(79 days)
The Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions and for the removal of hair in skin types I - VI.
The Epi-Star Surgical Laser System is an 800 nm continuous wave device coupled with cooling accessory. The Epi-Star laser is self-limiting in the size of spots (2, 3, 4, and 5mm), output power, dwell time, density and fluence rates. The Epi-Star Surgical Laser can achieve fluence rates of up to 400 J/cm² when coupled with the cooling accessories. The treatment parameters for the classifications of various skin types is provided. The Epi-Star laser can be coupled with either a scanner handpiece that has a cooling window (Model A) or with a scanner and cold air system (Model B).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nidek Epi-Star Surgical Laser System:
Based on the provided text, the device is the "Epi-Star Surgical Laser System, Models A and B." This submission is an amendment (K013864) to a previously cleared device (K990119) to allow for higher fluence rates.
1. Table of acceptance criteria and the reported device performance:
The document primarily focuses on the modification of increasing the allowed fluence rates. It does not explicitly state acceptance criteria in a quantitative, measurable format with target values. Instead, it describes performance in terms of safety and intended function.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety of higher fluence rates for intended uses (vascular and pigmented lesions, hair removal). | "A preclinical animal study was conducted to determine the safety of the Epi-Star Surgical Laser System with the higher fluence rates. The Epi-Star Surgical Laser System was found to perform as intended." "The Epi-Star Surgical Laser System with the higher fluence rates was found to perform as intended during validation testing and in preclinical animal studies." |
| Device performs as intended for its specified indications for use. | "Performance testing was conducted on the Epi-Star Surgical Laser System. System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. ... The Epi-Star Surgical Laser System was found to perform as intended." |
| Substantial equivalence to predicate device. | "The modifications to the Epi-Star Laser System allow for higher fluence rates of up to 400 J/cm2... The Epi-Star Surgical Laser System is substantially equivalent to the current Epi-Star Surgical Laser System in commercial distribution." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified beyond "preclinical animal study."
- Data provenance: Preclinical animal study. The country of origin is not specified, but given the submitter's location (Fremont, CA, USA) and FDA submission, it's likely the study was conducted in the US or under protocols adhering to US standards. It is a prospective study as it was conducted to determine safety with higher fluence rates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "ground truth" for the animal study would likely be based on pathological examination of tissue samples from the treated animals, but the experts involved are not detailed.
4. Adjudication method for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This device is a surgical laser system, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is a physical medical device (surgical laser), not a standalone algorithm. Therefore, a standalone algorithm performance study is not applicable and was not reported.
7. The type of ground truth used:
For the preclinical animal study, the ground truth would have been established through direct observation and histopathological examination of the treated animal tissues to assess safety and efficacy (e.g., degree of lesion treatment, hair follicle damage, absence of adverse tissue reactions) at the higher fluence rates.
8. The sample size for the training set:
This information is not applicable as the device is not an AI/machine learning model that requires a training set in the typical sense. Performance testing and the animal study evaluate the physical device's function.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 18:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
18.1 SUBMITTER INFORMATION
| a. | Company Name: | Nidek, Inc. |
|---|---|---|
| b. Company Address: | 47651 Westinghouse DriveFremont, CA 94539 | |
| c. | Company Phone:Company Facsimile: | (510) 226-5700(510) 226-5750 |
| d. Contact Person: | Hiro MatsuzakiQuality Assurance Manager | |
| e. Date Summary Prepared: | January 4, 2002 |
DEVICE IDENTIFICATION 18.2.
| a. | Trade/Proprietary Name: | Epi-Star Surgical Laser System, Models Aand B |
|---|---|---|
| b. | Classification Name: | Surgical Laser Instrument21 CFR 878.4810 78 GEX |
IDENTIFICATION OF PREDICATE DEVICES 18.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Nidek, Inc. | Epi-Star Surgical LaserSystem | K990119 | 07/27/2000 |
DEVICE DESCRIPTION 18.4
The Epi-Star Surgical Laser System is an 800 nm continuous wave device coupled with cooling accessory. The Epi-Star laser is self-limiting in the size of
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K013864 2/3
Nidek Epi-Star Surgical Laser System 510(k) Amendment, #K013864, January 4, 2002
spots (2, 3, 4, and 5mm), output power, dwell time, density and fluence rates. The Epi-Star Surgical Laser can achieve fluence rates of up to 400 J/cm² when coupled with the cooling accessories. The treatment parameters for the classifications of various skin types is provided. The Epi-Star laser can be coupled with either a scanner handpiece that has a cooling window (Model A) or with a scanner and cold air system (Model B).
18.5 SUBSTANTIAL EQUIVALENCE
The Epi-Star Surgical Laser System with the proposed modifications is substantially equivalent to the current Epi-Star Surgical Laser System that is currently in commercial distribution by Nidek, Inc.
The fundamental technical characteristics of the Epi-Star Surgical Laser System are the same as those of the predicate device and the indications for use has not changed with the modifications of the device.
18.6 INDICATIONS FOR USE
The Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions and for the removal of hair in skin types I - VI.
18.7 TECHNOLOGICAL CHARACTERISTICS
The modifications to the Epi-Star Laser System allow for higher fluence rates of up to 400 J/cm2 for the treatment of vascular and pigmented lesions and the removal of hair. The increased fluence rates are dependent on the skin types to be treated and are self-limiting by the laser system. The output power of the system is from 5 - 60 Watts, the aiming beam is 620 - 650 nm and the pulse duration is 5 - 700 ms. Spot sizes of 2, 3, 4, and 5mm can be accomplished with the Epi-Star. Model A includes a scanner with a 2-TE chip cooling window and Model B includes a scanner attached to a cold air system. The current Epi-Star Laser
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Nidek Epi-Star Surgical Laser System 510(k) Amendment, #K013864, January 4, 2002
System allows for fluence rates of up to 50 J/cm². The current Epi-Star includes a scanner with a 1-TE chip cooling window.
PERFORMANCE DATA 18.8
Performance testing was conducted on the Epi-Star Surgical Laser System. System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. A preclinical animal study was conducted to determine the safety of the Epi-Star Surgical Laser System with the higher fluence rates. The Epi-Star Surgical Laser System was found to perform as intended.
CONCLUSION 18.9
This notification contains all information required by 21 CFR 807.87. The Epi-Star Surgical Laser System with the higher fluence rates was found to perform as intended during validation testing and in preclinical animal studies. The Epi-Star Surgical Laser System is substantially equivalent to the current Epi-Star Surgical Laser System in commercial distribution. The Epi-Star Surgical Laser System is intended for the treatment of vascular and pigmented lesions and for the removal of hair.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 8 2002
Nidek, Inc. c/o Ms. Carol White Patterson Consulting Group, Inc. 21521 Hummingbird Street Trabuco Canyon, California 92679
Re: K013864
Trade/Device Name: Epi-Star Surgical Laser System, Models A and B and Zimmer Elektromedizin Cryo 5 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: November 19, 2001 Received: November 21, 2001
Dear Ms. White:
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. Iisting 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 - Ms. Carol White
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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Nidek Epi-Star Surgical Laser System 510(k) Amendment, #K013864, January 4, 2002
INDICATION FOR USE
K013864 510(k) Number:
Epi-Star Surgical Laser System, Models A and B Device Name:
The Epi-Star Surgical Laser System is intended to be used for Indications for Use: Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions and for the removal of hair in skin types I - VI.
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number_KO 3864
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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.