The Straight Fire 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 have been cleared for surgical use.

Device Description

The proposed modified Straight Fire Laser Fiber is a fiber optic laser energy delivery device consisting of a silica core fiber jacketed with ethelylene tetraflouroethylene (ETFE) and a SMA 905 connector. It is equipped with a polished, flat output tip. This fiber may be used in a variety of laser based surgical cases as an integral part of laser systems.

For use with holmium (Ho:YAG) and neodymium (Nd:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use. Recommended lasers are Lumenis VeraPulse® PowerSuite™ Laser Systems.

AI/ML Overview

This document is a 510(k) summary for a modified laser fiber, focusing on its substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for novel device performance is not present.

However, I can extract information related to the device's characteristics and the basis for its clearance, which is substantial equivalence.

Here's an attempt to answer your questions based only on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this submission:

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

Since this is a 510(k) submission based on "substantial equivalence" to a predicate device, explicit quantitative acceptance criteria for new performance tests are not typically presented in the publicly available summary unless a specific performance characteristic is modified and requires new testing. The general acceptance criterion for a 510(k) is that the device is "as safe, as effective, and performs as well as" the predicate device.

The document states: "The proposed modified Straight Fire Laser Fiber is as safe, as effective, and performs as well as the predicate device."

Performance Characteristic (Implied)	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance
Safety	As safe as predicate	Meets (Substantially Equivalent)
Effectiveness	As effective as predicate	Meets (Substantially Equivalent)
Performance	Performs as well as predicate	Meets (Substantially Equivalent)
Technological Characteristics	Same as predicate (SMA 905 connector, length of fiber connector type, fiber core, and strain relief)	Same as predicate
Intended Use	Same as predicate	Same as predicate

2. Sample sized 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 provided. The submission focuses on demonstrating substantial equivalence through technological and intended use comparisons, not a specific performance study with a test set of data.
Data Provenance: Not provided. The submission does not describe a clinical or lab study as the basis for clearance, but rather a comparison to an already cleared device.

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 submission does not describe a study involving a test set with ground truth established by experts.

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

Not applicable. This submission does not describe a study involving a test set requiring adjudication.

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 is a medical device (laser fiber), not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

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

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

Not applicable. The clearance is based on substantial equivalence, not on validating performance against a specific ground truth in a clinical study. The "ground truth" here is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

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

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

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

Summary

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100078

FEB 1 2 2010

Boston Scientific Corporation

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CONFIDENTIAL

510(k) Summary for Modified Straight Fire Laser Fiber
A. Sponsor	Boston Scientific CorporationUrology and Women's Health Division100 Boston Scientific WayMarlborough, MA 01756
B. Contact	Janet A. McGrathSpecialist, Regulatory Affairs508-683-4726orDonna GardnerDirector, Regulatory Affairs508-683-4398
C. Device Name
Trade name:	To Be Determined*Although the Trade Name is to be determined, forpurposes of this submission the proposed devicewill be referred to as the Modified Straight FireLaser Fiber
Common/usual name:Classification Name:	Laser Instrument, Surgical, PoweredGEX - Laser surgical instrument for use in generaland plastic surgery and in dermatology21 CFR 878.4810, Class II
D. Predicate Device(s)
Trade name:	Straight Fire Holmium Laser Fiber
Common/usual name:	Laser Instrument, Surgical, Powered
Classification Name:	GEX - Laser surgical instrument for use in generaland plastic surgery and in dermatology21 CFR 878.4810, Class II
Premarket Notification:	Boston Scientific; K082928
Trade name:	SlimLineEZTM Laser Lithotripsy Fibers
Common/usual name:	Laser Instrument, Surgical, Powered
Classification Name:	GEX - Laser surgical instrument for use in generaland plastic surgery and in dermatology21 CFR 878.4810, Class II
Premarket Notification:	Lumenis; K011703
Traditional 510(k)
Modified Straight Fire Laser FiberFebruary 1, 2010

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Boston Scientific Corporation

E. Device Description

F. Intended Use

G. Technological Characteristics

The proposed modified Straight Fire Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber connector type, fiber core, and strain relief) as the predicate device.

H. Substantial Equivalence

Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" 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 proposed modified Straight Fire Laser Fiber is as safe, as effective, and performs as well as the predicate device.

Traditional 510(k) Modified Straight Fire Laser Fiber February 1, 2010

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

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

FEB 1 2 2010

Boston Scientific Corp. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

Re: K100078

Krood76
Trade/Device Name: Modified Straight Fire Laser Fiber Regulation Number: 21 CFR 878.4810 Regulation Number. 21 CFR 876.4616
Regulation Name: Laser surgerical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: Class II Product Code: GEX Dated: February 2, 2010 Received: February 3, 2010

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(t) premained is substantially equivalent (for the indications
referenced above and have determined the device is substancements in interstat referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally manced promises and Device Amendments, or to commerce prior to May 28, 1970, the chaculence with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance who was and application (PMA).
and Cosmetic Act (Act) that do not require approval sentrals provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, stolect to the gentlations of the mained with and general controls provisions of the Act mender requirement as a sunst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in the states the started and main major resultstips affecting your d If your device is classified (see adver) micr ciass in (epicisms affecting your device can be
may be subject to additional controls. Existing major regulation FDA may may be subject to additional controls. Existing major regarations on and one of the Sederal Register found in the Code of Federal Regulations, This 2017-11-2017
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 Please be advised that FDA s issuance of a substance organies with other requirements of the Act
that FDA has made a determination that your device and agencies. You must that FDA has made a determination that your device compiles Federal agencies. You must

and the first of the states

. . .

: " :'

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Page 2 - Mr. Daniel W. Lehtonen

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant by over 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 n 70d abblic upvw.fda.gov/AboutFDA/CentersOffices/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 note the for questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ 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 r out may obtain only general reservers, 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/cdrh/industry/support/index.html.

Sincerely yours,

For Rh m

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

CONFIDENTIAL

Indications for Use Statement

K/000 510(k) Number (if Known):

Device Name: Undetermined

Indications For Use:

The Straight Fire Laser Fiber is designed for use with Ho: Y AG and Nd: Y AG 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)
	(Division Sign-Off)
	Division of Surgical, Orthopedic,and Restorative Devices.
Traditional 510(k)Modified Straight Fire Laser FiberFebruary 1, 2010	510(k) Number1400078	510(k) Number	1400078
510(k) Number	1400078

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.