The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

Device Description

The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C. Therapy System which is an integrated negative pressure wound management system. The dressing is polyurethane foam with a silver coating designed specifically for use with the V.A.C. family of negative pressure wound therapy devices.

AI/ML Overview

The provided documentation describes the V.A.C. GranuFoam Silver Protection Dressing and its substantial equivalence to a predicate device (K053627). The information primarily focuses on demonstrating equivalence rather than establishing acceptance criteria and performance against novel targets.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in terms of quantitative performance metrics for a new study. Instead, it demonstrates that the new device has "Same as predicate" or "equivalent results" for certain characteristics.

Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (New Device)
Indications for Use: Should be same as predicate with the addition of venous insufficiency ulcers.	"Same as predicate with the addition of venous insufficiency ulcers, cleared under 510(k) K091585."
Dressing composition: Should be same as predicate.	"Same as predicate"
Antibacterial activity: Should show equivalent activity against S. aureus, P. aeruginosa, and E. coli as the predicate device.	"Testing has been conducted and the product has been shown to pass these tests with equivalent results."

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for the antibacterial activity testing. The document mentions "Studies of the antibacterial activity of the predicate device were previously conducted" and then states "testing has been conducted" for the proposed change. It does not provide the sample size of the new testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the nature of the tests (antibacterial activity) suggests laboratory-based testing rather than patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here relates to the results of antibacterial activity in a laboratory setting, not clinical expert assessment.
Adjudication method for the test set:
- Not applicable, as the evaluation is based on laboratory test results, not expert review or adjudication.
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 (dressing) submission, not an AI software or imaging study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For antibacterial activity, the ground truth is likely defined by standardized microbiological testing protocols and quantitative measurements of bacterial reduction or inhibition, as compared to the established performance of the predicate device.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable.

Summary

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510(k) SUMMARY V.A.C. GranuFoam Silver Protection Dressing

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter Information [21 CFR 807.929(a)(1)]
Name	KCI USA, Inc. (Kinetic Concepts, Inc.)
Address	6203 Farinon Drive
	San Antonio, TX 78249
Phone number	210.515.4126
Fax number	210.255.6727
EstablishmentRegistration Number	1625774
Name of contactperson	Shannon Scott, Regulatory Affairs Manager
Date prepared	December 14, 2010
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietaryname	V.A.C. GranuFoam Silver® Protection Dressing
Common or usualname	Negative pressure wound therapy dressing
Classification name	Negative pressure wound therapy powered suction pump
Classification panel	General and Plastic Surgery
Regulation	878.4780
Product Code(s)	OMP
Legally marketeddevice(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)]	V.A.C. GranuFoam Silver Protection Dressing (K053627)
Device description[21 CFR 807.92(a)(4)]	The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C.Therapy System which is an integrated negative pressure wound managementsystem. The dressing is polyurethane foam with a silver coating designedspecifically for use with the V.A.C. family of negative pressure wound therapydevices.
Indications for use[21 CFR 807.92(a)(5)]	The V.A.C. GranuFoam Silver Protection Dressing is intended for use with theV.A.C. family of negative pressure wound therapy systems to help promote woundhealing. The dressing is an effective barrier to bacterial penetration and may helpreduce infection in chronic, acute, traumatic, subacute and dehisced wounds,partial thickness burns, ulcers (such as diabetic, pressure or venousinsufficiency), flaps and grafts.

DEC 1 5 2010

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Image /page/1/Picture/0 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in a bold, sans-serif font. A small registered trademark symbol appears to the right of the "I".

K102956
pg 2082

510(k) SUMMARY V.A.C. GranuFoam Silver Protection Dressing

Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
Characteristic	New DeviceV.A.C. GranuFoamSilver Protection Dressing	PredicateV.A.C. GranuFoamSilver Protection DressingK053627
Indications for use	Same as predicate with theaddition of venous insufficiencyulcers, cleared under 510(k)K091585.The V.A.C. GranuFoam SilverProtection Dressing is intendedfor use with the V.A.C. family ofnegative pressure wound therapysystems to help promote woundhealing. The dressing is aneffective barrier to bacterialpenetration and may help reduceinfection in chronic, acute,traumatic, subacute anddehisced wounds, partialthickness burns, ulcers (such asdiabetic, pressure or venousinsufficiency), flaps and grafts.	The V.A.C. GranuFoam SilverProtection Dressing is intendedfor use with the V.A.C. family ofnegative pressure woundtherapy systems to help promotewound healing. The dressing isan effective barrier to bacterialpenetration and may help reduceinfection in chronic, acute,traumatic, subacute, anddehisced wounds, diabeticulcers, pressure ulcers, flaps,grafts and partial thicknessburns.
Dressing composition	Same as predicate	Black, reticulated, polyurethanefoam with silver coating
Antibacterial activity	Same as predicate	Studies of antibacterial activityagainst S. aureus, P.aeruginosa, and E. coli.
Performance Data [21 CFR 807.92(b)]
[21 CFR 807.92(b)(1)]Summary of non-clinical tests conducted for determination of substantial equivalence	Studies of the antibacterial activity of the predicate device were previously conducted against S. aureus, P.aeruginosa, and E. coli. In support of the proposed change to the product specification, testing has beenconducted and the product has been shown to pass these tests with equivalent results.
[21 CFR 807.92(b)(2)]Summary of clinical tests conducted for determination of substantial equivalence or of clinicalinformation	No clinical tests were necessary.
Conclusions drawn [21 CFR 807.92(b)(3)]	The V.A.C. GranuFoam Silver Protection Dressing and its predicate (K053627) are identical in productdesign, composition and processing. V.A.C. GranuFoam Silver Protection Dressing is substantiallyequivalent to its predicate (K053627) in terms of safety, function and indications for use.

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Image /page/2/Picture/1 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 resembling an eagle or a stylized human figure, possibly representing health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

KCI USA, Inc. % Shannon Scott Regulatory Affairs Manager 6203 Fairnon Drive San Antonio, Texas 78249

DEC 15 2019

Re: K102956

Trade/Device Name: V.A.C. GranuFoam Silver Protection Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: November 22, 2010 Received: November 23, 2010

Dear Shannon 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 misleding.

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 - Shannon Scott

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 801); good manufacturing of medical
forth in the quality systems (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control (QD) regulation (21 CFR Part 820); and if applicable, the elections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Pat 801), please
go to http://www.fda.gov/AboutEDA/CentersOff go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/11/20/2019
the Center for Devices and Radiological Hoolth in ODE DRH/CDRHOffices/ucm/11/5809.htm for the Center for Devices and Radiological Health's (CDRH's) Offices/ucm1115809.html for
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, p note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part and of the other chance, "Insolanding of Ference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regu CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 the many of the Act from the
(800) 638-2041 or (301) 796-7100 or at its International and (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Harvard Business Resources for You/industry/default.htm.

Sincerely yours,

Az 13-nt

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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102956

DEC 1 5 2010

INDICATIONS FOR USE

510(k) Number (if known): Device Name: V.A.C. GranuFoam Silver Protection Dressing Indications for Use:

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)

David Kume for MXM
Division Sign-Off

Division of Surgical, Orthopedic, and Restorative Devices

Page of

(Posted November 13, 2003)

510(k) Number K102956
Page 1

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.