(91 days)
The PhotoGenica sV laser is indicated for vascular and vascular dependent lesions of the upper airway including, but not limited to, glottal dysplasia, laryngeal papillomas and haemorrhagic telangiectasia.
The PhotoGenica sV is a pulse-dye laser, having the organic dye as the lasing medium. It is a pulsed dye laser with a wavelength of 585nm. Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
Analysis of Acceptance Criteria and Study for Cynosure PhotoGenica sV Laser (K032539)
Based on the provided 510(k) summary and FDA clearance letter, it's evident that no clinical performance data or specific acceptance criteria for device performance related to a clinical study were provided or required for the substantial equivalence determination of the PhotoGenica sV laser.
The submission focuses primarily on demonstrating substantial equivalence to predicate devices (PhotoGenica V and PhotoGenica sV - implying a prior version or a very similar model) based on shared principle of operation, wavelength, and pulse energy range, rather than performance against predetermined clinical metrics.
Therefore, the following sections will reflect the absence of such information in the provided documents.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (No specific clinical performance or acceptance criteria were defined or required for this 510(k) submission based on the provided documents.) | Not Applicable (No clinical performance data was reported or used to establish substantial equivalence.) |
Explanation: The 510(k) summary explicitly states "Clinical Performance Data: none." The FDA clearance letter makes no mention of clinical data review, but rather focuses on substantial equivalence to predicate devices based on technical specifications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set data was provided.
- Data Provenance: Not applicable. No clinical data was provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. No clinical ground truth was established through expert review for this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set and thus no adjudication method was employed or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The provided documents explicitly state "Clinical Performance Data: none," indicating no such study was conducted or submitted.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not applicable. This device is a medical laser system, not an algorithm-driven diagnostic or therapeutic device requiring a standalone performance study.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No clinical ground truth was required or used for this 510(k) submission. Substantial equivalence was based on comparison to existing predicate devices' technical specifications and intended use.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a physical laser system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As the device is a laser system and not an AI/ML model, the concept of a "training set" and associated ground truth is not relevant.
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NOV 17 2003
:
510(K) Summary
| K032539 | |
|---|---|
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | August 15, 2003 |
| Device Trade Name: | PhotoGenica sV |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | PhotoGenica V and PhotoGenica sV |
| Device Description: | The PhotoGenica sV is a pulse-dye laser, having the organic dye as thelasing medium. It is a pulsed dye laser with a wavelength of 585nm.Laser activation is by footswitch. Overall weight of the laser is 285lbs,and the size is 44"x19"x24" (HxWxD).Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz,single phase. |
| Intended Use: | The PhotoGenica sV is indicated for treatment of vascular and vasculardependent lesions of the upper airway. |
| Comparison: | The PhotoGenica sV laser has an equivalent indication for uses, thesame principle of operation, the same wavelength and pulse energyrange as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica sV laser is another safe and effective device for softtissue applications. |
| 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 & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2003
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K032539 Trade/Device Name: PhotoGenica sV 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 15, 2003 Received: August 19, 2003
Dear Mr. Cho:
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. Ilisting 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 - Mr. George Cho
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
miriam C Provost
forCelia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Cynosure PhotoGenica sV Laser
Indications For Use:
The PhotoGenica sV laser is indicated for vascular and vascular dependent lesions of the upper airway including, but not limited to, glottal dysplasia, laryngeal papillomas and haemorrhagic telangiectasia.
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number --
Prescription Use
Over-The-Counter Use_
§ 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.