The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.

The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA-905 connector that have been cleared for surgical use.

Device Description

The Straight Fire Holmium 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 Ho:YAG laser systems with a standard SMA 905 connector that have been cleared for surgical use. Recommended Ho: YAG lasers are Dornier and New Star.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Straight Fire Holmium Laser Fiber by Boston Scientific Corporation. This type of submission is focused on demonstrating substantial equivalence to a currently marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.

Therefore, the structure of the provided text does not contain the specific information you've requested regarding acceptance criteria and a study proving device performance in the context of diagnostic accuracy, human reader performance, or standalone algorithm performance.

Here's an explanation based on the provided text, addressing your points where applicable and explaining why other points are not present:

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

This information is not present in the provided document. A 510(k) submission for a device like a laser fiber typically focuses on demonstrating that the new device has the same technological characteristics and performs as well as predicate devices, through bench testing (e.g., power output, fiber integrity) and materials characterization. Specific "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (like sensitivity, specificity, AUC) or clinical outcomes are not typically part of this type of submission for this class of device. The document states: "The Straight Fire Holmium Laser Fiber is as safe, as effective, and performs as well as the predicate devices." This is the core claim of substantial equivalence.

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

This information is not present. As explained above, this submission is not based on a clinical trial with a "test set" in the sense of patient data. Performance is typically evaluated through laboratory-based engineering and materials testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not present. This is not relevant to a 510(k) submission for a laser fiber. Ground truth adjudicated by experts is typically for diagnostic imaging or similar devices where interpretation is involved.

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

This information is not present. This is not relevant for this type of device and submission.

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

This information is not present. An MRMC study is not applicable to a laser fiber, which is a surgical instrument, not a diagnostic imaging or AI-assisted interpretation device. AI is not mentioned or implied in this submission.

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

This information is not present. This is not relevant. The device is a physical laser fiber, not an algorithm.

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

This information is not present. The concept of "ground truth" as typically discussed in diagnostic studies is not relevant here. Performance is assessed against engineering specifications and comparison to the predicate device's known characteristics.

8. The sample size for the training set

This information is not present. No "training set" is applicable for this type of device submission.

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

This information is not present. No "training set" or "ground truth" in this context is applicable for a laser fiber.

Summary based on the document:

The 510(k) submission for the Straight Fire Holmium Laser Fiber focuses on establishing "Substantial Equivalence" to legally marketed predicate devices (AccuFlexTM Laser Lithotripsy Fibers and SlimLineEZ™ Fiber Device).

The core of the "study that proves the device meets the acceptance criteria" in this context is demonstrated by:

Technological Characteristics Comparison: The document states, "The Straight Fire Holmium Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate devices." This implies that the design and components are critically similar.
Performance Characteristics: The document claims the device "performs as well as the predicate devices." While no specific performance data is included in this summary, a typical 510(k) for such a device would include bench testing data comparing parameters like power transmission, durability, and compatibility with specified laser systems, against the predicate devices or established engineering standards. The acceptance criteria would likely be defined by these engineering specifications and a demonstration of equivalence to the predicate's performance under various test conditions. For example, acceptance criteria might include a specified power output tolerance, bending radius tolerance without damage, or tensile strength, with the associated testing demonstrating the fiber meets these. However, these specific details are not provided in the public 510(k) summary.
Intended Use Equivalence: The intended use statement for Straight Fire Holmium Laser Fiber closely mirrors the general applications of existing Holmium laser fibers, involving "vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue." This demonstrates that the device is intended for the same clinical applications as its predicates.

In conclusion, for this specific device and submission type, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in technological characteristics, intended use, and performance to predicate devices through engineering and materials testing, rather than clinical studies with human subjects or AI algorithm performance assessments.

Summary

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Boston Scientific Corporation

510(k) Summary for Straight Fire Holmium Laser Fiber

A. Sponsor

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

B. Contact

Lauren B. Anderson Specialist, Regulatory Affairs 508-683-4707

or Donna Gardner Director, Regulatory Affairs 508-683-4398

C. Device Name

Trade name:	To Be Determined*Although the Trade Name is to be determined, forpurposes of this submission the proposed device will bereferred to as the Straight Fire Holmium Laser Fiber
Common/usual name:	Laser Instrument, Surgical, Powered
Classification Name:	GEX - Laser surgical instrument for use in general andplastic surgery and in dermatology21 CFR 878.4810, Class II

D. Predicate Device(s)

Trade name:	AccuFlexTM Laser Lithotripsy Fibers
Common/usual name:	Laser Instrument, Surgical, Powered
Classification Name:	GEX - Laser surgical instrument for use in general andplastic surgery and in dermatology
	21 CFR 878.4810, Class II
Premarket Notification:	InnovaQuartz, Inc., K050108

and

SlimLineEZ™ Fiber Device Trade name: 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: Lumenis, K011703

Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008

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Boston Scientific Corporation

E. Device Description

For use with Ho:YAG laser systems with a standard SMA 905 connector that have been cleared for surgical use. Recommended Ho: YAG lasers are Dornier and New Star.

F. Intended Use

The Straight Fire Holmium Laser Fiber is intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.

The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use.

G. Technological Characteristics

The Straight Fire Holmium Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate devices.

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 Straight Fire Holmium Laser Fiber is as safe, as effective, and performs as well as the predicate devices.

Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

OCT 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation % Intertek Testing Services Kachi C. Enyinna Staff Engineer - Medical Devices 2307 East Aurora Road Twinsburg, Ohio 44087 .

Re: K082928

Trade/Device Name: Undetermined 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: September 30, 2008 Received: October 1, 2008

Dear Kachi Enyinna:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set

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Page 2 -- Kachi C. Enyinna

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Boston Scientific Corporation

Indications for Use Statement

510(k) Number (if Known): K082923

Device Name: Undetermined

Indications For Use:

The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers 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

Hilke Olds for mixer

Division of General, Restorative. and Neurological Devices

Traditional 510(k) Straight Fire Holmium Laser Fiber August 25, 2008

510(k) Number K082928

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.