(232 days)
EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.
The provided text is a 510(k) summary for the EpiLight® and PhotoDerm® HR devices, which are electro-optical medical devices for hair removal. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Based on the information given, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) for a new device's performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through technical comparisons and clinical trials.
The primary performance claim for the EpiLight® and PhotoDerm® HR is:
- Permanent hair reduction: Defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
The document states that a technical comparison and clinical trials were performed to establish substantial equivalence. However, no specific performance metrics resulting from these studies are provided in this summary.
| Acceptance Criteria (Implicit from Intended Use) | Reported Device Performance |
|---|---|
| Removal of unwanted hair | Achieved (by substantial equivalence to predicates) |
| Stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles | Achieved (by substantial equivalence to predicates) |
| Permanent hair reduction: a long-term stable reduction in the number of hairs regrowing after a treatment regime. | Achieved (by substantial equivalence to predicates) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical trials were performed by ESC Medical Systems," but it does not provide any details about:
- The sample size of the test set (number of participants or observations).
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The devices described are medical devices for hair removal, not AI-assisted diagnostic tools requiring reader interpretation. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The devices are physical medical devices for hair removal, not AI algorithms.
7. The Type of Ground Truth Used
Given the nature of the device (hair removal), the "ground truth" for "permanent hair reduction" would most likely be based on clinical observation and measurement of hair regrowth over time following a treatment regime. However, the document does not explicitly state the method for establishing this ground truth (e.g., photographic assessment, hair count, patient self-reporting, etc.).
8. The Sample Size for the Training Set
This question is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable.
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JAN 2 7 2000
I. 510(K) SUMMARY OF SAFETY AI FFECTIVENESS
ESC Medical Systems, Ltd Submitter's name:
Submitter's address: Yokneam Industrial Park PO Box 240 Yokneam 20692 ISRAEL
011-972-4-959-9000 Telephone:
001-972-4-959-9050 Fax:
EpiLight®, PhotoDerm® HR Names of devices:
Predicate devices:
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- EpiLight® Hair Removal System, made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249
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- PhotoDerm® HR , Made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K974536
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- EpiLaser™ Normal Mode Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #980517.
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- LightSheer™ Long Pulse Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #982980.
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- LightSheer™ Pulsed Diode Array Laser System made by Star Medical Technologies of Pleasanton CA, USA 510(k) #K982940.
Description of device:
EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.
Summary:
Pursuant to section 513(I) of the Safe Medical Devices Act of 1990, ESC Medical Systems has elected to include in this premarket notification a Summary of Safety and Effectiveness upon which we believe a substantial equivalence determination for the EpiLight® Hair Removal System and the PhotoDerm® HR can be based.
Intended use:
EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair.
EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
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Comparing technical characteristics:
Both a technical comparison and clinical trials were performed by ESC Medical Systems to establish the substantial equivalence to the predicate devices.
No performance standards applicable to the PhotoDerm® HR have been adopted under Section 514 of the Act.
In summary we believe that the analysis and clinical data establish that the PhotoDerm® HR is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2000
Dr. Zvi Ladin Corporate Vice President, Clinical and Regulatory Affairs ESC Medical Systems LTD U.S. Operations 250 First Avenue Needham, Massachusetts 02494
Re: K991935
Trade Name: Epiderm Hair Removal System and PhotoDerm Hair Removal System Regulatory Class: II Product Code: GEX Dated: October 26, 1999 Received: October 27, 1999
Dear Dr. Ladin:
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 (OS) 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 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.
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Page 2 - Dr. Zvi Ladin
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,
James E. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K991935 510(k) Number (if known):
ESC Family of Intense Pulsed Light Hair Removal Device Name: Systems: EpiLight® and PhotoDerm® HR
Indications For Use:
EpiLight®
EpiLight® is used for the removal of unwanted hair.
EpiLight® is also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
PhotoDerm® HR
PhotoDerm HR is used for the removal of unwanted hair.
PhotoDerm® HR is also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991935 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.