The Ceralas D 980 nm Diode Lasers are intended for endovascular coagulation of blood vessels. The Ceralas D 980 nm Diode Lasers are indicated for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Device Description

Ceralas D 980 nm Diode Laser System (Model D50)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Ceralas Diode Laser System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Complete closure of the vein (for superficial vein reflux of the greater saphenous vein)	96% of patients achieved complete closure of the vein
Adverse events duration	All adverse events were of limited duration and resolved completely

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a numerical value, but described as "a single arm, open study at a single site." The number of patients is not directly provided, only the percentage of success.
Data Provenance: Single site, described as a "single arm, open study." No explicit country of origin is mentioned, but the submitter is based in Massachusetts, USA. The study was prospective as it involved enrolling patients to determine the device's ability to treat reflux.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: "Two clinical investigators" were involved in the study.
Qualifications: Their specific qualifications (e.g., medical specialty, years of experience) are not specified in the provided text.

4. Adjudication Method for the Test Set

The text does not specify an adjudication method. It only mentions the involvement of "two clinical investigators," but doesn't detail how they made decisions or resolved disagreements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study was a "single arm, open study" to determine the device's ability to treat vein reflux, not to compare human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Ceralas Diode Laser System is a physical medical device, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm is not applicable to this device. The study evaluated the device's performance directly on patients.

7. The Type of Ground Truth Used

The ground truth was established by clinical observation and assessment by the two clinical investigators, specifically focusing on "complete closure of the vein" and "adverse events" in patients. This aligns with patient outcomes data and expert clinical assessment.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Ceralas Diode Laser System is a physical laser device, not an AI model that requires a training set. The clinical study described is for evaluating the device's efficacy.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as the device is not an AI model with a training set.

Summary

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AUG 1 3 2002

510(k) Summary Ceralas Diode Laser System (K013691)

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

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

Contact Person: Carol J. Morello, V.M.D. Date prepared: May 29, 2001

Name of Device and Name/Address of Sponsor

Ceralas D 980 nm Diode Laser System (Model D50) biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Surgical laser

Predicate Devices

Ceralas D Diode Laser System VNUS Medical Technologies' VNUS Closure System DioMed, Inc.'s 810 nm Surgical Laser and EVLT Procedure Kit Laser

Intended Use/Indication for Use

Performance Data

The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 60601-1; IEC 601-2-22; and EN 60825-1.

In addition, biolitec performed a single arm, open study at a single site with two clinical investigators to determine the ability of the Ceralas D Laser System to treat

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013691 2/2

superficial vein reflux of the greater saphenous vein. Ninety-six percent of the patients enrolled in the study achieved complete closure of the vein. All adverse events were of limited duration and resolved completely.

Substantial Equivalence

The Varicose Vein Ceralas D has the same intended use and indications for use as VNUS Medical Technologies' VNUS Closure System and Diomed, Inc.'s 810 nm Surgical Laser and EVLT Procedure Kit laser. In addition, the superficial vein reflux Ceralas D is the exact same device as the cleared Ceralas D. Furthermore, clinical data demonstrate that the superficial vein reflux Ceralas D is substantially equivalent for endovascular coagulation of blood vessels in patients with superficial vein reflux.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

Biolitec. Inc. c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-5910

Re: K013691

Trade/Device Name: Ceralas D 980nm Diode Laser Systems Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: May 29, 2002 Received: May 29, 2002

Dear Mr. Kahan:

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, 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 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 – Mr. Jonathan Kahan

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" (21 CFR 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 vour

Sincerely yours,

Stypt Rhodes

ia 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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Appendix 1

Indications for Use Statement

510(k) Number (if known): K013691

Device Name: Ceralas D Diode Laser System

In addition to the already cleared indications:

The Ceralas D 980 nm Diode Lasers are indicated for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V (Per 21 C.F.R. 801.109)

Over-The-Counter Use_ (Optional Format 1-2-96)

Stup Edwards

(Divisio Division of General Bertorative and Neurological Devices

510(k) Number_K DI3691

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.