MEGAPULSE LASER SYSTEM AND FIBERS

K090776 · Richard Wolf Medical Instruments Corp. · GEX · Jun 2, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090776
• Device Name: MEGAPULSE LASER SYSTEM AND FIBERS
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stone, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.

Device Story

MegaPulse Laser System is a Holmium YAG laser (approx. 2080 nm) with integrated cooling and fiber delivery system. Device inputs include user-selected parameters via touch screen; system utilizes automated fiber recognition to ensure parameter safety. Laser energy is delivered via single-use fiberoptic waveguides using total internal reflection to the surgical site. Used in OR/clinic settings by physicians for tissue cutting, ablation, and lithotripsy. System monitors essential functions and components; provides visual/audible warnings for faults. Output is laser energy for surgical intervention; clinical benefit includes efficient treatment with minimal adjacent tissue stress.

Clinical Evidence

No clinical data was required to confirm safety and effectiveness. Bench testing of specifications and software validation were performed to verify safe operation and control of software functions.

Technological Characteristics

Holmium YAG laser (2080 nm); Class 4 laser. Includes integrated cooling unit, touch screen display, and automated fiber recognition system. Laser energy delivered via glass fiberoptic waveguides. Single-use sterile fibers. Software-controlled monitoring of system parameters.

Indications for Use

Indicated for surgical procedures including open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, colonscopic) applications for tissue ablation, vaporization, excision, incision, coagulation, and lithotripsy in urology, pulmonology, arthroscopy, gastroenterology, gynecology, ENT, orthopedics, discectomy, and general surgery. Must be used by trained medical personnel.

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

• Dornier Medilas H Laser (K001243)
• Trimedyne OmniPulse Models 1210, 1210-VHP, and 1500-A (K002308)
• AURIGA (K051399)
• Dornier Medilas H Laser Fiber Cables (K022544)
• Megabeam Fiber Optic Delivery System (K943445)
• Resposable Holmium Bare Fibers (K973172)

Submission Summary (Full Text)

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# 510(k) Summary

:

K090776

| Submitter: | |
|--------------------------------|------------------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Ron Haselhorst |
| Contact title: | Quality Assurance / Regulatory Affairs Manager |

| Date of Preparation: | March 11, 2009 |
|----------------------------------------|----------------|
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | [phone] |
| FAX number (include area code): | [phone] |

Product Information: (Base)

| Trade name: | MegaPulse Laser System |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Model number: | 2285011 |
| Common name: | Laser Instrument, Surgical, Powered |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and in dermatology, Class II. (21 CFR 878.4810, Product Code GEX) |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|---------------------------------------------------------|------------------------------|
| 1 K001243 | 1 Dornier Medilas H Laser | 1 Dornier |
| 2 K002308 | 2 Trimedyne OmniPulse Models 1210, 1210-VHP, and 1500-A | 2 Trimedyne, Inc. |
| 3 K051399 | 3 AURIGA | 3 WaveLight Laser Tech., AG. |

Product Information: (Laser Fibers)

| Trade name: | MegaPulse Laser Fibers |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model number: | 48750.xxx |
| Common name: | Laser Fibers, Single Use |
| Classification name: | Laser fibers have not been specifically classified by FDA. Laser fibers are an accessory to Laser-Powered Instruments. Class II. (21 CFR 878.4810, Product Code GEX) |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|-----------------------------------------|--------------------------------------|
| K022544 | 1. Dornier Medilas H Laser Fiber Cables | 1. Dornier MedTech America, Inc. |
| K943445 | 2. Megabeam Fiber Optic Delivery System | 2. Ceramoptec, Inc. (Biolitec, Inc.) |
| K973172 | 3. Resposable Holmium Bare Fibers | 3. Trimedyne, Inc. |

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#### Device Description:

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is comprised of a Holmium YAG laser base unit with integrated cooling unit and system specific laser fibers.

The laser system base contains the switching elements and interfaces, the display unit, the fiber connection point, components inside the laser system, and software. For a safe operation, essential functions and components are monitored automatically. The MegaPulse Laser system is designed with automated fiber recognition to ensure only permissible parameters are used. A warning message appears on the touch screen monitor and is accompanied by a signal should a fault or error occur.

The MegaPulse Laser Fibers are intended to be used in with MegaPulse Laser System to deliver laser energy. The laser fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to provide access to the surgical procedure site. The laser fiber works on the principle of internal reflection. Laser energy is focused into the fiber at the proximal end and it travels the length of the fiber by means of total reflection. The fiber contains the laser beam and channels the laser energy from the proximal end of the fiber to its distal end. The laser fibers are single-use sterile packaged. They are similar if not equivalent in design and performance to other legally marketed laser fibers with an integrated fiber identification system designed to work only with the MegaPulse laser system base.

#### Intended Use:

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stone, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.

#### Indications and Field of Use:

The MegaPulse 2285 is a Class 4 laser emitting laser radiation at a wavelength of approx. 2080 nm. This particular wavelength is transmitted by a fiberoptic wave guide (glassfiber) allowing efficient treatment in conjunction with the application - related preselected parameters with at the same time minimum stress for the adjacent tissue.

This device must only be used by adequately qualified and trained medical personnel.

These indications and field of use are equivalent if not identical to the named predicate devices.

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## Technological Characteristics:

The Richard Wolf MegaPulse Laser System and its predicate devices may have minor differences in the technological characteristics; however, those differences do not raise new questions of safety or efficacy. Thus the Richard Wolf Medical Instruments Corporation MegaPulse Laser System is substantially equivalent to the predicate devices in terms of technological characteristics.

#### Performance Data:

Bench testing of specifications were verified and validated and software validation was performed to assure safe and effective operation / control of software functions. The Richard Wolf MegaPulse Laser System meets the same safety standards as the named predicate devices.

#### Clinical Data:

No clinical data was required to confirm safety and effectiveness.

# Rational for Substantial Equivalence:

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System laser fibers perform the same function, have basically the same material composition and are substantially equivalent to the lasers fiber delivery systems cleared for Dornier MedTech. America, Inc. (K022544), Biolitec Inc. (K943445), and Trimedyne (K973172).

The Richard Wolf Medical Instruments Corporation MegaPulse Laser base shares the same general indications for use and has similar functional features and technological characteristics as the named predicate devices. These minor differences do not raise new questions of safety or efficacy. For these reasons The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is substantially equivalent to the existing 510(k) cleared devices sold by: Dornier (K001243), Wavelight Laser Technologies (K051399), and Trimedyne (K002308).

Thus the Richard Wolf Medical Instruments Corporation MegaPulse Laser System is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

JUN - 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard Wolf Medical Instruments Corporation ' % Mr. Ron Haselhorst Quality Assurance/Regulatory Affairs Manager 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K090776

Trade/Device Name; MegaPulse Laser System 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: March 11, 2009 Received: March 23, 2009

Dear Mr. Haselhorst:

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 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

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Page 2- Mr. Ron Haselhorst

(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 go to http://www.fda.gov/cdrh/comp/ 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 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/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 " Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

# 510(k) Number (if known): K 090776.

#### Device Name: MegaPulse Laser System

#### Intended Use:

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stones, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as: Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.

Prescription use (Part 21 CFR 801 Subpart D)

and / or

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ANOTHER PAGE IF NEEDED

currence of CDHR office of Device Evaluation (ODE)

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090776

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