The Twister™ Side-Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non-contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

Device Description

The Biolitec SIA Twister™ Side-Fire Fiber Optic Delivery System contains identical components and identical patient contact materials as the cleared Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System. Twister is a fiber optic delivery system designed to deliver optical energy from a surgical laser to soft or fibrous tissue for the indicated uses. The distal end of the Twister possesses a slight bend at the capillary tip, producing 30° lateral firing which is identical to the predicate. The fiber makeup remains silica, silica cladding, hard plastic cladding, and Tefzel jacketing as is the predicate. The numerical aperture (NA) of the fiber however is 0.26/ 0.37 (whereas the predicate is 0.22/ 0.37) giving a better coupling efficiency and correcting for the truncation in power transmission seen with the predicate fiber when using larger NA lasers.

AI/ML Overview

The provided text is a 510(k) summary for the Twister™ Side-Firing Fiber Optic Delivery System. It describes the device, its intended use, and its technological characteristics. However, it explicitly states that no performance testing was included in the submission because the performance of the device on soft tissue is "well established and documented."

Therefore, based on the provided document, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented in the document.
Sample sized used for the test set and the data provenance: No test set was used for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was analyzed.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable as no performance data was collected.
The sample size for the training set: Not applicable as this is a physical medical device.
How the ground truth for the training set was established: Not applicable.

The document focuses on establishing substantial equivalence to a predicate device (Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System, K112987) based on technological characteristics and identical components/patient contact materials. The key difference noted is a change in the numerical aperture (NA) of the fiber for better coupling efficiency, which is presented as an improvement rather than a factor requiring new performance testing for soft tissue applications.

Summary

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K120437 - 510(k) Summary ister™ Side-Firing Fiber Optic Delivery System

Submitter's Name Biolitec SIA

Address

Kaniera iela 10a, Riga, LV-1063 Latvia

Telephone Number, Contact Person and Date Prepared Phone: (413) 525-0600/ 413 250-0779 (Cell) Facsimile: (413) 525-0611

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: February 10, 2012

Name of Device and Name/Address of Sponsor

Twister™ Side-Firing Fiber Optic Delivery System

Biolitec SIA Kaniera iela 10a, Riga, LV-1063 Latvia

Classification Name

Surgical laser & accessories

Common Name of Device

Twister™, SF & L

Predicate Devices

Twister™ Side Fire Fiber Optic Delivery System, (K112987) Evolve® 980-1470nm Multiwavelength Diode Laser, (K112013)

Intended Use/Indication for Use

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or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

Technological Characteristics

Twister is a fiber optic delivery system designed to deliver optical energy from a surgical laser to soft or fibrous tissue for the indicated uses. The distal end of the Twister possesses a slight bend at the capillary tip, producing 30° lateral firing which is identical to the predicate. The fiber makeup remains silica, silica cladding, hard plastic cladding, and Tefzel jacketing as is the predicate. The numerical aperture (NA) of the fiber however is 0.26/ 0.37 (whereas the predicate is 0.22/ 0.37) giving a better coupling efficiency and correcting for the truncation in power transmission seen with the predicate fiber when using larger NA lasers.

Performance Data

Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.

Substantial Equivalence

The Twister™ Side-Fire Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Medical Devices, Inc's Side Fire Fiber Optic Delivery System. Thus, the Twister™ Side-Fire Fiber Optic Delivery System for Biolitec SIA is substantially equivalent to its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

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

Biolitec SIA % Genmarhay BDA Harry Hayes, Ph.D. 1349 Main Road Granville, Massachusetts 01034

APR 2 6 2012

Re: K120437

Trade/Device Name: Twister™ Side-Firing Fiber Optic Delivery 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 Product Code: GEX Dated: April 11, 2012 Received: April 13, 2012

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 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

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Page 2 - Harry Hayes, Ph.D.

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 (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.

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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

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 Statement

510(k) Number (if known): K120437

Device Name:

Twister™ Side-Firing Fiber Optic Delivery System

Indications for Use:

The Twister™ Side-Firing Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any surgical laser with SMA 905 compatible connector. The Twister™ Side-Firing Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser, marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

(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) OR

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

.l. RP Oyler for mxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120437

GBDA/ BioSIA-TW-021012-01

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.