The Hogue Surgical EndlessFiber® SMA-BAR family of medical devices is intended for clinical use in laser surgery procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: Y AG, Ho: Y AG, Diode, and KTP laser systems have been cleared for medical use, provided they are fitted with a launch port aperture compatible with the EndlessFiber® SMA 905 connector.

Device Description

The Hogue Surgical EndlessFiber® Reusable Surgical Laser Fiber is a family of optical fibers that are terminated at one end with industry standard SMA 905 connectors. Each connector is fitted with a collar, a strain relief to the fiber, and a dust cover to protect the mechanically-cleaved fiber endfaces.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Hogue Surgical EndlessFiber® Reusable Surgical Laser Fiber. This document focuses on demonstrating substantial equivalence to a previously approved predicate device (K050738), rather than presenting a study where specific acceptance criteria are defined and then proven by the device's performance in a clinical trial or a detailed standalone performance study with a test set, expert readers, and ground truth in the typical sense of AI/medical imaging device evaluations.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not directly applicable or available in the provided text as they relate to typical clinical performance studies for diagnostic or AI-driven systems. This document is a regulatory submission for a surgical instrument, which primarily focuses on safety and functional equivalence.

Here's the information that can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the "PERFORMANCE DATA" section, which focuses on safety and functional characteristics, demonstrating that the device is no less safe or effective than the predicate.

Acceptance Criteria (Functional/Safety Benchmarks)	Reported Device Performance (Hogue Surgical EndlessFiber®)
Optical input attenuation of less than 10%	Less than 10% @ 30W, 30 minutes, 1064nm, discharging into air
SMA905 connection temperature rise of less than 10°F	Less than 10°F @ 30W, 30 minutes, 1064nm, discharging into air
Comparable functional (optical transmission) performance to predicate	"Samples of this device and samples of its predicate, in their various sizes, have been compared experimentally for functional (optical transmission) performance." "Bench testing performance data demonstrates that the two types of device are comparable in their performance."
Operates in the same manner as the predicate	"The Hogue Surgical, LLC surgical laser delivery fiber operates in the same manner as the predicate device"

2. Sample size used for the test set and the data provenance

The document mentions "Samples of this device and samples of its predicate, in their various sizes," were compared experimentally. However, specific sample sizes (e.g., number of fibers tested) and the provenance of the data (country of origin, retrospective/prospective) are not provided. This was likely bench testing performed by the manufacturer.

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

Not applicable. This is a bench testing study for a surgical instrument, not a study evaluating human interpretation against a ground truth.

4. Adjudication method 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

Not applicable. The device is a surgical laser fiber, not an AI or diagnostic imaging system.

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

This concept doesn't directly apply as the device is a physical instrument. However, the "PERFORMANCE DATA" section describes standalone bench testing of the device's optical and thermal properties without human interaction during the measurement process. The results reported (optical input attenuation, temperature rise) are from this standalone functional testing.

7. The type of ground truth used

For the functional and safety performance, the "ground truth" is established by bench testing measurements against specified physical and performance thresholds (e.g., maximum attenuation, maximum temperature rise) and comparison to the predicate's known performance.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

Summary

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

August 15, 2014

Hogue Surgical, LLC Mr. Roger S. Hogue, MD, RVT Chief Executive Officer 7365 Kirkwood Court, North, Suite 350 Maple Grove, Minnesota 55369

Re: K140366

Trade/Device Name: Hogue Surgical EndlessFiber® Reusable Surgical 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: July 24, 2014 Received: July 29, 2014

Dear Mr. Hogue:

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. 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.

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

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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 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 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/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

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

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Indications for Use

510(k) Number (if known) K140366

Device Name

Hogue Surgical EndlessFiber® Reusable Surgical Laser Fiber

Indications for Use (Describe)

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

2 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)

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DATE	March 20, 2014
NAME OF FIRM	Hogue Surgical, LLC7365 Kirkwood Ct. N., Suite 350Maple Grove, MN 55369
510(k) CONTACT	Roger S. Hogue, MD, RVT (763) 424-8682
TRADE NAME	Hogue Surgical EndlessFiber® Reusable Surgical Laser FiberModel Number: HSEF-R-SMA-SMA-xxx-yyy
COMMON NAME	Laser Surgery Fiber Optic Delivery System
CLASSIFICATION	Classified by the General and Plastic Surgery Device Panel into Class II, under 21 CFR 878.4810
PRODUCT CODE	GEX
PREDICATE	K050738
DESCRIPTION	The Hogue Surgical EndlessFiber® Reusable Surgical Laser Fiber is a family of optical fibers that are terminated at one end with industry standard SMA 905 connectors. Each connector is fitted with a collar, a strain relief to the fiber, and a dust cover to protect the mechanically-cleaved fiber endfaces.
INDICATIONSFOR USE	The Hogue Surgical EndlessFiber® SMA-BAR family of medical devices is intended for clinical use in laser surgery procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd:YAG, Ho:YAG, Diode, and KTP laser systems have been cleared for medical use, provided they are fitted with a launch port aperture compatible with the EndlessFiber® SMA 905 connector.
TECHNOLOGICALCHARACTERISTICS	Characteristic	K140366	K050738
	Manufacturer	Hogue Surgical, LLC	FiberTech GmBH (Leoni Fiber Optics, Inc)
	Indications for Use	"". cutting, coagulating, or vaporizing of soft tissue"	"". cutting, coagulating, or vaporizing of soft tissue"
	Connector Termination	Special High Power SMA 905 Connector with Air-gap Well-Type Design	Special High Power SMA 905 Connector with Air-gap Well-Type Design
	Ferrule Adjustability	Adjustable ferrule position relative to precision-cleaved proximal fiber endface with set screw to secure ferrule position relative to fiber	Non-adjustable, fixed ferrule position relative to mechanically-polished proximal fiber endface with adhesive used to secure ferrule position relative to fiber
	Ferrule Design	Surgical Stainless with air-gap, well-type design	Surgical Stainless with air-gap, well-type design
	Optical Fiber Manufacturer	CeramOptec®	Unknown
	Nominal Wavelength	Suitable for 532nm up to 2200 nm	Suitable for 532nm up to 2200nm
	Optical Fiber CoreOptical Fiber Primary Cladding	Glass compositionFluorine Silica	Glass compositionFluorine Silica
	Optical Fiber Secondary Cladding	Hard Polymer	Hard Polymer
	Tefzel® ETFE	Tefzel® ETFE
Optical Fiber Jacket
Inner Core Diameter (um)	365, 550, 600, 800, 940	365, 550, 600, 800, 940
Standard Length (m)	3.5	3.0
Optical Fiber Numerical Aperture	0.22	0.22
Connector Collar	Color-coded by fiber size	Color-coded by device family
Model Identification	Laser-inscribed on color-coded collar	Laser-inscribed on color-coded collar
Max Power into Air (W)	30	30
Protective Cap	Stainless Steel	Plastic
Sold As	Non-Sterile, reusable device	Sterile, reusable; and sterile disposable
Strain Relief Boot Specifics	Plastic Boot secured by friction fit	Plastic Boot secured by adhesive
Known technological differences	Special High Power SMA 905 Connector can be completely disassembled into its component parts; these differences do not raise safety or effectiveness concerns because the components can be inspected, repaired or replaced to ensure intended device performance	Special High Power SMA 905 Connector cannot be disassembled as its components are secured with adhesive
Proximal Fiber Endface	Mechanically cleaved, flat	Mechanically polished, flat
Distal Fiber Endface	Mechanically cleaved, flat	Mechanically cleaved, flat
The only known technological differences between this device and its predicate are the optical connector design and the mechanical preparation of the proximal fiber endface (in the optical connector). Bench testing performance data demonstrates that the two types of device are comparable in their performance.
Samples of this device and samples of its predicate, in their various sizes, have been compared experimentally for functional (optical transmission) performance. Using the SE flowchart (BB Memorandum #K86-3), the Hogue Surgical EndlessFiber® SMA-BAR family of medical devices has the same intended use and technological characteristics as the legally-marketed predicate (K050738). The device is no less safe or effective and performs as well as the predicate devices.
BASIS FORSUBSTANTIALEQUIVALENCE
The device has been verified to possess the following safe handling characteristics as confirmed by bench testing @30W @30 minutes @1064nm discharging into air: (a) optical input attenuation of less than 10%; (b) SMA905 connection temperature rise of less than 10°F. The Hogue Surgical, LLC surgical laser delivery fiber operates in the same manner as the predicate device and performs with no
PERFORMANCEDATA

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Section 7: 510(k) Summary

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.