(91 days)
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (- e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue.
Based on the provided text, the QYAG Laser Handpiece is not a device that would typically have acceptance criteria focused on diagnostic accuracy or performance metrics like sensitivity, specificity, or image quality, which are common for AI/ML-based medical devices.
Instead, this document describes a 510(k) Pre-Market Notification for a laser handpiece, which is a regulatory submission demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. The "performance data" section explicitly states:
"The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information."
This indicates that Palomar Medical Technologies, Inc. did not conduct a new study to prove specific performance criteria for the QYAG Laser Handpiece beyond demonstrating its substantial equivalence to previously approved predicate devices. They are asserting that because it's substantially equivalent, it meets the safety and effectiveness standards already established by those predicates.
Therefore, many of the requested points regarding acceptance criteria, study details, expert review, and AI performance are not applicable or cannot be extracted from this document, as the submission relies on substantial equivalence rather than new performance studies with specific metrics.
Here's a breakdown based on the information provided and the regulatory context of a 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (For this 510(k) submission, the primary "acceptance criteria" is demonstrating substantial equivalence to predicate devices, not specific quantitative performance metrics tested in a new study.) | Substantially Equivalent to predicate devices (Palomar Q-YAG 5 ND: YAG LASER SYSTEM K061436, HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System K083899, Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM K123168, Lutronic Corporation Spectra Laser System K113588). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states that the device's specifications and indications for use "do not result in additional safety or effectiveness information" beyond what is established for the predicate devices. This implies that no new clinical or performance test set (in the sense of a diagnostic study) was conducted for this 510(k) submission. The evidence for "performance" is based on the substantial equivalence to existing, approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No new test set for evaluating specific performance metrics was described or required for this substantial equivalence claim.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No new test set requiring adjudication was described.
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. This device is a laser handpiece, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant to its type of function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical laser handpiece, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No new ground truth for performance evaluation was established for this submission. The "ground truth" for its safety and effectiveness is implicitly derived from the existing approvals of the predicate devices.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for machine learning is relevant here.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the Palomar QYAG Laser Handpiece meets "acceptance criteria" is essentially the 510(k) Pre-Market Notification process itself, where Palomar Medical Technologies, Inc. demonstrated substantial equivalence to four legally marketed predicate devices:
- Palomar Q-YAG 5 ND: YAG LASER SYSTEM (K061436)
- HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System (K083899)
- Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM (K123168)
- Lutronic Corporation Spectra Laser System (K113588)
The document explicitly states under "6. PERFORMANCE DATA" that "The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information."
Under "7. SUBSTANTIAL EQUIVALENCE," it further clarifies: "The QYAG Laser Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the QYAG Laser also shares the same technological characteristics as its predicates."
This means that the "proof" is the successful comparison of the new device's technological characteristics, intended use, indications for use, and potential risks to those of the already approved predicate devices. The FDA, by issuing the 510(k) clearance (K130250), concurred with this assessment of substantial equivalence.
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3 2013 MAY
510(k) Summary QYAG Laser Handpiece
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
Palomar Medical Technologies, Inc. NAME:
15 Network Drive ADDRESS: Burlington, MA 01803 Phone: (781) 993-2348 Fax: (781) 993-2330
CONTACT: Nicole Brown Regulatory Affairs Specialist II
DATE PREPARED: January 21, 2013
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | Palomar QYAG Laser Handpiece | |
|---|---|---|
| COMMON/USUAL NAME: | Q: SWITCHED : Nd:YAG laser | |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general andplastic surgery and in dermatology.(21 CFR §878.4810) |
GEX PRODUCT CODE:
3. PREDICATE DEVICES
Palomar Medical Technologies, Inc. PALOMAR Q-YAG 5 ND: YAG LASER SYSTEM K061436
HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System
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K083899
Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM K123168
Lutronic Corporation Spectra Laser System K113588
4. INTENDED USE
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions ( e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
5. DEVICE DESCRIPTION
The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue.
6. PERFORMANCE DATA
The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information.
SUBSTANTIAL EQUIVALENCE 7.
The QYAG Laser Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the QYAG Laser also shares the same technological characteristics as its predicates.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 3, 2013
Palomar Medical Technologies, Inc. % Ms. Nicole Brown Regulatory Affairs Specialist II 15 Network Drive Burlington, Massachusetts 01803
Re: K130250
Trade/Device Name: Palomar QYAG Laser 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: GEX Dated: March 01. 2013
Received: March 04, 2013
Dear Ms. Brown:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Nicole Brown
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 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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, For
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130250
Device Name: QYAG Laser System
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (- e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
Prescription Use X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (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)
Neil R Ogden
2013.05.08 15:49:47 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number K130250
§ 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.