(58 days)
The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.
The StarLight system delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². The corresponding pulse energy delivered through the 9 x 9 mm handpiece tip is 8 – 32 J. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. 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.
Acceptance Criteria and Study Details for StarLight™ Pulsed Diode Array Laser System
The provided document describes the StarLight™ Pulsed Diode Array Laser System, intended for the treatment of leg veins. The submission indicates that clinical studies were conducted to demonstrate safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating substantial equivalence to the legally-marketed predicate device, the PhotoGenica LPIR™ by Cynosure, Inc. Therefore, the "acceptance criteria" revolve around the absence of different performance and no new questions of safety or efficacy compared to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No significant differences in performance compared to predicate device. | "Observations of vessel clearing and skin responses were recorded as a function of vessel and treatment parameters. Vessel effects included reduction in vessel diameter, vessel coagulation, and vessel disappearance." This indicates that the device achieved the intended therapeutic effect of treating leg veins. |
| No new questions of safety or efficacy. | "There was no scarring or permanent depigmentation of the skin in any subject." This directly addresses a critical safety aspect for dermatological laser treatments, indicating an acceptable safety profile. The statement "The study demonstrated that the StarLight Pulsed Diode Array Laser System is a safe and effective tool for the treatment of leg veins" summarizes the overall conclusion regarding efficacy and safety. |
| Substantial equivalence to predicate device. | "Based on the foregoing, the StarLight Pulsed Diode Array Laser System is substantially equivalent to the legally-marketed claimed predicate device for the purposes of this 510(K) submission." This is the ultimate conclusion drawn from the clinical study, implying that the performance and safety observed were comparable to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample size (number of subjects) used in the clinical study. It refers to "clinical studies" and "any subject" in the context of safety.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though the description of "clinical studies were conducted" and "observations... were recorded" typically implies a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts or their qualifications used to establish ground truth for the test set. It mentions "Observations of vessel clearing and skin responses," which implies clinical assessment by medical professionals, but specific details are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set. Evaluation appears to have been based on direct clinical observation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study's purpose was to demonstrate substantial equivalence to a predicate device, focusing on the device's own performance and safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical laser system for medical treatment, not an algorithm or AI. Therefore, the concept of a "standalone (algorithm only)" performance assessment is not applicable. The performance is inherently "human-in-the-loop" as it is operated by a medical professional.
7. The Type of Ground Truth Used
The ground truth appears to be based on expert clinical observation and assessment of the treatment outcomes. This includes:
- Vessel effects: reduction in vessel diameter, vessel coagulation, and vessel disappearance.
- Skin responses: absence of scarring or permanent depigmentation.
8. The Sample Size for the Training Set
This document describes a clinical study for a physical medical device, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there is no "training set" and thus no ground truth established for such a set.
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974346
JAN 1 6 1998
Attachment 9
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the StarLight™ Pulsed Diode Array Laser System is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows 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: | November 14, 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: | PhotoGenica LPIR™Cynosure, Inc. |
| System Description: | The StarLight system delivers pulsed infrared laser lightwith a wavelength of 800 nm, a selectable pulse duration of5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². Thecorresponding pulse energy delivered through the 9 x 9 mmhandpiece tip is 8 – 32 J. The laser pulses are generated at amaximum pulse repetition frequency of 1 Hz by an array ofdiode lasers located in the handpiece. |
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| The complete system consists of a console, a footswitch,and a handpiece connected to the console with anumbilical. In standard use, the handpiece is pressed againstthe patient's skin and a light pulse is delivered when thefootswitch and handpiece trigger are depressed. Thehandpiece tip is water-cooled to provide active skincooling. Laser parameters and other system features arecontrolled from the touch-screen on top of the console,which provides an interface to the system computer. | |
|---|---|
| Intended Use of the Device: | The StarLight Pulsed Diode Array Laser System is intendedfor the treatment of leg veins in Dermatology and PlasticSurgery procedures. |
| Performance Data: | Clinical studies were conducted to provide assurance thatdifferences in the specifications of the StarLight system andthe predicate device do not result in different performanceor raise new questions of safety or efficacy. |
| Results of Clinical Study: | Observations of vessel clearing and skin responseswere recorded as a function of vessel and treatmentparameters. Vessel effects included reduction in vesseldiameter, vessel coagulation, and vessel disappearance.There was no scarring or permanent depigmentation of theskin in any subject. The study demonstrated that theStarLight Pulsed Diode Array Laser System is a safe andeffective tool for the treatment of leg veins. |
| Conclusion: | Based on the foregoing, the StarLight Pulsed Diode ArrayLaser System is substantially equivalent to the legally-marketed claimed predicate device for the purposes of this510(K) submission. |
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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
JAN 16 1998
Star Medical Technologies, Incorporated "C/O Ms. Marcy Moore Manager of Clinical Studies 9516 Candor Oaks Drive Raleigh, North Carolina 27615
Re: K974346
Trade Name: StarLight™ Pulsed Diode Array Laser System Regulatory Class: II Product Code: GEX Dated: November 14, 1997 Received: November 19, 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 (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 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,
a 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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K974346
INDICATION FOR USE STATEMENT
510(K) Number: Pending
StarLight™ Pulsed Diode Array Laser System Device Name:
Indications for Use:
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The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.
(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
Prescription Use
OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ (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.