LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM

K050639 · Lumenis, Inc. · GCJ · Mar 31, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050639
• Device Name: LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
• Applicant: Lumenis, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lumenis VersaCut™ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

Device Story

VersaCut™ Tissue Morcellator System is an electrosurgical cutting and aspiration device for tissue removal. System components include a motor-driven handpiece, reciprocating cutting blade sets, endoscope adapters, aspiration pump-control unit, and footswitch. Device is used in OR settings by surgeons during pelviscopic, laparoscopic, percutaneous, or open procedures. Surgeon operates device under direct or endoscopic visualization to morcellate and aspirate tissue. Reciprocating blade action cuts tissue, which is then removed via aspiration. System facilitates tissue removal through limited access sites, potentially reducing procedure time and invasiveness. Device is provided non-sterile; requires enzymatic cleaning and steam sterilization before use.

Clinical Evidence

Bench testing only. In vitro physical testing conducted to demonstrate performance against product specifications. Biocompatibility testing performed for materials with direct or limited/indirect patient contact.

Technological Characteristics

Electrosurgical cutting and aspiration system. Components: motor-driven handpiece, reciprocating cutting blades, endoscope adapters, aspiration pump, footswitch. Materials: biocompatible materials for patient contact. Sterilization: steam sterilization for reusable components (handpiece, blades, adapters). Connectivity: none (standalone).

Indications for Use

Indicated for morcellation and removal of dissected tissue in patients undergoing pelviscopic, laparoscopic, percutaneous, or open surgical procedures where surgical site access is limited.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Coherent Tissue Morcellator Kit (K980079)

Submission Summary (Full Text)

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## 510(k) Summary for the Lumenis VersaCut™ Tissue Morcellator System

The 510(k) Summary is submitted in accordance with 21 CFR §807.92.

Submitters Name: Lumenis, Inc.

Submitters Address: 2400) Condensa Street Santa Clara. CA 95051

Telephone: [phone] TeleFAX: 408-764-3934

Contact Person: Martha Murari, Ph.D.

Date Prepared: March 11, 2005

Device Trade Name: Lumenis VersaCut™ Tissue Morcellator System

Device Common Name: Soft Tissue Morcellator and Accessories

Device Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories

Device Classification: Class II

Predicate Devices: Coherent Tissue Morcellator Kit (K980079, concurred April 9, 1998)

#### Device Description:

The VersaCut™ Tissue Morcellator System is a multiple-use clectrosurgical cutting and aspiration device that is intended for the morcellation and removal of dissected tissue under direct or endoscopic visualization. The cutting action of the VersaCut™ Tissue Morcellator System is driven by the motor in the handpiece and the treatment site is accessed through the sheath of a nephroscope using the endoscope adapter as needed to keep the cutting blades in the field of view. The VersaCut™ Tissue Morcellator System is comprised of main components as listed below. These main components are available separately when replacements are needed.

- Reusable, steam sterilizable handpiece (motor-body unit) with power cable .
- Limited reuse, steam sterilizable cutting blade sets .
- Reusable, steam sterilizable endoscope adapters .
- Reusable aspiration pump-control unit combination with main power cable and fuses �
- Reusable, multi-position, multi-staged footswitch with power cable .
- Sterile, single use aspiration tubing ◆
- Reusable sterilization tray, including cleaning brushes .

The VersaCut™ Tissue Morcellator System is provided as a production-cleaned, non-sterile device. Before use in a sterile procedure, the handpiece, blade set(s), and endoscope adapter(s) are to be enzymatically-cleaned and steam-sterilized. Sterile aspiration tubing is provided with the device.

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050639 2/2

### Indications for Use:

The Lumenis VersaCut™ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic. laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

#### Rationale for Substantial Equivalence:

The VersaCut™ Tissue Morcellator System has the same intended use / indications for use and same operating principle and technology (no change to the reciprocating as the operational mode for the cutting blades) as the predicate device, Tissue Morcellator Kit. In addition, the devices have similar design features, components, and materials.

### Safety and Effectiveness Information:

Physical testing was conducted to demonstrate performance of the Lumenis VersaCut™ Tissue Morcellator System in accordance with product specifications. Component materials intended for direct patient contact or having the potential for limited/indirect contact were demonstrated to have acceptable biocompatibility. Sterilization was repeated to support the modifications described.

### Conclusion:

The VersaCut™ Tissue Morcellator System as modified by changes submitted is substantially equivalent to the predicate device, Tissue Morcellator Kit (K980079, concurred April 9, 1998). The devices have the same intended use / indications for use, same operating principle, and technology. The devices have similar design features, components, and materials. Results of in vitro bench testing demonstrate acceptable performance characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is composed of three wavy lines.

Public Health Service

MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Martha Murari, Ph.D. Senior Regulatory Affairs Associate Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051

Rc: K050639

Trade/Device Name: VersaCut™ Tissue Morcellator System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 11, 2005 Received: March 14, 2005

Dear Dr. Murari:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and have acterimes ally marketed predicate devices marketed in interstate for use stated in the enclosate) to regary the Medical Device Amendments. Or to conninered processified in accordance with the provisions of the Federal Food. IDug. devices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelove, mains of the Act include requirements for annual registration, listing of general controls profitering 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to subject to basil 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 I Tease of advised that 1977 brainn that your device complies with other requirements of the Act that + 27 the Internations administered by other Federal agencies. You must or any I ederal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cl K Part 8077, laboring (21 OFR Part 820); and if applicable, the electronic form in the quant) Byticles (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Martha Murari, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to organ maintial equivalence of your device to a legally prematics notheadon: The PDF intelligstification 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 If you desire specific arrive 101 Jour as 1040) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoranuing by reference to premainterial international the Act from the Division of Small other general information on your response 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,

Stypt Rhodes

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K CSC6.39

Device Name: Lumenis VersaCut™ Tissue Morcellator

Indications for Use:

The Lumenis VersaCut™ Tissue Morcellator System is intended for use under direct or endossopic visualization for the morcellation and removal of dissccted tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 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)

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