The V.A.C. System is a powered suction pump system that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.

Device Description

This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448.

AI/ML Overview

The provided text describes the V.A.C. System, a powered suction pump intended to promote wound healing. However, the document provided is a 510(k) summary and subsequent FDA approval letter for a labeling change only, not a new device submission that would typically include a detailed clinical study for novel acceptance criteria.

The key statement is: "This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448."

Therefore, the document does not contain specific acceptance criteria from a new study proving performance against those criteria in the way one would expect for a novel device or a major design change. Instead, it refers to existing market experience and previously established safety and effectiveness.

Here's a breakdown of what can be inferred or is explicitly stated, addressing the prompt's questions as much as possible, while also noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This table cannot be created from the provided text, as formal acceptance criteria for a new clinical study are not presented. The document focuses on expanding the "Indications for Use" based on existing data and market experience of an already cleared device.

The implied acceptance criteria for the labeling change appear to be:

Safety and Effectiveness for Partial-Thickness Burns: Demonstrated through existing clinical experience and literature for an already cleared device.

The reported "performance" (or evidence supporting the labeling change) is:

"KCI has worked through non-KCI clinicians to gather data to establish the safety and effectiveness of the V.A.C. System."
"V.A.C. units have been used internationally treating well over 20,000 acute and chronic wound patients."
"Major burn centers have been using V.A.C. therapy to assist with healing burns for several years."
"We believe the findings of the clinical studies, cases reported in the literature, as well as informal reports by clinicians warrants the additional claim that V.A.C. treatment assists in healing partial-thickness burns."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "well over 20,000 acute and chronic wound patients" used internationally prior to this submission. This is the collective experience, not a single 'test set' for this specific labeling change. The document does not specify a separate 'test set' for the partial-thickness burn indication beyond the general market experience.
Data Provenance: The data comes from "non-KCI clinicians" and "Major burn centers" using V.A.C. internationally. This suggests a collection of real-world use data, likely a mix of prospective and retrospective observations, reported cases, and literature. Specific countries are not mentioned beyond "internationally."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided. The text mentions "non-KCI clinicians" and "Major burn centers" but does not detail a specific panel of experts used to establish ground truth for a controlled test set in the context of this submission. The "ground truth" seems to be derived from the accumulated clinical experience of various practitioners.

4. Adjudication Method for the Test Set

This information is not provided. Given that the evidence is based on accumulated market experience and literature reviews rather than a single, controlled clinical trial, a specific adjudication method as typically understood for a new study's test set would not apply.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done (or at least not reported in this document). The submission is for a labeling change based on existing device use and general clinical experience, not a study comparing human readers with and without AI assistance. The device in question is a medical pump, not an AI diagnostic tool.

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

Not applicable. The V.A.C. System is a medical device (powered suction pump), not an algorithm or AI system. Its performance is intrinsically linked to its application by a healthcare professional ("human-in-the-loop").

7. The Type of Ground Truth Used

The ground truth relies on clinical outcomes and observations from real-world usage ("safety and effectiveness," "healing burns," "assists in healing"). This is based on aggregated clinical experience, reports, and published literature, rather than a single, pre-defined ground truth like pathology or a tightly controlled expert consensus for a specific test set.

8. The Sample Size for the Training Set

Not applicable in the AI/Software sense. The V.A.C. System is a hardware device. If "training set" refers to the prior data informing its original clearance and subsequent use, it would be the "well over 20,000 acute and chronic wound patients" mentioned. However, this is not a 'training set' in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable in the AI/Software sense. For a medical device like the V.A.C., the "ground truth" for its efficacy and safety (which guides its development and indications) is established through established medical practices, clinical trials (for its initial clearance, K992448), and ongoing clinical experience and research.

In summary, this document is an FDA 510(k) summary for a labeling change of an already cleared medical device. It does not describe a new clinical study with defined acceptance criteria, test sets, or ground truth establishment in the way one would for a novel device or an AI/software product. Instead, it leverages the extensive real-world experience and existing literature on the device to justify the expanded indication.

Summary

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K021500

510(K) SUMMARY: V.A.C.

I. Name of Device:	V.A.C.® (Vacuum Assisted Closure™)
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.510(k) No.K945062

V.A.C. PLUS

510(k) No.K992448

V. Description of Device

V. Indications for Use

The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.

VI. Clinical Studies to Support Labeling Claims

Since the V.A.C.® System was placed on the market in 1995, KCI has worked through non-KCI clinicians to gather date to establish the safety and effectiveness of the V.A.C. System. V.A.C. units have been used internationally treating well over 20,000 acute and chronic wound patients. Major burn centers have been using V.A.C. therapy to assist with healing burns for several years. We believe the findings of the clinical studies, cases reported in the literature, as well as informal reports by clinicians warrants the additional claim that V.A.C. treatment assists in healing partial-thickness burns.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

APR -7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021500

Trade/Device Name: Vacuum Assisted Closure (VAC) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: October 7, 2002 Received: October 10, 2002

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of December 20, 2002.

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 vour 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

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Page 2 - Ms. Christy Oviatt

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 (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.

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,

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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510(k) Number (if known): K021500

Device Name: The V.A.C.® System

Indications For Use:

*The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

(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) Over-The-Counter Use (Optional Format 1-2-96)

Page

Miriam C. Provost

: Vision Sign-Off Civision of General, Restorative and Neurological Devices

K021500

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.