(88 days)
The DermaStar Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
The DermaStar Er: YAG Laser System is an Erbium:YAG laser with a wavelength of 2.94um. It consists a laser enclosure and fiber optic delivery system (including hand piece).
The provided text is a 510(k) summary for the ASCLEPION-MEDITEC AG DermaStar Er:YAG Laser System. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting novel performance data from a clinical study with detailed acceptance criteria and expert reviews.
Here's a breakdown based on the request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in a table. The primary acceptance criterion for a 510(k) is substantial equivalence to a predicate device.
- Reported Device Performance: "None" is explicitly stated. The submission relies on the specifications and intended uses being "the same or very similar" to legally marketed predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Dermablate Er: YAG Laser System (K980361) and MCL 29 Dermablate Er: YAG Laser System (K964128)) | "The specifications and intended uses of the DermaStar Er:YAG laser system are the same or very similar to those of claimed predicate devices." |
| No new questions of safety or effectiveness raised | Implied by substantial equivalence claim. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable. No performance data or test set was used for this submission. The determination of substantial equivalence was based on a comparison of device specifications and intended uses.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set requiring expert ground truth was utilized.
4. Adjudication method for the test set:
- Not applicable. No test set was utilized.
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, and no MRMC study was performed.
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:
- Not applicable. No ground truth was established as no performance study was conducted. The basis for clearance was a comparison of features and intended use with predicate devices already cleared by the FDA.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. The determination was based on existing predicate device specifications.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
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8 2002
MAR
510(k) SUMMARY ASCLEPION-MEDITEC AG DermaStar Er:YAG Laser System
This 510(k) summary of safety and effectiveness for the ASCLEPION-MEDITEC AG DermaStar Er: YAG Laser System is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION-MEDITEC AG |
|---|---|
| Address: | Goeschwitzer Strasse 51-5207745 Jena, Germany |
| Contact Person: | Dr. Dirk ColditzVice President Operations andInternational Regulatory Affairs |
| Phone:Fax:e-mail: | +49 3641 220 501+49 3641 220 502ctz@asclepion.com |
| Preparation date: | September 2001 |
| Device name: | DermaStar Er: YAG Laser System |
| Common Name: | DermaStar |
| ClassificationName: | Laser surgical instrument for use in general and plastic surgeryand in dermatology (21 CFR 878.4810)Product code: GEX - Laser instrument, surgical, poweredPanel: 79 |
| Legally marketed: | Dermablate Er: YAG Laser System (K980361)MCL 29 Dermablate Er: YAG Laser System (K964128) |
| Description: | The DermaStar Er: YAG Laser System is an Erbium:YAG laserwith a wavelength of 2.94um. It consists a laser enclosure andfiber optic delivery system (including hand piece). |
| Intended Use: | The DermaStar Er: YAG Laser System is intended forcoagulation, vaporization, ablation or cutting of soft tissue (skin)in dermatology, plastic surgery (including aesthetic surgery), oralsurgery, and ophthalmology (skin around the eyes). |
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Premarket Notification DermaStar
Image /page/1/Picture/2 description: The image shows a handwritten alphanumeric string. The string is "KO14057". The characters are written in a bold, slightly slanted font. The image is a close-up of the string, with a white background.
Comparison to: The specifications of the DermaStar are the same as or very similar to those of legally marketed lasers such as Dermablate Er: YAG Laser System (K980361) and MCL 29 Dermablate Er: YAG Laser System (K964128) Performance data: None. The specifications and intended uses of the DermaStarEr:YAG laser system are the same or very similar to
- those of claimed predicate devices. Because of this, performance data were not required.
- The DermaStar Er: YAG laser system is substantially equivalent CONCLUSION: to legally marketed devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three human figures are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Asclepion-Meditec AG c/o Mr. William Kelley Asclepion-Meditec, Inc. 23832 Via Monte Coto De Caza, CA 92708
Re: K014057
Trade/Device Name: DermaStar Er:YAG Laser System Regulation Number: 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, 2001 Received: December 10, 2001
Dear Mr. Kelley:
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.
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Page 2 - Mr. William Kelley
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematicated predicated. The aclassification 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 prometion 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 Onlor general mionnazion turers, 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,
iriam C. Provost
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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Page 44 of 68
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K O14057
Device Name: _DermaStar Er: YAG Laser System
Indication For Use:
The DermaStar is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes)
The laser system DermaStar is restricted to sale to or use by licensed professionals in the United States.
isiam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K014057
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Over-The-Counter Use
§ 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.