(164 days)
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Not Found
No
The device description clearly states it is a silicone occlusive sheeting and the intended use is based on the physical properties of the material for scar management and prevention. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is intended for the "MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS" and "PREVENTION OF HYPERTROPHIC AND KELOID SCARS," and is described as a "NON-INVASIVE MEDICAL DEVICE THAT REDUCES HYPERTROPHIC AND KELOID SCARS," which indicates a therapeutic purpose.
No
The device description clearly states that ReJuveness is a "soft, durable reusable silicone occlusive sheeting" used to manage and prevent hypertrophic and keloid scars by softening, smoothing, and flattening them. Its function is therapeutic and preventative, not to identify or diagnose a medical condition.
No
The device description explicitly states that ReJuveness is a "SOFT, DURABLE REUSABLE SILICONE OCCLUSIVE SHEETING" and a "MEDICAL-GRADE, PURE SILICONE SHEETING," indicating it is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that ReJuveness is a "soft, durable reusable silicone occlusive sheeting." It is applied externally to the skin.
- Intended Use: The intended use is the "MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS" and "PREVENTION OF HYPERTROPHIC AND KELOID SCARS." This is a therapeutic and preventative application, not a diagnostic test performed on a sample.
The device is a topical medical device used for scar management, not for diagnosing a condition by analyzing a biological sample.
N/A
Intended Use / Indications for Use
MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS
- ReJuveness™ is effective in the management of hypertrophic and keloid scars. .
- Consistent use of ReJuveness ™ can reduce hypertrophic and keloid scarring. .
PREVENTION OF HYPERTROPHIC AND KELOID SCARS
- ReJuveness may be useful as a prophylaxis on closed scars to aid in the prevention of . hypertrophic and keloid scarring.
- If used following surgical procedures, ReJuveness™ may prevent hypertrophic and . keloid scarring.
- ReJuveness™ can be used as soon as the wound is closed, dry and the sutures have . been removed.
- ReJuveness™ may prevent scarring disorders. .
Product codes (comma separated list FDA assigned to the subject device)
MDA
Device Description
REJUVENESS IS A SOFT, DURABLE REUSABLE SILICONE OCCLUSIVE SHEETING. IT IS A MEDICAL-GRADE, PURE SILICONE SHEETING THAT IS MANUFACTURED IN THE USA.
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)
REJUVENESS HAS BEEN CIJNICALLY PROVEN EFFECTIVE IN THE NEW SCARS. MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS AND MAY RELIEVE THE BURNING AND ITCHING THAT IS CHARACTERISTIC OF SCARRING DISORDERS. REJUVENESS HAS ALSO SHOWN SUCCESS IN THE PREVENTION OF HYPERTROPHIC AND KELOID SCARS WHEN APPLIED FOLLOWING SURGICAL PROCEDURES.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
5188995320 P.02
K974380
510K SUMMARY
APR - 3 1998
RE: REJUVENESS 510(K) K974380
RICHMARK INTERNATIONAL CORP 100 SARATOGA VILLAGE BLVD. BALLSTON SPA, NY 12020
REJUVENESS IS A SOFT, DURABLE REUSABLE SILICONE OCCLUSIVE SHEETING. IT IS A MEDICAL-GRADE, PURE SILICONE SHEETING THAT IS MANUFACTURED IN THE USA.
REJUVENESS IS A NON-INVASIVE MEDICAL DEVICE THAT REDUCES HYPERTROPHIC AND KELOID SCARS RESULTING FROM BURNS, SURGICAL PROCEDURES AND TRAUMATIC EVENTS. IT SOFTENS, SMOOTHES AND FLATTENS SCARS AND RESTORES THEM TO A MORE NORMAL TEXTURE AND COLOR. WHEN USED DAILY AS DIRECTED, REJUVENESS HAS THE POTENTIAL TO DRAMATICALLY IMPROVE THE APPEARANCE OF BOTH OLD AND REJUVENESS HAS BEEN CIJNICALLY PROVEN EFFECTIVE IN THE NEW SCARS. MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS AND MAY RELIEVE THE BURNING AND ITCHING THAT IS CHARACTERISTIC OF SCARRING DISORDERS. REJUVENESS HAS ALSO SHOWN SUCCESS IN THE PREVENTION OF HYPERTROPHIC AND KELOID SCARS WHEN APPLIED FOLLOWING SURGICAL PROCEDURES.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1998
Mr. Richard Piccolo ·Richmark International Corporation 100 Saratoga Village Boulevard Ballston Spa, New York 12020
Re: K974380 Rejuveness Trade Name: Regulatory Class: Unclassified Product Code: MDA Dated: February 19, 1998 February 23, 1998 Received:
Dear Mr. Piccolo:
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, Druq, 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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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. Piccolo
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,
Joelle
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of Page_
510(k) Number (if known): K974380/S1
Device Name: ReJuveness Silicone Sheeting
Indications For Use:
MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS
- ReJuveness™ is effective in the management of hypertrophic and keloid scars. .
- Consistent use of ReJuveness ™ can reduce hypertrophic and keloid scarring. .
PREVENTION OF HYPERTROPHIC AND KELOID SCARS
- ReJuveness may be useful as a prophylaxis on closed scars to aid in the prevention of . hypertrophic and keloid scarring.
- If used following surgical procedures, ReJuveness™ may prevent hypertrophic and . keloid scarring.
- ReJuveness™ can be used as soon as the wound is closed, dry and the sutures have . been removed.
- ReJuveness™ may prevent scarring disorders. .
(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 | K974380 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ✓ |
|---|---|---|
| ------------------------------------------ | ---- | ------------------------ |
(Optional Format 1-2-96)