(59 days)
The PhotoGenica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.
The PhotoGenica Er Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 20 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 20 watts.
This document pertains to a 510(k) premarket notification for a medical laser system, specifically the PhotoGenica Er Laser by Cynosure, Inc. The core of this submission is to demonstrate substantial equivalence to a predicate device, not to establish new safety and efficacy criteria through clinical trials. As such, the information you've requested regarding acceptance criteria and performance studies for a new device's clinical performance, ground truth, and expert evaluation is largely not applicable in this context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are not typically performance metrics demonstrating new clinical safety and efficacy. Instead, the acceptance criteria are met by demonstrating the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing:
- Same intended use.
- Same technological characteristics, or if different, that the differences do not raise new questions of safety and effectiveness and that performance data (non-clinical or clinical) demonstrate the device is as safe and effective as the predicate.
- Reported Device Performance:
Since this is a 510(k) for substantial equivalence, clinical performance data demonstrating novel safety and efficacy was not provided and not required. The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." The device's performance is assumed to be substantially equivalent to the predicate.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (as demonstrated for 510(k)) |
|---|---|
| Same Intended Use as Predicate Device | Yes, stated Intended Use for PhotoGenica Er Laser is "Skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues," which is implied to be the same as the predicate Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser. |
| Same Technological Characteristics as Predicate Device | The PhotoGenica Er Laser is compared to the predicate in terms of "treatment wavelength, pulse duration, pulse energy, and biological effects," implying substantial similarity. |
| Differences in Technology Do Not Raise New Questions of Safety and Effectiveness | Explicitly stated: "The PhotoGenica Er Laser is substantially equivalent to the Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser in terms of treatment wavelength, pulse duration, pulse energy, and biological effects." |
| Performance Data (if technological differences exist) | None provided; the submission relies on the substantial equivalence of technological characteristics and intended use, rather than new performance data. |
Regarding the other points you've asked for, they are largely not applicable to this 510(k) submission:
2. Sample Size Used for the Test Set and the Data Provenance
- Not Applicable. No test set was used for a de novo clinical study in this 510(k). The submission relies on the established safety and efficacy of the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. No new ground truth was established by experts for a test set for this 510(k).
4. Adjudication Method for the Test Set
- Not Applicable. No test set existed that required adjudication.
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 or interpretation tool. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device (a laser), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth was established or used for a clinical study within this 510(k) submission. The "ground truth" for a 510(k) is essentially that the predicate device is already recognized as safe and effective, and the new device is equivalent.
8. The Sample Size for the Training Set
- Not Applicable. There was no training set for an AI algorithm or a clinical trial in this 510(k). This is a hardware submission.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there was no training set (see point 8), no ground truth for it was established.
In summary: The provided document is a 510(k) premarket notification for a laser system. This regulatory pathway primarily focuses on demonstrating "substantial equivalence" to a previously cleared device. It does not typically require new clinical studies, performance data, or AI-related metrics like those you've inquired about, unless significant technological differences exist that could raise new safety and effectiveness questions, which was not the case here. The FDA concluded that the PhotoGenica Er Laser is "another safe and effective laser" based on its substantial equivalence to the predicate device.
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קמותחתרית החוקרים הרב
K97349P
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| NOV 13 1997 | |
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | September 11, 1997 |
| Device Trade Name: | PhotoGenica Er Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser |
| Device Description: | The PhotoGenica Er Laser consists of three interconnected sections:the power supply, the water cooling system and the optical bench.At 20 pulses per second and a pulse energy of 2 Joules, the averagepower from the laser is 20 watts. |
| Intended Use: | Skin resurfacing and for the incision, excision, ablation orvaporization of soft bodily tissues |
| Comparison: | The PhotoGenica Er Laser is substantially equivalent to theContinuum Biomedical CB Erbium / 2.94™ Er:YAG Laser interms of treatment wavelength, pulse duration, pulse energy, andbiological effects. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica Er is another safe and effective laser for skinresurfacing and for the incision, excision, ablation or vaporizationof soft bodily tissues. |
| Additional Information: | None requested at this time |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
NOV 1 3 1997
Re: K973498 Trade Name: CYNOSURE PhotoGenica ER Laser Regulatory Class: II Product Code: GEX Dated: September 12, 1997 Received: September 15, 1997
Dear Mr. Cho:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. George Cho
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
toscella
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_K973498
Device Name: __ Cynosure PhotoGenica Er Laser___
Indications lior Usc:
The PhotoGenica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.
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Concurrence of CDRH. Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973418 |
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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.