings
Reusable	Single use only	Single use only
Sterilization	EtO	EtO
Dressing KitComponents	• Layered dressing containing a film drape, foamand contact underlayer that wicks fluid away fromthe surface of the incision• Dual lumen polyvinyl urethane tubing withSpeedConnect to connect to dressing and Twist'N Connect ABS exudate canister connector• Drape strips	• Layered dressing containing a filmdrape, foam and contact underlayercontaining Iconic Silver that wicks fluidaway from the surface of the incision• Tubing with SENSAT.R.A.C to connectto dressing and exudate canisterconnector• Patch/Sealing strips, drapes
Dressing Sizes	• 10 x 20 cm• 10 x 41 cm• 15 x 20 cm• 10 x 30.5 cm• 15 x 30.5 cm	• 35 cm Peel and Place• 20 cm Peel and Place• 13 cm Peel and Place• Customizable
Compatible NPWTDevices	• CATALYST• ALLY• ALLY TO GO	• Prevena Plus
Negative Pressure atWound Site	• ALLY/ALLY TO GO: -50, -75, -100, -125,-150mmHg• CATALYST: -70, -120, -150mmHg	• -125mmHg
Use Life of Dressing	7 days maximum	14 days maximum

Table of Comparison to Predicate Device

At a high level, the Kendall NPWT Incision Management Dressing Kit and the predicate device are based on the following same technological elements:

Indications for Use
Environment of Use
· Patient Population
· Use of drape/sealing strips to patch potential leaks in the dressing
· Use of a multi-lumen tubing for identification of blockages
· Connections at proximal end to dressing and distal end to exudate canister
· Layered dressing containing foam and non-stick contact layer
Single use only

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The following technological differences exist between the subject and predicate device:

. Prevena skin interface layer contains silver to reduce microbial colonization in the fabric, Kendall NPWT Incision Management Dressing does not contain silver
. Prevena dressing kit is used at -125mmHg. Kendall NPWT Incision Management Dressing Kit can be used at the following negative pressures: -50mmHg, -75mmHg. -100mmHg, -125mmHg and -150mmHg with the ALLY/ALLY TO GO and-70mmHg, -120mmHg and -150mmHg with the CATALYST.

These differences are not critical to the intended use of the device. When the Kendall NPWT Incision Management Dressing Kit is used as indicated, these differences do not affect the safety and effectiveness and are not critical to the intended use.

7. Performance Data

Biocompatibility Testing:

The biocompatibility of the Kendall NPWT Incision Management Dressing Kit has been demonstrated through testing per ISO 10993-1 to support limited contact exposure (>24 hours to <30 days) on a breached or compromised surface. The biocompatibility testing included the following:

Cytotoxicity
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Subacute/Subchronic Toxicity ●
4 Week Full Thickness Wound Healing in Rats ●

Non-Clinical Testing

Bench Testing

The following testing has been conducted to support the conclusion that the proposed device is substantially equivalent to the predicate device:

Absorbency to demonstrate that the proposed incision management dressing can; in the absence of negative pressure absorb wound exudate.
Alert Testing to demonstrate that the Kendall NPWT Incision Management Dressing Kit does not inhibit the NPWT CATALYST/ALLY Systems from detecting and producing an alert of leaks, or occlusion detection/canister full.
. Useful Life Testing to confirm the proposed Kendall NPWT Incision Management Dressing Kit can maintain target pressure and transport a simulated exudate away from the wound site into a fluid collection canister over the useful life of the dressing comparable to the predicate device.

There were no Human Clinical or Animal Performance Studies required for substantial equivalence determination.

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8. Conclusion:

The performance data demonstrate that the proposed Kendall NPWT Incision Management Dressing Kits function as intended and are considered substantially equivalent to the predicate device and does not raise different questions of safety and effectiveness.

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.