(89 days)
The LuxGTM handpiece is intended for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
The LuxGTM handpiece is an accessory to the EsteLux Pulsed Light System, a light-based medical device designed for effective treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI).
The provided text describes the Palomar LuxG™ handpiece and its 510(k) submission. However, it explicitly states that no performance data is presented because "The differences in the specifications... do not result in different performance or raise new questions of safety or efficacy."
Therefore, based on the provided text, I cannot complete the requested information regarding acceptance criteria and the study that proves the device meets them, as no such study or data is detailed. The submission relies on substantial equivalence to predicate devices rather than direct performance testing for this particular 510(k).
Here's a breakdown of why each section cannot be answered based on the provided text:
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A table of acceptance criteria and the reported device performance
- Reason: The text states, "The differences in the specifications... do not result in different performance or raise new questions of safety or efficacy." No performance data or acceptance criteria are presented for the LuxG™ handpiece itself.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Reason: No test set or performance study is detailed in the provided information.
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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)
- Reason: No test set or ground truth establishment relevant to the LuxG™ handpiece's performance is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Reason: No test set or adjudication process is mentioned.
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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
- Reason: This device is a laser handpiece, not an AI-assisted diagnostic tool. No MRMC study is relevant or described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Reason: This is a physical medical device (handpiece), not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Reason: No ground truth for performance evaluation is described for the LuxG™ handpiece.
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The sample size for the training set
- Reason: No training set is mentioned as no performance study or machine learning component is detailed for this device's 510(k).
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How the ground truth for the training set was established
- Reason: No training set or ground truth for it is mentioned.
Conclusion from the provided text:
The 510(k) submission for the LuxG™ handpiece did not include new performance data or studies. Instead, it argued for substantial equivalence based on the premise that its specifications, while different from predicate devices (EsteLux Standard handpiece, Lumenis (ESC) Quantum SR), "do not result in different performance or raise new questions of safety or efficacy." Therefore, the submission relied on the established safety and effectiveness of its predicate devices rather than new performance testing for its clearance.
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Attachment 5
K b2094J
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the LuxG™ handpiece 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: | Palomar Medical Technologies, Inc. |
|---|---|
| Address: | 82 Cambridge St.Burlington, MA 01803781-993-2300 |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | February 6, 2002 |
| Device Trade Name: | Palomar LuxGTM |
| Common Name: | LuxGTM |
| 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: | EsteLux Standard handpieceLumenis (ESC) Quantum SR |
| System Description: | The LuxGTM handpiece is an accessory to theEsteLux Pulsed Light System, a light-based medicaldevice designed for effective treatment of facial andleg veins, and treatment of pigmented lesions in allskin types (I-VI). |
| Intended Use of the Device: | The EsteLux™ System is intended for effectivetreatment of facial and leg veins, and treatment ofpigmented lesions in all skin types (I-VI). |
CONFIDENTIAL AND PROPRIETARY
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Performance Data:
The differences in the specifications of the EsteLux LuxG™, the EsteLux Standard handpiece and the Quantum SR do not result in different performance or raise new questions of safety or efficacy.
Conclusion:
Based on the foregoing, the LuxGTM handpiece is substantially equivalent to the legally-marketed claimed predicate devices.
CONFIDENTIAL AND PROPRIETARY
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Technologies, Inc. 131 Kelekent Lane Cary, NC 27511
JUN 1 9 2002
Re: K020941 Trade/Device Name: LuxGTM Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 21, 2002 Received: March 22, 2002
Dear Ms. Moore:
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 - Ms. Marcy Moore
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Stupt Rhodes
Celia 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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Corrected Pages
INDICATIONS FOR USE STATEMENT
K 020941 510(K) Number:
LuxGTM Device Name:
Indications for Use:
The LuxGTM handpiece is intended for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-the-Counter Use (per-21 CFR 801.109)
Sturt Rhodes
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZO941 510(k) Number _
CONFIDENTIAL AND PROPRIETARY
4
§ 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.