(69 days)
The TattooStar Y is intended for use for incision, excision, ablation, vaporization of soft tissue for general dematology and the romovial of hair. benign pigmented lesion, the removal of vascular lesion and the removal of hair.
The TattooStar Y is a q-switched solid state lasers emitting wavelengths of 1064, 532 and 585 nm. It consists of a laser enclosure and optic delivery system (articulated mirror arm).
The provided 510(k) summary for the ASCLEPION LASER TECHNOLOGIES GmbH TattooStar Y does not include any acceptance criteria or studies demonstrating device performance.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device, the Medlite C6. This means the manufacturer is asserting that their device is as safe and effective as a device already legally marketed, without needing to conduct new performance studies.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
Explanation: The document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, there are no acceptance criteria or stated performance metrics provided in this 510(k) summary. The submission's argument for market clearance is based on substantial equivalence, not on specific performance data against acceptance criteria.
2. Sample size used for the test set and the data provenance
Not applicable. No performance studies were conducted as part of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No performance studies were conducted.
4. Adjudication method for the test set
Not applicable. No performance studies were conducted.
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 for medical procedures, not an AI-assisted diagnostic tool. No MRMC studies were mentioned or would typically be relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser for medical procedures, not an algorithm.
7. The type of ground truth used
Not applicable. No performance studies were conducted.
8. The sample size for the training set
Not applicable. No performance studies were conducted, and this is not an AI/machine learning device that would typically have a training set.
9. How the ground truth for the training set was established
Not applicable. No performance studies were conducted, and this is not an AI/machine learning device.
Conclusion from the 510(k) Summary:
The device (TattooStar Y) achieved market clearance by demonstrating substantial equivalence to a legally marketed predicate device (Medlite C6). This means the FDA concluded that the TattooStar Y has the "same intended use" and "same technological characteristics" as the predicate, or if there are differences, those differences "do not raise different questions of safety and effectiveness." The manufacturer did not provide new performance data or clinical studies in this submission because the substantial equivalence pathway allows for this, particularly when the technology is well-established.
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510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH TattooStar Y
AUG - 1 2007
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH TattooStar Y 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 GmbHAm Semmicht 1A07751 Jena, Germany |
|---|---|
| Contact Person: | Mrs Antje KatzerProduct Management andInternational Regulatory Affairs |
| Phone:Fax:e-mail: | +49 3641 77 00 309+49 3641 77 00 302antje.katzer@asclepion.com |
| Preparation Date: | May 21th, 2007 |
| Device Name: | TattooStar Y |
| Common Name: | TattooStar Y |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.481 |
| Equivalent Device: | Medlite C6 |
| Device Description: | The TattooStar Y is a q-switched solid state lasers emittingwavelengths of 1064, 532 and 585 nm. It consists of a laserenclosure and optic delivery system (articulated mirror arm). |
| Intended Use: | The TattooStar Y is indicated for incision, excision, ablationand vaporization of soft tissue in general dermatology andthe removal of tattoos, pigmented lesions, vascular lesionsand unwanted hair. |
| Comparison to: | The TattooStar Y is substantially equivalent to the MedliteC6, with the same principles of operation, and the sameindication for use. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The TattooStar Y is another safe and effective devicefor incision, excision, ablation, vaporization of softtissue for general dermatology and the removal oftattoos, pigmented lesions, vascular lesions and hair. |
| Additional Information : | None |
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EXHIBIT F
INDICATION FOR USE STATEMENT
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asclepion Laser Technologies % Antje Katzer 1A; IM SEMMICHT JENA, GERMANY 07751
AUG = 1 2007
Re: K071451 Trade/Device Name: TattooStar Y Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: June 29, 2007 Received: July 2, 2007
Dear Antje Katzer:
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 – Antje Katzer
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), 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, ハモ 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 STATEMENT
510(k) Number (if known):
Device Name: TattooStar Y
Indications for Use:
The TattooStar Y is intended for use for incision, excision, ablation, vaporization The Tattoostal T is Intended for use for the belows of tattoos, the removal of hair of soft tissue for general dematology and the romovial of hair.
benign pigmented lesion, the removal of vascular lesion and the removal of hair.
Division Signa
vision Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071481 k11
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)
§ 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.