(195 days)
The Candela Smoothbeam Laser is indicated for the following uses: For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, New indication: Treatment of Sebaceous Hyperplasia
The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used in dermatology for the treatment of 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 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 operations. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
The provided document, K041242 for the Candela Smoothbeam Laser System, describes the device and its intended uses, including a new indication for the treatment of sebaceous hyperplasia. However, it does not include detailed information regarding specific acceptance criteria, a clinical study design with performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods for the new indication.
The document primarily focuses on establishing substantial equivalence to a predicate device (Candela Smoothbeam 1450 nm Diode Laser System, K013825, K030834) for the expanded indication. It states: "Published clinical data, using t he predicate Smoothbeam Laser, cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser is safe and effective for the expanded indication, - the treatment of sebaceous hyperplasia." This suggests that the substantial equivalence hinges on existing clinical data from the predicate device rather than a new standalone study for this specific 510(k) submission.
Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text for the new indication of sebaceous hyperplasia. The document states that "Published clinical data, using the predicate Smoothbeam Laser, cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser is safe and effective for the expanded indication." This implies that the acceptance criteria for "safety and effectiveness" for sebaceous hyperplasia were met by the existing data from the predicate device, but the specific quantitative criteria (e.g., percentage reduction in lesion size, number of lesions cleared, etc.) are not detailed.
2. Sample size used for the test set and the data provenance
Not explicitly stated for the sebaceous hyperplasia indication in this document. The document refers to "Published clinical data" from the predicate device, but does not provide details of that specific study, including its sample size or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. Ground truth for the published clinical data of the predicate device is not described in this submission.
4. Adjudication method for the test set
Not explicitly stated. Adjudication method for the published clinical data of the predicate device is not described in this submission.
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. The Candela Smoothbeam Laser System is a physical medical device, not an AI-assisted diagnostic or imaging system involving human readers. Therefore, an MRMC study with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical laser device, not an algorithm.
7. The type of ground truth used
Not explicitly stated for the sebaceous hyperplasia indication. For a laser treatment, ground truth in clinical data would typically involve clinical assessment (e.g., visual grading, photographic assessment of lesions by dermatologists, possibly histology from biopsies if performed). The document only broadly refers to "results that demonstrate that the Smoothbeam Laser is safe and effective."
8. The sample size for the training set
Not applicable. The device is a physical laser system, not a machine learning algorithm that requires a training set in this context. The "training" in this context would refer to physician training on using the laser, which is not what this question is asking.
9. How the ground truth for the training set was established
Not applicable, as it's not an AI system with a machine learning training set.
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NOV 2 2 2004
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Smoothbeam Laser System, I mis 10(x) is to provide notheaton of succements veal notended for use in the treatment of facial acne
| Submitted by: | Candela Corporation530 Boston Post RoadWayland, MA 01778-1886 |
|---|---|
| Contact Person: | Lorraine Calzetta Patrovic |
| Date prepared: | April 23, 2004 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in Generaland Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, Smoothbeam Laser System |
| Predicate Devices: | Candela Smoothbeam 1450 nm Diode Laser System (K013825 ,K030834) |
Description:
The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used I Is Doc tase is a continued of 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 power supply, optical defreery of claring cosmation of the produces circular beams on the skin. The Dynamic Clooling 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 a hose to a nozine risunizing 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 operations. IJsers of the device, make selections from a control panel to regulate operation during the laser treatment.
Testing:
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.
Safety and Effectiveness Information:
The modality of action for the treatment of sebaceous hyperplasia is similar to that of previously cleared indications in the treatment of back acne and the treatment of inflammatory acne vulgaris. Published clinical data, using t he predicate Smoothbeam Laser, cleared for use in the market, produced results that demonstrate that the Smoothbeam Laser is safe and effective for the expanded indication, - the treatment of sebaceous hyperplasia
Summary of Substantial Equivalence:
The Candela Smoothbeam Laser System described in this submission is identical to the currently marketed Candela Smoothbeam Laser System based on operating principles, materials, mechanism of action, design, construction and intended use. Candela believes that the Smoothbeam Laser is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure with outstretched arms. The emblem is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2004
Ms. Lorraine Calzetta Patrovic Manager, Regulatory Affairs Candela Corporation 530 Boston Port Road Wayland, Massachusetts 01778-1886
Re: K041242
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: II Product Code: GEX Dated: August 24, 2004 Received: August 26, 2004
Dear Ms. Patrovic:
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 10 rate exaction 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark A. Millmann
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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Indications for Use
510(k) Number (if known):
Device Name: Candela Smoothbeam Laser ( aka Candela MID IR Laser)
Indications For Use:
The Candela Smoothbeam Laser is indicated for the following uses :
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue,
Treatment of back acne
Treatment of atrophic acne scars
Treatment of facial wrinkles
Treatment of mild to moderate acne vulgaris
New indication : Treatment of Sebaceous Hyperplasia
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mellem
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K041242
02:3
§ 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.