The DuraLaze™ HoLEP Laser Fiber is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH). The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use only. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.

Device Description

The DuraLaze™ HoLEP Laser Fiber is a straight fire fiber optic laser energy delivery device. The laser fiber contains a 550µm silica core jacketed with ethylene tetrafluoroethylene (ETFE) and a standard SMA-905 laser connector with a strain relief. The distal 10 cm of the ETFE jacket is pre-stripped and coated during the manufacture of the laser fiber to minimize the potential of laser fiber damage caused by jacket stripping during surgical use and for the convenience of the operating room staff. The pre-stripped distal tip comes with a printed axial line that improves the surgeon's visibility by increasing the contrast between the fiber tip and the surrounding tissue. The DuraLaze™ HoLEP Laser Fiber is contained within a 9 French, polyurethane stability sheath that holds and secures the laser fiber during surgical use. The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.

AI/ML Overview

The provided text describes a medical device called the DuraLaze™ HoLEP Laser Fiber and its submission for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

However, based on the non-clinical testing section, we can infer the acceptance criteria and study type.

Here’s a breakdown of the requested information, where available and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. Instead, it lists the types of non-clinical tests performed, with an overarching statement that "The testing and assessments performed on the subject device meet all specified criteria." This implies that for each test listed, there were internal acceptance criteria (e.g., minimum energy transmission, maximum dimension deviation, acceptable bend radius, successful tensile strength, no aiming beam issues, packaging integrity, biological compatibility, successful sterilization).

Since the document confirms the device met these criteria, we can infer "Compliance" or "Met Criteria" as the reported device performance for each test.

Acceptance Criteria (Inferred from Test Name)	Reported Device Performance (Inferred)
Sufficient Fiber Energy Transmission	Met Criteria (Satisfactory)
Acceptable Fiber & Stability Sheath Interactions	Met Criteria (Satisfactory)
Fiber Dimensions within Specification	Met Criteria (Within Spec)
Fiber Bend Radius within Specification	Met Criteria (Satisfactory)
Distal Fiber Coated OD within Specification	Met Criteria (Within Spec)
Fiber Stability Sheath Dimensions and Functionality	Met Criteria (Satisfactory)
Sufficient Fiber Connector Strength	Met Criteria (Satisfactory)
Sufficient Connector Tensile Strength	Met Criteria (Satisfactory)
Correct Aiming Beam Functionality	Met Criteria (Satisfactory)
Packaging Integrity (per ISO 11607-1:2006)	Met Criteria (Satisfactory)
Biological Evaluation (per ISO 10993-1:2009)	Met Criteria (Biocompatible)
ETO Sterilization Validation (per ISO 11135-1:2007)	Met Criteria (Sterilized)

2. Sample Size Used for the Test Set and Data Provenance

The document states, "MedKey has conducted performance testing with samples aged at T=0 and T=1 year accelerated aging." It does not specify the individual sample sizes for each non-clinical test. This testing is typically performed in a laboratory setting, making the data provenance retrospective (lab-based bench testing), not human clinical data. The country of origin of the data is not specified but would presumably be the country where MedKey, LLC is based (USA, as indicated by the address: Bloomington, Indiana).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this submission. The tests are non-clinical, bench-top evaluations of the device's physical and functional properties, not diagnostic or interpretive tasks requiring expert consensus on a 'ground truth' in the way a clinical study would for a diagnostic AI device. The "ground truth" for these tests refers to established engineering specifications, industry standards (e.g., ISO), and material properties.

4. Adjudication Method for the Test Set

This is not applicable as the evaluations are objective measurements and validations against predetermined specifications/standards, not subjective assessments requiring expert 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI systems that assist human readers, not for a physical laser fiber.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (laser fiber), not an algorithm or AI software. The performance testing evaluates the physical and functional aspects of the fiber itself.

7. The type of ground truth used

The ground truth used for these non-clinical tests is based on engineering specifications, industry standards (e.g., ISO 11607-1:2006, ISO 10993-1:2009, ISO 11135-1:2007), and material science principles. For example, "Fiber Dimensions" would be compared against the designed dimensions, "Packaging integrity" against the requirements of ISO 11607-1, and "Biological evaluation" against the criteria of ISO 10993-1.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI or machine learning model that requires a training set. The "samples aged at T=0 and T=1 year accelerated aging" refer to test samples for validation, not a training set.

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

This is not applicable for the reasons stated above (not an AI/ML device, no training set).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

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

July 26, 2016

MedKey, LLC Babacar Diouf Catheter Research, Inc. 5610 W. 82nd Street Indianapolis, IN 46278

Re: K153124

Trade/Device Name: DuraLaze HoLEP 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: June 22, 2016 Received: June 23, 2016

Dear Babacar Diouf:

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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); 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 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.

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K153124

Device Name DuraLaze™ HoLEP Laser Fiber

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

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510(K) Summary

Applicant/Sponsor:	MedKey, LLC.2620 N. Walnut Street, Suite 1205Bloomington, Indiana 47404
Contact Person:	Babacar DioufVP of RA and QSCRI317-872-0074 x3512bdiouf@cri-devices.com
Date Prepared:	April 4th, 2016

Device Name:

Proprietary Name:	DuraLaze™ HoLEP Laser Fiber
Classification Name:	Powered Laser Surgical Instrument
Review Panel:	General and Plastic Surgery
Product Code:	GEX
Classification Regulation:	21 CFR 878.4810. Class II

Predicate Device (Legally Marketed Devices to Which Substantial Equivalence Is Claimed):

Proprietary Name:	Lumenis VersaPulse PowerSuite
Classification Name:	Powered Laser Surgical Instrument (and Accessories)
Review Panel:	General and Plastic Surgery and Dermatology
Product Code:	GEX
Classification Regulation:	21 CFR 878.4810. Class II
Premarket Notification:	K011703

Secondary Predicate (Used to Substantiate Technological Characteristics' Equivalency):

Proprietary Name:	AccuMax™
Classification Name:	Powered Laser Surgical Instrument
Review Panel:	General and Plastic Surgery and Dermatology
Product Code:	GEX
Classification Regulation:	21 CFR 878.4810. Class II
Premarket Notification:	K093691

Device Description:

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tip comes with a printed axial line that improves the surgeon's visibility by increasing the contrast between the fiber tip and the surrounding tissue. The DuraLaze™ HoLEP Laser Fiber is contained within a 9 French, polyurethane stability sheath that holds and secures the laser fiber during surgical use. The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.

Indications for use:

The DuraLaze™ HoLEP Laser Fiber is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH). The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use only. It is specifically designed for use with Ho:YAG laser systems, with requlatory clearance for surgical use and compatible with a standard SMA-905 connector.

Technological Characteristics:

The DuraLaze™ HoLEP Laser Fiber is substantially equivalent in technological characteristics and fundamental design to its predicates. The materials and dimensions of the subject device and its predicates are comparable with the exception of the fiber's stripped distal tip. The DuraLaze™ HoLEP Fiber distal tip is pre-stripped 10.0 cm to minimize potential of laser fiber damage caused by stripping the jacket during surgery, whereas the predicate device(s) fiber distal tip is pre-stripped 0.4 cm, which requires additional stripping during use. The subject device distal tip is also printed with an axial line that improves the surgeon's visibility.

Technological Characteristics	Primary Predicate DeviceName: Lumenis VersaPulsePowerSuite	Secondary Predicate DeviceName:AccuMax™	Proposed DeviceName: DuraLaze™ HoLEP LaserFiber
Energy Specifications
Energy type	Ho:YAG / ND:YAG laser energy	Ho:YAG laser energy	Ho:YAG laser energy
Max. Input Wattage	100 Watts - 550µm core fiber	100 Watts - 550µm core fiber	100 Watts - 550µm core fiber
Dimensional Specifications
Laser Fiber:
Core Size	550µm	550µm	550µm
Outside Diameter	780 µm	750 µm	750 µm
Working Length	2.5 m	2.6 m	2.6 m
Distal tip:ETFE jacket stripped length	0.4 cm	0.4 cm	10.0 cm
Sheath:
Sheath	Provided Separately	Provided Separately	Fiber is placed in sheath
Sheath OD	7 French	7 French	9 French
Sheath length	N/A	N/A	36 cm
Sheath Tip ID	N/A	N/A	0.030 in
Materials (Individual components)
Fiber Core	Silica	Silica	Silica
Fiber Jacket	Tetrafluoroethylene (ETFE)	Tetrafluoroethylene (ETFE)	Tetrafluoroethylene (ETFE)
Coating - Distal Fiber Tip	N/A	N/A	Acrylate coating: 10cm
Strain Relief - Laser Fiber to SMA-905Connector	Unknown Polymer	Sanoprene	Sanoprene
Sheath	Provided Separately	Provided Separately	Polyurethane tubing
Tuohy Borst Adapter for sheath	N/A	N/A	Fluoropolymer seal & Polycarbonatehousing
Laser Fiber Connector	SMA-905 Connector	SMA-905 Connector	SMA-905 Connector
Tip Marking	Not included	Not included	Marabou Ink, Axial 10cm distal line
Packaging Pouch	Tyvek Pouch	Tyvek Pouch	Tyvek Pouch

Reference the table below for details.

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Substantial Equivalence:

A direct comparison of key characteristics demonstrates that the DuraLaze™ HoLEP Laser Fiber is substantially equivalent to its predicates in terms of intended use, technological characteristics, and performance characteristics.

Non-Clinical Testing / Performance Testing (Bench Evaluation):

MedKey has conducted performance testing with samples aged at T=0 and T=1 year accelerated aging in support of the proposed laser device. The following testing was completed to evaluate the safety and effectiveness of the proposed device:

Fiber Enerqy Transmission .
Fiber & Stability Sheath Interactions ●
. Fiber Dimensions
. Fiber Bend Radius
Distal Fiber Coated OD
Fiber Stability Sheath Dimensions and Functionality
. Fiber Connector Strength
. Connector Tensile
Aiming Beam ●
. Packaging integrity Testing per ISO 11607-1:2006
Biological evaluation of medical devices per ISO10993-1:2009 ●
. ETO Sterilization validation per ISO 11135-1:2007

Conclusion:

The testing and assessments performed on the subject device meet all specified criteria. The results of the performance testing demonstrate that the DuraLaze™ HoLEP Laser Fiber is substantially equivalent to the predicate device.

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.