(83 days)
The Palomar Vectus Laser is intended for all Fitzpatrick skin types, including tanned skin for use in aesthetic, dermatology, general and plastic surgery applications for the treatment of
- · The treatment of vascular lesions, such as angiomas, telangiectasia and other benign vascular lesions.
- Treatment of leg veins.
- · The treatment of benign pigmented lesions.
- · Hair removal and permanent hair reduction.
- · Treatment of pseudofolliculitis barbae.
The Skintel™ Reader is intended as an objective measurement tool for examining skin. melanin content for determining and setting a test spot starting fluence.
The Palomar Vectus Laser consists of a diode-powered handpiece, Skintel Reader, base module, coolant reservoir, and chiller module. The handpiece connects to the base module via the umbilical.
The provided 510(k) summary for the Palomar Vectus™ Laser and Skintel™ Reader focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, indications for use, and verification/validation. It includes a general statement about clinical data supporting the Skintel Reader. However, the document does not explicitly detail specific acceptance criteria for the Skintel Reader's performance, nor does it describe a dedicated study designed to prove the device meets established acceptance criteria for its objective measurement of skin melanin content.
Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported performance, or provide detailed information about a study that proves the device meets those criteria.
Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states "clinical data to support the use of the Skintel Reader when used with the Palomar Vectus Laser was also included," but it does not specify what performance metrics (e.g., accuracy, precision) were evaluated against what acceptance thresholds. | Not provided in the document. While clinical data was mentioned as "included," no specific performance values (e.g., specific accuracy percentage, correlation coefficient with a reference method) are reported. |
Missing Information (Not available in the provided text):
Since the document does not describe a study to explicitly prove acceptance criteria, the following information is also not available:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
- 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 specified.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 specified. A multi-reader study is generally not relevant for a melanin reader; this type of study is more applicable for diagnostic AI interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not specified. The Skintel Reader itself is a standalone objective measurement tool, distinct from an "algorithm only" in the sense of a software-based AI interpreting images. Its performance would inherently be "standalone." However, its specific validation is not detailed.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. For a melanin reader, ground truth would likely involve a reference spectrophotometer or other validated melanin measurement technique.
- 8. The sample size for the training set: Not specified (if a machine learning model were involved, which isn't explicitly stated for the Skintel Reader).
- 9. How the ground truth for the training set was established: Not specified.
Conclusion based on provided text:
The provided 510(k) summary for the Palomar Vectus™ Laser and Skintel™ Reader primarily focuses on demonstrating substantial equivalence to predicate devices and states that clinical data for the Skintel™ Reader was included. However, it does not explicitly define acceptance criteria for the Skintel™ Reader's performance, nor does it describe the details of any study that specifically proves the device meets such criteria, as would typically be presented with performance metrics. The information needed to complete the requested table and detailed study description is absent from this document.
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510(k) Summary
MAY 2 3 2012
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
SUBMITTER'S INFORMATION 1.
| NAME: | Palomar Medical Technologies, Inc. |
|---|---|
| ADDRESS: | 15 Network DriveBurlington, MA 01803Phone: (781) 993-2300Fax: (781) 418-1169 |
| CONTACT: | Sharon Timberlake, MSHS, RAC, CCRAVice President of Global Regulatory & Quality Affairs |
| DATE PREPARED: | February |
DEVICE INFORMATION 2.
| TRADE/PROPRIETARY NAME: | Palomar Vectus™ Laser |
|---|---|
| COMMON/USUAL NAME: | Diode Laser System |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general andplastic surgery and in dermatology(21 CFR § 878.4810) |
| PRODUCT CODE: | GEX |
3. PREDICATE DEVICES
Lumenis, Inc. · LightSheer Duet Laser System K053628
Milesman, S.L. Milesman Premium Pulsed Diode Array Laser K073300
Sandstone Medical Technologies, Inc. The Cheveux Diode Laser System K100893 ::
Palomar Medical Technologies, Inc. Skintel™ Reader K110907
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4. INTENDED USE
The Palomar Vectus Laser is intended for use in aesthetic, dermatology, general and plastic surgery applications for the treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions. Additionally. treatment of leg veins, benign pigmented lesions, hair removal and permanent hair reduction as well as pseudofollilculitis barbae. Treatment for these indications is intended for all Fitzpatrick skin types, including tanned skin.
The Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
DEVICE DESCRIPTION 5.
The Palomar Vectus Laser consists of a diode-powered handpiece, Skintel Reader, base module, coolant reservoir, and chiller module. The handpiece connects to the base module via the umbilical.
6. PERFORMANCE DATA
The review of the technical characteristics, indications for use, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Palomar Vectus Laser is substantially equivalent to its predicate devices. Additionally, clinical data to support the use of the Skintel Reader when used with the Palomar Vectus Laser was also included.
7. SUBSTANTIAL EQUIVALENCE
The Palomar Vectus Laser is substantially equivalent to its predicate devices when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the Palomar Vectus Laser shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human figure embracing or protecting something.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 3 2012
Palomar Medical Technologies, Inc % Ms. Sharon Timberlake, MSHS, RAC, CCRA 15 Network Drive Burlington, Massachusetts 01803
Re: K120622
Trade/Device Name: Palomar Vectus Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and in plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX Dated: February 29 , 2012 Received: March 01, 2012 .
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. 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
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Page 2 – Ms. Sharon Timberlake: MSHS, RAC, CCRA
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 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.
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
KIDO 622 510(k) Number (if known):
Device Name: Palomar Vectus Laser
Indications for Use:
The Palomar Vectus Laser is intended for all Fitzpatrick skin types, including tanned skin for use in aesthetic, dermatology, general and plastic surgery applications for the treatment of
- · The treatment of vascular lesions, such as angiomas, telangiectasia and other benign vascular lesions.
- Treatment of leg veins.
- · The treatment of benign pigmented lesions.
- · Hair removal and permanent hair reduction.
- · Treatment of pseudofolliculitis barbae.
The Skintel™ Reader is intended as an objective measurement tool for examining skin. melanin content for determining and setting a test spot starting fluence.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil RPolh for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120622
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.