(109 days)
The Palomar Aspire™ Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further 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 intended for coagulation of soft tissue and laser-assisted lipolysis. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study on the device's performance against those criteria. As such, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not explicitly present in the provided text.
Here's an attempt to answer the questions based on the available information, noting where details are not provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in a structured table. The primary assessment is for "substantial equivalence" to predicate devices, implying that its performance is considered comparable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific test set or clinical study with patient samples. The performance assessment is based on a review of "technical characteristics, indications for use, risk analysis information, and verification and validation information," rather than clinical trial data detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set or adjudication method.
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 device is a laser platform for medical procedures, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated for performance evaluation against specific criteria. The "ground truth" implicitly used for demonstrating safety and effectiveness is based on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. The document does not describe a "training set" in the context of an algorithm or AI development.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a "training set" or its ground truth establishment.
Summary of what is available from the document regarding performance and acceptance:
The primary "acceptance criteria" appear to be meeting the standard for substantial equivalence to legally marketed predicate devices.
- Substantial Equivalence Statement: "The review of the technical characteristics, indications for use, risk analysis information, and verification and validation information provided demonstrate that the modified Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices."
- Performance Claim: "The Palomar Aspire™ Laser Platform is as safe and effective as its predicate devices."
- Basis for Equivalence: "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. Therefore, the Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices."
The "study that proves the device meets the acceptance criteria" is implicitly the 510(k) submission itself, which provides "technical characteristics, indications for use, risk analysis information, and verification and validation information" to support the claim of substantial equivalence. However, the details of these "verification and validation information" (e.g., specific tests, their methodologies, and quantitative results) are not elaborated upon in this summary document.
It is common for 510(k) summaries to present the conclusion of substantial equivalence without detailing all the underlying testing and data that led to that conclusion, as the full submission would contain such details.
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FEB 1 3 2009
510(k) Summary
KO83165
This 510(k) Summary is being submitted in accordance with 21 CFR 807.92
Applicant:
Contact:
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Product Code:
Predicate Devices:
System Description:
Palomar Medical Technologies, Inc. 82 Cambridge St. Burlington, MA 01803
Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs (781) 993-2414
December 2, 2008
The Palomar Aspire™ Laser Platform
Medical laser system
Laser surgical instrument for use in General and Plastic Surgery and Dermatology (21 CFR 878.4810)
79 GEX
The Palomar Aspire™ Laser Platform Palomar Medical Technologies, Inc. K081416, K080567
Sciton, Inc. Profile Multi-Platform System K070388
Cynosure, Inc. Cynosure SmartLipo Multiwavelength Laser K080121
Biolitec, Inc. Ceralas D 980 nm Diode Laser System K081015
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.
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Intended Use:
Performance:
Substantial Equivalence:
The Palomar Aspire™ Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further indicated for laser assisted lipolysis.
The review of the technical characteristics, indications for use, risk analysis information, and verification and validation information provided demonstrate that the modified Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices.
The Palomar Aspire™ Laser Platform is as safe and effective as its 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. Therefore, the Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
FEB 1 3 2009
Re: K083165
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: October 24, 2008 Received: November 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, 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 (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.
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Page 2 - Ms. Sharon Timberlake, RAC, CCRA
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. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enolosure
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Indications for Use
510(k) Number (if known): _ K O8 3 | Vo S
Device Name: Palomar Aspire™ Laser Platform
Indications for Use:
The Palomar Aspire™ Laser l'iatform is imen vel for coagalation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue.
The device is further indicated for laser assisted lipolysis.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 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)
Clank Miller
sion Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083165
Page 1 of 1
CONFIDENTIAL
§ 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.