(90 days)
The SpaTouch is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.
The SpaTouch is a Pulsed Light Hair Removal System. With the exception of contact switches added to the handpiece, the SpaTouch is the exact same device as the previously cleared DeLight II device. The only differences between the cleared DeLight II and the SpaTouch are the addition of the contact switches to the handpiece and the expanded indications for use.
The provided text describes the SpaTouch® PhotoEpilation System, but it does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The document is a 510(k) summary for a substantial equivalence determination, focusing on comparison to a predicate device.
Here's an analysis based on the information provided, highlighting the limitations in addressing your specific requests:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or a table of performance metrics are provided in the document. The submission states: "Clinical data demonstrated that the device can be used safely and effectively under the supervision of a health professional." This is a general statement and not a set of measurable acceptance criteria with corresponding performance data.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical data" but does not specify the sample size, data provenance (country of origin), or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
An MRMC study is not mentioned. The device described is a photoepilation system for hair removal, which typically does not involve "readers" or AI assistance in the context of medical image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical system for hair removal, not an algorithm. The "human-in-the-loop" aspect is explicit: "under the direction of a physician, after training by a healthcare professional."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a hair removal device, "ground truth" would typically refer to the actual hair reduction observed. However, the document does not specify how this was measured or whether it involved expert assessment, photographic evidence, or patient self-reporting. It broadly states "Clinical data demonstrated that the device can be used safely and effectively."
8. The sample size for the training set
This information is not available in the provided text. The device is a physical device, not an AI algorithm that typically uses "training sets."
9. How the ground truth for the training set was established
Not applicable as this is not an AI algorithm.
Summary of what is available and what is missing:
The provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device (Radiancy (Israel) Ltd. DeLight II Hair Removal System). The core argument for equivalence hinges on the SpaTouch being "the exact same device" as the DeLight II, with only minor additions (contact switches) and expanded indications for use.
The clinical data mentioned serves to support the general safety and effectiveness for the purpose of substantial equivalence, rather than detailing a rigorous performance study with specific acceptance criteria as might be expected for novel devices or AI/diagnostic applications. The information needed to answer your questions exhaustively is not present in this type of regulatory submission.
{0}------------------------------------------------
020856 1/2
:
JUN 1 3 2002
510(k) SUMMARY
Radiancy (Israel) Ltd.'s SpaTouch® PhotoEpilation System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Radiancy (Israel) Ltd. 9 Gan Ravve Street Industrial Park Yavne Israel Telephone: +972-8-9438010 Facsimile: +972-8-9438020
Jonathan S. Kahan, Esq. Contact Person: Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: (202) 637-5794 Facsimile: (202) 637-5910 Email: JSKahan@HHLaw.com
Date Prepared: March 12, 2002
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | SpaTouch® PhotoEpilation System |
|---|---|
| Common Name: | Pulsed Light Hair Removal System |
| Classification Name: | Laser surgical instrument for use ingeneral and plastic surgery and indermatology (21 CFR § 878.4810) |
| Address of Manufacturing Facility: | Radiancy (Israel) Ltd.9 Gan Ravve StreetIndustrial ParkYavneIsrael |
| Establishment Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |
{1}------------------------------------------------
2086 2/2
Predicate Devices
Radiancy (Israel) Ltd. DeLight II Hair Removal System
Intended Use / Indications for Use
The SpaTouch is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.
Technological Characteristics and Substantial Equivalence
The SpaTouch and its predicate device are intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. With the exception of contact switches added to the handpiece, the SpaTouch is the exact same device as the previously cleared DeLight II device. The only differences between the cleared DeLight II and the SpaTouch are the addition of the contact switches to the handpiece and the expanded indications for use. Neither of these differences raises new issues of safety or effectiveness. Thus, the SpaTouch can be found substantially equivalent.
Performance Data
Clinical data demonstrated that the device can be used safely and effectively under the supervision of a health professional.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked slightly on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2002
Radiancy (Israel) Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N. W. Washington, D.C. 20004-1109
Re: K020856
Trade Name: SpaTouch® PhotoEpilation System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: May 14, 2002 Received: May 14, 2002
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 comply 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.
{3}------------------------------------------------
Page 2 -- Mr. Jonathan Kahan
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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Stupt Rlvedn
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
{4}------------------------------------------------
Page 1 of 1
Indications for Use Form
K020856 510(k) Number (if known):___
Device Name:
SpaTouch® PhotoEpilation System
Indications for Use:
The SpaTouch PhotoEpilation System is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Rhode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZO85B 510(k) Number _
OR
Over-The-Counter
(Per 21 C.F.R. 801.109)
(Optional Format 1-2-96)
Use_
Prescription Use __ X_
§ 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.