(76 days)
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:
- Removal of dark tattoos
- Treatment of pigmented lesions
The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:
- A system console (including software and control electronics, key-operated power control switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
- A control and display panel;
- One or more delivery handpiece(s), the Treatment Heads.
The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.
The Q-switched Nd: YAG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.
The provided text describes the Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device "shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices." It also notes that a "Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use." However, specific quantitative acceptance criteria (e.g., a certain percentage of tattoo removal, reduction in lesion size) and their corresponding performance metrics are not explicitly stated in the provided document. The document relies on substantial equivalence to predicate devices rather than establishing new, specific performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: Safety and effectiveness for: - Removal of dark tattoos - Treatment of pigmented lesions | Reported Performance: "A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use." (No specific numerical performance metrics were provided in this document as the basis for substantial equivalence). |
| Technical specifications (wavelength, fluence range, spot sizes) comparable to predicate devices | "The technical specifications of the Q-switched Nd: YAG Laser Treatment Head for the Quantum series are similar or identical to those of the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460)." |
2. Sample size used for the test set and the data provenance
The document mentions "A Clinical Evaluation Report" but does not provide details about the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature).
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 given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
A multi-reader multi-case (MRMC) study is not mentioned in the document. The device is a laser treatment head, not an AI-assisted diagnostic or interpretative tool, so an MRMC study related to human reader improvement with AI would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a laser treatment head, which is a physical instrument used for medical procedures, not a standalone software algorithm. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its inherent treatment efficacy, which the clinical evaluation report broadly addressed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document refers to a "Clinical Evaluation Report" which demonstrated "safety and effectiveness." This implies that clinical outcomes data (e.g., visual assessment of tattoo removal, reduction in lesion pigmentation, adverse event rates) would have been used as the ground truth. However, the exact methods for defining and measuring this ground truth are not detailed.
8. The sample size for the training set
The document does not mention a training set. This is consistent with a medical device submission focused on substantial equivalence to existing predicate devices, where extensive de novo training data for an algorithm might not be required or relevant in the same way it would be for an AI-powered diagnostic tool. The "Clinical Evaluation Report" would likely involve a test or validation set of patients, not a separate training set as understood in machine learning.
9. How the ground truth for the training set was established
As no training set is mentioned or implied, this information is not applicable.
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Attachment 17 K043173 510(k) Summary for the Q-switched Nd: YAG Laser Treatment Head for the Lumenis Quantum Series
I. General Information
| Submitter: | Lumenis, Inc.2400 Condensa StreetSanta Clara, CA 95051 |
|---|---|
| Contact Person: | Martha Murari, Ph.D.Senior Regulatory Affairs Associate |
| Connie HoyGlobal Director RA / QA | |
| Summary Preparation Date: | November 15, 2004 |
II. Names
Device Names:
Q-switched Nd:YAG Laser Treatment Head for the Quantum Series
Laser Powered Surgical Instrument (and Accessories) Primary Classification Name:
Predicate Devices III.
- Lumenis family of Intense Pulsed Light (IPL) and IPL/Nd: YAG laser systems (K020839, . K030527, K024093, K030342) marketed by Lumenis.
- MedLite C3- Q Switched Nd: YAG laser (K011677) marketed by Hoya ConBio (formerly ● Continuum Electro-Optics)
- Light-Age O-Clear laser (K033259) marketed by Light Age Inc. .
- Q-YAG 5 laser (formerly Clear Light)(K003460, K023967) marketed by Palomar ● Medical Technologies Inc.
IV. Product Description
The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:
- A system console (including software and control electronics, key-operated power control . switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
- . A control and display panel;
- One or more delivery handpiece(s), the Treatment Heads. .
The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.
The Q-switched Nd: Y AG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.
510(k) Submission: Q-switched Nd: YAG Laser Treatment Head for the Quantum Series Attachment 17 - Page 1
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V. Indications for Use
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:
- Removal of dark tattoos �
- Treatment of pigmented lesions .
Rationale for Substantial Equivalence VI.
The Q-switched Nd:YAG Laser Treatment Head for the Quantum series shares the same indications for use as the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460), in that the 1064 nm wavelength is indicated for:
- Removal of dark tattoos �
- Treatment of pigmented lesions .
The technical specifications of the Q-switched Nd: YAG Laser Treatment Head for the Quantum series are similar or identical to those of the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460).
Therefore, the Q-switched Nd:YAG Laser Treatment Head for the Quantum series is substantially equivalent to the predicate devices.
Safety and Effectiveness Information VII.
The Q-switched Nd:YAG Laser Treatment Head for the Quantum series shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices. A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use. The Q-switched Nd: Y AG Laser Treatment Head for the Quantum series does not raise new questions of safety and efficacy.
VIII. Conclusion
Based on the foregoing, the Q-switched Nd: Y AG Laser Treatment Head for the Quantum series was found to be substantially equivalent to the predicate MedLite C2 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2005
Lumenis, Ltd. c/o Martha Murari, Ph.D. Senior Regulatory Affairs Associate Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K043173
Trade/Device Name: Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series (Quantum HR, Quantum SR and Quantum DL) 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: November 15, 2004 Received: November 16, 2004
Dear Dr. Murari:
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 – Martha Murari, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ maing of substantial equivalence of your device to a legally premative hotification. The PDF Interessification 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 If you desire specific advision at (240) 276-0115. 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 other general information on Jour Copsumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Cclia 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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Indications for Use
510(k) Number (if known): < 043173
Device Name: _Q-switched Nd: YAG Laser Treatment Head for the Lumenis Quantum series [Quantum HR, Quantum SR, and Quantum DL]
Indications for Use:
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series in indicated for:
- Removal of dark tattoos .
- Treatment of pigmented lesions .
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE 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
510(k) Number K043173
Page 1 of 1
Lumenis 510(k) Submission: Q-switched Nd:YAG Laser Treatment Head for the Quantum Series Attachment 2 - Page 1
§ 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.