(85 days)
This device is intended for use in: 1. Source of illumination for curing dental restorative materials, 2. Assisting in the whitening process in dental office.
The device is a standard air-cooled argon laser emitting energy at 457 and 502nm. Output energy is less than 450 mW. The delivery system is a fused silica fiber optic system with a stainless steel handpiece. The laser operates on any 120 volt, alternating current, 20 ampere circuit. The unit is about 16" by 10" by 6.7" in dimension and weighs 20 lbs.
The provided text describes a 510(k) summary for a medical device called CYBER-LASE 2000™, an Argon Laser system. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance as one might find for a novel device with clinical endpoints.
Therefore, the requested information elements related to clinical study design, performance metrics, ground truth, experts, and sample sizes for testing and training sets cannot be extracted from this document, as such a study was not the basis for clearance.
However, I can provide the relevant information based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria and device performance in the manner requested, as it relies on substantial equivalence. The "performance standards" mentioned refer to general regulatory standards for laser products, not specific clinical performance metrics.
| Acceptance Criteria (Not explicitly stated for clinical performance) | Reported Device Performance (Operational Characteristics) |
|---|---|
| Meets legal predicate device characteristics for substantial equivalence | Emits energy at 457 and 502nm |
| Adheres to Performance Standards for Light-Emitting Products (21 CFR 1040.10) | Output energy less than 450 mW |
| Adheres to Performance Standards for Medical Laser Products (21 CFR 1040.11(a)) | Delivery system: fused silica fiber optic with stainless steel handpiece |
| Operates on 120 volt, AC, 20 ampere circuit | |
| Dimensions: 16" x 10" x 6.7"; Weight: 20 lbs |
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. The device clearance is based on substantial equivalence to predicate devices, not on a clinical performance study with a 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. No ground truth was established by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication was performed for a test set.
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 an Argon Laser system, not an AI-powered diagnostic device, 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 device is an Argon Laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The clearance is based on demonstrating the device's technological characteristics and intended use are similar to legally marketed predicate devices, not on clinical performance against a medical ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth.
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JAN 1 2 1999
983654
XII, 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)
A. Submitter: Alan A. Creamer, President, ICS of North American, Inc., 10054 Mesa Ridge Ct. San Diego. CA 92121
I. Classification: Class II.
II, Common or usual name: Argon Laser system
III. Proprietary Name: CYBER-LASE 2000™
IV. Registration No .: 61073
V. Classification Name: Argon laser system, powered, 79GEX, CFR 878.4810, Class II.
VI. Performance standards: None established (as a medical device) under section 514. Meets Performance Standards for Light-Emitting Products, 21 CFR 1040.10 (Laser Products) and 21 CFR 1040.11(a) (Medical Laser Products).
VII. Description: The device is a standard air-cooled argon laser emitting energy at 457 and 502nm. Output energy is less than 450 mW. The delivery system is a fused silica fiber optic system with a stainless steel handpiece. The laser operates on any 120 volt, alternating current, 20 ampere circuit. The unit is about 16" by 10" by 6.7" in dimension and weighs 20 lbs.
VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided and the products are compared.
IX. Indications for Use: source of illumination for curing dental restorative materials, and for tooth whitening activities.
X. Substantial Equivalence: The CYBER-LASE 2000™ is substantially equivalent to lasers cleared by Premier Laser Systems, Inc., as the product, "Arago" under 510(k) K971118, and other Premier lasers including Argon Curing Laser cleared under K961682. It also is equivalent to similar lasers cleared by other laser companies such as LaserMed, Inc. (Accucure 1000, cleared under K970637) and American Medical laser.
The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1999
Mr. Alan A. Creamer President ICS of North America. Inc. 10054 Mesa Ridge Court San Diego, California 92121
Re: K983654 Trade Name: Cyber-Lase 2000™ Regulatory Class: II Product Code: GEX Dated: October 16, 1998 Received: October 19, 1998
Dear Mr. Creamer:
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 Quality System Regulation (OS) 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 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. Alan A. Creamer
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,
f 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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IX. Indications for Use: [Separate Page]
510(k) Number: NA
Device Name: CYBER-LASE 2000™
This device is intended for use in:
-
Source of illumination for curing dental restorative materials,
-
Assisting in the whitening process in dental office.
(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
(Division Sign-Off)
Division of General Restorative Deviges
510(k) Number 1983654
3
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.