The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.
The Palomar Lux1440 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue and skin resurfacing procedures.
The Lux1540 Handpiece & Lux1440 Handpiece each attach to the StarLux Pulsed Light and Laser Systems. The complete StarLux System console consists of a power supply, chiller, electronics, portable cart, and a footswitch.
The provided document is a 510(k) summary for the Palomar Lux1540 and Lux1440 Fractional Laser Handpieces. It details the device's intended use and claims substantial equivalence to predicate devices. However, it does not describe specific acceptance criteria or an analytical study proving the device meets those criteria in the way typically expected for performance claims like sensitivity, specificity, or reader study results.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that, rather than conducting new performance studies against pre-defined acceptance criteria, the manufacturer argues that their device is as safe and effective as devices already on the market.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's an attempt to answer based on the available information, noting what cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission hinges on "substantial equivalence" rather than quantitative performance against specific acceptance criteria. The document states: "The specifications and indications for use of the Lux1540 Handpiece &Lux1440 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) Premarket Notification."
2. Sample size used for the test set and the data provenance
This information is not provided in the document. As the submission relies on substantial equivalence and a comparison to predicate devices rather than a de novo performance study, details about a test set and its provenance are not included.
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 document. There is no mention of a test set with established ground truth by experts.
4. Adjudication method for the test set
This information is not provided in the document.
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
There is no mention of an MRMC study. This device is a laser handpiece, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical laser handpiece, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided as there is no specific performance study against a defined ground truth mentioned in the document.
8. The sample size for the training set
This information is not provided. As the submission is for substantial equivalence of a physical device, a "training set" in the context of an algorithm or AI is not relevant.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of device and submission.
Summary based on the document:
The device's acceptance criteria and proof of meeting them are established through the process of substantial equivalence to existing predicate devices (Lux1540 Fractional Laser Handpiece K080244, Lux 1440TM Fractional Laser Handpiece K073583, and Fraxel Re:store™ Laser System (Formerly SR1500) K070284). The manufacturer asserts that "The Lux1540 Handpiece and Lux1440 Handpiece are substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this 510(k) Premarket Notification demonstrates that the Lux1540 Handpiece and Lux1440 Handpiece also share the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."
This means that the "study" proving the device meets its "acceptance criteria" is the 510(k) Premarket Notification submission itself, which argues that the new device is as safe and effective as the predicate devices based on a comparison of their characteristics, rather than new, independent performance studies with detailed acceptance metrics.
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U911446 page (1) of (2)
510(k) Summary
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
OCT 2 7 2009
Name: Palomar Medical Technologies, Inc. 82 Cambridge Street ADDRESS: Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 993-2330
Sharon Timberlake, MSHS, RAC, CCRA CONTACT: Director of Regulatory Affairs
DATE PREPARED: May 14, 2009
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | Lux1540TM Fractional Laser Handpiece,Lux1440TM Fractional Laser Handpiece |
|---|---|
| COMMON/USUAL NAME: | Lux 1540, Lux1440 |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general andplastic surgery and in dermatology(21 CFR § 878.4810) |
PRODUCT CODE: GEX
PREDICATE DEVICES 3.
Palomar Medical Technologies, Inc. Lux1540TM Fractional Laser Handpiece K080244
Palomar Medical Technologies, Inc. Lux 1440TM Fractional Laser Handpiece K073583
Reliant Technologies, Inc. Fraxel Re:store™ Laser System (Formerly SR1500) K070284
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091446 Page (2) of
4. INTENDED USE
The Lux1540 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.
The Lux 1440 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue and skin resurfacing procedures.
ડ. DEVICE DESCRIPTION
The Lux1540 Handpiece & Lux1440 Handpiece each attach to the StarLux Pulsed Light and Laser Systems. The complete StarLux System console consists of a power supply, chiller, electronics, portable cart, and a footswitch.
6. PERFORMANCE DATA
The specifications and indications for use of the Lux1540 Handpiece &Lux1440 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) Premarket Notification.
7. SUBSTANTIAL EQUIVALENCE
The Lux1540 Handpiece and Lux1440 Handpiece are substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this 510(k) Premarket Notification demonstrates that the Lux1540 Handpiece and Lux1440 Handpiece also share the same technological characteristics, mechanism of action, intended use and physical properties to its predicates.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Palomar Medical Products, Inc. % Ms. Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
OCT 2 7 2009
Re: K091446
Trade/Device Name: Lux1440 Handpiece & Lux 1540 Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG Dated: September 25, 2009 Received: September 28, 2009
Dear Ms. Timberlake:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Sharon Timberlake, MSHS, RAC, CCRA
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html.
Sincerely yours.
erely yours,
For
N. M.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO91446
510(k) Number (if known):
Device Name: Lux1440 Handpiece & Lux1540 Handpiece
Indications for Use:
The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.
The Palomar Lux1440 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue and skin resurfacing procedures.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nefre Dalm for mixm
(Division Sign-Of (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K04
Page 1 of 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.