V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT by KINETIC CONCEPTS, INC.

The V.A.C. Instillamat device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

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

Device Description

The V.A.C. Instillamat device is a modified V.A.C. device manufactured by Kinetic Concepts Inc. The V.A.C. Instillamat device combines technologies and features of the V.A.C. Plus device previously cleared by the FDA in 1999 [510(k) No. K992448] and the Ambulatory V.A.C. device previously cleared by the FDA in 1997 [510(k) No. K971548] with the additional modifications to provide a controlled delivery system for applying secondary wound treatments to a wound.

AI/ML Overview

This document is a 510(k) summary for the V.A.C. Instillamat device, which is a medical device for wound care. It discusses the device's classification, applicant information, description, indications for use, and substantial equivalence.

Based on the provided text, there is no acceptance criteria or study information that proves the device meets specific performance criteria in the way you've outlined for an AI/device performance study.

Here's why and what information is available:

This is a 510(k) submission for substantial equivalence. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically involve detailed performance studies with acceptance criteria in the manner of a novel AI algorithm.
The "study" referenced is compliance with safety standards. The document states: "The V.A.C. Instillamat device has essentially the same technologies and features as the previously cleared predicate devices and has been independently tested and successfully approved to the following medical safety standards: UL2601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4." This demonstrates electrical safety, electromagnetic compatibility, and general safety requirements for medical electrical systems, not clinical performance for wound healing or specific diagnostic accuracy.

Therefore, many of your requested points cannot be answered from this document.

Here's a breakdown of what can be extracted or inferred, and what cannot:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The implicit acceptance criterion is adherence to the listed safety standards (UL2601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4) and being "substantially equivalent" to predicate devices (V.A.C. Plus, Ambulatory V.A.C.) in terms of technology, features, and indications for use.
- Reported Device Performance: The document states the device was "independently tested and successfully approved to" these standards. No specific performance metrics like accuracy, sensitivity, or specificity (common for AI algorithms) are provided because this is not that type of study.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as no clinical performance study on a "test set" is described for this 510(k). The "testing" refers to compliance with engineering and electrical safety standards.
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):
- Not applicable. Ground truth establishment for a test set is not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is a powered suction pump for wound care, not an AI diagnostic or assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of clinical performance. For the safety standards, the "ground truth" is typically defined by the requirements of those standards (e.g., specific voltage limits, leakage current limits, EMC emission/immunity limits), and the device's electrical and mechanical performance is measured against these.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable.

In summary: The V.A.C. Instillamat device gained clearance (K021501) through a 510(k) pathway by demonstrating substantial equivalence to predicate devices (V.A.C. Plus, Ambulatory V.A.C.) and by successfully complying with relevant medical electrical safety and electromagnetic compatibility standards (UL2601-1, IEC 60601 series). This process does not involve clinical performance studies with acceptance criteria, sample sizes, or ground truth methodologies as would be seen for a diagnostic or AI-powered device.

Summary

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November 18, 2002

K021501

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

I. Name of Device:	V.A.C.® Instillamat Device	DEC 02 2002
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.K992448
	Ambulatory V.A.C.510(k) No.K971548

V. Description of Device

VI. Indications for Use

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

VII. Substantial Equivalence

The V.A.C. Instillamat device has essentially the same technologies and features as the previously cleared predicate devices and has been independently tested and successfully approved to the following medical safety standards:

UL2601-1, The Standard for Safety of Medical Electrical Equipment, 15 Edition 1994 .
. IEC 60601-1-1. Medical Electrical Equipment - Part 1: General Requirements for Safety; 1. Collateral Standard: Safety Requirements for Medical Electrical Systems
IEC 60601-1-2, Medical Electrical Equipment Part 1: General Requirements for Safety; . 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-4, Medical Electrical Equipment Part 1; General Requirements for Safety; . 4. Collateral Standard: Programmable Electrical Medical Systems

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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: K021501

Trade/Device Name: Vacuum Assisted Closure Instillamat Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 31, 2002 Received: September 2, 2002

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of December 2, 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 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

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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 vours.

For Pete Moore

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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Page

510(k) Number (if known): K021501

Device Name: V.A.C. Instillamat®

Indications For Use:

The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, 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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

110(k) Number ________________________________________________________________________________________________________________________________________________________________

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.