REJUVENESS by REJUVENESS PHARAMCEUTICALS, INC.

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. .

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.

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.

AI/ML Overview

The provided text describes the 510(k) clearance for "Rejuveness Silicone Sheeting" (K974380), a device intended for the management and prevention of hypertrophic and keloid scars. However, it does not include a study that proves the device meets specific acceptance criteria with quantitative performance metrics.

The document primarily focuses on:

Introducing the device and its intended use.
The FDA's determination of substantial equivalence to a predicate device.
The indications for use for which the device was cleared.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the provided document.	Rejuveness "clinically proven effective in the management of hypertrophic and keloid scars." "Has the potential to dramatically improve the appearance of both old and new scars." "May relieve the burning and itching." "Has also shown success in the prevention of hypertrophic and keloid scars."

Explanation: The document states that Rejuveness is "clinically proven effective." However, it does not provide specific, quantifiable acceptance criteria (e.g., "reduce scar elevation by X% in Y% of patients") or the detailed performance against such criteria. The statements provided are general claims of efficacy rather than specific performance metrics from a study.

2. Sample size used for the test set and the data provenance:
Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not provided in the document. The document refers to "clinically proven effective" but does not detail how this clinical proof was established, nor the role or qualifications of any experts involved in a ground truth assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not provided in the document.

5. 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 device is a silicone sheeting, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a silicone sheeting, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states "clinically proven effective," implying that the ground truth would likely be based on clinical outcomes data related to scar appearance, texture, color, and potentially subjective patient reports of burning/itching. However, the specific methodology for establishing this ground truth (e.g., blinded assessments, objective measurements, patient-reported outcomes) is not detailed.

8. The sample size for the training set:
Not applicable. This device is a silicone sheeting; there is no "training set" in the context of an algorithm.

9. How the ground truth for the training set was established:
Not applicable. As above, there is no "training set" for an algorithm.

Summary

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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.

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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.

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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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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 ✓
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(Optional Format 1-2-96)

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.