(141 days)
Not Found
Not Found
No
The device description and intended use focus solely on the physical properties and application of silicone sheets for scar reduction, with no mention of AI or ML technology.
Yes
The device is intended to reduce the appearance of hypertrophic scars by flattening and softening scar tissue and helping improve and regain natural skin color, which constitutes a therapeutic effect.
No
The device description states its purpose is to reduce the appearance of scars by flattening and softening scar tissue and helping to improve skin color. There is no mention of it being used to identify, detect, or monitor a medical condition, which are characteristic functions of a diagnostic device.
No
The device description clearly states it is a physical silicone sheet, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The description clearly states that the RETOUCH™ Silicone Scar Reduction Sheets are applied on the skin to reduce the appearance of scars. This is a topical application, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to reduce the appearance of scars by being worn on the skin. This is a physical intervention on the body's surface, not a diagnostic test.
Therefore, the device described is a topical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
NEARLY NETOUCHTMY Stillcone Scar Reduction Sheets are Soft durable silicone sheets designed to be worn on the skin for linited periods of time to reduce the appearance of hyp scars.
Product codes
MDA
Device Description
RETOUCH™ Silicone Gel Pads are designed to be worn on the skin for limited periods of time to reduce the appearance of healed hypertrophic and keloid scars. This is not a wound covering or dressing and should be worn 2-3 hours the first day and increase usage 1-2 hours each additional day, not to exceed 12 hours per day for 2-9 months depending on the type and severity of the scar.
RETOUCH™ Silicone Scar Reduction Sheets are soft, slightly adherent silicone gel sheets that are applied over healed hypertrophic and/or keloid scars. The sheets are not made of medical grade silicone and are not sterile. The sheets are rectangular and come in three sizes, 3.5 cm x 7 cm, 7 cm x 10.5 cm and 10.5 cm x 14 cm. They are approximately .125 of an inch thick. The customers will determine which size sheet is best for their own application. A sheet will not remove or eliminate the scar but will flatten and soften the scar tissue and help improve and regain the natural skin color.
The sheets are not for use on an open wound, are not sterile but can be washed. They are to be temporarily used on old or new healed hypertrophic or keloid scars and can be cut to other shapes if necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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)
Not Found
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.
0
APR 14 1999
510(k) SUMMARY
Submitter's Data:
State of intended use:
Device Description:
Capital Marketing Technologies, inc. 3630 South Interstate 35, Suite A Waco. Texas 76706 1-800-887-3370 or (254) 662-1752 Telephone: (254) 662-1760. Fax: Contact person(s): John Snyder or Vonna Muesse November, 1998 Date prepared:
RETOUCH™ Silicone Gel Pads are designed to be worn on the skin for limited periods of time to reduce the appearance of healed hypertrophic and keloid scars. This is not a wound covering or dressing and should be worn 2-3 hours the first day and increase usage 1-2 hours each additional day, not to exceed 12 hours per day for 2-9 months depending on the type and severity of the scar.
RETOUCH™ Silicone Scar Reduction Sheets are soft, slightly adherent silicone gel sheets that are applied over healed hypertrophic and/or keloid scars. The sheets are not made of medical grade silicone and are not sterile. The sheets are rectangular and come in three sizes, 3.5 cm x 7 cm, 7 cm x 10.5 cm and 10.5 cm x 14 cm. They are approximately .125 of an inch thick. The customers will determine which size sheet is best for their own application. A sheet will not remove or eliminate the scar but will flatten and soften the scar tissue and help improve and regain the natural skin color.
The sheets are not for use on an open wound, are not sterile but can be washed. They are to be temporarily used on old or new healed hypertrophic or keloid scars and can be cut to other shapes if necessary.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle faces left and is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," which are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1999
Mr. John Snyder Director of Research and Development Capital Marketing Technologies, Inc. 3630 South Interstate 35, Suite A Waco. Texas 76706
Re: K984213
Trade Name: Nearly Me® Retouch™ Silicone Scar Reduction Sheets Regulatory Class: Unclassified Product Code: MDA Dated: February 26, 1999 Received: March 1, 1999
Dear Mr. Snyder:
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 (Act). 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 (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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
2
Page 2 - Mr. John Snyder
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.
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
3
K984213
Page】 of l
510(k) Number (if known): K984213
Device Name: NEARLY ME(R) RETOUCH(TM) Silicone Scar Reduction Sheet: Indications For Use:
NEARLY NETOUCHTMY Stillcone Scar Reduction Sheets are
Soft durable silicone sheets designed to be worn on the skin for
linited periods of time to reduce the appearance of hyp scars.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Formal 1-2-96)
bradley
(Division Sign-Off) Division of General Restorative Devices / 9, 842 / 3 510(k) Number