(121 days)
Not Found
No
The 510(k) summary describes a topical silicone spray for scar management and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the "management of old and new hypertrophic and keloid scarring," which is a therapeutic purpose.
No
The device is described as a topical silicone spray for the management of scars, not for diagnosing any condition. Its function is to form a film to manage scarring.
No
The device description clearly states it is a topical silicone spray with physical components (fumed silica, silicone elastomer, liquid, gum) and is provided in a can with a spray nozzle. This indicates a physical product, not software.
Based on the provided information, Kelo-Cote Spray is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "topical silicone spray intended for the management of old and new hypertrophic and keloid scarring." This is a therapeutic application, applied directly to the body surface.
- Device Description: The description details a "lightweight, self-drying silicone gel spray" that forms a film on the skin. This is consistent with a topical medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVDs are devices used to perform tests on samples taken from the human body to detect diseases, conditions, or infections. Kelo-Cote Spray does not fit this description.
N/A
Intended Use / 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.
Product codes
MDA
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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
72
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