(47 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the Palomar Aspire™ Laser Platform:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the Palomar Aspire™ Laser Platform. Instead, it relies on the concept of substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Capable of performing laser-assisted lipolysis. | "The Palomar Aspire™ Laser Platform is capable of performing the same intended use as its predicates." |
| Safety and Effectiveness Equivalence: As safe and effective as predicate devices. | "The Palomar Aspire™ Laser Platform is as safe and effective as its predicate devices." |
| Technological Characteristics Equivalence: Shares similar technological characteristics with predicate devices. | "The information provided in this application demonstrates the Palomar Aspire™ Laser Platform shares the same indications for use, similar technological characteristics, and principals of operation." |
| Principles of Operation Equivalence: Shares similar principles of operation with predicate devices. | "The information provided in this application demonstrates the Palomar Aspire™ Laser Platform shares the same indications for use, similar technological characteristics, and principals of operation." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a classic "test set" sample size for a clinical study in the way one might expect for a diagnostic or treatment efficacy device. The primary approach for demonstrating equivalence appears to have been through a comparison of the device's technical specifications and intended use against existing predicate devices.
- Sample Size: Not applicable in the context of a comparative clinical trial for this specific 510(k) submission. The "data" refers to the technical specifications and functional capabilities compared to predicates.
- Data Provenance: The document does not provide information about the country of origin or whether the data for the new device was retrospective or prospective. The "performance data" mentioned is generalized and suggests technical testing rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided and is likely not relevant to this type of 510(k) submission, which focuses on substantial equivalence rather than establishing a new clinical benefit or diagnostic accuracy against a ground truth standard via clinical experts.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable to the substantial equivalence framework used here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to predicate devices, not on demonstrating an improvement in human reader performance with or without AI assistance. The device in question is a medical laser system for lipolysis, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Study Was Done:
No, a standalone (algorithm only) study was not done. The Palomar Aspire™ Laser Platform is a physical medical device (laser system), not a software algorithm or AI. Its performance is evaluated based on its physical and functional characteristics for performing laser-assisted lipolysis.
7. The Type of Ground Truth Used:
The concept of "ground truth" as typically used in diagnostic AI evaluation (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" in this context is implicitly the established safe and effective performance of the predicate devices for laser-assisted lipolysis. The new device demonstrates its equivalence to these known safe and effective devices.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The device is a hardware system, not a machine learning model, so there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided as there is no training set for a machine learning model.
Summary of the Study:
The "study" referenced in the 510(k) summary is not a traditional clinical trial or performance study with acceptance criteria in the sense of a new technology proving its efficacy. Instead, it is a technical and functional comparison of the Palomar Aspire™ Laser Platform against existing, legally marketed predicate devices. The "performance data" provided was sufficient to demonstrate that the new device shares:
- The same intended use (laser-assisted lipolysis).
- Similar technological characteristics.
- Similar principles of operation.
This demonstration led the FDA to conclude substantial equivalence to its predicate devices, implying that it is as safe and effective without requiring a full-scale clinical trial to prove new safety or efficacy. The predicates listed are other laser systems for lipolysis (e.g., Cynosure SmartLipo, Biolitec Ceralas, Sciton Profile ProLipo, New Star Lasers CoolLipo).
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Ko80567
510(K) Summary
APR 1 6 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, RAC, CCRADirector of Regulatory Affairs(781) 993-2414 |
| Preparation Date: | April 9, 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: | Cynosure, Inc.Cynosure SmartLipo Multiwavelength LaserK080121, K0733394, K062321 |
| Biolitec, Inc.Ceralas D 980 nm Diode Laser SystemK072779 | |
| Sciton, Inc.Profile Multi-Platform SystemProLipoK070388 | |
| New Star Lasers, Inc.CoolLipo Nd: YAG Laser SystemK072751 | |
| 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. |
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| Intended Use: | The Palomar Aspire™ Laser Platform is indicated for laserassisted lipolysis. |
|---|---|
| Performance: | Performance data was provided in this 510(k) PremarketNotification showing the Palomar Aspire™ Laser Platform iscapable of performing the same intended use as its predicates. |
| 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 it is substantially equivalent to its predicatedevices. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2008
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director, Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
Re: K080567
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: April 9, 2008 Received: April 10, 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, 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
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Page 2 - Ms. Sharon Timberlake, RAC, CCRA
forth in the quality systems (OS) 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 M. Millman
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):
Device Name: Palomar Aspire™ Laser Platform
Indications for Use:
The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
Neil R.B. Ogen Saman
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K080567 |
|---|---|
| --------------- | --------- |
PALOMAR MEDICAL TECHNOLOGIES, INC.
CONFIDENTIAL
TRADITIONAL 510(K): PALOMAR ASPIRE™ LASER PLATFORM
Page v
§ 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.