The purpose of the LIFETECH CASSETTE is to serve as an adjuvant to normally accepted methods of wound and ulcer treatment and to prevent airborne organisms from landing on the site. The device may be indicated for non-healing surgical wounds, burns, and pressure ulcers.

Device Description

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria. This document is a 510(k) submission for a medical device (Lifetech Cassette) seeking substantial equivalence to a previously marketed device.

Here's what can be inferred from the provided text regarding the closest relevant sections you've requested:

1. A table of acceptance criteria and the reported device performance

The document does not specify any quantitative acceptance criteria or provide performance data for the Lifetech Cassette itself. Instead, it relies on substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

No test set or data provenance is mentioned as this is a 510(k) submission based on substantial equivalence, not a clinical trial with a test set.

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

Not applicable, as no test set or ground truth establishment by experts is described for performance evaluation.

4. Adjudication method for the test set

Not applicable, as no test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No MRMC study is mentioned. The submission focuses on substantial equivalence based on intended use and technological characteristics.

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

This is not applicable as the device described is a physical medical device (Topical Oxygen Chamber), not an algorithm or software.

7. The type of ground truth used

Not applicable, as a ground truth is not established or discussed for the purpose of performance evaluation. The "truth" in this context is the substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable, as this is a physical medical device and does not involve a training set as would be used for an algorithm.

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

Not applicable, for the same reason as point 8.

Summary of what the document does provide:

Device Name: Lifetech Cassette
Intended Use: Adjuvant to normally accepted methods of wound and ulcer treatment and to prevent airborne organisms from landing on the site. Indicated for non-healing surgical wounds, burns, and pressure ulcers.
Classification: Class III, but proposed for Class II.
Substantial Equivalence: The submission asserts that the Lifetech Cassette is substantially equivalent to generic topical oxygen chambers (CFR 878.5650) and specifically to the device cleared by K920948.
Rationale for Substantial Equivalence:
1. Same intended use as topical oxygen chambers.
2. Technological characteristics are substantially equivalent to generic and previously cleared predicate devices.
3. Materials (polyvinyl chloride or polyethylene) are equivalent and nearly identical to similar products on the market.
4. Sufficiently precise specifications for materials have been supplied.
Sterilization: Gamma radiation or Ethylene Oxide, following AAMI guidelines, with validation for a minimum sterility assurance level of 10^-6.

The document is a regulatory submission for premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive new performance data or clinical study results against defined acceptance criteria.

Summary

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K 460756

100 29

X. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. [Separate page].

A. Submitted by: Lifetech Systems, Inc.
A. Contact: John Oberst, Vice President, 11350 Random Hills Rd., Fairfax, VA 22030
I. Classification Names and numbers:

Oxygen Chamber, Topical, Extremity, 79KPJ (CFR 878.5650, Class III)

II. Common/Usual Names:
Topical Oxygen Chamber.
III. Proprietary Names:
Lifetech Cassette
IV. Establishment Registration Number: In process
V. Classification:

مدالي ام ام به ولب عل البراب

Topical oxygen chambers were classified in CFR 878.5650, Class III, by the General and Plastic Surgery Panel. They were proposed for Class II by this panel (FR Jan. 10, 1982) but this proposed rule apparently has not been acted upon.

VI. Performance Standard:

None established under section 514.

VII. Description of the Device:
The purpose of the LIFETECH CASSETTE is to serve as an adjuvant to normally accepted methods of wound and ulcer treatment and to prevent airborne organisms from landing on the site. The device may be indicated for non-healing surgical wounds, burns, and pressure ulcers.

VII.1 Sterilization Cleaning, and Packaging Procedures

Lifetech Cassettes are sterilized using gamma radiation or gas sterilization with Ethylene Oxide. When sterilized with radiation, the AAMI guideline "Process Control Guidelines for Gamma Radiation Sterilization of Medical Devices," is followed for this process. Sterilization cycles are validated to provide a minimum sterility assurance level of 10% (10 to the minus 6th). Validation is established by the overkill method. The specified dosage range is from 2.5 to 4.0 MRads.

VIII. Labels and Labeling:
Labels and labelling for the Lifetech Cassettes and competitive products were provided and compared.
IX. Substantial Equivalence Statement:
The Lifetech Cassette is substantially equivalent to the generic devices which were proposed for classification under CFR 878.5650 under "Topical 0xygen Chamber for Extremities".

The device is also substantially equivalent to several oxygen chambers used for topical purposes, for example that cleared by K920948.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from

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ODE Guidance Memorandum #86-3 was followed as described below:

The Cassettes have the same intended use as an aid in healing as described in the topical oxygen chamber.
The technological characteristics for the new product are substantially equivalent to those of the generic devices and particularly close to the previously cleared predicate devices, currently on the market.
Descriptive information provided shows that the materials from which the Lifetech Cassette are made (polyvinyl chloride or polyethylene) are equivalent to and nearly identical with those of similar products used for medical purposes currently on the market.
Sufficiently precise specifications for the materials from which the Lifetech Cassettes are constructed, have been supplied.

(End)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Oberst LifeTech Systems, Inc. 11350 Random Hills Road, Suite 800 Fairfax, Virginia 22030

AUG 2 9

Re: K960756 Lifetech Cassette Trade Name: Regulatory Class: III Product Code: KPJ Dated: May 29, 1996 Received: May 31, 1996

Dear Mr. Oberst:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 You may, therefore, market the device, subject to the (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under

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Page 2 - Mr. John Oberst

sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

fo Sellez

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PAGE 06

K960756

INDICATIONS FOR USE VII.1 (Separate Page)

510(k) Number: 960765

JUL 6 6 Jan 20

Device Name: Lifetech Cassettes

1. Surgical wounds, non-healing
1. Burns,
1. Pressure Ulcers

DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use

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

repl. p. 9a

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number.

Regulation Number and Section

§ 878.5650 Topical oxygen chamber for extremities.

(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.