(185 days)
Not Found
Not Found
No
The device description and intended use clearly describe a topical silicone gel for scar management, with no mention of any computational or analytical capabilities that would involve AI or ML.
Yes
The device is indicated for the topical management of keloid and hypertrophic scars, and for use in managing wound and keloid scarring resulting from various traumas, which constitutes a therapeutic purpose.
No
The device description indicates that HANSON SCAR ADE is a topical gel used for the management of scars. It is applied to the skin and is not described as being used to identify or diagnose any condition.
No
The device description clearly states it is a "topical gel made from silicones" and is "packaged in half ounce and one ounce plastic tubes," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "topical management of keloid and hypertrophic scars." This is a therapeutic or management use, not a diagnostic one.
- Device Description: The device is a "topical gel made from silicones" applied to the skin. This is a physical application to the body, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. HANSON SCAR ADE does not fit this description.
N/A
Intended Use / Indications for Use
HANSON SCAR ADE is indicated for the topical management of keloid and hypertrophic scars
Product codes
MDA
Device Description
HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended for use in many surgery, laser abrasion, chemical peels and other trauma. This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions. HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.
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)
Kelo-Cote topical gel (Advanced Bio-Technologies)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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AUG 1 2 2004
SECTION 9
510(k) SUMMARY STATEMENT
February 6, 2004
| Applicant: | Hanson Medical, Inc.
PO Box 1160, Kingston, Washington, 98346
Tel: 800.771-2215 Fax: 360.297-1998 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact
Representative: | John Harrison, PhD
Medical Devices Associates, International
Tel/Fax: 805.961-9334) Email: joli@west.net) |
"HANSON SCAR ADE" Proprietary Name: Elastomer, Silicone, for Scar Management Classification Name: Silicone gel for hypertrophic and keloid scar management Common Name: Class I Classification:
HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended HANSON SCAR ADE is a topical got mace from would and keloid scarring resulting from OTC for ass in many surgery, laser abrasion, chemical peels and other trauma.
This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions.
HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.
Hanson Medical HANSON SCAR ADE is substantially equivalent to Kelo-Cote topical gel (Advanced Bio-Technologies).
John Harrison, PhD (Consultant) Tel/Fax: 805-961-9334 Email: joli@west.net
1
Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three curved lines forming its wings and body, giving it a sense of motion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2004
Mr. Erik Hanson Vice President Hanson Medical, Inc. P.O. Box 1160 Kingston, Washington 98346
Re: K040307
Trade/Device Name: Hanson Scar Ade Regulatory Class: Unclassified Product Code: MDA Dated: July 27, 2004 Received: July 27, 2004
Dear Mr. Hanson:
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). and Oosmetie For ( roo ) roo ) roo, 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 If your device to such additional controls. Existing major regulations affecting your 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 or any I 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 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.
2
Page 2 - Mr. Erik Hanson
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 premarket notification. The sults 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 n you active of Compliance at (301) 594-4659. 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 other general mitotal 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 yours,
Muriam C. Provost
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K040307
HANSON SCAR ADE Device Name:
HANSON SCAR ADE is indicated for the topical Indications For Use: management of keloid and hypertrophic scars
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative. and Neurological Devices
510(k) Number K040307