(259 days)
The Palomar Lux1540 handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.
The Palomar Lux1540 handpiece is an accessory to the StarLux Pulsed Light & Laser System. The handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Capability to perform fractional photothermolysis (creation of a pattern of microscopic islets of damage at superficial skin layers). | "Performance data was provided showing the Lux1540 is capable of performing fractional photothermolysis, i.e., creation of a pattern (lattice) of microscopic islets of damage at superficial skin layers." |
| Device performs as clinically intended. | "The results from the clinical testing demonstrated that the Lux1540 performs as clinically intended..." |
| No new issues of safety or effectiveness are present. | "...and that no new issues of safety or effectiveness were present." |
Note: The provided 510(k) summary does not specify quantitative acceptance criteria (e.g., a specific percentage of a certain outcome, a defined threshold for adverse events). The criteria are qualitative, focusing on the device's ability to achieve its intended mechanism of action and overall clinical performance without new safety concerns, in line with its predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing" but does not provide the number of subjects or samples used in this testing.
- Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The document refers to "clinical testing" but does not detail the roles or qualifications of the individuals who assessed the outcomes or established ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Status
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or implied. The study described focuses on the device's performance against its own intended use and safety profile, not a comparison of human reader performance with and without AI assistance.
- Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as no MRMC study with AI assistance was conducted or reported.
6. Standalone (Algorithm Only) Performance Study Status
- Standalone Study: The Lux1540 is a physical medical device (handpiece for a laser system), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The performance evaluation is for the device itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground-truth appears to be based on clinical observation and assessment by medical professionals regarding the device's ability to perform fractional photothermolysis and achieve its clinically intended effects without new safety issues. There is no mention of pathology, imaging, or specific objective biomarkers being used to establish ground truth in the provided text.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As the Lux1540 is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set." The device's design and manufacturing process would be based on engineering principles and knowledge of laser-tissue interaction for dermatological applications.
{0}------------------------------------------------
510(K) Summary
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 Person:
Sharon Timberlake, RAC, CCRA
Director of Regulatory Affairs
(781) 993-2414
Preparation Date:
June 12, 2006
Device Trade Name:
Palomar Lux1540 Handpiece
Common Name:
Lux1540
Classification Name:
Laser surgical instrument for use in General and Plastic Surgery
and Dermatology (21 CFR 878.4810)
Product Code:
GEX
Predicate Device:
Reliant Laser System (Fraxel SR Laser System) K042319
Palomar Lux1540 handpiece K060301
System Description:
The Palomar Lux1540 handpiece is an accessory to the
StarLux Pulsed Light & Laser System. The handpiece
delivers light with a wavelength of 1540 nm. The complete
system consists of a power source, chiller, a footswitch, and a
handpiece connected to the power unit with an umbilical.
Intended Use:
The Palomar Lux1540 handpiece is intended for skin
resurfacing procedures in addition to dermatological
procedures requiring the coagulation of soft tissue.
Performance:
Performance data was provided showing the Lux1540 is
capable of performing fractional photothermolysis, i.e.,
creation of a pattern (lattice) of microscopic islets of damage
at superficial skin layers. The results from the clinical testing
demonstrated that the Lux1540 performs as clinically
intended and that no new issues of safety or effectiveness
were present.
Substantial Equivalence:
The Palomar Lux1540 Handpiece is substantially equivalent
to its predicate device when indicated for skin resurfacing.
The data in this application demonstrates that the Palomar
Lux1540 handpiece shares the same indications for use,
similar design features, functional features, and therefore is
substantially equivalent
FEB 27 2007
substantially equivalent to its predicate devices.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES. USA
[Illustration of the Department of Health and Human Services logo]
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 2 7 2007
Re: K061652 Trade/Device Name: Palomar Lux 1540 Handpiece 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: November 27, 2006 Received: November 28, 2006
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 (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.
{2}------------------------------------------------
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K061652
Device Name: PalomarLux1540 Handpiece
Indications for Use:
Dermatological procedures requiring the coagulation of soft tissue;
Skin resurfacing procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061652
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
PALOMAR MEDICAL TECHNOLOGIES, INC. LUX1540 510(K): SKIN RESURFACING
§ 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.