The device is intended for endovascular coagulation of blood vessels. Th indicated for the endovascular coagulation of the Greater Saphenous Vein of the thigh in patients with superficial vein reflux.

Device Description

The ELVeS kit with 2 Ring Radial Fibers contain the following components: (1) 2 ring radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K101712 and K112299 except for the 2 ring radial tip design. The design provides 2 adjacent points of radial emission.

AI/ML Overview

This submission describes the Endovascular Laser Venous System Kit (ELVeS®) with 2 Ring Radial Fiber. The information provided focuses on the device's substantial equivalence to predicate devices rather than establishing novel acceptance criteria through a specific study with a test set, experts, and ground truth.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document defines "acceptance criteria" through compliance with voluntary consensus standards and clinical equivalence to predicate devices, rather than specific numerical targets for a new performance study.

Acceptance Criteria (Inferred from Document)	Reported Device Performance
Compliance with Voluntary Consensus Standards:	Device complies with:- 21 C.F.R. § 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products)- ANSI/AAMI ES1 (Medical Electrical Equipment - General Requirements for Safety)- IEC 601-2-22 (Medical Electrical Equipment - Particular Requirements for the Safety of Surgical Lasers)- EN 60825-1 (Safety of Laser Products)- ANSI/AAMI/ISO 10993-7 (Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals)
Clinical Effectiveness Equivalent to Predicate Devices:	Evidenced by several clinical evaluations showing:- Study 1: Reduction in recanalization rates, reduction in applied Watt/LEED, reduction in adverse events (bruising, pain, induration, numbness). Concluded EVLA with 2 ring radial fiber is effective and safe, decreasing energy and providing good occlusion rates with lowered side effects.- Study 2: Effective for large insufficient GSV (>8mm), less energy needed, optimal homogenous radiation, high patient satisfaction, improved modified CEAP severity after 1 & 2 days. No significant difference in occlusion rate between >8mm and <8mm diameter subgroups.- Study 3: Efficacy, adverse events, occlusion rates, patient satisfaction, and VCSS scores comparable to radiofrequency (RF) energy for very large diameter (>12 mm) GSV. No statistically significant difference in VCSS scores or patient satisfaction between groups. 2-ring radial fiber resulted in almost no pain.
Acceptable Sterility:	Sterilization cycle parameters and validation reports showed an acceptable sterility was achieved.
Substantial Equivalence:	The ELVeS with 2 Ring Radial Fiber is substantially identical to K101712 and K112299, and has the same intended use and indications for use as cleared Evolve HPD and Ceralas ELVeS kits.

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

The document mentions "several clinical evaluations" but does not provide specific sample sizes for these studies, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective) for each study. The nature of the studies (e.g., comparison of outcomes, patient satisfaction) suggests they were prospective clinical studies, but this is not explicitly stated.

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

The document does not specify the number or qualifications of experts used to establish ground truth for any of the mentioned clinical evaluations. The outcomes measured (recanalization rates, adverse events, patient satisfaction, CEAP severity, VCSS scores) would have been assessed by treating physicians and/or study personnel, but their specific roles as "ground truth" experts or their qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the 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

No MRMC comparative effectiveness study was done. This device is a surgical laser system, not an imaging or diagnostic AI-powered device that would typically involve human readers interpreting cases.

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

No standalone algorithm-only performance was done. This is a medical device (a laser system), not an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in the clinical evaluations refers to various clinical outcomes data, including:

Recanalization rates (likely based on ultrasound follow-up)
Adverse events (clinically observed and reported)
Applied Watt/LEED (objective measurement of energy delivery)
Patient satisfaction (patient reports)
Modified CEAP severity (clinical assessment by physicians)
VCSS scores (clinical assessment by physicians)
Occlusion rates (likely based on ultrasound follow-up)

8. The Sample Size for the Training Set

This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The clinical evaluations mentioned are for validating the device's performance, not for training an algorithm.

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

As there is no training set, this point is not applicable.

Summary

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K130681 Page 1 of 2

JAN - 8 2014

K130681 - 510(k) Summ Endovascular Laser Venous System Kit with 2 Ring Radial En

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

Kaniera iela 10a, Riga, LV-1063 Latvia * (413) 525-0600 or 413-250-0779 Phone: Facsimile: * (413) 525-0611

Contact Person: *Harry Hayes, Ph.D. – Regulatory Consultant Date prepared: March 4, 2013

Name of Device and Name/Address of Sponsor

Endovascular Laser Venous System Kit (ELVeS®) with 2 Ring Radial K Biolitec SIA Kaniera iela 10a, Riga, LV-1063 Latvia

Classification Name Surgical laser accessories

Predicate Devices

ELVeS Kit with Radial Fiber

Intended Use/Indication for Use

Technological Characteristics

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Performance Data

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

The clinical effectiveness is equivalent to its predicate devices, as evidence by several clinical evaluations.

In one study, the circumferential ablation of the vein with introduction of the 2 ring radial fiber provided a better outcome following EVLA: 1) reduction in recanalization rates 2) reduction in applied Watt/LEED. & 3) reduction in adverse events; including bruising, pain, induration & numbness. The study supported the conclusion concluded that EVLA with 2 ring radial fiber for GSV and SSV is an effective and safe procedure, giving the advantage of decreasing delivered energy during the procedure and also providing very good occlusion rates with lowered rates of side/adverse effects.

Another study demonstrated an effective method to treat large insufficient GSV (diameter above 8 mm) by using the 2 ring radial-fiber. The procedure needed less energy and resulted in an optimal homogenous radiation. The patient satisfaction rate was high and the clinical evaluators could demonstrate that modified CEAP severity was much better after 1&2 days. No significant difference was observed in the occlusion-rate between subgroups of >8mm dia. and <8mm dia.

A further study compared the efficacy, adverse events, occlusion rates, patient satisfaction and changes in venous clinical severity scores in the treatment of very large diameter (>12 mm) greater saphenous veins (GSV) with the 2 ring radial fiber compared to radio frequency (RF) energy. VCSS scores were improved after the procedures and there was no statistically significant difference between groups. There was also no statistically significant difference in patient satisfaction between groups. Both treatment modalities were safe and effective in the treatment of very large diameter GSVs. The 2-ring radial fiber also resulted in almost no pain.

Sterilization cycle parameters and the validation reports showed an acceptable sterility was achieved with the device.

Substantial Equivalence

The ELVeS with 2 Ring Radial Fiber is substantially identical to that cleared under K101712 and K112299 and has the same intended use and indications for use as the cleared Evolve HPD 980-1470nm Multiwavelength and Ceralas 1470, 980 and 810nm ELVeS kits. Thus, the ELVeS with 2 Ring Radial Fiber is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Biolitec SIA Dr. Harry Hayes Regulatory Consultant Kaniera iela 10a Riga, LV-1063 Latvia

January 8, 2014

Re: K130681

Trade/Device Name: Endo Laser Vein System Kit with 2 Ring Radial Fiber Regulation Number: 21 CFR 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: November 22, 2013 Received: December 11, 2013

Dear Dr. Hayes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Dr. Harry Hayes

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CER Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua G. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical 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): K130681

Device Name: Endo Laser Vein System Kit with 2 Ring Radial Fiber

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 _ OR Over The Counter Use (Per 21 C.F.R. 801.109) (Optional Format 1-2-96)

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(Division Sign-Off) for BSA

Division of Surgical Devices

510(k) Number _K130681

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.