(44 days)
Nidek Dio-Light Laser System is intended for the treatment of vascular and pigmented lesions.
Not Found
The provided text is a 510(k) summary for the Nidek Dio-Light 60 Surgical Laser System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not available in this type of regulatory submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo or PMA where specific performance criteria for new device types would be detailed. The "acceptance criteria" here is fundamentally meeting the standard of being "substantially equivalent" to an existing, legally marketed device (Cynosure's Photogenica LPIR laser system).
- Reported Device Performance: No specific performance metrics (e.g., efficacy rates, precision, accuracy) are reported for the Dio-Light 60 itself in comparison to quantitative criteria. The performance is implied to be comparable to the predicate device.
Table of "Acceptance Criteria" and "Reported Device Performance" (based on substantial equivalence):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Cynosure Photogenica LPIR) in terms of: | Declared substantially equivalent to the predicate device. |
| - Indications for Use (treatment of vascular and pigmented lesions) | "Nidek Dio-Light system is substantially equivalent to Cynosure's Photogenica LPIR laser system." |
| - Materials | "substantially equivalent with respect to... materials" |
| - Method of Operation | "substantially equivalent with respect to... method of operation" |
| - Physical Construction | "substantially equivalent with respect to... physical construction" |
| - Risks and Benefits | "The risks and benefits of the Nidek Dio-Light are comparable to the predicate device when used for similar clinical applications." |
| - Compliance with 21 CFR 1040.10 and 1040.11 (FDA regulations for medical laser products) | "The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document does not describe a clinical performance study with a test set. Substantial equivalence is often demonstrated through comparison of technical specifications, intended use, and safety profiles to a predicate device, rather than a new clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is described.
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 surgical laser system, not an AI-powered diagnostic or assistive device for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for a performance study is mentioned. The "ground truth" for this submission is the accepted safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable. This is a hardware device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth establishment is applicable here.
In summary: The K981447 document is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device, as opposed to presenting a de novo performance study with specific acceptance criteria and detailed clinical trial data typically found in PMA applications or submissions for novel devices. Therefore, much of the requested information regarding performance studies is not contained within this type of regulatory filing.
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2 1608 JUN
SUMMARY OF SAFETY AND EFFECTIVENESS DIO - LIGHT 60 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:
Dio-Light Laser System
DEVICE COMMON NAME:
Laser Diode Surgical Laser System
DEVICE CLASSIFICATION:
Surgical 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:
Nidek Dio-Light Laser System is intended for the treatment of vascular and pigmented lesions.
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COMPARISON WITH PREDICATE DEVICE:
The Nidek Dio-Light system is substantially equivalent to Cynosure's Photogenica LPIR laser system.
The risks and benefits of the Nidek Dio-Light are comparable to the predicate device when used for similar clinical applications.
Since the Nidek Dio-Light 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol is composed of three intertwined figures, possibly representing people, and is oriented diagonally within the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1698 IUN
Mr. Ken Kato ·Vice President Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539
Re: K981447 Trade Name: Dio-Light 60 Laser System Requlatory Class: II Product Code: GEX Dated: April 20, 1998 Received: April 22, 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. ਬੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in requlatory 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,
Ph.D., M.D. · Celia M. Witten, Director Division of General and Restorative 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: Nidek Dio-Light 60 Laser System
Indications for Use: Treatment of vascular and pigmented lesions in Dermatology.
Concurrence of CDRH, Office of Device Evaluation (ODE)
hooll
eral Restorative De
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.