(86 days)
The Viridis Derma laser is intended for photocoagulation of pigmented lesions in dermatology. These include the following specific applications: Benign Vascular Lesions, Facial Telangiectasias, Port Wine Stains, Café au-lait, Erythrosis, Benign Pigmented Lesions, Cuperosis, Senile Lentigo, Keratoses, Hemangiomas (spider and cherry/strawberry), Dermatosis Papulosis Nigra (DPN), Leg Telangiectasia - only as a complement to sclerotherapy and for small superficial red vessels.
The Viridis Derma frequency doubled Nd:YAG laser emits a beam of coherent light at 532 microns.
The Viridis Derma laser device is a frequency-doubled Nd:YAG surgical laser.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| None explicitly stated as quantitative acceptance criteria. The submission focuses on substantial equivalence. | The device is deemed "substantially equivalent" to predicate devices for the indicated uses. |
| Intended for photocoagulation of pigmented lesions in dermatology, specifically: Facial Telangiectasias, Benign Vascular Lesions, Café au-lait, Port Wine Stains, Benign Pigmented Lesions, Erythrosis, Senile Lentigo, Cuperosis, Hemangiomas (spider and cherry/strawberry), Keratoses, Dermatosis Papulosis Nigra (DPN), Leg Telangiectasia (only as a complement to sclerotherapy and for small superficial red vessels). | The FDA confirmed substantial equivalence for these stated Indications for Use. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document explicitly states: "Performance Data: None required." This indicates that no specific clinical study or test set data was used to demonstrate the device's efficacy or safety. The approval was based on demonstrating substantial equivalence to existing predicate devices.
Therefore, there is no information regarding:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no performance data or test set was required, there is no mention of experts being used to establish a ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no test set data was required or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission specifically states "Performance Data: None required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study was not done. This device is a laser surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used:
Not applicable, as no performance data or test set was required for this 510(k) submission. The basis for approval was substantial equivalence to predicate devices, not direct evidence of efficacy against a defined ground truth derived from a study.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device (laser), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this device is not an AI algorithm requiring a training set.
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APR = 5 2002
K 020071
SECTION 10
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Viridis Derma (frequency doubled I MD > ( ( ) sa is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
Applicant: QUANTEL MEDICAL
Address:
QUANTEL MEDICAL 21 rue Newton ZI du BREZET 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 +33 (0)473 745 700 (Fax)
- Mr. Jean Abascal Contact Person: Regulatory Affairs Manager (+33) 169 29 17 25 (+33) 169 29 17 29 (Fax)
Preparation Date: December 2001 (of the Summary)
Viridis Derma Device Name:
Frequency Doubled Nd: Y AG Surgical Laser Common Name:
Laser surgical instrument for use in general and plastic surgery and in Classification dermatology (see: 21 CFR 878.4810). Name: Product Code: GEX Panel: 79
- The Viridis Laser (K001784): Nuvo-Lase 660 Laser System (K970667) Predicate device COMPACT KTP Laser (K983020); DioLite 532 Laser System (K964074); Nidek Dio-Lite 60 Laser System (K981447); Altus Family of CoolGlide Aesthetic Lasers (K003202)
Device description: The Viridis Derma frequency doubled Nd:YAG laser emits a beam of coherent light at 532 microns.
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The Viridis Derma laser is intended for photocoagulation of pigmented Indications: lesions in dermatology.
These include the following applications:
Facial Telangiectasias Benign Vascular Lesions Café au-lait Port Wine Stains Benign Pigmented Lesions Erythrosis Senile Lentigo Cuperosis Hemangiomas (spider and cherry/ Keratoses Dermatosis Papulosis Nigra (DPN) strawberry) Leg Telangiectasia - only as a complement to sclerotherapy and for small superficial red vessels
The Viridis Derma laser will be labeled as a prescription device as follows:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals
Performance Data: None required.
CONCLUSION:
Based on the information in the notification Quantel Medical concludes that the Viridis Derma frequency doubled Nd: YAG laser is substantially equivalent to the Viridis laser and to other cited legally marketed predicates, under the conditions of intended use (above).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ouantel Medical c/o Mr. Roger W. Barnes 342 Sunset Bay Road Hot Springs, AR 71913
APR = 5 2002
Re: K020071
Trade/Device Name: Viridis Derma Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 7, 2002
Received: January 9, 2002
Dear Mr. Barnes:
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.
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. Roger W. Barnes
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Muriam C. Provost
For Celia 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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SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO2007
Device Name:_Viridis Derma (Frequency doubled Nd: YAG laser)
Indications for Use Statement:
The Viridis Derma laser is intended for photocoagulation of pigmented lesions in dermatology.
These include the following specific applications:
| Benign Vascular Lesions | Facial Telangiectasias |
|---|---|
| Port Wine Stains | Café au-lait |
| Erythrosis | Benign Pigmented Lesions |
| Cuperosis | Senile Lentigo |
| Keratoses | Hemangiomas (spider and cherry/strawberry) |
| Dermatosis Papulosis Nigra (DPN) | Leg Telangiectasia - only as a complement to sclerotherapy and for small superficialred vessels |
The Viridis Derma laser is labeled as a prescription device as follows:
CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician.
Musiaml-Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020671
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
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.