(55 days)
Nidek Dio-Light Laser System is intended for all cleared Cynosure Photogenica LPIR applications.
Treatment of vascular and pigmented lesions in Dermatology.
Not Found
The provided text describes a 510(k) premarket notification for the "Nidek Dio-Light Laser System". This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, many of the typical study-related questions cannot be directly answered from this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device should be substantially equivalent to a legally marketed predicate device with respect to indications for use, technological characteristics, and safety and effectiveness. This implies that the new device should not raise new questions of safety and effectiveness, and its performance should be comparable to the predicate for similar applications. | The Nidek Dio-Light system is stated to be substantially equivalent to Cynosure's Photogenica LPIR laser system. The document explicitly states: "The risks and benefits of the Nidek Dio-Light are comparable to the predicate device when used for similar clinical applications." And "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..." |
| Regulatory Compliance (General) | Compliance with general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. | The FDA letter grants permission to market the device, subject to these general controls. It assumes compliance with the current Good Manufacturing Practice requirement (21 CFR Part 820). |
| Laser Safety Compliance | Compliance with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products. | The document states: "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 (Clinical Scope) | The device should be proven safe and effective for its stated indications for use. For a 510(k), this means the indications should be the same as or comparable to the predicate device. | The Nidek Dio-Light Laser System is indicated for: "Treatment of vascular and pigmented lesions in Dermatology." The submission states: "Nidek Dio-Light Laser System is intended for all cleared Cynosure Photogenica LPIR applications," implying the predicate device has established safety and effectiveness for these indications. |
Study Description (Implicit from 510(k) submission):
The "study" in this context is primarily a comparison and demonstration of equivalence to a predicate device, rather than a de novo clinical trial.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. No clinical "test set" in the traditional sense was used for this specific device's performance evaluation in comparison to a ground truth. Instead, the focus was on demonstrating that the new device's specifications (e.g., wavelength, power, pulse duration) and intended use were highly similar to a device already cleared by the FDA (the predicate).
- Data Provenance: Not applicable. The "proof" of meeting acceptance criteria comes from technical specifications and comparison to the predicate, not from patient data collected for this specific submission. Any clinical data supporting the safety and effectiveness of the predicate device would have been collected previously and would have been part of its 510(k) or PMA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. No ground truth was established by experts for a novel test set in this 510(k) submission. The FDA reviewers and the company's engineers/scientists would have assessed the technical and functional equivalence to the predicate.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" requiring adjudication in the context of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study is for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The Nidek Dio-Light is a surgical laser system, and its premarket notification is for substantial equivalence to an existing device, not for evaluation of an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. The Nidek Dio-Light is a physical medical device (laser system), not a software algorithm, so the concept of "standalone performance" for an algorithm does not apply. Its performance is demonstrated through its technical specifications and comparison to the predicate device.
7. Type of Ground Truth Used
- Implicitly, the "ground truth" is the established safety and effectiveness of the predicate device, Cynosure Photogenica LPIR laser system. The Nidek Dio-Light uses this established history as its basis for substantial equivalence. No new, independent ground truth (e.g., pathology, outcomes data) was generated for this specific submission.
8. Sample Size for the Training Set
- Not applicable. This device is a laser system, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a physical device, there is no training set or associated ground truth establishment for AI.
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K48020/
MAR 1 6 1998
SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK PRIMA KTP 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 all cleared Cynosure Photogenica LPIR applications.
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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/2 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" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three curved lines forming the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1998
Mr. Ken Kato ·Vice President Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539
Re: K980201 Trade Name: Dio-Light Laser System Regulatory Class: II GEX Product Code: Dated: January 16, 1998 Received: January 20, 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 The general controls provisions of the Act 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. ದ 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 In addition, FDA may publish further announcements action. 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. 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,
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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Page 1 of 1
510(k) Number (if known): __ K 9 Jo 201
Device Name: Nidek Dio-Light Laser System
Indications for Use: Treatment of vascular and pigmented lesions in Dermatology.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980201 |
| Prescription Use(Pér 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.