Kelo-Cote Spray is a topical silicone spray intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Device Description

Kelo-Cote Spray is a lightweight, self-drying silicone gel spray for the treatment of scars. Upon drying, the silicone gel layer forms a film for the management of scars. The components of Kelo-Cote Spray include fumed silica and silicone elastomer, liquid, and gum. It is provided in a can with a spray nozzle for application purposes.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called Kelo-Cote Spray. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, or comparative effectiveness studies.

Specifically, the following points cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence.
Sample sizes used for the test set and the data provenance: Not present. No test set described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no test set described.
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 is not an AI device, and no MRMC study is described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
The sample size for the training set: Not applicable, no training set for an algorithm described.
How the ground truth for the training set was established: Not applicable.

The submission states: "ABT believes Kelo-Cote Spray is substantially equivalent to legally marketed products: ABT's Kelo-Cote Topical Gel (K002488) and the Curad Spray Bandage (K022645)." and further clarifies that "The ABT Kelo-Coat Topical Gel provides a substantial equivalence basis for the intended use and components of Kelo-Coat Spray. The Curad Spray Bandage provides a substantial equivalence basis for the method of application of Kelo-Cote Spray." This indicates that rather than new studies, the equivalence is based on existing, predicate devices.

Summary

{0}------------------------------------------------

Advanced Bio-Technology

Premarket notification Kelo-Cote Spray

APR 1 4 2006

K053481
Page 1 of 2

5. 510(k) Summary

This 510(k) summary of safety and effectiveness is provided in accordance with 21 CFR 807.92.

Date of preparation: March 29, 2006

Sponsor

Advanced Bio-Technology, Inc. 3100 Bucklin Hill Rd., #220 Silverdale, WA 98383

Contact

Steven Chernoff Drug & Device Development Co. Phone: 425-861-8262 Fax: 425-869-5854 Email: schernoff@druganddevice.com

Device identification

Proprietary name: Kelo-Cote Spray Classification name: elastomer, silicone, for scar management CFR 878.4025 Product code: MDA

Indications for Use

Kelo-Cote Spray is a topical silicone spray intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Substantial Equivalence

ABT believes Kelo-Cote Spray is substantially equivalent to legally marketed products: ABT's Kelo-Cote Topical Gel (K002488) and the Curad Spray Bandage (K022645).

The ABT Kelo-Coat Topical Gel provides a substantial equivalence basis for the intended use and components of Kelo-Coat Spray. The Curad Spray Bandage provides a substantial equivalence basis for the method of application of Kelo-Cote Spray.

{1}------------------------------------------------

K05348

Device description

Kelo-Cote Spray is a lightweight, self-drying silicone gel spray for the treatment of scars. Upon drying, the silicone gel layer forms a film for the management of scars.

The components of Kelo-Cote Spray include fumed silica and silicone elastomer, liquid, and gum. It is provided in a can with a spray nozzle for application purposes.

{2}------------------------------------------------

Image /page/2/Picture/12 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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2006

Advanced Bio-Technologies, Inc. c/o Drug & Device Development Corp. Mr. Steven Chernoff P.O. Box 3515 Redmond, Washington 98073-3515

Re: K053481

Trade/Device Name: Kelo-Cote Spray Regulation Number: 21 CFR 878.4025 Regulation Name: Silicone sheeting Regulatory Class: I Product Code: MDA Dated: March 7, 2006 Received: March 8, 2006

Dear Mr. Chernoff:

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 application (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 such additional controls. Existing major regulations affecting vour 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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. Steven Chernoff

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 begin 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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Herbert Leonard wo

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Advanced Bio-Technology

Confidential

Premarket notification Kelo-Cote Spray

Indications for Use Statement

510(k) Number (if known): _ K 053481

Device Name: Kelo-Cote Spray

Indication for Use:

Kelo-Cote Spray is a topical silicone spray intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-the-counter Use ___ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Lemus Q.

Division of General, Restorative, and Neurological Devices

510(k) Number K053481

006

Regulation Number and Section

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.