The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nm and 1320nm) are 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 BWF-5 Medical Laser Series are 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 thoracic surgery.

The device is specifically indicated for use as follows:

LASER 980nm:
Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

LASER 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

Device Description

BWF-5 Medical Laser Series are compact medical laser systems. The laser light delivery system consists of a flexible optical fiber. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.

AI/ML Overview

Here's an analysis of the provided text regarding the LiteCure, LLC BWF-5 Medical Laser Series, focusing on acceptance criteria and study details.

Based solely on the provided text, there is no information available about a separate study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or comparative effectiveness with human readers.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance through a clinical study with detailed acceptance criteria.

Therefore, many of your requested items cannot be fulfilled from this document. However, I can provide what is available.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) document refers to the device's compliance with safety and technical standards, and its substantial equivalence to predicate devices, rather than clinical performance metrics. The "reported device performance" is essentially that it meets these standards and is equivalent.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Safety and Effectiveness	Substantial equivalence to predicate devices regarding intended uses, indications, technological characteristics (wavelength, laser safety class, etc.), and principles of operation. Minor technological differences should raise no new issues of safety or effectiveness.	The BWF-5 Medical Laser Series is "as safe and effective as the predicate devices." It has "the same intended uses and similar indications, technological characteristics (such as wavelength, laser safety class, etc), and principles of operation as its predicate device. The minor technological differences between the BWF-5 Medical Laser Series and its predicate devices raise no new issues of safety or effectiveness."
Regulatory Compliance	21 C.F.R. § 1040.10 & 1040.11 Performance Standards for Light Emitting Products.	Implied compliance by mention.
	IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 (2nd Edition).	Implied compliance by mention.
	IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004).	Implied compliance by mention.
	IEC 60601-2-22 1995, 2nd Edition, "Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment".	Implied compliance by mention.
	IEC 60825-1 Ed. 2.0 (2007), Safety of laser products - Part 1: Equipment classification, and requirements.	Implied compliance by mention.

Study Information (Based on Available Text)

Unfortunately, the provided document does not describe a clinical study or performance study that would typically involve a test set, experts, ground truth, or comparative effectiveness measurements for an AI/device performance. The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, primarily through engineering specifications and adherence to recognized standards.

Here's a breakdown of what can be answered, and what cannot:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a clinical performance study with a test set.
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 / Not provided. This information would be relevant to a performance study, which is not described here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This is relevant for studies involving human interpretation or performance evaluation, which is not described.
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. The document does not describe an MRMC study. This device is a laser system, not an AI-assisted diagnostic or interpretive tool that would typically involve comparing human reader performance with and without AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. Given that this is a surgical laser device, "standalone algorithm performance" is not a relevant concept in the context of this 510(k). The device performs physical actions (laser light delivery for incision, excision, etc.), not algorithmic analysis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. There is no described performance study requiring a ground truth for clinical outcomes. The "ground truth" for the 510(k) process is essentially compliance with engineering standards and demonstration of substantial equivalence.
The sample size for the training set:
- Not applicable / Not provided. This device is a laser hardware system, not an AI/machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set for an algorithm, this question is not relevant to the information provided.

Conclusion:

The provided 510(k) summary for the LiteCure, LLC BWF-5 Medical Laser Series primarily demonstrates the device's substantial equivalence to predicate devices and adherence to relevant safety and performance standards (like IEC and CFR). It does not contain information about a clinical performance study with detailed acceptance criteria, test sets, expert adjudication, or AI performance metrics as these are not typically required for a device of this nature to achieve 510(k) clearance by demonstrating substantial equivalence.

Summary

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MAY 1 2 2010

1693087

斗

510(k) SUMMARY

The Summary of Safety and Effectiveness on the LiteCure, LLC BWF-5 Medical Laser Series reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

Applicant	LiteCure, LLC250 Corporate Blvd., Suite BNewark, Delaware 19702Tel: 302-709-0408
Date	April 02, 2010
Correspondent	Liang Lu, Regulatory Affairs Manager
Device Name	BWF-5 Medical Laser Series
Classification	Laser surgical instrument for use in general and plastic surgery and indermatology, 21 CFR 878.4810
Predicate Device	K053540 INTERmedic Arfran, S.A., INTERmedic Diode LaserFamily 810 nm and 980 nm and the delivery accessories that are usedwith them to deliver, ultrasound and RF Surgical 15TM, 30TM, 50TM,100TM, 120TM and SR 15 OFTTM, MULTIDIODE PL3DTM,ContrAgeTM, RF ContrAgeTM,MULTIDIODE VARIUSTM, VR1000TM,MULTIDIODE ODONTTM; K082263 Biolitec, Inc., Ceralas E 980nm Diode Laser (ModelsE15/980, E30/980); K083613 QUANTA SYSTEM POLYSURGE DIODE LASERFAMILY; K060304 BioTex, Inc., PhoTex 15 Diode Laser Series: 810, 940, 980,market clearance date March 21, 2006; and K972575 Laserscope, 800 Series Surgical Laser System OrionSurgical Laser System Angled Delivery Devices (ADD FamilyProduct Line), market clearance date July 17, 1998. K062363 B&W Tek, Inc., BWF-5 Medical Laser Series. K060033 Sciton, Inc., Profile Multi-Platform System. K071295 Biolitec, Inc., 100W CERALAS D 980NM DIODE LASER K070388 Sciton, Inc., Profile Multi-Platform System
Intended Use	The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nmand 1320nm) are intended for delivery of laser light to soft tissue in thecontact or non-contact mode during surgical procedures, including viaendoscopes, introducers, or catheters. The BWF-5 Medical Laser Series aregenerally indicated for incision, excision, vaporization, ablation,hemostasis or coagulation of soft tissue in ear, nose and throat and oralsurgery (otolaryngology), dental procedures, arthroscopy,gastroenterology, general surgery, dermatology, plastic surgery, podiatry,urology, gynecology, neurosurgery (peripheral nervous system),pulmonary surgery and thoracic surgery. The device is specificallyindicated for use as follows:
Intended Use(continued)	LASER 980nm:Indicated for use with the VARI-LASE Procedure Kit in the Endovascularcoagulation of the Greater Saphenous Vein (GSV) of the thigh in patientswith Superficial Vein Reflux.LASER 1320nm:Indicated for use with the VARI-LASE Procedure Kit in the treatment ofreflux of great saphenous veins associated with varicose veins andvaricosities.
Description	BWF-5 Medical Laser Series are compact medical laser systems. The laserlight delivery system consists of a flexible optical fiber. Activation occurswhen the operator enables the laser and presses the foot switch. Releasethe foot switch to deactivate the laser. Depending on laser systemconfiguration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level.The laser can operate in continuous wave mode or controlled pulse mode.
TechnologicalCharacteristicsand SubstantialEquivalence	The BWF-5 Medical Laser Series is as safe and effective as the predicatedevices. The BWF-5 Medical Laser Series has the same intended uses andsimilar indications, technological characteristics (such as wavelength, lasersafety class, etc), and principles of operation as its predicate device. Theminor technological differences between the BWF-5 Medical Laser Seriesand its predicate devices raise no new issues of safety or effectiveness.Thus, the BWF-5 Medical Laser Series is substantially equivalent to itspredicate devices.
Compliance	21 C.F.R. § 1040.10 & 1040.11 Performance Standards for Light Emitting Products;IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety,1988; Amendment 1, 1991-11, Amendment 2, 1995 (2nd Edition);IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety- Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition2:2001 with Amendment 1:2004);IEC 60601-2-22 1995, 2nd Edition, "Medical electrical equipment - Part 2: Particularrequirements for the safety of diagnostic and therapeutic laser equipment"IEC 60825-1 Ed. 2.0 (2007), Safety of laser products - Part 1: Equipment classification,and requirements.

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510(k) SUMMARY continued

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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 its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

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

LiteCure, LLC % Intertek Testing Services Mr. Jay Y. Kogoma 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAY 1 2 2010

Re: K093087

Trade/Device Name: BWF-5 Medical Laser Series 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: May 05, 2010 Received: May 07, 2010

Dear Mr. Kogoma:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Jay Y. Kogoma

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 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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.

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

Sincerely vours.

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name

Indications For Use:

The BWF-5 Medical Laser Series (810nm, 930nm, 1080mm and 1320nm) are 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 BWF-5 Medical Laser Series are 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 thoracic surgery.

The device is specifically indicated for use as follows:

LASER 980nm:

Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

LASER 1320nm:

Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

Over-The-Counter Use Prescription Use AND/OR X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Oyler for mxm
(Digital Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093087

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.