DuraLazeTM HoLEP Laser Fiber

K153124 · Medkey, LLC · GEX · Jul 26, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153124
• Device Name: DuraLazeTM HoLEP Laser Fiber
• Applicant: Medkey, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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 regulatory clearance for surgical use and compatible with a standard SMA-905 connector.

Device Story

DuraLaze HoLEP Laser Fiber is a straight-fire fiber optic device for laser energy delivery during endoscopic prostate surgery. It consists of a 550µm silica core with ETFE jacket, housed in a 9 French polyurethane stability sheath. The distal 10 cm is pre-stripped and coated to prevent damage during use and features a printed axial line for improved visibility. The device connects to standard Ho:YAG laser systems via an SMA-905 connector. Used by surgeons in an operating room setting, the fiber delivers laser energy to target prostate tissue. The pre-stripped tip and axial marking facilitate easier setup and enhanced visualization for the surgeon, potentially reducing procedural time and fiber damage. The device is single-use and ETO sterilized.

Clinical Evidence

Bench testing only. Testing included fiber energy transmission, fiber/sheath interactions, dimensions, bend radius, connector strength, aiming beam, packaging integrity (ISO 11607-1:2006), biological evaluation (ISO 10993-1:2009), and ETO sterilization validation (ISO 11135-1:2007). Samples were tested at T=0 and T=1 year accelerated aging. All results met specified criteria.

Technological Characteristics

550µm silica core fiber with ETFE jacket; 9 French polyurethane stability sheath; SMA-905 connector; distal 10cm acrylate coating; Marabou ink axial tip marking. Energy source: Ho:YAG laser (up to 100W). Single-use, ETO sterilized.

Indications for Use

Indicated for patients with benign prostatic hyperplasia (BPH) requiring laser-enabled endoscopic surgery for prostate tissue enucleation, vaporization, hemostasis, or excision.

Regulatory Classification

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.

Predicate Devices

• Lumenis VersaPulse PowerSuite (K011703)
• AccuMax (K093691)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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## 510(K) Summary

| Applicant/Sponsor: | MedKey, LLC.<br>2620 N. Walnut Street, Suite 1205<br>Bloomington, Indiana 47404 |
|--------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Babacar Diouf<br>VP of RA and QS<br>CRI<br>317-872-0074 x3512<br>[e-mail] |
| 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:

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

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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 Device<br>Name: Lumenis VersaPulse<br>PowerSuite | Secondary Predicate Device<br>Name:<br>AccuMax™ | Proposed Device<br>Name: DuraLaze™ HoLEP Laser<br>Fiber |
|-----------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------|
| 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-905<br>Connector | Unknown Polymer | Sanoprene | Sanoprene |
| Sheath | Provided Separately | Provided Separately | Polyurethane tubing |
| Tuohy Borst Adapter for sheath | N/A | N/A | Fluoropolymer seal & Polycarbonate<br>housing |
| 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.