The V.A.C.® family of devices with woundsite feedback control are negative pressure devices used to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.

Device Description

All models of the VAC family of devices, including the V.A.C.® ATS™, mini V.A.C.®, and the V.A.C.® Freedom™, consist of a vacuum control unit with an integrated collection canister and power supply.

AI/ML Overview

The provided 510(k) summary for the V.A.C.® Therapy family of devices does not include information about specific acceptance criteria or an analytical study with performance metrics in the way a typical AI/ML device submission would.

This particular 510(k) is for a medical device (powered suction pump) that was reviewed for substantial equivalence to existing predicate devices based on its design, intended use, and functional testing. The "study" referenced is primarily design verification and validation testing, not a clinical trial or performance study with quantified metrics and statistical analysis against ground truth.

Therefore, many of the requested categories cannot be directly extracted from the provided text. However, I will answer the questions based on the information that is present and explain where information is not available.

Response based on the provided text:

Acceptance Criteria and Device Performance Study (V.A.C® Therapy family of devices)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative performance metrics in the provided document. The submission focuses on substantial equivalence to predicate devices.	Functional Performance: The devices in the V.A.C. family were subjected to "functional performance testing" and "electrical leakage testing."
	Equivalence to Predicates: The devices "do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness" compared to the V.A.C. Plus (K992448) and Ambulatory V.A.C. (K971548).
	Intended Use: The device performs as intended, which is to help promote wound healing through negative pressure, vacuum-assisted drainage, and removal of infectious material/fluids.
	Safety & Effectiveness: "raises no new safety or effectiveness issues."

Explanation: The document describes a "510(k) Summary" for a conventional medical device (Powered Suction Pump). The acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through design verification and validation testing (including functional and electrical safety), rather than through a comparative performance study with specific quantifiable metrics like sensitivity/specificity for diagnosis or a precise treatment outcome measure.

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

Sample Size for Test Set: Not applicable or not specified in relation to patient data. The "testing" mentioned refers to internal device verification and validation (functional and electrical tests), not a clinical trial on a patient cohort.
Data Provenance (country of origin, retrospective/prospective): Not applicable, as this was not a study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical outcomes or diagnostic accuracy, was not established for a test set in this 510(k) submission. The "ground truth" for this device's performance would be its ability to consistently apply controlled negative pressure and function safely, which is assessed through engineering and functional tests.

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

Adjudication Method: Not applicable. There was no clinical test set requiring adjudication of findings.

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

MRMC Comparative Effectiveness Study: No, an MRMC study was not done. This device is not an AI/ML diagnostic or therapeutic assistance tool for human readers/clinicians, but rather a direct treatment device.
Effect Size of Human Readers with/without AI: Not applicable.

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

Standalone Performance: Not applicable. This device is a physical medical device (powered suction pump), not an algorithm or software. It functions with human setup and monitoring, applying negative pressure directly to a wound.

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

Type of Ground Truth: For the device's functional performance, the ground truth would be adherence to engineering specifications and safety standards for powered suction pumps (e.g., maintaining specified negative pressure levels, electrical safety standards). For "intended use," the predicate devices' established safety and effectiveness serve as the comparative ground truth. No patient-level ground truth (like pathology or clinical outcomes) was utilized for a performance study described here.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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OCT 1 0 2003

Kψ32310 (P, 1of2)

510(K) SUMMARY: V.A.C® Therapy family of devices.

I. Name of Device:	V.A.C.® ATS™™, mini V.A.C.®,V.A.C.® Freedom™™
II. Classification Name:	Powered Suction Pump21 CFR 878.4780
III. 510(k) Applicant:	Kinetic Concepts, Inc. (KCI)8023 Vantage DriveSan Antonio, TX 78265-8508Contact: Judith Harbour 1-800-275-4524
IV. Substantial Equivalence:	V.A.C. Plus510(k) No.K992448Ambulatory V.A.C.510(k) No.K971548

V. Description of Device

VI. Intended Use of the Device

The V.A.C.® family of devices are feedback-controlled negative pressure devices used to help promote wound healing, through means including vacuum assisted drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent suction pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.

VII.Summary of the technological characteristics of the device compared to the predicate device.

Each of the devices in the V.A.C. family of devices consists of the same basic technology, and do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness. Each device consists of a vacuum control unit with an integrated collection canister and power supply (battery or AC). The primary differences in these models relate to size and weight. All models of the V.A.C. family of devices are designed to help promote wound healing, through the application of controlled negative pressure to the surface and margins of the wound. This negative pressure therapy is applied to the V.A.C. foam dressing positioned in the wound cavity or over a flap or graft. This pressure distributing foam dressing helps remove fluids from the wound. The devices are designed to treat wounds such as chronic, acute, traumatic, subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure); flaps; and grafts.

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V.A.C. Family of Devices Page 2

VIII. Testing

Verification and validation testing of the V.A.C. family of devices, including functional performance testing and electrical leakage testing, was conducted in accordance with established design control procedures.

IX. Conclusions

Based upon the testing and comparison to the predicate devices, the V.A.C. family of devices has the same intended uses, with similar technological characteristics. The system performs as intended and raises no new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the seal of the United States Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR -7 2009

KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230

Re: K032310

Trade/Device Name: The V.A.C.® family of devices:

mini V.A.C.®, V.A.C. ® Freedom™, V.A.C.® ATSTM

Regulation Number: 21 CFR 878.4780

Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP

Dated: July 21, 2003

Received: August 4, 2003

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of October 10, 2003.

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 (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.

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

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Page 2 - Ms. Christy Oviatt

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

For Pete Romano

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

Enclosure

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Statement of Indications for Use

Page 1 of 1

510(k) Number (if known): 大922310

Device Name:

The V.A.C.® family of devices: mini V.A.C.®, V.A.C.® Freedom™, V.A.C.® ATSTM

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:(per 21 CFR 801.109)	ORmirian C. Provos	Over the Counter Use:, (Optional Format 1-2-96)
	(Division Sign-Off)Division of General, Restorativeand Neurological Devices
	510(k) Number _	K0232316

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.