(84 days)
For the removal or lightening of unwanted hair in the 1064nm mode only.
Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser
The provided document is a 510(k) summary for a medical laser device (Medlite™ Q-Switched Nd:YAG Laser / Medlite™ IV Q-Switched Nd:YAG Laser) and does not contain information about an AI/ML powered device or software. Therefore, most of the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted.
The document indicates that the device's substantial equivalence was established by comparison to a predicate device (ThermoLase LT-100 Nd:YAG Laser Hair Removal System, K950019). The "Clinical Performance Data" section states "Authorization provided to access data in K950019." This implies that the clinical data from the predicate device was used to support the safety and effectiveness of the new device, rather than new clinical trials specifically for the Medlite laser.
Below is an attempt to answer the questions based only on the provided text, highlighting what is missing due to the nature of the document.
Acceptance Criteria and Device Performance for Continuum Biomedical's Medlite™ Q-Switched Nd:YAG Laser
This document pertains to a traditional medical device (laser system) and therefore does not include detailed acceptance criteria or a study design typical for an AI/ML-powered device. The regulatory submission relies on substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided 510(k) summary. For a traditional medical device like a laser, acceptance criteria would typically involve engineering specifications, safety standards compliance, and potentially clinical outcomes shown to be equivalent to a predicate device. The performance is assessed by comparison to the predicate.
| Acceptance Criteria (e.g., Performance Threshold) | Reported Device Performance |
|---|---|
| Not specified for this device type in the document. | Not specified in this format. |
| (Implied: Equivalent efficacy and safety for hair removal/lightening as the predicate device K950019) | (Implied: Achieves removal or lightening of unwanted hair with comparable outcomes to K950019) |
2. Sample size used for the test set and the data provenance
Not applicable/not provided for a standalone AI/ML device study. The clinical performance data relies on the predicate device (K950019). The document states, "Clinical Performance Data: Authorization provided to access data in K950019." This implies that the data from the predicate device's studies were referenced. The specific sample size, country of origin, or retrospective/prospective nature of that predicate data is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/not provided. This concept (ground truth established by experts for a test set) is specific to AI/ML model evaluation. For this laser device, clinical efficacy against unwanted hair would likely have been assessed by clinicians or through patient outcomes in the predicate study.
4. Adjudication method for the test set
Not applicable/not provided. This refers to resolving disagreements among experts for ground truth establishment in AI/ML studies.
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 comparative effectiveness study was not done, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm.
7. The type of ground truth used
Not applicable for an AI device. For the laser device's intended use, the "ground truth" for efficacy would likely be direct observation of hair removal/lightening by clinicians or patient self-reporting, as established in the predicate device's clinical data.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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K973719
510(k) Summary
DEC 2 3 1997
| Submitter: | Continuum BiomedicalA Medical Division of Continuum Electro-Optics, Inc.6533 Sierra LaneDublin, CA 94568Phone: (510) 828-3210Fax: (510) 556-2222 | ||
|---|---|---|---|
| Contact: | Laurie A. RidenerRegulatory Affairs Officer | ||
| Date Summary Prepared: | September 29, 1997 | ||
| Device Trade Name: | Medlite™ Q-Switched Nd:YAG LaserMedlite™ IV Q-Switched Nd:YAG Laser | ||
| Common Name: | Medical laser system | ||
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CRF 878.48 | ||
| Equivalent Device: | ThermoLase LT-100 Nd:YAG Laser Hair Removal System(K950019, SE Date 04-03-95) | ||
| Intended Use: | For the removal or lightening of unwanted hair | ||
| Comparison: | Equivalent | ||
| Nonclinical Performance Data: | None | ||
| Clinical Performance Data: | Authorization provided to access data in K950019 | ||
| Conclusion: | The Medlite Laser Systems can be safely used to remove or lightenunwanted hair | ||
| Additional Information: | None requested at this time |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1997
Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical, Incorporated 6533 Sierra Lane Dublin, California 94568
Re: K973719
Trade Name: Medlite™ Q-Switched Nd: YAG Laser, Medlite IV Q-Switched Nd: YAG Laser Regulatory Class: II Product Code: GEX Dated: September 29, 1997 Received: September 30, 1997
Dear Ms. Ridener:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542
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Page 2 - Ms. Ridener
of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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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长973719 510(k) Number (if known):
Device Name:
Medlite™ Q-Switched Nd:YAG Laser Medlite™ IV Q-Switched Nd:YAG Laser
Indications for Use:
For the removal or lightening of unwanted hair in the 1064nm mode only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDR Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number |
Prescription Use /
OR
Over-the-Counter Use ____
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continuum Biomedical, A Medical Division of Continuum Electro-Optics, Inc.
§ 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.