(553 days)
Not Found
No
The summary describes a physical device (cassette) for wound treatment and protection, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as an "adjuvant to normally accepted methods of wound and ulcer treatment" for conditions like "surgical wounds, non-healing, burns, and pressure ulcers," indicating its therapeutic purpose in wound healing.
No
The device description states that the LIFETECH CASSETTE is intended to serve as an "adjuvant to normally accepted methods of wound and ulcer treatment and to prevent airborne organisms from landing on the site." It is a treatment device, not a diagnostic device as it does not identify the nature of a disease or condition.
No
The device description explicitly states "The purpose of the LIFETECH CASSETTE is to serve as an adjuvant...". The term "cassette" strongly implies a physical hardware component, and the description focuses on preventing airborne organisms, which is a function of a physical barrier, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for treating surgical wounds, burns, and pressure ulcers. This involves direct application or interaction with the patient's body surface, not the examination of specimens derived from the human body (like blood, urine, tissue, etc.) which is the hallmark of IVDs.
- Device Description: The description reinforces the intended use by stating it serves as an adjuvant to wound and ulcer treatment and prevents airborne organisms from landing on the site. This is a physical barrier/treatment device, not a diagnostic test performed on a specimen.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing information about a disease or condition.
- Using reagents or assays.
- Measuring analytes.
The device's function is clearly related to wound management and protection, which falls under the category of medical devices used for treatment or prevention, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes
79KPJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
1
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)
2
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
3
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
INDICATIONS FOR USE VII.1 (Separate Page)
510(k) Number: 960765
JUL 6 6 Jan 20
Device Name: Lifetech Cassettes
-
- Surgical wounds, non-healing
-
- Burns,
-
- Pressure Ulcers
DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the Counter Use
(Optional Format 1-2-96)
repl. p. 9a
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number.
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