The FlexivaTM TracTip Laser Fibers are designed for use with Ho:YAG and Nd:YAG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, laparoscopic, and open surgical procedures involving vaporization. ablation, coagulation, hemostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that have been cleared for surgical use.

Device Description

The Flexiva TracTip Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA-905 connector, strain relief, and a silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The Flexiva TracTip fibers are equipped with a polished and reinforced ball-shaped output tip. These fibers may be used in a variety of laser-based surgical cases as an integral part of laser systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Flexiva™ TracTip Laser Fiber, structured according to your request:

Acceptance Criteria and Study for Flexiva™ TracTip Laser Fiber

This device notification focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against a disease. Therefore, the "acceptance criteria" discussed here relate to the device's ability to perform equivalently to the predicate device in specific bench tests, rather than clinical efficacy against a medical condition.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Performance Metric)	Reported Device Performance (Flexiva™ TracTip)
Tip Fracture Resistance (Equivalence to Predicate)	Performance demonstrates equivalence to the predicate Flexiva laser fibers
Scope Testing (Equivalence to Predicate)	Performance demonstrates equivalence to the predicate Flexiva laser fibers
Power Rating/Output Efficiency Testing (Equivalence to Predicate)	Performance demonstrates equivalence to the predicate Flexiva laser fibers
Aiming Beam Testing (Equivalence to Predicate)	Performance demonstrates equivalence to the predicate Flexiva laser fibers

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

Sample Size: Not explicitly stated as a specific number of units for each test within the provided document. The text mentions "samples aged at T=0 and T=13 months accelerated aging," implying a comparison between new devices and devices subjected to accelerated aging.
Data Provenance: The testing was conducted by Boston Scientific Corporation, suggesting it was internal bench testing. The country of origin for this testing is not specified, but Boston Scientific is a U.S.-based company, making it likely the testing was performed within the U.S. The testing is retrospective in the sense that it evaluates the manufactured device's physical properties, not prospective clinical outcomes.

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

This information is not applicable and not provided in the document. The "ground truth" for this type of device (laser fiber) is its physical performance and ability to deliver energy as intended, which is assessed through engineering and bench testing, not expert clinical interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging studies) by multiple human readers to establish a consensus ground truth. For bench testing of a physical device, the performance is measured objectively.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a laser fiber used in surgical procedures, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical surgical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study is effectively defined by the objective measurements and engineering specifications of the predicate device. The performance of the Flexiva™ TracTip Laser Fiber is compared directly against the established performance characteristics of the predicate device (Flexiva™ Modified Straight Fire Laser Fiber) through bench testing. The goal is to demonstrate "equivalence" in physical and functional performance, not clinical outcomes or pathology.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. This is not a machine learning or AI-driven device, so there is no "training set." The device's design is based on engineering principles and comparison to a predicate, not data training.

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

This information is not applicable and not provided in the document, as there is no training set for this type of device.

Summary

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Special 510(k) Premarket Notification Flexiva TracTip Laser Fiber

Boston Scientific Corporation

510(k) Summary for Flexiva TracTip Laser Fiber

MAR 2 9 2011

K 110685

A. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756

B. Contact

Lauren Anderson Senior Specialist, Regulatory Affairs 508-683-4707 lauren.anderson@bsci.com

Nichole Riek Manager, Regulatory Affairs 508-683-4175 riekn@bsci.com

C. Device Name

Trade name: Flexiva™ TracTip Common/usual name: Laser Instrument, Surgical, Powered Classification Name: GEX - Laser surgical instrument for use in general and plastic surgery and in dermatology 21 CFR 878.4810, Class II

D. Predicate Device(s)

Trade name: Flexiva™ (Modified Straight Fire Laser Fiber) Common/usual name: Laser Instrument, Surgical, Powered Classification Name: GEX - Laser surgical instrument for use in general and plastic surgery and in dermatology 21 CFR 878.4810. Class II Premarket Notification: Boston Scientific, K100078

E. Device Description

For use with Ho:YAG and Nd:YAG laser systems with a standard SMA-905 connector that have been cleared for surgical use. Recommended for use with Lumenis manufactured Ho:YAG and Nd:YAG lasers. Please refer to the laser

Proprietary and Confidential Information of Boston Scientific Corporation

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system User Manual for complete information regarding applications, contraindications, precautions and warnings.

F. Intended Use

The Flexiva TracTip Laser Fibers are designed for use with Ho:YAG and Nd:YAG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, laparoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that have been cleared for surgical use.

G. Technological Characteristics

The Flexiva TracTip Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate device. It is equipped with a polished and reinforced ball-shaped output tip, whereas the predicate device has a polished flat tip.

H. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the proposed laser fiber is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The Flexiva TracTip Laser Fiber is as safe, as effective, and performs as well as the predicate device.

I. Performance Testing (Bench and User Evaluation)

Boston Scientific has conducted performance testing with samples aged at T=0 and T=13 months accelerated aging in support of the distal ball tip design change. The following testing was completed to evaluate the effects of the design change:

Tip Fracture Resistance
. Scope Testing
. Power Rating/Output Efficiency Testing
Aiming Beam Testing .

The results of the performance testing demonstrate equivalence of the Flexiva TracTip to the predicate Flexiva laser fibers. The Flexiva TracTip fibers are considered safe and effective for their intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

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

Boston Scientific Corporation Urology and Women's Health Division % Ms. Lauren Anderson 100 Boston Scientific Way, M21 Marlborough, Massachusetts 01752

WAR 2 9 2011

Re: K110685

Trade/Device Name: Flexiva™ TracTip Laser 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: March 24, 2011 Received: March 25, 2011

Dear Ms. Anderson:

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. Iisting 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.

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Page 2 – Ms. Lauren Anderson

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); medical device 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.goy/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aly B. Rh
for

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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Boston Scientific Corporation

Special 510(k) Premarket Notification Flexiva Laser Fiber

Indications for Use Statement

510(k) To be determined. Number Flexiva™ TracTip Laser Fiber Device Name Indications The FlexivaTM TracTip Laser Fibers are designed for use with For Use Ho:YAG and Nd:YAG lasers for indications that are cleared for

these laser systems, including, but not limited to endoscopic, laparoscopic, and open surgical procedures involving vaporization. ablation, coagulation, hemostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that have been cleared for surgical use.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niffl Ole for Mr
(Division Sign-Off)

Division of Surpical, Orthopedic, and Restorative Devices

510(k) Number K110685

Proprietary and Confidential Information of Boston Scientific Corporation

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.