(395 days)
The TattooStar Effect Combo is indicated for incision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows:
Wavelength 1064 nm: Removal of black and blue tattoo color, Skin resurfacing
Wavelength 532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented bum and boil scar, naevus Ota / Ito, freckles, Becker naevi, Cafe-au-lait spots), Removal of red tattoo color
Wavelength 585 nm: Removal of sky blue tattoo color
Wavelength 694nm: Removal of pigmented lesions, Removal of black, blue and green tattoo color
The TattooStar Effect Combo is a combination of a Nd:YAG laser and a Ruby laser. Both lasers are pulsed q-switched lasers, the Nd:YAG can optionally emit millisecond pulses in the Free-running mode. The Nd:YAG laser emits wavelengths of 1064nm and 532nm. The beam can be converted to 585nm by means of an optional dye handpiece. The Ruby laser emits 694 nm radiation.
The provided document is a 510(k) summary for the TattooStar Effect Combo, a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed acceptance criteria and performance data from a clinical or non-clinical study for a novel device.
Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fully extracted from this document as they are not present. This type of submission relies on showing that the new device is as safe and effective as a predicate device, often without new clinical studies if the technology and indications are sufficiently similar.
Here's the breakdown of what can be gathered:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense for a new clinical study. Instead, it compares the technical specifications and indications of the TattooStar Effect Combo to its predicate devices (TattooStar R and TattooStar Effect Y) to demonstrate substantial equivalence. The "performance" is implied by matching or being within acceptable ranges of the predicate device's specifications.
| Feature / Parameter | Proposed Modified Device (TattooStar Effect Combo - Ruby Module) | Un-Modified Predicate Device (TattooStar R) | Proposed Modified Device (TattooStar Effect Combo - Nd:YAG Module) | Un-Modified Predicate Device (TattooStar Effect Y) |
|---|---|---|---|---|
| Indications | Incision, excision, vaporization and ablation of soft tissue, the removal of tattoos and benign pigmented lesions | Cutting, vaporization and ablation of soft tissue, the removal of tattoos and of benign pigmented lesions | Incision, excision, vaporization and ablation of soft tissue, the removal of tattoos, pigmented lesions, vascular lesions and hair and skin resurfacing procedures | Incision, excision, vaporization and ablation of soft tissue, the removal of tattoos, pigmented lesions, vascular lesions and hair and skin resurfacing procedures |
| Device Type | Ruby | Ruby | Nd:YAG | Nd:YAG |
| Delivery | Articulated mirror arm | Articulated mirror arm | Articulated mirror arm | Articulated mirror arm |
| Wavelength | 694 nm | 694 nm | 1064 / 532 / 585 nm | 1064 / 532 / 585 nm |
| Max. Energy per Pulse | 1.15 J | 1.2 J | 1064 nm: 0.8 J (q-switch), 1.5 J (free running); 532 nm: 0.4 J (q-switch); 585 nm: 0.25 J (q-switch) | 1064 nm: 0.8 J (q-switch), 1.5 J (free running); 532 nm: 0.4 J (q-switch); 585 nm: 0.25 J (q-switch) |
| Max. Fluence on skin | 25 J/cm² | 20 J/cm² | 20 J/cm² (q-switch), 37 J/cm² (free running) | 20 J/cm² (q-switch), 37 J/cm² (free running) |
| Pulse Duration | 40 ns | 40 ns | 8 ns (q-switch), 300 µs (free running) | 8 ns (q-switch), 300 µs (free running) |
| Repetition Rate | Up to 2 Hz | Up to 2 Hz | Up to 10 Hz | Up to 10 Hz |
| Spot Sizes | 2 – 7 mm | 2.5 - 6 mm | 2 – 7 mm | 2 – 7 mm |
Note on "Acceptance Criteria": The implied acceptance criteria for a 510(k) submission primarily revolve around demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use, and either the same technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. The table above shows the comparison of technological characteristics.
2. Sample size used for the test set and the data provenance
The document explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
This means there was no specific test set or clinical study conducted for this 510(k) submission to assess the device's performance in a traditional sense. The device's safety and effectiveness are established by its substantial equivalence to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no dedicated test set or clinical study was presented.
4. Adjudication method for the test set
Not applicable, as no dedicated test set or clinical study was presented.
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-powered 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, as this is a medical device (laser) and not an algorithm requiring standalone performance evaluation in that context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no dedicated test set or clinical study was presented that would require establishing ground truth. The basis for clearance is substantial equivalence to predicate devices, whose ground truth for effectiveness would have been established historically.
8. The sample size for the training set
Not applicable, as this is a medical device (laser) and not an algorithm that typically uses a "training set."
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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510(k) SUMMARY ASCLEPION LASÈR TECHNOLOGIES GmbH TattooStar Effect Combo
JUL 17 2014 KI31757
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH TattooStar Effect Combo is submitted in accordance with the requirements of 21 CFR 807.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbHBruesseler Str. 1007747 Jena, Germany | |
|---|---|---|
| Contact Person: | Mrs. Antje KatzerProduct Manager andInternational Regulatory Affairs Manager | |
| Phone:Fax:e-mail: | +49 3641 77 00 309+49 3641 77 00 302antje.katzer@asclepion.com | |
| Preparation Date: | July 15, 2014 | |
| Device Name: | TattooStar Effect Combo | |
| Common Name: | q-switch laser | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology79-GEX21 CFR 878.4810 | |
| Equivalent Devices: | TattooStar Effect YTattooStar R | K112669K060787 |
| Device Description: | The TattooStar Effect Combo is a combination of a Nd:YAG laserand a Ruby laser. Both lasers are pulsed q-switched lasers, theNd:YAG can optionally emit millisecond pulses in the Free-running mode. The Nd:YAG laser emits wavelengths of 1064nmand 532nm. The beam can be converted to 585nm by means ofan optional dye handpiece. The Ruby laser emits 694 nmradiation. |
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The TattooStar Effect Combo is indicated for incision, Intended Use: excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures.
| Proposed Modified Device | Un-Modified Predicate Device | |
|---|---|---|
| Name | TattooStar Effect ComboModul: R (Ruby laser) | TattooStar RK060787 |
| Indications | Incision, excision, vaporizationand ablation of soft tissue, theremoval of tattoos and benignpigmented lesions | Cutting, vaporization andablation of soft tissue, theremoval of tattoos and of benignpigmented lesions |
| There are the same treatment recommendations for both systems: | ||
| 694nm: Removal of pigmented lesions: 3 J/cm², 4-5.5 mm, 0.5-2 Hz, 40 nsRemoval of black, blue and green tattoo: 2-3 J/cm², 4-5.5 mm, 0.5-2 Hz, 40 ns | ||
| Device Type | Ruby | Ruby |
| Delivery | Articulated mirror arm | Articulated mirror arm |
| Wavelength | 694 nm | 694 nm |
| Max. Energy perPulse | 1,15 J | 1,2 J |
| Max. Fluence onskin | 25 J/cm² | 20 J/cm² |
| Pulse Durationq-switch | 40 ns | 40 ns |
| Repetition Rate | Up to 2 Hz | Up to 2 Hz |
| Spot Sizes | 2 – 7 mm | 2,5 - 6 mm |
| Proposed Modified Device | Un-Modified Predicate Device | |
| Name | TattooStar Effect ComboModul: Y (Nd:YAG laser) | TattooStar Effect YModul: Y (Nd:YAG laser)K112669 |
| Indications | Incision, excision, vaporization andablation of soft tissue, the removal oftattoos, pigmented lesions, vascularlesions and hair and skin resurfacingprocedures | Incision, excision, vaporizationand ablation of soft tissue, theremoval of tattoos, pigmentedlesions, vascular lesions and hairand skin resurfacing procedures |
| There are the same treatment recommendations for both systems: | ||
| 1064 nm: Removal of black and blue tattoo color:3-3.5 J/cm², 2-4 mm, 1-10 Hz, 8 ns | ||
| Skin resurfacing: | 1.5-2.5 J/cm², 5.5 mm,10 Hz, 0.3 ms1.5 J/cm²,7 mm,2-5 Hz, 8 ns | |
| 532 nm: Removal of pigmented lesions(including but not limited to lentigo benigna,hyperpigmented burn and boil scar, naevus Ota / Ito,freckles, Becker naevi, Café-au-lait spots):2-2.5 J/cm²,4 mm,1-5 Hz,8 ns | ||
| Removal of red tattoo color: | 2 J/cm²,4 mm,1-5 Hz,8 ns | |
| 585 nm: Removal of sky blue tattoo color: | 2-3 J/cm²,2.5 mm,1-5 Hz,8 ns | |
| Device Type | Nd :YAG | Nd :YAG |
| Delivery | Articulated mirror arm | Articulated mirror arm |
| Wavelength | 1064 / 532 / 585 nm | 1064 / 532 / 585 nm |
| Max.Energy perPulse | 1064 nm: 0,8 J (q-switch mode)1064 nm: 1,5 J (free running mode)532 nm: 0,4 J (q-switch mode)585 nm: 0,25 J (q-switch mode) | 1064 nm: 0,8 J (q-switch mode)1064 nm: 1,5 J (free running mode)532 nm: 0,4 J (q-switch mode)585 nm: 0,25 J (q-switch mode) |
| Max.Fluence onskin | 20 J/cm² (q-switch mode)37 J/cm² (free running mode) | 20 J/cm² (q-switch mode)37 J/cm² (free running mode) |
| PulseDurationq-switch | 8 ns (q-switch mode)300 µs (free running mode) | 8 ns (q-switch mode)300 µs (free running mode) |
| RepetitionRate | Up to 10 Hz | Up to 10 Hz |
| Spot Sizes | 2 – 7 mm | 2 – 7 mm |
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The TattooStar Effect Combo is substantially equivalent to Comparison to: the TattooStar Effect Y Laser system and to the TattooStar R with the same principles of operation, with the same parameters and with the same indications for use.
Nonclinical Performance Data: None
Clinical Performance Data: None
Conclusion: The TattooStar Effect Combo is another safe and effective device for the incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Control - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2014
Asclepion Laser Technologies GmbH Mr. Antje Katze Regulatory Affairs Manager Bruesseler Street 10 Jena, Germanv 07747
Re: K131757
Trade/Device Name: TattooStar Effect Combo 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: June 20, 2014 Received: June 24, 2014
Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Mr. Antje Katze
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131757
Device Name TattooStar Effect Combo
Indications for Use (Describe)
The TattooStar Effect Combo is indicated for incision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows:
| Wavelength | Indication | Recommended Parameters for the Beginning |
|---|---|---|
| 1064 nm: | Removal of black and blue tattoo color | 3-3.5 J/cm^2, 2-4 mm, 1-10Hz, 8 ns |
| Skin resurfacing | 1.5-2.5 J/cm^2, 5.5 mm, 10 Hz, 0.3 ms1.5 J/cm^2, 7 mm, 2-5 Hz, 8 ns | |
| 532 nm: | Removal of pigmented lesions(including but not limited to lentigo benigna,hyperpigmented bum and boil scar,naevus Ota / Ito, freckles, Becker naevi,Cafe-au-lait spots) | 2-2.5 J/cm^2 4mm, 1-5Hz, 8 ns |
| Removal of red tattoo color | 2 J/cm^2, 4mm, 1-5Hz, 8ns | |
| 585 nm: | Removal of sky blue tattoo color | 2-3 J/cm^2, 2.5mm, 1-5Hz, 8 ns |
| 694nm: | Removal of pigmented lesions | 3 J/cm^2, 4-5.5 mm, 0.5-2 Hz, 40 ns |
| Removal of black, blue and greentattoo color | 2-3 J/cm^2, 4-5.5 mm, 0.5-2 Hz, 40 ns | |
| Type of Use (Select one or both, as applicable) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.07.17 11:18:23 -04'00' > < ---
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§ 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.