(90 days)
The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.
The StarLight™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.
The provided document is a 510(k) summary for the StarLight™ Pulsed Diode Array Laser System, focusing on substantial equivalence to a predicate device. It contains information about clinical studies but does not explicitly state acceptance criteria or provide a detailed breakdown of device performance against such criteria. It also lacks many of the specific details requested regarding the study methodology.
However, I can extract the available information and highlight what is missing based on your request.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: No scarring or permanent depigmentation of the skin. | "No scarring or permanent depigmentation of the skin in any subject." |
| Efficacy: Significant hair loss and prolonged growth delay. | "resulted in significant hair loss and prolonged growth delay." |
Note: The document does not explicitly state acceptance criteria in a quantitative or pass/fail manner. The reported performance implies that these qualitative outcomes were deemed acceptable for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document.
- Data Provenance: The document states "Clinical studies were conducted," implying prospective data collection for the purpose of the submission. The country of origin is not specified, but the applicant and contact information suggest a US-based study if conducted directly by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The "Observations of hair regrowth and skin responses" would likely have been assessed by clinical professionals, but their number and qualifications are not detailed.
4. Adjudication method for the test set
- This information is 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
- No, an MRMC study comparing human readers with and without AI assistance was not done. This device is a laser system for hair removal, not an imaging or diagnostic device that would typically involve "human readers" interpreting results assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a laser system for hair removal, where the "performance" is the direct physiological effect of the laser on hair and skin, not an algorithm's output.
7. The type of ground truth used
- Clinical observation: The ground truth for efficacy was "Observations of hair regrowth and skin responses" at various time points (1, 3, 6, and 9 months after treatment). For safety, it was the absence of adverse events like scarring or permanent depigmentation. This relies on direct clinical assessment.
8. The sample size for the training set
- This information is not applicable. The device is a physical laser system, not an AI/ML algorithm that requires a "training set." The clinical studies mentioned are for validation of the device's performance, not for training an underlying model.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no "training set" for this type of device.
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Attachment VI
DEC - 3 1997
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the StarLight™ Pulsed Diode Array This Jro(K) Sunmary of Bace, with the requirements of Safe Medical Device Dasol Bytenin is casinons the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Star Medical Technologies, Inc. |
|---|---|
| Address: | 1249 Quarry Lane, Suite 100Pleasanton, CA 94566 |
| Contact Person: | Robert E. Grove, Ph.D. |
| Telephone: | 510-484-2140 |
| Preparation Date: | August 26, 1997 |
| Device Trade Name: | StarLight™ Pulsed Diode Array Laser System |
| Common Name: | Pulsed Diode Array Laser |
| Classification Name: | Laser surgical instrument for use in General andPlastic Surgery and in Dermatology(see: 21 CFR 878-4810).Product Code: GEXPanel: 79 |
| Legally-Marketed Predicate Device: | EpiLaser™ Normal Mode Ruby LaserSpectrum Medical Technologies, Inc.K963947 |
| System Description: | The StarLight™ delivers pulsed infrared laser lightwith a wavelength of 800 nm, a selectable pulseduration of 5 - 30 ms, and a selectable pulse energyof 8 - 32 J. The corresponding fluence deliveredthrough the 9 x 9 mm handpiece tip is 10 - 40 J/cm.The laser pulses are generated at a maximum pulserepetition frequency of 1 Hz by an array of diode |
| The complete system consists of a console, afootswitch, and a handpiece connected to theconsole with an umbilical. In standard use, thehandpiece is pressed against the patient's skin and alight pulse is delivered when the footswitch andhandpiece trigger are depressed. The handpiece tip iswater-cooled to provide active skin cooling. Laserparameters and other system features are controlledfrom the touch-screen on top of the console, whichprovides an interface to the system computer. | |
| Intended Use of the Device: | The StarLight™ Pulsed Diode Array Laser Systemis indicated to remove hair in Dermatologyand Plastic Surgery procedures. |
| Performance Data: | Clinical studies were conducted to provideassurance that differences in the specifications of theStarLight™ laser and the predicate device did notresult in different performance or raise newquestions of safety or efficacy. |
| Results of Clinical Study: | Observations of hair regrowth and skin responseswere recorded prior to treatment and at 1, 3, 6, and9 months after treatment. There was no scarring orpermanent depigmentation of the skin in any subject.The study demonstrated that the StarLight™ PulsedDiode Array Laser System is a safe and effectivetool for hair removal, resulting in significant hair lossand prolonged growth delay. |
| Conclusion: | Based on the foregoing, the StarLight™ PulsedDiode Array Laser System is substantially equivalentto the legally-marketed claimed predicate device,i.e., the Spectrum EpiLaser™ for hair removal. |
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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 consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1997
Star Medical Technologies, Incorporated C/O Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Technologies, Incorporated 9516 Candor Oaks Drive Raleigh, North Carolina 27615
Re: K973324
Trade Name: StarLight™ Pulse Diode Array Laser System Regulatory Class: II Product Code: GEX Dated: August 28, 1997 Received: September 4, 1997
Dear Ms. Moore:
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 requirements , 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
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Page 2 - Ms. Moore
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Celia 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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K973324
INDICATION FOR USE STATEMENT
510(K) Number: Pending________________________________________________________________________________________________________________________________________________________
StarLight™ Pulsed Diode Array Laser System____________________________________________________________________________________________________________________________________ Device Name:
Indications for Use:
The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.
(Please do not write below this line - Continue on another page if needed)
11 . . . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of General Restorative Devices
| 510(k) Number | K973324 |
|---|---|
| --------------- | --------- |
Prescription Use X
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (per 21 CFR 801.109)
§ 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.