(91 days)
The Spectra Hair Removal Laser is intended to effect temporary hair removal.
The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
Here's an analysis of the provided text regarding the Spectra Hair Removal Laser, focusing on the acceptance criteria and study aspects you requested:
Acceptance Criteria and Study Analysis for Spectra Hair Removal Laser (K032846)
This 510(k) submission explicitly states that no performance data was required or submitted for the Spectra Hair Removal Laser. The basis for clearance was substantial equivalence to legally marketed predicate devices, and the indications for use were a subset of those claimed by the predicates. Therefore, the device did not undergo a specific study to prove it meets acceptance criteria, nor were explicit acceptance criteria defined within this document.
Given this, many of the specific questions about the study design cannot be answered from the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No performance data provided |
Explanation: The 510(k) states: "None. The specifications and indications for use of the Spectra Hair Removal Laser are a subset of those claimed in one or more of the clearances for the above-listed predicate devices. Thus performance data were not required." This means the device's performance was considered acceptable based on its similarity to already cleared devices, not on specific, pre-defined quantitative criteria.
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 (Test Set): Not applicable, no performance study was conducted.
- Data Provenance: Not applicable, no performance study was conducted.
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)
- Number of Experts: Not applicable, no performance study was conducted.
- Qualifications of Experts: Not applicable, no performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, no performance study was conducted.
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
- MRMC Study: No. This device is a hair removal laser, not a diagnostic AI system with human-in-the-loop interaction for interpretation tasks.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This device is a laser for hair removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable, no performance study was conducted. The "ground truth" for this submission was the established safety and effectiveness of its predicate devices for temporary hair removal.
8. The sample size for the training set
- Training Set Sample Size: Not applicable, no AI/ML algorithm was involved, and no performance study was conducted for this specific device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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DEC 1 1 2003
K 032846 1/2
Appendix A. 510(k) Summary
This 510(k) Summary of Safety and Effectiveness for the Spectra Hair Removal Laser is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and follows the HHS Publication FDA 95-4158 concerning the content and organization of a 510(k) summary.
| Applicant | SpectraGenics, Inc., |
|---|---|
| Address: | 7083 Commerce Circle, Ste. IPleasanton, CA 94588 |
| Contact person: | Robert E. Grove, Ph.D. |
| Telephone: | (925) 847-1762 |
| Preparation date: | September 10, 2003 |
| Device Trade Name: | Spectra Hair Removal Laser |
| Common Name: | Pulsed diode laser |
| Classification Name: | Laser Instrument, Surgical, Powered(Laser surgical instrument for use ingeneral and plastic surgery anddermatology)Regulation No. 878.4810Product Code: GEX; Panel: 79 |
| Legally Marketed Predicate Devices: | LightSheer (StarLight) pulsed diodelaserStar Medical / Coherent StarK973324, K982940, K001746 |
| SLP 1000 (LC 100) pulsed diode laserPalomar Medical TechnologiesK010580, K011747 | |
| Apex 800 pulsed diode laserIRIDEX CorporationK020849 | |
| F1 pulsed diode laserOpus Medical, Inc.K030235 |
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K032846 2/2
| System Description: | The Spectra Hair Removal Laser is asemiconductor diode laser system thatdelivers infrared light at a wavelength ofnominally 800 nm. |
|---|---|
| Intended Use of the Device: | The Spectra Hair Removal Laser isintended to effect temporary hair removal. |
| Performance Data: | None. The specifications and indicationsfor use of the Spectra Hair Removal Laserare a subset of those claimed in one or moreof the clearances for the above-listedpredicate devices. Thus performance datawere not required. |
| Conclusion: | The Spectra Hair Removal Laser issubstantially equivalent to the legally-marketed claimed predicate devices for thepurposes of this 510(k) submission. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three stripes forming its wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2003
Robert E. Grove, Ph.D. President and CEO SpectraGenics, Inc. 7083 Commerce Circle, Suite I Pleasanton, California 94588
Re: K032846 Trade/Device Name: Spectra Hair Removal Laser Regulation Number: 21 CFR 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 5, 2003 Received: September 15, 2003
Dear Dr. Grove:
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 - Robert E. Grove, Ph.D.
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Miriam C. Provost
Celia M. Witton, 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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Indications for Use
510(k) Number (if known): K032846
Device Name: Spectra Hair Removal Laser
Indications for Use: Temporary hair removal
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTUNUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.