(313 days)
Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications.
Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.
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The provided text is related to a 510(k) clearance for the Nidek UniPulse CO2 Surgical Laser System. It is an administrative document confirming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance as typically expected for in-vitro diagnostic (IVD) devices or AI/ML-driven medical devices.
Therefore, most of the requested information regarding acceptance criteria, study details, expert consensus, and training/test set specifics for an AI/ML device is not applicable to this document. This document primarily focuses on regulatory clearance based on substantial equivalence to an already marketed device.
Here's a breakdown of what can be extracted and why other parts are not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not describe specific performance-based acceptance criteria for the Nidek UniPulse CO2 Laser System in terms of classification metrics (e.g., sensitivity, specificity, AUC) or quantitative measurements. Instead, it relies on substantial equivalence to a predicate device. The "performance" assessment here is conceptual, relating to the device's ability to perform its intended function safely and effectively, similar to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No explicit test set or clinical study data (in the sense of a controlled trial with a defined sample size for performance evaluation) is described. The clearance is based on the comparison to a predicate device, not on new clinical performance data from a specific test set.
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)
- Not Applicable. Since there is no described test set or performance study, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or corresponding adjudication method is discussed.
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 is a laser surgical system, not an AI-driven diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As no specific performance study is detailed, no ground truth methodology is described. The "ground truth" for the clearance is essentially the established safety and efficacy profile of the predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set.
Summary of Relevant Information from the Document:
While most of the requested information for an AI/ML device is not applicable, here's what can be gleaned about the regulatory approach:
- Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
- Device Trade Name: UniPulse CO2 Laser System
- Device Common Name: CO2 Surgical Laser System
- Device Classification: Class II
- Performance Standards (Regulatory Compliance, not performance metrics): The laser systems comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
- Indications for Use: Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows, and acne scar revision.
- Basis for Clearance: Substantial equivalence to the Coherent CO2 laser system (the predicate device). The document states: "The Nidek CO2 system is substantially equivalent to Coherent's CO2 laser system. The risks and benefits of the Nidek UniPulse CO2 are comparable to the predicate device when used for similar clinical applications."
The clearance is granted because the Nidek UniPulse CO2 laser system is "substantially equivalent with respect to indications for use, materials, method of operation and physical construction" to the predicate device, thereby assuring safety and effectiveness. This is a common pathway for medical device clearance, especially for non-novel technologies like surgical lasers.
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DEC 16 1998
SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK UNIPULSE CO2 SURGICAL LASER SYSTEM
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Ken Kato Vice President 47651 Westinghouse Drive Fremont, CA 94539 Phone: (510) 226-5700 Fax: (510) 226-5750
DEVICE TRADE NAME:
UniPulse CO2 Laser System
DEVICE COMMON NAME:
CO2 Surgical Laser System
DEVICE CLASSIFICATION:
CO2 laser systems are classified as Class II.
PERFORMANCE STANDARDS:
The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
INDICATIONS FOR USE STATEMENT:
Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications.
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COMPARISON WITH PREDICATE DEVICE:
The Nidek CO2 system is substantially equivalent to Coherent's CO2 laser system.
The risks and benefits of the Nidek UniPulse CO2 are comparable to the predicate device when used for similar clinical applications.
Since the Nidek UniPulse CO2 laser system is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence according to 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1998
Mr. Ken Kato Vice President of Administration Nidek, Incorporated 47651 Westinghouse Drive Fremont, California 94539
K980475 Re:
Trade Name: UniPulse CO, Surgical Laser System Regulatory Class: II Product Code: GEX Dated: November 30, 1998 Received: December 1, 1998
Dear Mr. Kato:
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 Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. Ken Kato
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,
Scalef
Celia 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): Device Name: Nidek UniPulse CO2 Laser System
Indications for Use: Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off) (Divisiok (Division of General Restorative Devices (L g g O4 7 S 510(k) Number
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.