The KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™, V.A.C. ® Freedom, V.A.C. ATS® and V.A.C.Ulta™ Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Wound types include chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The KCI NPWT Gauze Dressing is not intended for use with instillation therapy, intermittent therapy or over closed incisions.

Device Description

The KCI NPWT Gauze Dressing is a convenience kit that consists of the following currently marketed products:
• One Kerlix AMD Roll, identical to predicate (antimicrobial gauze wound dressing)
• One V.A.C. SensaT.R.A.C.™ Pad (connection to KCI NPWT source)
• Two V.A.C. Drapes
• One wound measuring ruler

The currently marketed sterile products are kitted in a non-sterile package. The kit is provided in one size and is intended to be single use.

AI/ML Overview

The KCI NPWT Gauze Dressing is a convenience kit for Negative Pressure Wound Therapy (NPWT). The 510(k) summary (K123507) outlines non-clinical tests to demonstrate substantial equivalence to a predicate device, Smith and Nephew's RENASYS™ Gauze NPWT Wound Dressing Kit with Softport (K110647).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KCI NPWT Gauze Dressing were primarily focused on performance specifications related to negative pressure delivery and exudate removal. These were evaluated through non-clinical validation tests.

Acceptance Criteria	Reported Device Performance
Delivers negative pressure within specification to the top of the wound site for a period of 72 hours.	The KCI NPWT Gauze Dressing, when used with KCI V.A.C. Negative Pressure Wound Therapy Units, delivers negative pressure within specification to the top of the wound site for a period of 72 hours.
Removes exudate from the wound for a period of 72 hours.	The KCI NPWT Gauze Dressing, when used with KCI V.A.C. Negative Pressure Wound Therapy Units, removes exudate from the wound for a period of 72 hours.
Does not contribute to false blockage alarms when used with KCI V.A.C. Negative Pressure Wound Therapy Units.	The KCI NPWT Gauze Dressing, when used with the V.A.C. Negative Pressure Wound Therapy Units, do not contribute to false blockage alarms.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The provided document does not specify the sample size for the non-clinical tests (design verification and validation). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These were laboratory-based performance tests, not human subject studies.

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

Not applicable. The "ground truth" in this context refers to engineering and performance specifications for negative pressure delivery and exudate removal, rather than clinical diagnoses or interpretations that would require expert consensus. The non-clinical tests would have been designed and evaluated by engineers and testing personnel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to establish a ground truth. For these non-clinical performance tests, the outcome would be determined by objective measurements against predefined engineering specifications.

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. This is a medical device (wound dressing kit) and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.

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

The device is a medical dressing kit and does not involve an "algorithm" in the sense of software for diagnosis or image analysis. The "standalone performance" refers to the dressing kit's ability to, for example, maintain negative pressure and remove exudate independently, which was indeed evaluated in the non-clinical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these tests was based on engineering specifications and scientific principles related to negative pressure wound therapy. This would involve:

Physical measurements: Quantifying negative pressure exerted, volume of exudate removed.
Functional performance: Observing the absence of false blockage alarms.
Comparison to predicate: Demonstrating that the performance is comparable to the legally marketed predicate device (RENASYS™ Gauze NPWT Wound Dressing Kit).

8. The sample size for the training set

Not applicable. This device is a physical medical dressing kit and does not require a "training set" in the context of machine learning. The components are pre-existing, legally marketed products that are kitted together. The evaluation focused on the performance of the combined kit.

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

Not applicable. As the device does not employ machine learning or AI, there is no "training set" or corresponding ground truth establishment process in that regard.

Summary

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K123507

510(k) SUMMARY

APR 4 2013

KCI NPWT Gauze Dressing

Date prepared	March 4, 2013
510(k) owner
• Name	KCI USA, Inc. (Kinetic Concepts, Inc.)
• Address	6203 Farinon Drive; San Antonio, Texas 78249
• Phone number	210 255-6345
• Fax number	210 255-6727
• Name ofcontact person	Anona Goebel
Name of the device
Trade orproprietaryname	KCI NPWT Gauze Dressing
Common orusual name	Negative pressure wound therapy system (gauze dressing component)
Classificationname	Negative pressure wound therapy powered suction pump(and components)
Legallymarketeddevice(s) towhichequivalence isclaimed	Smith and Nephew's RENASYS™ Gauze NPWT Wound Dressing Kit withSoftport510(k) Number: K110647
Device description
• Device design	The KCI NPWT Gauze Dressing is a convenience kit that consists of thefollowing currently marketed products:• One Kerlix AMD Roll, identical to predicate (antimicrobial gauze wounddressing)• One V.A.C. SensaT.R.A.C.™ Pad (connection to KCI NPWT source)• Two V.A.C. Drapes• One wound measuring ruler
	The currently marketed sterile products are kitted in a non-sterile package.The kit is provided in one size and is intended to be single use.
• Indications forUse	The KCI NPWT Gauze Dressing is intended to be used with the followingKCI Therapy Units (ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™, V.A.C.®Freedom, V.A.C. ATS® and V.A.C.Ulta™ Therapy Systems). The system isintended to create an environment that promotes wound healing bysecondary or tertiary (delayed primary) intention by preparing the woundbed for closure, reducing edema, promoting granulation tissue formationand perfusion, and by removing exudate and infectious material. Woundtypes include chronic, acute, traumatic, subacute and dehisced wounds,partial-thickness burns, ulcers (such as diabetic, pressure or venousinsufficiency), flaps and grafts.
	The KCI NPWT Gauze Dressing is not intended for use with instillation
Summary of thetechnologicalcharacteristicsof the devicecompared tothe predicatedevice	Feature	KCI NPWT GauzeDressing	Predicate RenasysGauze NPWTDressing Kit
	Dressing
		Material	Same as predicate
		Configuration	Identical to the large size ofthe predicate
		Drape	Currently marketed V.A.C.Drape (polyurethane filmwith acrylic adhesive)
		Interface pad andtubing	Currently marketedV.A.C. SensaT.R.A.C.TMPad
		Wound measuringruler	Same as predicate
		Accessories: Saline,skin prep, non-adherent layer	Not provided
	NPWT Therapy UnitsCompatibility	Compatible with thefollowing KCI V.A.C.Negative Pressure WoundTherapy Units:ActiV.A.C.InfoV.A.C.V.A.C. ATSV.A.C. FreedomV.A.C. SimplicityV.A.C.Ulta	Compatible with S&Ntherapy units:RENASYS EZRENASYS GO
Summary of non-clinical testsconducted fordetermination ofsubstantialequivalence	The KCI NPWT Gauze Dressing was evaluated under a number of designverification and validation tests to assure performance requirements fordelivery of negative pressure wound therapy were met.
	● The KCI NPWT Gauze Dressing when used with the V.A.C. NegativePressure Wound Therapy Units delivers negative pressure withinspecification to the top of the wound site for a period of 72 hours.● The KCI NPWT Gauze Dressing when used with the V.A.C. NegativePressure Wound Therapy Units removes exudate from the wound fora period of 72 hours.● The KCI NPWT Gauze Dressing when used with the V.A.C. NegativePressure Wound Therapy Units do not contribute to false blockagealarms.
Summary ofclinical testsconducted for	None required for determining substantial equivalence

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[ [ [ [ ] [ ] ] ] therapy, intermittent therapy or over closed incisions.

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determination ofsubstantialequivalence
Conclusionsdrawn	Testing demonstrates that the KCI NPWT Gauze Dressing and theRENASYS™ Gauze NPWT Wound Dressing Kits with Softport aresubstantially equivalent in terms of both indications for use and delivery ofnegative pressure wound therapy.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 4, 2013

KCI USA, Inc. % Ms. Anona Goebel Senior Manager, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249

Re: K123507

Trade/Device Name: KCI NPWT Gauze Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP, FRO Dated: March 04, 2013 Received: March 07, 2013

Dear Ms. Goebel:

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

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Page 2 - Ms. Anona Goebel

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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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, FOR

Peter Di Rumm -S

Mark N. Melkerson Acting 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): K123507 Device Name: KCI NPWT Gauze Dressing

Indications for Use:

The KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™, V.A.C. ® Freedom, V.A.C. ATS® and V.A.C.Ulta™ Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudate and infectious material. Wound types include chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The KCI NPWT Gauze Dressing is not intended for use with instillation therapy, intermittent therapy or over closed incisions.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of a

(Posted November 13, 2003)

Jiyoung Dang -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123507

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.