(211 days)
The Affinity QS laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal, and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
The Affinity QS Q-Switched Nd:YAG Laser is a Q-Switched, frequency doubled laser system. It provides both 1064nm and 532nm wavelengths. Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 25" x 15" x 78" (LxWxH). Electrical requirement is 230 VAC, 20A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the Cynosure Affinity QS Q-Switched Nd:YAG Laser system. Based on this document, the following information can be extracted regarding acceptance criteria and the study (or lack thereof) proving the device meets them:
1. A table of acceptance criteria and the reported device performance
Based on the provided K050382 510(k) summary, specific acceptance criteria and detailed device performance metrics are not present. The submission primarily relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable performance metrics for "acceptance." | The device is deemed "safe and effective for the treatment of vascular and pigmented lesions, for hair and tattoo removal, and for the incision, excision, ablation, vaporization of soft tissue for general dermatology" by demonstrating substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary explicitly states under "Nonclinical Performance Data" and "Clinical Performance Data" that there is "none". This indicates that no specific test set was used for performance evaluation of this device as part of this submission, nor is there any data provenance.
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)
Since there was no "Clinical Performance Data" or "Nonclinical Performance Data" provided for this specific device in this 510(k) submission, there is no information on experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no performance data was submitted, there is no adjudication method described for a test set.
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
The document does not mention any MRMC comparative effectiveness study, nor does it pertain to AI assistance. This device is a laser system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a laser system, not an algorithm. Therefore, no standalone performance study was done in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no performance data was submitted for this device, there is no mention of the type of ground truth used.
8. The sample size for the training set
Given that no performance data was submitted and the device is a physical laser system (not an AI algorithm), there is no training set sample size mentioned.
9. How the ground truth for the training set was established
As there is no training set for this type of device and submission, there is no information on how ground truth for a training set was established.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none."
Instead of performance studies, this 510(k) submission primarily relies on demonstrating substantial equivalence to an already legally marketed predicate device, the Medlite C6 Q-Switched Nd:YAG Laser system. The document states:
"The Affinity QS laser system has identical indication for use, the same principle of operation, and essentially the same wavelength range and pulse energy range as the predicate device."
Therefore, the "study" proving the device meets the acceptance criteria (implicitly, that it is safe and effective for its intended uses) is the legal and regulatory argument of substantial equivalence, rather than new performance data generated specifically for the Affinity QS laser. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the actived [sic] device is substantially equivalent... for the indications for use stated... to legally marketed predicate devices."
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510(K) : ummary
SEP 1 4 2005
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | February 14, 2005 |
| Device Trade Name: | Affinity QS Q-Switched Nd:YAG Laser system |
| Common Name: | Q-Switched Nd:YAG laser |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Medlite C6 Q-Switched Nd:YAG Laser system |
| Device Description: | The Affinity QS Q-Switched Nd:YAG Laser is a Q-Switched,frequency doubled laser system. It provides both 1064nm and 532nmwavelengths.Laser emission activation is by foot switch. Overall weight of the laseris 180 lbs., and the size is 25" x 15" x 78" (LxWxH).Electrical requirement is 230 VAC, 20A, 50-60 Hz, single phase. |
| Intended Use: | The Affinity QS laser is intended for treatment of vascular lesions,pigmented lesions, and for hair, tattoo removal, and the incision,excision, ablation, vaporization of soft tissue for general dermatology. |
| Comparison: | The Affinity QS laser system has identical indication for use, the sameprinciple of operation, and essentially the same wavelength range andpulse energy range as the predicate device. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Affinity QS laser is a safe and effective device for the treatment ofvascular and pigmented lesions, for hair and tattoo removal, and forthe incision, excision, ablation, vaporization of soft tissue for generaldermatology. |
| Additional Information: | none |
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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President Medical Technoogy Cynosure Incorporated 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K050382 Trade/Device Name: Cynosure Affinity QS Laser 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 31, 2005 Received: September 2, 2005
Dear Mr.Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 9 rotty premained is substantially equivalent (for the indications referenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule for legally manatise to of the Medical Device American of Grod. Ford, Drug commerce prior to May 28, 1776, the enacting with the provisions of the Federal Food. Drug. devices that have been reclassified in acceraanse while has remarket approval application (PMA). and Cosment Act (Act) that to not require approvide controls provisions of the Act. The You may, therefore, market the device, belyer to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Hecking, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can may be subject to such additional controlls. Extrangemand on 898. In addition, FDA may be found in the Code of Peachar Regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I Dri- 3 issuation or our device complies with other requirements of the Act that TDA has made a decorminations administered by other Federal agencies. You must of ally Federal statures and regulations adminited to: registration and listing (21 comply with an the Act 81equire Rart 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. George Cho
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your article quivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits vo premarket notification. The FDA Inding of substantial equice 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
rs the latest of the many of the 1076 0115 . Algeralation entitled If you desire specific advice for your de not on on S. Also, please note the regulation entitled, the may obtain contact the Office of Compliance at (240) 270 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by relerence to premarket notifiedavin (e. the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the Admanain html Manufacturers, International and Consulter Piersons. Passions of thinksma/dsmamain.html
Sincerely yours,
Aubrey Buchus
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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510(k) Number (if known):
Device Name: _Cynosure Affinity QS Laser
Indications For Use:
The Affinity QS Laser is intended for the treat nent of vasular lesions, and for The Affinity QS Laser is intended for the treat of vascular resoluly plantined and of the for general dermatology.
OR Prescriptive Use_ x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINF - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, ( vffice of Device Evaluation (ODE)
Barbara Buell for MM
(Division Sign-O Division of General, Re and Neurological Devices
510(k) Number L050382
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Over-The-Counter Use_______
(Optional Format 1-2-96)
§ 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.