The biolitec, Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece is intended to be used as a fiberoptic laser delivery accessory with the CeralasD 980nm Diode Laser for the dental indications that the laser has already been cleared for in K983058, K991891 and K993002. Please refer to the Laser User Manual for the specific list of indications.

Device Description

The Mega Beam / Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in a handpiece. The handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size.

AI/ML Overview

I am sorry, but based on the provided text, there is no specific acceptance criteria or detailed study information to fulfill your request. The document is a 510(k) summary for a medical device (Mega Beam/Ceralas Nonsterile Collimating Handpiece) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with acceptance criteria.

The "Performance Data" section states that:

"biolitec conducted testing comparing the Mega Beam Ceralas Collimating Handpiece's and the Mega Beam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These performance tests demonstrate that the Mega Beam/Ceralas Collimating Handpiece is as safe and effective as the bare fiber optic delivery system."

However, it does not provide any of the following crucial details you requested:

Specific Acceptance Criteria: There are no defined numerical or qualitative thresholds for "handpiece efficiency, energy density, and divergent half angle."
Reported Device Performance: No actual values or ranges for these parameters are provided for either the new device or the predicate.
Sample Size: No information on the number of units tested.
Data Provenance: No details on where or when the testing was performed.
Number of Experts/Qualifications: These are irrelevant for this type of performance testing on a laser accessory.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable to a performance study of a device accessory.
Standalone Performance: While performance testing was done, the results are not presented in a quantitative way to determine "standalone" performance against specific criteria.
Type of Ground Truth: Not applicable for engineering performance tests.
Training Set Sample Size/Ground Truth for Training Set: These relate to AI/machine learning models, which are not involved in this device's performance evaluation as described.

In summary, the document states that tests were performed and that the new device is "as safe and effective" as the predicate based on these tests, but it does not disclose the specific data or criteria necessary to complete your table and answer your detailed questions.

Summary

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K 020099

510(k) Summary Ceralas Diode Laser System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611 Contact Person: Carol J. Morello, V.M.D.

Date prepared: January 9,2002

Name of Device and Name/Address of Sponsor

Mega Beam / Ceralas Nonsterile Collimating Handpiece biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Accessory to Surgical Laser Instrument

Predicate Device

biolitec Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece

Intended Use/Indications for Use

Technological Characteristics

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Performance Data

biolitec conducted testing comparing the Mega Beam Ceralas Collimating Handpiece's and the Mega Beam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These performance tests demonstrate that the Mega Beam/Ceralas Collimating Handpiece is as safe and effective as the bare fiber optic delivery system.

Substantial Equivalencies

The Mega Beam/Ceralas Collimating Handpiece has the same intended use as its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/11 description: The image shows a partial view of a circular emblem or logo. The text "DEPARTMENT OF HEALTH & HUM" is visible along the curved edge of the circle, suggesting it is part of a larger phrase, likely "Department of Health & Human Services". A stylized graphic element, possibly representing a symbol or design, is also present within the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2002

Ms. Carol J. Morello, VMD Regulatory Affairs Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028

Re: K020099

Trade/Device Name: Mega Beam/Ceralas Nonsterile Collimating Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: January 9, 2002 Received: January 11, 2002

Dear Dr. Morello:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 - Ms. Carol J. Morello, VMD

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

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) 594-4639. Additionally, for questions on the promotion and advertising of your device, (1) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 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 at (301) 443-6597.

Sincerely yours,

for Mark N. Millman

Celia M. Witten, Ph.D., M.D. Directir Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): 1 020099

Device Name: Mega Beam/Ceralas Nonsterile Collimating Handpiece

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
Use
(Per 21 C.F.R. 801.109)

Over-The-Counter

Mark N Milker
(Division Sign-Off) (Optional Format 1-2-96)

ivision of General. Restorative and Neurological Devices

510(k) Number _

\DC - 61213/1 - #1331532 v1

Regulation Number and Section

§ 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.