(78 days)
Not Found
Not Found
No
The device description and performance studies focus on the material composition and biocompatibility of a wound dressing, with no mention of AI or ML technology.
No.
The device is a dressing for managing wounds and does not contain bioactive components, indicating it primarily provides a physical barrier and support, not a therapeutic action to treat a disease or condition.
No
The device description and intended use indicate it is a wound dressing, not a device used to diagnose medical conditions.
No
The device description clearly states it is a physical dressing made of cellulose acetate fabric impregnated with a petrolatum emulsion, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dressing for managing wounds. This is a topical application for physical wound care.
- Device Description: The description details the physical composition of the dressing (cellulose acetate fabric impregnated with petrolatum emulsion). This is a physical barrier and treatment, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are designed to perform tests on such samples.
The device is a medical device, specifically a wound dressing, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kendall Curity Non-Adhering Dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the supervision of a health care professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.
Product codes
KMF
Device Description
The proposed Kendall Curity Non-Adhering Dressing is a sterile, single-use, dressing consisting of cellulose acetate fabric impregnated with a specially formulated petrolatum emulsion. It is packaged in clear polyester pouches and is available in 3" x 3", 3" x 8", 3" x 16" and 14" x 4 yds sizes.
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
Health care professional
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
Biocompatibility testing of the Kendall Curity Non-Adhering Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1. with the FDA modified matrix presented in memorandum G95-1.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Johnson & Johnson Medical, Inc., Adaptic® Non-Adhering Dressing
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
DEC I O 1997
EXHIBIT #6
510(k) Summary
Kendall Curity Non-Adhering Dressing
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by
Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 September 17, 1997 Date Prepared:
-
Contact Person 1.
David A. Olson Manager Regulatory Affairs (508) 261-8530 -
Name of Medical Device 2.
Classification Name: Unclassified Common or Usual Name: Non-Adhering Dressing -
Identification of Legally Marketed Device ਤੇ.
The proposed Kendall Curity Non-Adhering Dressing is substantially equivalent in intended use and composition to the Johnson & Johnson Medical, Inc., Adaptic® Non-Adhering Dressing which was in commercial distribution before May 28, 1976.
Device Description 4.
The proposed Kendall Curity Non-Adhering Dressing is a sterile, single-use, dressing consisting of cellulose acetate fabric impregnated with a specially formulated petrolatum emulsion. It is packaged in clear polyester pouches and is available in 3" x 3", 3" x 8", 3" x 16" and 14" x 4 yds sizes.
- Device Intended Use 5.
The Kendall Curity Non-Adhering Dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the supervision of a health care professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.
1
6. Product Comparison
The Kendall Curity Non-Adhering Dressing is equivalent to the referenced predicate device in that they are fabricated from similar materials, have a similar function and equivalent indications for use.
7. Nonclinical Testing
Biocompatibility testing of the Kendall Curity Non-Adhering Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1. with the FDA modified matrix presented in memorandum G95-1.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1997
Mr. David A. Olson "Manger, Regulatory Affairs The Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K973619 Kendall Curity Non-Adhering Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 18, 1997 Received: September 23, 1997
Dear Mr. Olson:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
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- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual
3
Page 2 - Mr. David A. Olson
registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4595. 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 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K973619
Device Name: Kendall Curity Non-Adhering Dressing
Indications For Use:
Theae dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burne, abrasions and lacerations. These dressings may also be used under the care of a health tare professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973619 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |