(9 days)
The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.
The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and handpiece.
The provided text is a 510(k) summary for the Palomar Aspire™ Laser Platform, a medical device. It does not describe an AI/ML device or a study with acceptance criteria in the way typically associated with performance metrics like sensitivity, specificity, or F1-score. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, the requested information elements related to AI/ML device performance, ground truth, expert review, and sample sizes for training/test sets are not applicable or cannot be extracted from this document.
Here's the breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
Not applicable in the context of typical AI/ML acceptance criteria. This submission is for demonstrating substantial equivalence. The "performance" aspect is framed around meeting the criteria for substantial equivalence to a predicate device, not on quantitative metrics against a defined acceptance threshold for specific clinical outcomes or AI model output.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Palomar Aspire™ Laser Platform (K080567) | The modified Palomar Aspire™ Laser Platform is reported as "substantially equivalent to its predicate device." Shared indications for use, similar technological characteristics and principles of operation are cited as the basis for this determination. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/ML device clinical trial with a test set of data. The submission is based on engineering and design characteristics, intended use, and comparison to a legally marketed predicate.
3. 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)
Not applicable. This document does not describe a study involving expert consensus or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method 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
Not applicable. This document does not describe an MRMC comparative effectiveness study or an AI-assisted workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser platform, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" as applied to AI/ML performance data is not relevant to this medical device submission. The basis for approval is substantial equivalence to a predicate device.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth establishment pertinent to AI/ML described.
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510(K) Summary
MAY 2 9 2008
This 510(k) Summary is being submitted in accordance with 21 CFR 807.92
| Applicant: | Palomar Medical Technologies, Inc.82 Cambridge St.Burlington, MA 01803 |
|---|---|
| Contact: | Sharon Timberlake, MSHS, RAC, CCRADirector of Regulatory Affairs(781) 993-2414 |
| Preparation Date: | May 19, 2008 |
| Device Trade Name: | The Palomar Aspire™ Laser Platform |
| Common Name: | Medical laser system |
| Classification Name: | Laser surgical instrument for use in General and Plastic Surgeryand Dermatology (21 CFR 878.4810) |
| Product Code: | 79 GEX |
| Predicate Device: | The Palomar Aspire™ Laser PlatformPalomar Medical Technologies, Inc.K080567 |
| System Description: | The Palomar Aspire™ Laser Platform is a small transportablesystem which includes a cart, power supply, software, userinterface panel, footswitch, cooling system and handpiece. |
| Intended Use: | The Palomar Aspire™ Laser Platform is indicated for laserassisted lipolysis. |
| Performance: | The review of the technical characteristics, indications foruse, risk analysis information, and verification and validationinformation provided demonstrate that the modified PalomarAspire™ Laser Platform is substantially equivalent to itspredicate device. |
| Substantial Equivalence: | The Palomar Aspire™ Laser Platform is as safe and effectiveas its predicate devices. The information provided in thisapplication demonstrates the Palomar Aspire™ LaserPlatform shares the same indications for use, similartechnological characteristics and principals of operation.Therefore, the Palomar Aspire™ Laser Platform substantiallyequivalent to its predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2008
Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
Re: K081416
Trade/Device Name: Palomar Aspire™ Laser Platform 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: May 19, 2008 Received: May 20, 2008
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. Iisting 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
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Page 2 - 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,
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milliman
Mark N. Melkerson 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): _ KO8 14160
Device Name: Palomar Aspire™ Laser Platform
Indications for Use:
The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.
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)
Nel Rp. Opl - fr min
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081416
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.