(26 days)
The MultiStar Laser System is intended for the coagulation, ablation, vaporization, incision, excision, cutting of soft tissue in plastic surgery, general surgery, oral surgery, ENT, gynecology and dermatology.
The MultiStar Laser System is a CO2 - Gas Laser. It emits a beam of coherent light at the wavelength of 10600 nm with a maximum power of 30 Watt
The provided 510(k) summary does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it indicates:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. No performance or clinical data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. No performance or clinical data is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No performance or clinical data is provided.
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. No MRMC study was mentioned.
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. No performance or clinical data is provided.
8. The sample size for the training set:
Not applicable. This device is a laser system, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is a laser system, not a machine learning algorithm requiring a training set.
Summary from the document:
The 510(k) summary for the MultiStar Laser System states that it is "substantially equivalent to the Multipulse Laser System, with the same principles of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses." The conclusion is that "The MultiStar Laser System is another safe and effective device for coagulation, ablation, vaporization, incision, excision, cutting of soft tissue..." This submission relies on substantial equivalence to a predicate device rather than presenting new performance data.
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510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar miXT Laser System
KOLOYST
This 510(k) summary of safety and effectiveness for the Asclepion Laser This of othy Juminary of Sales) Laser System is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbHGoeschwitzer Str. 51-5207745 Jena, Germany |
|---|---|
| Contact Person: | Mr Reinhard ThiemeQuality Assurance andInternational Regulatory Affairs |
| Phone:Fax:e-mail: | +49 3641 220 211+49 3641 220 322reinhard.thieme@asclepion.com |
| Preparation Date: | January 31st, 2006 |
| Device Name: | MultiStar |
| Common Name: | MultiStar |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.481 |
| Equivalent Device: | Multipulse |
| Device Description: | The MultiStar Laser System is a CO2 - Gas Laser. It emitsa beam of coherent light at the wavelength of 10600 nmwith a maximum power of 30 Watt |
| Intended Use: | The MultiStar is intended for coagulation, ablation.vaporization, incision, excision, cutting of soft tissue inplastic surgery, general surgery, oral surgery, ENT,gynecology and dermatology. |
| Comparison to: | The MultiStar Laser System is substantially equivalent tothe Multipulse Laser System, with the same principles ofoperation, the same wavelength and essentially the samepower range as the predicate device for the sameindications for uses. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The MultiStar Laser System is another safeand effective device for coagulation, ablation,vaporization, incision, excision, cutting of softtissue in plastic surgery, general surgery,oral surgery, ENT, gynecology anddermatology. |
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Additional Information :
None
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2006
Asclepion Laser Technologies GmbH c/o Mr. Reinhard Thieme Goeschwitzerstrasse 51-52 Jenna, Germany 07745
Re: K060455
Trade/Device Name: MultiStar 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: February 14, 2006 Received: February 22, 2006
Dear Mr. Thicme:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of 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 r ou may, atere, marros 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 rryour device 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. Reinhard Thieme
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) This letter will and in yourse organ finding of substantial equivalence of your device to a legally premarket noticated 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 If you attire 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 vours,
Sincerely yours,
dl.gmee
Mark N. Melkerson Acting 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 STATEMENT
510(k) Number (if known): צור צ
Device Name: MultiStar Laser System
Indications for Use:
The MultiStar Laser System is intended for the coagulation, ablation, THE Mantistar Laser of excision, cutting of soft tissue in plastic surgery, general surgery, oral surgery, ENT, gynecology and dermatology.
× 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E.gndee
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K06c452
14.FEB.2006 0000117
§ 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.