(90 days)
The ProLite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.
The ProLite Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power sypply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
This document describes the ProLite Pulsed Light System for hair removal. However, it does not contain acceptance criteria in the typical sense for a medical device study leading to performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria (e.g., "90% hair reduction after X treatments") or detailed device performance metrics (e.g., "average hair reduction of Y%").
Instead, the "Performance Data" section states: "Clinical studies were conducted to provide assurance that difference in the specifications of the ProLite Pulsed Light System and the predicate device for hair removal did not result in different performance during use." And the "Results of Clinical Study" section states: "Observation in the clinical study were recorded prior to Results of Clinical Study: treatment and at 3-6 months after treatment. There was no scarring in any subject. The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal."
The "Conclusion" then states: "The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for removal of hair in Dermatology and Plastic Surgery."
Therefore, the implicit acceptance criterion is that the ProLite Pulsed Light System performs similarly to the legally marketed predicate device (EpiLight/Photoderm HR System, K974536) in terms of efficacy for hair removal and safety (no scarring). The documented performance is that the study "demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal" and that there was "no scarring in any subject."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the sample size of subjects in the clinical study. It only refers to "any subject" in the results, implying a group of individuals participated.
- Data Provenance: Not specified. The applicant is from Sweden, but the location of the clinical study is not mentioned.
- Retrospective or Prospective: Not specified, but clinical studies are generally 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 provided in the document. The evaluation of hair removal and scarring would typically involve medical professionals, but their number and qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This document describes a medical device, not an AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a physical pulsed light system, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable and not mentioned. The device's performance is inherently "standalone" in that it performs the therapeutic action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or primary endpoints for this type of device would typically be observed hair reduction and absence of adverse events (like scarring). The document states "Observations in the clinical study were recorded prior to treatment and at 3-6 months after treatment." This implies clinical observation and outcomes data were used.
8. The sample size for the training set
This is a physical device, not a machine learning model, so there is no training set in the context of AI.
9. How the ground truth for the training set was established
As there is no training set for an AI model, this is not applicable.
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Attachment I 510(K) Summary ProLite Pulsed Light System
K613366
This 510(K) Summary of safety and effectiveness for the ProLite Pulsed Light System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Medical Bio Care Sweden AB. |
|---|---|
| Address: | Lona Knapes gata 5421.32 Vastra Frolunda,Sweden |
| Contact Person: | Morgan Gustafsson |
| Telephone / Fax / Email | 46.31.709.30.70 - Phone46.31.709.30.79 - Faxmorgan@medicalbiocare.com |
| Preparation Date: | September 22, 2001 |
| Device Trade Name: | ProLite Pulsed Light System |
| Common Name: | Pulsed Light for Photoepilation |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | EpiLight / Photoderm HR SystemK number K974536 |
| Description of the ProLite Pulsed LightSystem | The ProLite Pulsed Light System delivers pulsed light at awavelength beginning at a wavelength of 600 nm. Thedevice consists of three interconnected sections: The cabinetwhich houses the internal cooling system, power sypply andmicrocontroller, the umbilical to the handpiece, and thehandpiece, which houses the waveguide |
| Intended use of the ProLite Pulsed LightSystem | The ProLite Pulsed Light System is indicated for use toremove unwanted hair in all skin types according to theFitzpatrick Scale. |
| Performance Data: | Clinical studies were conducted to provide assurance thatdifference in the specifications of the ProLite Pulsed LightSystem and the predicate device for hair removal did notresult in different performance during use. These resultswere previously reported to the FDA in 510(K) 010927. |
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Attachment I 510(K) Summary ProLite Pulsed Light System
Observation in the clinical study were recorded prior to Results of Clinical Study: treatment and at 3-6 months after treatment. There was no scarring in any subject. The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal. The ProLite Pulsed Light System is substantially equivalent Conclusion: to other existing pulsed light systems in commercial distribution for removal of hair in Dermatology and Plastic Surgery.
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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. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical BioCare Sweden AB c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776
'JAN 0 8 2002
Re: K013366
Trade/Device Name: ProLite Pulsed Light System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX
Dated: September 22, 2001 Received: October 10, 2001
Dear Ms. Hoy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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.
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Page 2 - Ms. Connie White Hoy
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,
Stept Rhodes
S. Colin McWhirter, Ph.D., M.D.
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
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Page 2 - Ms. Connie White Hoy
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,
Stepten Rhodes
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
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INDICATION FOR USE STATEMENT
510(k) Number: ____ Pending _ KO1336b ________________________________________________________________________________________________________________________________________
Device Name: ProLite Pulsed Light System______________________________________________________________________________________________________________________________________
Indications for Use:
The ProLite Pulsed Light System is intended to remove unwanted hair for all skin types according to the Fitzpatrick Scale.
(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
and Neurological Devices
| 510(k) Number | K013366 |
|---|---|
| --------------- | --------- |
| Prescription Use(per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
§ 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.