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, 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.

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

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

These fibers may be used in a variety of laser-based surgical cases. For Flexiva Pulse ID 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 FDA 510(k) clearance letter and summary for the Flexiva Pulse Laser Fibers does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study particulars for a medical device. This document is a premarket notification for laser fibers, which are physical components and not typically subject to the same kind of performance studies as, for example, an AI diagnostic algorithm.

Specifically, it lacks information about:

Acceptance Criteria for a diagnostic output: As the device is a laser fiber for surgical use, its "performance" is about its physical properties and ability to transmit laser energy, not diagnostic accuracy.
Study proving device meets acceptance criteria in the context of diagnostic accuracy.
Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size and ground truth establishment for AI-based devices. These are all concepts related to clinical performance evaluation, particularly for AI/Machine Learning devices, which is not the nature of the Flexiva Pulse Laser Fibers.

The document does describe performance testing related to the physical and functional attributes of the laser fiber. I will present the information contained in the document that most closely aligns with the spirit of your request, interpreting "acceptance criteria" and "reported device performance" in the context of a physical medical device.

Overview of Device Performance and Testing (Flexiva Pulse Laser Fibers)

The document describes a Special 510(k) submission for the Flexiva Pulse Laser Fibers, indicating that it is a modification to a previously cleared device (predicate device K210925). The core of the submission is to demonstrate substantial equivalence to the predicate device, primarily due to a "secondary coating resin material change." Therefore, the "study" described is focused on validating that this material change does not negatively impact the critical performance characteristics of the laser fiber.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (laser fiber), the "acceptance criteria" and "reported device performance" are related to its functional integrity and safety. These are not performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic AI device.

Characteristic Tested	Description / Acceptance Standard (Implicit)	Reported Device Performance
Bent Transmission	Ensure efficient laser energy transmission even when bent, indicating fiber integrity and stability.	Successfully passed (implied by "Design Verification was executed to support the safe and effective use").
Fiber Durability while Firing	Maintain structural integrity and performance during active laser firing, resisting degradation.	Successfully passed (implied by "Design Verification was executed to support the safe and effective use").
Fiber Connector Temperature	Maintain connector temperature within safe limits during operation to prevent overheating.	Successfully passed (implied by "Design Verification was executed to support the safe and effective use").
Laser System Output Accuracy	Ensure the fiber accurately transmits the intended laser energy output without significant loss or alteration.	Successfully passed (implied by "Design Verification was executed to support the safe and effective use").
Biocompatibility	No new biocompatibility risks from the material change.	Concluded that "there are no biocompatibility risks associated with the proposed Flexiva Pulse/ ID Laser Fiber."

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of fibers tested) for the performance tests (Bent Transmission, Fiber Durability, etc.). It generally states that a "Design Verification was executed." The data provenance is internal testing performed by Boston Scientific Corporation. The studies are by nature prospective in the sense that they are performed on newly manufactured devices with the changed coating resin material to verify their performance. There is no mention of country of origin for test data, but it would typically be conducted at the manufacturer's R&D facilities.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not a diagnostic device where expert ground truth is established for clinical outcomes or interpretations. The "ground truth" for the performance tests mentioned above would be engineering and physical measurement standards.

4. Adjudication Method

Not applicable. This is not a diagnostic device requiring adjudication of clinical interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with and without AI assistance, which is irrelevant for a laser fiber.

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

No. This refers to the performance of a diagnostic algorithm without human intervention, which is not applicable to a laser fiber.

7. The Type of Ground Truth Used

For the physical performance tests:

Engineering Specifications/Standards: The "ground truth" is adherence to predefined engineering specifications for power transmission, temperature limits, durability, etc. These would be established based on industry standards, the predicate device's performance, and safety requirements.
Biocompatibility Standards: For biocompatibility, the ground truth is compliance with recognized biological evaluation standards (e.g., ISO 10993 series), ensuring the materials are safe for human contact.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of what the document indicates about the "study":

The study was a "Design Verification" executed by Boston Scientific Corporation to support the "safe and effective use" of the proposed laser fibers after a "secondary coating resin material change." The purpose was to demonstrate that the modified device remains "substantially equivalent" to its predicate device (K210925). The tests involved evaluating the fiber's ability to transmit laser energy (Bent Transmission), its resilience during use (Fiber Durability while Firing), and safety (Fiber Connector Temperature, Laser System Output Accuracy, Biocompatibility). The document implies that all these tests were successfully completed, confirming that the material change did not compromise the device's performance or safety.

Summary

FDA 510(k) Clearance Letter - Flexiva Pulse Laser Fibers

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 9, 2025

Boston Scientific Corporation
Galit Gershon
Senior Regulatory Affairs Specialist
100 Boston Scientific Way - Urology Division
Marlborough, Massachusetts 01752

Re: K251759
Trade/Device Name: Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
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: June 8, 2025
Received: June 9, 2025

Dear Galit Gershon:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K251759 - Galit Gershon
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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K251759 - Galit Gershon
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 -S

Mark J. Antonino, M.S.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K251759

Device Name:
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary for Flexiva Pulse/ ID Laser Fiber

Page 1 of 5
Flexiva Pulse/ ID Single Use Laser Fibers
Special 510(k)
Confidential & Proprietary Information of Boston Scientific Corporation

Date Prepared: 08-June-2025

A. Submitter

Boston Scientific Corporation
Urology Division
100 Boston Scientific Way
Marlborough, MA 01752

B. Contacts

Galit Gershon
Sr. Regulatory Affairs Specialist
+972-52-8786899
Galit.gershon@bsci.com

C. Device Name

Trade Name	Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
Common Name	Laser Instrument, Surgical, Powered
Classification	Class II per 21 CFR 878.4810
Classification Name	Laser Surgical Instrument for use in general and plastic surgery and in dermatology
Product Code	GEX
Product Code Name	Powered Laser Surgical Instrument

D. Predicate Devices

For the purposes of establishing substantial equivalence, the designs and technological characteristics of the proposed Flexiva Pulse/ ID Laser Fiber were compared to the following 510(k)-cleared device.

Table 11-1: Predicate Device for Establishing Substantial Equivalence

Characteristics	Predicate Device
Device Trade Name	Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
Classification Name	Laser Surgical Instrument for use in general and plastic surgery and in dermatology

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Page 2 of 5
Flexiva Pulse/ ID Single Use Laser Fibers
Special 510(k)
Confidential & Proprietary Information of Boston Scientific Corporation

Regulation Number	21 CFR 878.4810
Classification	Class II
Product Code	GEX
510(k) Submitter/ Holder	Boston Scientific Corporation
510(k) Clearance Number & Date	K210925 Cleared 28-April -2021

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Page 3 of 5
Flexiva Pulse/ ID Single Use Laser Fibers
Special 510(k)
Confidential & Proprietary Information of Boston Scientific Corporation

E. Device Description

F. Intended Use/Indication for Use

G. Principles of Operation

The operating principle for the Flexiva Pulse/ ID Laser Fiber (submitted under K210925) remains unchanged.

Flexiva Pulse/ ID Laser Fibers deliver holmium (Ho:YAG) laser energy endoscopically from a laser console to soft tissues or urinary calculi. The energy travels within the fiber's glass core and exits through the distal end of the fiber. Upon impact, the holmium energy fragments urinary calculi and/or ablates soft tissue.

H. Comparison of Key Technological/Performance Characteristics

The proposed Flexiva Pulse/ ID Laser Fiber have the same technological characteristics and fundamental design as the predicate Flexiva Pulse/ ID Laser Fiber (K210925).

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Page 4 of 5
Flexiva Pulse/ ID Single Use Laser Fibers
Special 510(k)
Confidential & Proprietary Information of Boston Scientific Corporation

Table 11-2: Flexiva Pulse/ ID Laser Fiber Comparison and Substantial Equivalence

Characteristics	Predicate Flexiva Pulse/ ID Laser Fiber (K210925)	Proposed Flexiva Pulse/ ID Laser Fiber	Similarities / Differences
Indication for Use	Flexiva Pulse and Flexiva Pulse TracTip Laser Fiber: 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, 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. Flexiva Pulse ID and Flexiva Pulse ID TracTip Laser Fiber: 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.	Flexiva Pulse and Flexiva Pulse TracTip Laser Fiber: 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, 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. Flexiva Pulse ID and Flexiva Pulse ID TracTip Laser Fiber: 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.	Identical
Reusability	Single Use	Single Use	Identical
Flexiva Pulse/ ID Laser Fiber is Supplied	Sterile	Sterile	Identical

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Page 5 of 5
Flexiva Pulse/ ID Single Use Laser Fibers
Special 510(k)
Confidential & Proprietary Information of Boston Scientific Corporation

Sterilization	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Identical
Packaging	Tyvek pouch	Tyvek pouch	Identical
Sizes Offered (μm)	242, 365, 550, and 910; 242 μm TracTip configuration	242, 365, 550, and 910; 242 μm TracTip configuration	Identical
Overall Length	242 µm: 3 meters; 365, 500, 910 µm: 2.6 meters	242 µm: 3 meters; 365, 500, 910 µm: 2.6 meters	Identical

I. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the proposed Flexiva Pulse/ ID Laser Fibers are substantially equivalent to the predicate Flexiva Pulse/ ID Laser Fibers (K210925) in terms of intended use, technological characteristics, and performance characteristics. The proposed Flexiva Pulse/ ID Laser Fiber is as safe, as effective, and performs as well as the predicate devices (K210925).

J. Performance Testing

To evaluate the secondary coating resin material change introduced with the proposed Flexiva Pulse/ ID Laser Fiber, a Design Verification was executed to support the safe and effective use of the proposed Flexiva Pulse/ ID Laser Fiber. The new secondary coating resin was subjected to the following tests:

Bent Transmission
Fiber durability while firing
Fiber connector temperature
Laser System output accuracy

From a biocompatibility standpoint, the contact classification of the proposed Flexiva Pulse/ ID Laser Fiber is identical to the predicate Flexiva Pulse/ ID Laser Fiber (cleared under K210925). A biological evaluation assessment for the proposed Flexiva Pulse/ ID Laser Fiber was conducted and it was concluded there are no biocompatibility risks associated with the proposed Flexiva Pulse/ ID Laser Fiber.

K. Conclusion

Based on the intended use/indications for use, comparison of key technological characteristics, and performance testing presented in this premarket submission, it is concluded that the proposed Flexiva Pulse/ ID Laser Fibers are substantially equivalent to the predicate Flexiva Pulse/ ID Laser Fibers (cleared under K210925).

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.