Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho: YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Device Description

The Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. The Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242um, 365um, 550um and 910um size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242um size).

For the Flexiva Pulse ID and the Flexiva Pulse ID TracTip laser fibers, an RFID (radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).

AI/ML Overview

The provided document is a 510(k) summary for the Flexiva Pulse Laser Fibers. It describes the device, its intended use, and how it demonstrates substantial equivalence to predicate devices. However, this document does not contain a formal study that establishes specific acceptance criteria and then proves the device meets those criteria for the performance of the device in a clinical or simulated clinical setting. Instead, it focuses on demonstrating that the new device is as safe and effective as pre-existing, legally marketed predicate devices through a comparison of technological characteristics and extensive bench testing.

Therefore, it's not possible to populate the requested table and answer many of the specific questions about a "study that proves the device meets the acceptance criteria" in the way one might for a novel AI/software medical device or a device requiring clinical performance validation against specific endpoints.

Here's an attempt to address the request based only on the information provided in the given text, highlighting where information is absent:

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

The document does not explicitly state acceptance criteria in a quantitative format for clinical performance or sensitivity/specificity typical of diagnostic studies. Instead, the acceptance criteria are implicitly that the new device performs at least as well as, or equivalently to, the predicate devices in various bench tests and meets biocompatibility standards.

Acceptance Criteria (Implicit from testing)	Reported Device Performance
Biocompatibility standards (ISO 10993-1:2018) met.	All patient contacting materials meet applicable biocompatibility standards as per ISO 10993-1:2018 and FDA guidance. Passing results for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Materials Mediated Pyrogenicity.
Connector temperature within limits for normal use (IEC 60601-1:2005).	The Flexiva Pulse laser fibers conform to Section 11.1.1, Maximum temperature during Normal Use, of IEC 60601-1:2005.
Fiber Jacket Outer Diameter, Ball Tip Fracture Resistance, Distal Tip Length,	Specific quantitative performance values are not provided, but the document states, "The results of the performance testing demonstrate that the Flexiva Pulse Laser Fiber, Flexiva PulseTracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are considered safe and effective for their intended use." This implies that the device met the pre-defined (but not specified) acceptance limits for these tests, demonstrating equivalence or superior performance compared to the predicate for the design changes.
Fiber Length, Bent Transmission, Fiber Stiffness, Power Rating & Efficiency
Fiber Connector Temperature, Fiber Aiming Beam Visualization, Laser Compatibility
RFID Recognition (for ID versions), Scope Adaptor Compatibility,
Tensile Strength of fiber to connector housing, Fiber Hub to Connector Housing Torque
Pouch Seal Integrity, Pouch Seal Strength
No Damage to Scope Liner (Ball-Tip)

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

Sample size for test set: Not explicitly stated for each bench test. The testing involved "samples aged at T=0 and T=3 year accelerated aging," but the number of samples for each test is not provided.
Data provenance: Bench evaluations conducted by Boston Scientific. The country of origin and whether it's retrospective or prospective are not applicable in the context of bench testing.

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 as this is a device clearance based on substantial equivalence through bench testing, not a study evaluating human interpretation or a diagnostic algorithm against expert-established ground truth.

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

Not applicable.

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, an MRMC comparative effectiveness study was not done. This device is a laser fiber for surgical use, not an AI/software diagnostic device.

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

Not applicable. This is a physical medical device (laser fiber), not an algorithm.

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

The "ground truth" for this submission are the established engineering and safety standards (e.g., ISO 10993-1, IEC 60601-1) and the performance characteristics of the predicate devices. The tests were designed to confirm that the new device meets these standards and performs comparably to or better than the predicate.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable.

Summary of why information is missing:

This document is a 510(k) summary for a physical medical device (laser fiber), not a software or AI-based diagnostic device. The clearance is based on demonstrating "substantial equivalence" to legally marketed predicate devices. This typically involves:

Comparing the intended use and technological characteristics.
Conducting extensive bench testing to ensure the new device meets safety and performance standards and performs comparably to the predicate.
Confirming biocompatibility.

Therefore, the study described is a series of engineering and material performance tests, not a clinical trial or a diagnostic performance study, which would involve concepts like sample size for test/training sets, experts for ground truth, MRMC studies, or standalone algorithm performance.

Summary

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April 28, 2021

Boston Scientific % Dave Yungvirt, CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K210925

Trade/Device Name: Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID 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: II Product Code: GEX Dated: March 24, 2021

Dear Dave Yungvirt:

Received: March 29, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark J. Antonino, M.S. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210925

Device Name

Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fiber

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for the Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber

Date Prepared A.

April 26, 2021

B. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752

Contact C.

Rebecca Perrine Sr. Regulatory Affairs Specialist 508-683-4604 rebecca.perrine@bsci.com

John Capone Regulatory Affairs Director 617-842-9632 john.capone@bsci.com

D. Proposed Device

Trade Name(s):	Flexiva Pulse Laser FiberFlexiva Pulse TracTip Laser FiberFlexiva Pulse ID Laser FiberFlexiva Pulse ID TracTip Laser Fiber
Common/Usual Name:	Laser Instrument, Surgical, Powered
Classification Number:	21 CFR 878.4810
Classification Name:	Laser Surgical Instrument for use in general and plasticsurgery and in dermatology
Classification:	Class II
Product Code:	GEX
Product Code Name:	Powered Laser Surgical Instrument
510(k) Number:	K210925

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E. Predicate Devices

Trade Name:	Flexiva™ High Power Single Use Laser Fiber
Common/Usual Name:	Laser Instrument, Surgical, Powered
Classification Number:	21 CFR 878.4810
Classification Name:	Laser Surgical Instrument for use in general and plasticsurgery and in dermatology
Classification:	Class II
Product Code:	GEX
Product Code Name:	Powered Laser Surgical Instrument
Identification ofPredicate Device:	Modified Straight Fire Laser Fiber, Boston Scientific,K100078
Trade Name:	Flexiva™ TracTip Single Use Laser Fiber
Common/Usual Name:	Laser Instrument, Surgical, Powered
Classification Number:	21 CFR 878.4810
Classification Name:	Laser Surgical Instrument for use in general and plasticsurgery and in dermatology
Classification:	Class II
Product Code:	GEX
Product Code Name:	Powered Laser Surgical Instrument
Identification ofPredicate Device:	Flexiva™ TracTip™ Single Use Laser Fiber, Boston

F. Device Description

Scientific, K110685

These fibers may be used in a variety of laser-based surgical cases. For the Flexiva Pulse ID and the Flexiva Pulse ID TracTip laser fibers, an RFID (radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).

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G. Intended Use/Indications for Use

H. Technological Characteristics Compared to Predicate

The principles of operation are identical between the predicate and subject devices. The Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID, and Flexiva Pulse ID TracTip laser fibers have the same technological characteristics and fundamentals design as the predicate devices.

The differences between the subject device and the predicates are minor. Differences include:

Use with holmium lasers only with an increased maximum frequency ●
Connector/hub including: manufacturing, shape and non-patient contacting . connector/hub materials
. Primary and Secondary Coating on fiber length

The technological characteristics remain equivalent to the predicate device because the modifications that are the subject of this submission are limited to improvements to the existing design.

I. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are substantially equivalent to the predicate devices in terms of intended use, technological characteristics and performance characteristics. The Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are as safe and effective as the predicate devices.

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J. Biocompatibility

Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2018 and the FDA guidance: Use of International Standard ISO 10993-1 "Biological evaluation of medical devices. Evaluation and testing within a risk management process."

The following testing was performed with passing results to support the biocompatibility of the device:

Cytotoxicity
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Materials Mediated Pyrogenicity ●

K. Performance Testing (Bench Evaluation)

Boston Scientific has conducted performance testing with samples aged at T=0 and T= 3 year accelerated aging in support of the proposed laser device. IEC 60601-1:2005 was considered when testing connector temperature. The Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID, and Flexiva Pulse ID TracTip laser fibers conform to Section 11.1.1, Maximum temperature during Normal Use. All other sections of IEC 60601-1 Clause 11 are not applicable, as the fiber functions only as an accessory to the Medical Electrical Equipment (laser).

The following testing was completed to evaluate the effects of the design changes.

Fiber Jacket Outer Diameter
No Damage to Scope Liner (Ball-Tip) ●
Ball Tip Fracture Resistance ●
Distal Tip Length ●
Fiber Length ●
Bent Transmission ●
Fiber Stiffness ●
Fiber Power Rating and Power Output Efficiency of Fiber
Fiber Connector Temperature and Durability ●
Fiber Aiming Beam Visualization ●
Laser Compatibility ●

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RFID Recognition ●
Scope Adaptor Compatibility ●
Tensile Strength of fiber to connector housing ●
Fiber Hub to Connector Housing Torque ●
Pouch Seal Integrity ●
Pouch Seal Strength ●
Biocompatibility ●

The results of the performance testing demonstrate that the Flexiva Pulse Laser Fiber, Flexiva PulseTracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are considered safe and effective for their intended use.

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.