(561 days)
The Epi-Star Surgical Laser System is for Plastic Surgery The and Dermatology, intended use for the treatment of vascular and pigmented lesions in dermatology, and for the removal of hair.
The Nidek Epi-Star Surgical Laser System consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical rail, and a cooling mechanism to dissipate the heat generated by the system. A touch key pad control panel with alphanumeric displays that enables the user to control the laser systems operating parameters. The Epi-Star Surgical Laser System is a "Long Pulse Diode Laser" which operates at a wavelength of 800 nm, using a Near Infrared Diode Laser Array lasing medium. The system uses a separate laser diode for its aiming beam (635 nm) and the system has a Fluence Range of up to 50 Joules/cm2, variable Frequency Range (Repeat Rate) up to 15 Hz, and variable Pulse Width (Pulse Duration) up to 100 msec.
The Nidek Epi-Star Diode Surgical Laser System is a medical device intended for plastic surgery and dermatology, specifically for the treatment of vascular and pigmented lesions and for hair removal.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Predicate Device Equivalence | The Epi-Star system must be substantially equivalent to currently marketed predicate devices in terms of indications for use, design, methods of operation, physical construction, and functional/performance features. | The Epi-Star system is stated to be exactly the same as the Nidek Dio-Light 60 Diode Surgical Laser System (K981447) except for the intended use for hair removal, and shares the same design, functional, and performance features. It is also compared to other legally marketed predicate devices and found to have the same or similar design, functional, and performance features. |
| Safety and Effectiveness | The device must be safe and effective for its indicated uses. | The submission states that safety and effectiveness are reasonably assured, especially for hair removal, based on the information provided, and through design control procedures. |
| Regulatory Compliance | Manufacturing and design must comply with 21 CFR 1040.10 and 1040.11 (FDA regulations for Medical Laser Products). | The device is manufactured and designed to comply with these requirements. |
2. Sample Size Used for the Test Set and Data Provenance
No test set was described. The submission explicitly states "Clinical Performance Data: None presented" (Section VII) and "Non-Clinical Performance Data: None presented" (Section VIII). The basis for clearance is substantial equivalence to predicate devices, not direct testing on a new dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No test set was used, and therefore no experts were required to establish ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set was used.
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 laser system, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser surgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of device performance testing. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which the Epi-Star system is being compared.
8. The sample size for the training set
Not applicable. As this is a physical medical device (laser system) and not an AI/algorithm, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
Summary of the Study Proving Acceptance Criteria:
The Nidek Epi-Star Diode Surgical Laser System gained regulatory clearance through the 510(k) pathway based on a demonstration of substantial equivalence to already legally marketed predicate devices, rather than through new clinical or non-clinical performance studies.
The core of the "study" demonstrating that the device meets acceptance criteria is a comparison of the Epi-Star's specifications and features against those of several predicate devices.
- Rationale for Substantial Equivalence (Section IX): The submission argues that the Epi-Star is "exactly the same" as the Nidek Dio-Light 60 Diode Surgical Laser System (K981447) in methods of operation, physical construction, and design, functional, and performance features, with the only difference being the intended use for hair removal. It also asserts that the Epi-Star shares "the same or similar design, functional, and/or performance features" with other predicate devices (Coherent/Palomar LightSheer, Sharplan Lasers EpiTouch ALEX, Candela Corp. GentleLASE, Cynosure Inc. Photogencia LPIR).
- Documentation: The comparison details are expected to be provided in "Appendix B, Substantial Equivalence Comparison" (though Appendix B is not included in the provided text).
- Safety and Effectiveness Justification (Section X & XI): The safety and effectiveness are "reasonably assured" because the device is substantially equivalent to predicates that are already deemed safe and effective. Design control procedures (mentioned in Appendix E) and safety features (in Appendix D, "DEVICE DESCRIPTION") are also cited to ensure safe use.
In essence, the "study" is a document-based comparison that leverages the prior regulatory clearance and established safety/effectiveness profiles of similar devices already on the market. No new clinical trials or performance evaluations with human subjects or dedicated test datasets were conducted or presented for the Epi-Star device itself in this submission.
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Appendix C
K 990 119
510(k) Summary Statement of Safety and Effectiveness
General Information I
Submitter:
Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474
Contact:
Mr. Jerry Tsutsumi Regulatory/Quality Manager
Date of Application:
10 January 1999
II Device Name
Trade/Proprietary Name: Model Number:
Epi-Star Diode Surgical Laser System Epi-Star
Classification Name: Common Name:
Laser Instrument, Surgical, Powered Diode Surgical Laser
Device Classification: Product Code: Regulation:
Class II Medical Device GEX 21 CFR 878.4810
III Predicate Devices
The Epi-Star CO2 Laser System is substantially equivalent to the following currently marketed devices:
| Manufacturer | Product Model | 510(k) Number | Decision Date |
|---|---|---|---|
| • Nidek Inc. | DioLight 60 | K981447 | 5 June 1998 |
| • Coherent/Palomar | LightSheer | K98420 | 4 May 1998 |
| • Sharplan Lasers | EpiTouch ALEX | K973354 | 4 December 1997 |
| • Candela Corp. | GentleLASE | K981351 | 13 July 1998 |
| • Cynosure Inc. | Photogencia LPIR | K971737 | 8 August 1997 |
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Product Description IV
The Nidek Epi-Star Surgical Laser System consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical rail, and a cooling mechanism to dissipate the heat generated by the system. A touch key pad control panel with alphanumeric displays that enables the user to control the laser systems operating parameters. The Epi-Star Surgical Laser System is a "Long Pulse Diode Laser" which operates at a wavelength of 800 nm, using a Near Infrared Diode Laser Array lasing medium. The system uses a separate laser diode for its aiming beam (635 nm) and the system has a Fluence Range of up to 50 Joules/cm2, variable Frequency Range (Repeat Rate) up to 15 Hz, and variable Pulse Width (Pulse Duration) up to 100 msec. More details are provided in Appendix D.
V Indications for Use
Epi-Star Surgical Laser System is for Plastic Surgery The and Dermatology, intended use for the treatment of vascular and pigmented lesions in dermatology, and for the removal of hair.
Performance Standards VI
The Nidek Incorporated Epi-Star Diode Surgical Laser System is manufactured and designed to comply with the requirements defined in Title 21 CFR 1040.10 and 1040.11, FDA regulations for Medical Laser Products, as applicable.
Clinical Performance Data VII
None presented. The specifications and indications for use for the Epi-Star Diode Surgical Laser System are the same or very similar to those of the claimed predicate devices. The Epi-Star Diode Surgical Laser System has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use.
VIII Non-Clinical Performance Data
None presented.
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Rational for Substantial Equivalence IX
Comparison of system specifications between the Nidek Epi-Star Diode Surgical Laser System and the Nidek Dio-Light 60 Diode Surgical Laser System (K981447) are exactly the same, except for the intended use for hair removal. As both of these systems are the same in their methods of operation and physical construction, and both systems utilize the same design, functional, and performance features (as demonstrated in Appendix B), and are therefore substantially equivalent.
Comparison of system specifications and features of the Nidek Epi-Star Diode Surgical Laser System and the other legally marketed predicate devices demonstrates the systems to be equivalent. The systems compared all have the same or similar design, functional, and/or performance features (as demonstrated in Appendix B, Substantial Equivalence Comparison), and are therefore substantially equivalent.
Since the Nidek Epi-Star Diode Surgical Laser System is substantially equivalent with respect to the indications for use, design, methods of operation, physical construction, functional and performance features to other predicated devices, we believe that this device clearly meets the requirements for substantial equivalence according to the 510(k) guidelines. The Safety and Effectiveness are reasonably assured, and therefore justifying 510(k) Premarket Notification Clearance for commercial sale and distribution.
Safety and Effectiveness ×
The information provided in Appendix B demonstrates that the Nidek Inc. Epi-Star Diode Surgical Laser System is safe and effective, when indicated for use for general and specific applications in the medical specialties of dermatology and plastic surgery as describe above in Section V.
Appendix D "DEVICE DESCRIPTION" provides information regarding the systems control features and safety features designed into this product to ensure it safe use.
Appendix E provides information on the product development processes used to ensure the products safety and effectiveness during the design process.
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Conclusion XI
Thus, with the information provided in this 510(k) Submission, the Nidek Epi-Star Diode Surgical Laser is felt to be substantially equivalent to other similar currently marketed predicate devices. Based on the information provided in Appendix B of this submission, the differences noted in the various products compared DOES NOT pose any new, significant effects on the safety, performance, use or effectiveness of the Epi-Star Diode Surgical Laser System. Thus, the Safety and Effectiveness of this product is reasonably assured for use in hair removal.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "HUMAN SERVICES - USA DEPARTMENT" surrounding it. The text is arranged along the circumference of the circle, with "HUMAN SERVICES" at the top and "DEPARTMENT" at the bottom.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2000
Nidek, Inc. c/o Ms. Carol L. Patterson Patterson Consulting Group 21911 Erie Lane Lake Forest, California 92630
K990119 Re:
Trade Name: Epi-Star Diode Surgical Laser System Regulatory Class: II Product Code: GEX Dated: April 28, 2000 Received: May 3, 2000
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your bootion of o(x) ce is substantially equivalent (for the indications for above and we have dosure) to devices marketed in interstate commerce prior to use stated in the cherosure) to de roos in he Medical Device Amendments, or to devices that May 20, 1770, the enactivent date ee with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costlience Act (Act). " Fournaly, the controls provisions of the Act include requirements for provisions of the Frea "ing 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 (1 remarket / tpproval), it may of can be found in the Code of Federal Regulations, Title 21, regulations arrooting 70at with equivalent determination assumes compliance with the I arts 600 to 095. 11 babban and Practice requirement, as set forth in the Quality System Current Good Manatetaling Previces: General regulation (21 CFR Part 820) and that, Regulation (QD) inspections, the Food and Drug Administration (FDA) will verify through perfours (QS) inspreasomply with the GMP regulation may result in regulatory Such assumptions: Tunal to volupish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does rederal Register. Prease now night have under sections 531 through 542 of the Act for not arrect any oongation you might in adiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Carol L. Patterson
This letter will allow you to begin marketing your device as described in your 510(k) This letter will and in Jourse Finding of substantial equivalence of your device to a premarket notification. - The evice 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 and additionally 6091594-4595. 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 notification (21 OF IC on 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,
Dune R. bochner.
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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Concurrence of CDRH, Office of Device Evaluation (ODE)
K990119 510(k) Number (if known): _
Device Name: Nidek Inc. Epi-Star Laser System
Indications for use: The Epi-Star Surgical Laser System is intended to be used for Hurcations for aber The Lp ology, with the intended uses for the treatment of r ascular and pigmented lesions in dermatology, and for the removal of hair.
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma P. Vochner.
(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices
Division of General Restorative Devices Division of Sen Kagon J
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.