The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux.

Device Description

The Ceralas D 980 nm Laser with Endo Laser Vein System Kit consists of the cleared Ceralas D 980 and the ELVeS. Twelve versions of the ELVeS kit contain various combinations of the following components: (1) 19 gauge needle; (2) 21 gauge needle; (3) 5 French (F) introducer sheath; (4) 5 F introducer sheath/dilator; (5) a 0.035" J-tip guidewire; (6) a 0.018" J-tip guidewire; (7) surgical drape; (8) surgical tape; and (9) a surgical pen.

AI/ML Overview

This 510(k) summary does not contain information typically found in a study proving a device meets acceptance criteria as would be expected for a diagnostic AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a medical laser system. Therefore, most of the requested fields cannot be filled.

Here's a breakdown based on the provided text, highlighting where information is absent:

1. A table of acceptance criteria and the reported device performance

No direct acceptance criteria or a performance table are provided in the document. The submission asserts substantial equivalence based on intended use, indications for use, and technological characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission concerns a physical medical device (laser system) and its accessories, not an AI/ML diagnostic or measurement device that would typically involve a test set of data.

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. As above, this isn't a study involving ground truth establishment for a diagnostic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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. No AI component is mentioned, and no MRMC study was conducted or referenced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable. No training set is mentioned for this device.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device Acceptance:

The device's "acceptance" is determined through the process of demonstrating substantial equivalence to legally marketed predicate devices, rather than through a performance study against predefined acceptance criteria for a novel diagnostic claim.

The provided text states:

Predicate Devices: Ceralas D Diode Laser System (980 nm and 810 nm)
Basis for Substantial Equivalence:
- Same intended use and indications for use as the cleared Ceralas D 980 nm Laser System and Ceralas D 810 nm Diode Laser System.
- Same technological characteristics as the cleared Ceralas D 810 and the cleared Ceralas D 980.
- The ELVeS kit, the new component with the 980nm laser, is already cleared for use with the Ceralas D 810 for the same indication.

Therefore, the study implicitly demonstrating "acceptance" is the comparison to predicate devices and the argument that the added ELVeS kit does not introduce new technological characteristics or safety/effectiveness concerns for the specified indication. The FDA's issuance of the 510(k) clearance signifies their agreement with this substantial equivalence argument.

Performance Data (as stated in the document):

The only "Performance Data" mentioned are compliance with voluntary consensus standards:

21 C.F.R. §§ 1040.10 & 1040.11
ANSI/AAMI ES1
IEC 601-1
IEC 601-2-22
EN 60825-1
ANSI/AAMI/ISO 10993-7

These standards address aspects like electrical safety, laser safety, and biocompatibility, which are essential for such a device, but they do not constitute a clinical performance study in the way typically required for AI/ML diagnostic tools.

Summary

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Ko24088 1/2

JAN 02 2003

510(k) Summary Ceralas Diode 980 nm Laser System with Endo Laser Vein System Kit

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: December 11, 2002

Name of Device and Name/Address of Sponsor

Ceralas D Diode Laser System with Endo Laser Vein System Kit biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Surgical laser and accessories

Predicate Devices

Ceralas D Diode Laser System (980 nm and 810 nm)

Intended Use/Indication for Use

Technological Characteristics

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K024088 2/2

Performance Data

The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.

Substantial Equivalence

The Ceralas D 980 nm Laser System with ELVeS has the same intended use and indications for use as the cleared Ceralas D 980 nm Laser System and Ceralas D 810 nm Diode Laser System and the same technological characteristics as the cleared Ceralas D 810 and the cleared Ceralas D 980. The technological differences between the Ceralas D 980 with ELVeS kit and the cleared Ceralas D 980 is the addition of the ELVeS kit, which is cleared for use with the Ceralas D 810 for the same indication. Thus, the ELVeS kit is not a new technological characteristic for diode lasers for endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux. Thus, the Ceralas D 980 with ELVeS is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are arranged on a single line, with "Public" and "Health" being the most prominent words.

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0 Corporate Boulevard Rockville MD 20850

Biolitec. Inc. c/o Hogan & Hartson, L.L.P. Jonathan S. Kahan 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K024088

Trade/Device Name: Ceralas Diode 980 nm Laser System with Endo Laser Vein System Kit Regulation Number: 878.4810 Regulation Name: Surgical laser and accessories Regulatory Class: Class II Product Code: GEX Dated: December 11, 2002 Received: December 11, 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

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Page 2 – Mr. Jonathan S. Kahan

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.

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), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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Indications for Use Statement

K024088 510(k) Number (if known):

Device Name: Ceralas D 980 nm Diode Laser System with Endo Laser Vein System Kit

For endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

(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 C.F.R. 801.109)

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

Muriam C. Provost

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

(k) Number K024088

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.