(19 days)
The PhotoGenica SPIR is indicated for use in dermatology, specifically cutaneous vascular lesions.
The Cynosure PhotoGenica SPIR laser is indicated for coagulation of dermatological vascular lesions.
The PhotoGenica SPIR is a solid state laser, having the alexandrite crystal as the lasing medium. It is a pulsed laser with an invisible wavelength of 755nm and a non-contact handpiece. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.
The provided 510(k) summary for the Cynosure PhotoGenica SPIR does not contain information regarding acceptance criteria or a study to prove the device meets acceptance criteria.
Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (Cynosure PhotoGenica LPIR and Cynosure Apogee Laser). This means that the manufacturer is asserting the new device is as safe and effective as a legally marketed device, rather than providing new performance data against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document. Here's a breakdown of what can be inferred or explicitly stated:
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Table of Acceptance Criteria and Reported Device Performance: Not applicable. No specific acceptance criteria or performance data for the PhotoGenica SPIR are reported in this document. The submission states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
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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 test set data is provided for the PhotoGenica SPIR.
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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 test set data or ground truth establishment is described for the PhotoGenica SPIR.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set data or adjudication method is described for the PhotoGenica SPIR.
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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.
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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.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth data is presented for the PhotoGenica SPIR.
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The sample size for the training set: Not applicable. This device is a laser system, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable. This device is a laser system, not a machine learning model.
In summary, the 510(k) process for this device, at this stage, relies on demonstrating substantial equivalence rather than presenting new performance data against pre-defined acceptance criteria.
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JAN 18 2000
K994437
510(K) Summary
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | December 29, 1999 |
| Device Trade Name: | PhotoGenica SPIR |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Cynosure PhotoGenica LPIR |
| Device Description: | The PhotoGenica SPIR is a solid state laser, having the alexandritecrystal as the lasing medium. It is a pulsed laser with an invisiblewavelength of 755nm and a non-contact handpiece. |
| Laser activation is both by finger switch and footswitch. Overallweight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). | |
| Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase. | |
| Intended Use: | The PhotoGenica SPIR is indicated for use in dermatology,specifically cutaneous vascular lesions. |
| Comparison: | The PhotoGenica SPIR Laser is substantially equivalent to theCynosure Apogee Laser. They are both solid state near infra-red lasersusing alexandrite crystal as their lasing medium. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica SPIR Laser is another safe and effective device fordermatologic applications. |
| Additional Information: | None |
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Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person with outstretched arms, representing health and well-being. The logo is simple and recognizable, conveying the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
K994437 Re:
Trade Name: Cynosure PhotoGenica SPIR Regulatory Class: II Product Code: GEX Dated: December 29, 1999 Received: December 30,1999
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 requirement, 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.
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
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Page 2 - Mr. George Cho
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,
Styptn Rluvels
E. Dillard III James Acting 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): _ K 99 44 37
Device Name: _ Cynosure PhotoGenica SPIR
Indications For Use:
The Cynosure PhotoGenica SPIR laser is indicated for coagulation of dermatological vascular lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hugh Rhodes
(Division Sign-Off) Division of General Restorative Devices <994437 510(k) Number
Prescription Use 0 (Per 21 CFR 801.109)
OR
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.