(88 days)
The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.
The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment
The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of periorbital wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
The provided text describes a 510(k) premarket notification for the "Candela Smoothbeam Laser System" for the treatment of periorbital wrinkles. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.
The document primarily focuses on regulatory approval based on substantial equivalence to predicate devices (Laser Aesthetics CoolTouch K003715 and Candela 1450 nm Diode laser K002421). It confirms that "Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of periorbital wrinkles," but it doesn't elaborate on the methodology, sample sizes, ground truth establishment, or specific quantitative performance metrics.
Therefore, I cannot provide a complete answer to your request in the specified format from the given text.
Here's what I can extract and what is missing based on your request:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms. The primary acceptance criterion appears to be "substantial equivalence" to predicate devices and demonstration of "effectiveness in the treatment of periorbital wrinkles."
- Reported Device Performance: "effective in the treatment of periorbital wrinkles." No quantitative metrics (e.g., percentage reduction in wrinkles, physician global assessment scores, patient satisfaction scores) are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "Clinical trials."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: 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 applicable/Not mentioned. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned. This is a medical device for direct treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied to be clinical outcomes related to "treatment of periorbital wrinkles." The specific method (e.g., blinded physician assessment, photographic analysis, patient questionnaires) is not detailed.
8. The sample size for the training set:
- Not applicable/Not mentioned for a laser treatment device. This concept is typically relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned.
In summary: The provided document is a regulatory submission focused on demonstrating substantial equivalence and does not contain the detailed clinical study data, acceptance criteria, and performance metrics typically found in scientific publications or more comprehensive clinical study reports.
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Image /page/0/Picture/1 description: The image shows the date February 15, 2002. The month is represented by the abbreviation FEB. The day is represented by the number 15. The year is represented by the number 2002.
ANDELA
General Information: This 510(k) is to provide notification of su
General Information: This 510(k) is to provide notification of substantial equivalence for the Candela Smoothbeam Laser System, which is substantially equivalent to a previously marketed device intended for use in the treatment of periorbital wrinkles.
| Submitted by: | Candela Corporation |
|---|---|
| Address: | 530 Boston Post RoadWayland, MA 01778-1886 |
| Contact Person: | Lorraine NelsonManager, Regulatory Affairs |
| Date Prepared: | November 16, 2001 |
| Device Trade Name: | Smoothbeam Laser System |
| Device Common Name: | Dermatology Laser |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in Generaland Plastic Surgery and in Dermatology) |
| Predicate Devices: | Laser Aesthetics CoolTouch (K003715) and Candela 1450 nm Diode laser(K002421) |
Description of the Smoothbeam Laser System: The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of periorbital wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
Intended use of Smoothbeam Laser System: The Smoothbeam Laser System is indicated for the treatment of periorbital wrinkles.
Performance Standards: As a laser product, the Smoothbeam Laser System is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition, the device will conform to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by the European Community.
Clinical Performance Data: Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of periorbital wrinkles.
Summary of Substantial Equivalence: The Candela Smoothbeam Laser System has the same intended use, utilizes similar operating principles and matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Smoothbeam Laser System is substantially equivalent to the predicate device.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a bird. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2002
Ms. Lorraine Nelson Manger, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778
Re: K013825
Trade/Device Name: Candela Smoothbeam Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 16, 2001 Received: November 19, 2001
Dear Ms. Nelson:
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. Lorraine Nelson
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
to" Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number (if known): K013825
Candela Corporation Smoothbeam Laser System Device Name: Indications For Use:
The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.
The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Muriam C. Provost
Division of General, Resto ative and Neurological Devices
CANDELA CORPORATIO 530 Boston Post Road, Month Not 508-358-7637 Fax: 508-358-5602 12 0
§ 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.