The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).

Device Description

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AI/ML Overview

The provided text describes a 510(k) submission for the Ceralas D 980 Diode Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not directly applicable or available in this submission.

Here's a breakdown of the available information and how it relates to your request:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are primarily established by the performance characteristics of the predicate devices and relevant voluntary consensus standards. The device performance is demonstrated by showing that it meets these standards and has comparable characteristics to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Intended Use/Indication for Use (Same as predicates)	The Ceralas D 980 has the same intended use as the previously cleared Ceralas D 980 and its predicate devices, including incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in various surgical specialties, specifically for hemostasis and coagulation of soft tissue (including cardiac tissue).
Technological Characteristics (Same or comparable to predicates)	The Ceralas D 980 has the exact same technological characteristics as the previously cleared Ceralas D 980 (with an exception of a handpiece modification) and similar characteristics to the CardioFocus, Inc.'s Diode Laser System (a 980 nm diode laser).
Compliance with Voluntary Consensus Standards	The device complies with 21 C.F.R., IEC 601-1; IEC 601-2-22; and EN 60825-1.

Summary of Device Performance: The primary "proof" of meeting acceptance criteria for a 510(k) submission like this is arguing that the device is "substantially equivalent" to legally marketed predicate devices. This means it has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety and effectiveness.

Study Details (Not Applicable for this 510(k) Submission)

The 510(k) submission for the Ceralas D 980 Diode Laser System is focused on demonstrating substantial equivalence to predicate devices, and as such, it does not include a new clinical study or performance study in the way you've outlined for proving a device meets acceptance criteria. Information regarding test sets, ground truth establishment, expert adjudication, or MRMC studies for this specific device's performance is not provided because it's not typically required for a substantial equivalence claim for a laser system of this nature.

Here's why many of your questions cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not applicable. This submission doesn't present a test set to validate a new algorithm or performance metric.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established in this type of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-based device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical laser, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of proving new performance data. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
The sample size for the training set: Not applicable. There is no algorithm being trained.
How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) is a regulatory argument of "this device is like these other devices that are already on the market and proven safe and effective," rather than a detailed report of a new performance study. The performance data mentioned (compliance with standards) is about the technical specifications and safety of the laser itself, not its clinical efficacy against a new set of criteria measured in a specific clinical study.

Summary

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MAR 1 9 2004

510(k) Summary Ceralas D 980 Diode Laser System

ko32863

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

biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: (413) 525-0611 Facsimile:

Carol J. Morello, V.M.D. Contact Person: March 18, 2004 Date prepared:

Name of Device and Name/Address of Sponsor

Ceralas D 980 Diode Laser System biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Surgical laser

Predicate Devices

Ceralas D 980 Diode Laser System CardioFocus, Inc.'s Diode Laser System used with CardioFocus, Inc.'s Surgical Lightstic

Intended Use/Indication for Use

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Performance Data

The device complies with the following voluntary consensus standards: 21 C.F.R. The device complies will and themes in IEC 601-1; IEC 601-2-22; and EN 60825-1.

Substantial Equivalence

The Ceralas D 980 has the same intended use and the exact same technological characteristics as the previously cleared Ceralas D 980, with the exception of a enturation to the handpiece for hemostasis and coagulation of cardiac tissue. In addition, all of the Ceralas D 980's general and specific indications for use are cleared indications of at least one of its predicate devices. The Ceralas D asc are around and armanderical characteristics as the CardioFocus, Inc.'s Diode Laser System, which is also a 980 nm diode laser. Thus, the Ceralas D 980 is substantially equivalent.

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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 stylized eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolitec, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004

Re: K032863

Trade/Device Name: Ceralas D 980 Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: December 22, 2003 Received: December 22, 2003

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of March 19, 2004.

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 (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, 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 (PMA), it may be subject to 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.

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Page 2 - Mr. Jonathan Kahan

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

ellmall

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Ceralas D 980 Diode Laser System

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

H. Office_of Device Evaluation (ODE) Concurrence of

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number K032863

Prescription Use X (Per 21 C.F.R. 801.109) Over-The-Counter Use_ (Optional Format 1-2-96)

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.