The Flexiva SF Side-Firing Single-Use Laser Fiber is 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 has been cleared for surgical use.

Device Description

The Flexiva SF Side-Firing Single-Use Laser Fibers (Flexiva SF) are fiber optic laser energy delivery devices consisting of an SMA-905 connector and a coated silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The Flexiva SF fibers are equipped with a metal cap with circumferential solid black line guides, an adjustable hand piece and rigid tubing. The laser aperture is located near the tip of the metal cap. Laser energy is delivered at an approximately 70° angle to tissue from the tip of the fiber. The line guides assist with correct positioning of the fiber tip within the endoscope. The adjustable hand piece enables manipulation of the laser fiber tip at the treatment site. The rigid tubing aids in control of the fiber tip. These fibers may be used in a variety of laserbased surgical cases as an integral part of laser systems.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Flexiva™ SF Side-Firing Single-Use Laser Fiber) and primarily focuses on demonstrating substantial equivalence to predicate devices based on performance testing (bench evaluation), rather than clinical studies involving human patients or complex algorithms requiring ground truth establishment with expert consensus.

Therefore, many of the requested categories in your prompt are not applicable to the information contained within this specific 510(k) summary.

Here's an analysis based on the provided text:

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

The document lists the types of performance testing conducted but does not provide specific acceptance criteria or quantitative reported device performance for each test. Instead, it makes a general statement: "The results of the performance testing demonstrate that the Flexiva SF fiber is considered safe and effective for its intended use."

Performance Test Category	Reported Device Performance
Operating Life	Considered safe and effective for its intended use
Hand-Piece Retention Strength	Considered safe and effective for its intended use
Initial Fiber Power Transmission	Considered safe and effective for its intended use
Fiber Power Transmission	Considered safe and effective for its intended use
Fiber Control	Considered safe and effective for its intended use
Protective Cap Retention Strength	Considered safe and effective for its intended use
Fiber Length	Considered safe and effective for its intended use
Distal Fiber Max OD	Considered safe and effective for its intended use
Aiming Beam	Considered safe and effective for its intended use
Connector Temperature/Durability	Considered safe and effective for its intended use
Connector Tensile	Considered safe and effective for its intended use
Seal Integrity	Considered safe and effective for its intended use
Seal Strength	Considered safe and effective for its intended use

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

The document mentions "samples aged at T=0 and T=6 months accelerated aging" for testing. However, it does not specify the sample size for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned, as this was a bench evaluation of the device's physical and functional characteristics.

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. This was a bench evaluation of a physical device, not an algorithm requiring expert-established ground truth.

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

Not applicable. This was a bench evaluation of a physical device.

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. This device is a laser fiber for surgical procedures, not an AI-assisted diagnostic tool or an imaging device that would typically involve MRMC studies.

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

Not applicable. This device is not an algorithm. Performance testing was done on the physical device itself.

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

Not applicable. For bench testing of a physical device, "ground truth" would be established by engineering specifications, material properties, and a controlled test environment to measure performance against those specifications.

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. This device is not an algorithm that requires a training set.

Summary

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APR 1 5 2014

Side-Firing Laser Fiber Traditional 510(k)

K140503 Boston Scientific

510K SUMMARY SECTION 5 . .

510(k) Summary for Flexiva™ SF Side-Firing Single-Use Laser Fiber

A. Sponsor

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

B. Contact

Jeanne O'Toole Senior Specialist, Regulatory Affairs' ·508-683-4271 jeanne.otoole@bsci.com

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

C. Device Name

Flexiva™ SF Side-Firing Single-Use Laser Fiber Trade name: Common usual/name: Laser Instrument, Surgical, Powered GEX - Laser surgical instrument for use in general and Classification: plastic surgery and in dermatology 21 CFR 878.4810. Class II

D. Predicate Device(s)

Trade name:	DuoTome™ SideLite™ Fiber (cleared under K011703 asLumenis delivery devices)
Common usual/name:	Laser Instrument, Surgical, Powered
Classification:	GEX - Laser surgical instrument for use in general andplastic surgery and in dermatology21 CFR 878.4810, Class II

Premarket Notification: Lumenis, K011703

and

Trade name:	Flexiva™ High Power Single-Use Laser Fiber (cleared under K100078 as Modified Straight Fire Laser Fiber)
Common usual/name:	Laser Instrument, Surgical, Powered
Classification:	GEX - Laser surgical instrument for use in general and plastic surgery and in dermatology21 CFR 878.4810, Class II
Premarket Notification:	Boston Scientific K100078

Premarket Notification: Boston Scientific, K 100078

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510K SUMMARY SECTION 5

E. Device Description

F. Intended Use

The Flexiva SF fiber is 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 has been cleared for surgical use.

G. Technological Characteristics

The Flexiva SF fiber has the same technological characteristics and fundamental design as the predicate devices. The proposed Flexiva SF fiber is available in a single configuration.

H. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the Flexiva SF fiber is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The Flexiva SF fiber is as safe and effective as the predicate devices.

I. Performance Testing (Bench Evaluation)

Boston Scientific has conducted performance testing with samples aged at T=0 and T=6 months accelerated aging in support of the proposed laser device. The following testing was completed to evaluate the effects of the design change:

Operating Life .
Hand-Piece Retention Strength ●
Initial Fiber Power Transmission .
Fiber Power Transmission .
Fiber Control .

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Side-Firing Laser Fiber Traditional 510(k)

SECTION 5 -510K SUMMARY 11

Protective Cap Retention Strength .
Fiber Length .
Distal Fiber Max OD .
. Aiming Beam
. Connector Temperature/Durability
Connector Tensile . .
Seal Integrity .
Seal Strength .

The results of the performance testing demonstrate that the Flexiva SF fiber is considered safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

April 15, 2014

Boston Scientific Corporation Ms. Jeanne O'Toole Senior Specialist, Regulatory Affairs 100 Boston Scientific Way Marlborough, Massachusetts 01756

Re: K140503

Trade/Device Name: Flexiva" SF Side-Firing Single-Use 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 31, 2014 Received: April 1, 2014

Dear Ms. O'Toole:

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 10 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 docs 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 that I Dri has made a and regulations administered by other Federal agencies. You must or any Federal 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

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Page 2 - Ms. Jeanne O'Toole

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 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/Resourcesfor You/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/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 Industry and Consumer Education 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.

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140503

Device Name

Flexiva™ SF Side-Firing Single-Use Laser Fiber

Indications for Use (Describe)

The Flexiva SF Side-Firing Single-Use Laser Fiber is designed for use with Ho:Y AG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision of soft and cartitaginous tissue, and fragmentation of urinary and biliary calculi (Ho:Y AG wavelength only). The fiber is designed for use with a standard SMA-905 connector that has been cleared for surgical use.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Consistence of Center for Devices and Radiological Health (CDRH) (original)

Neil R Oga 2014.04.14 1

FORM FDA 3881 (1/14) For BSA

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.