(75 days)
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:
Pigmented Lesions
Tattoos
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consists of an Alexandrite laser head, a Q-switching mechanism, a power supply and a deionized water circulator. The laser head contains the cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the control panel, which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is fully air cooled.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm with a nominal pulse width of 50 nanoseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems supports 2mm, 3mm, and 4mm nominal spot sizes.
The provided text is a 510(k) summary for a medical device called the "Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems." This document does not describe a study to prove the device meets acceptance criteria, but rather asserts substantial equivalence to predicate devices based on similarities in intended use, functional features, and design aspects.
Therefore, many of the requested details, such as a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable or not provided in this type of regulatory submission.
The document primarily focuses on establishing that the new device is as safe and effective as existing, legally marketed predicate devices, and thus does not require new clinical studies to demonstrate efficacy against specific acceptance criteria.
However, I can extract the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable / Not provided. The document states that the new device "has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system)" as the predicate devices. It relies on the predicate devices' established safety and effectiveness rather than presenting new performance data against specific acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This 510(k) summary does not describe a test set or clinical study to establish performance for the new device. It relies on substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment for a test set is not described as no new clinical study data is presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are not discussed as no new clinical study data is presented.
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 system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. Ground truth refers to the verified condition against which a diagnostic device's performance is measured. Since this document establishes substantial equivalence of a treatment device rather than presenting new diagnostic performance data, a new "ground truth" for the device's efficacy is not established in this submission. Its effectiveness is inferred from the predicate devices' established efficacy.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
Summary of what the document does state regarding acceptance criteria and "proving" it:
The document asserts that the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems meets its intended purpose by demonstrating substantial equivalence to existing, legally marketed predicate devices.
-
Acceptance Criteria (Implicit via Substantial Equivalence): The device is "accepted" if it is determined to be substantially equivalent to predicate devices in:
- Intended Use: "Pigmented Lesions" and "Tattoos".
- Technological Features: Similar functional features (power output, spot size, repetition rate, energy, fluence) and key design aspects (wavelength, light generation medium, power supply, cooling, controls system).
- Safety and Effectiveness: Risks and benefits are comparable to predicate devices, raising no new questions of safety or effectiveness.
-
Study Proving Acceptance:
- Type of "Study": This is a premarket notification (510(k)) submission based on the principle of substantial equivalence, not a clinical trial or performance study against pre-defined acceptance criteria.
- Method of Proof: The submission describes the new device and compares it to the predicate devices, highlighting their similarities. The "proof" is based on the argument that because the new device is so similar to legally marketed and safe/effective predicate devices, it is also safe and effective.
- Conclusion: "Based on the similarities in indications for use, design features, and functional features the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems has been shown to be substantially equivalent to the current legally marketed predicate devices."
Predicate Devices Used for Comparison:
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Image /page/0/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black on the left side and has horizontal lines on the right side. The word "CANDELA" is in a simple, sans-serif font.
510(k) Summarv
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 100k) summary have been provided in conformance with 21 CFR §807.92.
Submitter Information
| Company Name: | Candela Corporation | DEC 20 2006 |
|---|---|---|
| Company Address: | 530 Boston Post RoadWayland, MA 01778 | |
| Company Phone: | 508-358-7400 | |
| Company Facsimile: | 508-358-5602 | |
| Contact Person: | Mr. Jeffrey RobertsManager, Regulatory Affairs | |
| Date summary Prepared: | 10/05/06 | |
| Device Identification |
Device Trade/Proprietary Name: The Candela Family of Q-Switched Alexandrite Laser
| (AlexLAZR) systems | ||
|---|---|---|
| Common Name: | Q-Switched Alexandrite Laser | |
| Classification Name: | Laser Surgical Instrument, for use in General and PlasticSurgery and Dermatology | |
| Classification Regulation: | 21 CFR § 878.4810 | |
| Device Classification: | II |
Identification of Predicate Device
| Predicate Device(s): | Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662 |
|---|---|
| Candela Q-Switched Alexandrite Laser (AlexLAZR), K950831 |
Device Description
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consists of an Alexandrite laser head, a Q-switching mechanism, a power supply and a deionized water circulator. The laser head contains the cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the contril bronnel. which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is fully air cooled.
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The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm with a nominal pulse width of 50 nanoseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems supports 2mm, 3mm, and 4mm nominal spot sizes.
Description of Intended Use
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for treatment in the following uses:
Pigmented Lesions Tattoos
Rationale for Substantial Equivalence
The Candela Family of O-Switched Alexandrite Laser (Alexi.AZR) systems, has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system) , as the predicate devices.
The Candela Family of Q-Switched Alexandrite Laser (Alex) systems shares similar methods of assembly, method of operation, and intended uses, and therefore is substantially equivalent to the currently legally marketed Candela Q-Switched Alexandrite Laser, (AlexLAZR), K955662, Candela Q-Switched Alexandrite Laser (AlexLAZR), K95083 predicate devices.
Safety and Effectiveness Information
The Candela Family of Q-Switched Alexandrite Laser (Alex(AZR) systems is substantial equivalent to the currently legally marketed Candela O-Switched Alexandrite Laser, (AlexyAZR), K955662, Candela Q-Switched Alexandrite Laser (AlexiAZR), K950831 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Candela Family of Q-Switched Alexandrite Laser (Alex147R) systems
Conclusion
Base on the similarities in indications for use, design features, and functional features the Candela Family of O-Switched Alexandrite Laser (Alex(AZR) systems has been shown to be substantially equivalent to the current legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2006
Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778
Re: K063073
Trade/Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems 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 5, 2006 Received: October 10, 2006
Dear Mr. Roberts:
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 - Mr. Jeffrey Roberts
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 premained nevice 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,
Sincerely, yours,
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): K063073
Device Name: Candela Family of Q-Switched Alexandrite Leser (AlexyAzB) systems
Indications for Use:
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:
Pigmented Lesions Tattoos
Prescription Use × (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 NELDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 4663073 |
|---|---|
| --------------- | --------- |
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§ 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.