VERSACUT + TISSUE MORCELLATOR

K133272 · Lumenis, Ltd. · GCJ · May 13, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133272
• Device Name: VERSACUT + TISSUE MORCELLATOR
• Applicant: Lumenis, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VersaCut + Tissue Morcellator is a multiple-use electrosurgical cutting and aspiration system. System components include a control unit with aspiration pump, motor-driven handpiece, cutting blade sets, endoscope adapters, footswitch, and single-use aspiration/tissue collection accessories. Device is used by surgeons in OR settings during pelviscopic, laparoscopic, percutaneous, or open procedures. Surgeon operates handpiece and footswitch under direct or endoscopic visualization to morcellate and aspirate dissected soft tissue. System facilitates tissue removal through limited access sites. Modifications from predicate include an inverted handpiece design and a disposable tissue collector with a one-way valve to prevent reverse aspiration. Device is provided non-sterile; handpieces, blades, and adapters require cleaning and steam sterilization before use.

Clinical Evidence

Bench testing only. No clinical studies were conducted or deemed necessary to demonstrate safety and efficacy.

Technological Characteristics

Electrosurgical cutting and aspiration system. Components: control unit, motor-driven handpiece, cutting blades, endoscope adapters, footswitch. Materials: reusable, steam-sterilizable components. Standards: AAMI TIR30:2011, AAMI TIR12:2010, ISO 14971:2009, ISO 10993-1:2009, ISO 13485:2003, IEC 60601-1:2005, IEC 60601-1-2:2007, ANSI/AAMI/ISO 17665-1:2006.

Indications for Use

Indicated for morcellation and removal of dissected soft tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures where surgical 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

• VersaCut Tissue Morcellator system (K050639)

Submission Summary (Full Text)

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UMENIS®

### 510(K) SUMMARY

## MAY 1 3 2014

K133272

Page 1 of 5

VersaCut + Tissue Morcellator

### 510(k) Number K

| Applicant's Name: | Lumenis Ltd. |
|-------------------|--------------------------|
| | 6 Hakidma Street |
| | P.O.Box 240 |
| | Yokneam Industrial Park |
| | Yokneam, 2069204, ISRAEL |
| Tel: | [phone] |
| Fax: | [phone] |
| Contact Person: | Yoram Levy, Qsite |
| | 31 Haavoda St. |
| | Binyamina, Israel 30500 |

Tel [phone]

Fax [phone]

[e-mail]

| Common Name | Soft Tissue Morcellator and Accessories | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Trade Name: | VersaCut + Tissue Morcellator | |
| Device Type: | Soft Tissue Morcellator and Accessories | |
| Preparation Date: | October 20, 2013 | |
| Classification: | Regulatory Name: Endoscope and accessories<br>Product Code: GCJ<br>Regulation No: 21 CFR 876.1500<br>Class: II<br>Classification Panel: Gastroenterology Urology devices | |

Device Description:

2-1 VersaCut + Tissue Morcellator – Traditional 510k Notification

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# MENIS®

The VersaCut + Tissue Morcellator system is a multiple-use electrosurgical cutting and aspiration device that provides rapid and efficient morcellation and removal of dissected tissue under direct or endoscopic visualization. The cutting action of the VersaCut + Tissue Morcellator 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 is comprised of a main component as listed below:

- · Control unit with aspiration pump
- · Limited reuse, steam sterilizable handpieces (motor-body unit) with power cable
- · Limited reuse, steam sterilizable cutting blade sets
- · Reusable, steam sterilizable endoscope adapters
- · Drainage tube, single use
- · Reusable, multi-position, multi-staged footswitch with power cable
- · Sterile, single use aspiration tubing
- · Tissue collection kit components, single use
- · Reusable sterilization tray, including cleaning brushes

The VersaCut + Tissue Morcellator is provided cleaned and non sterile. Before use, the handpiece, blades set and the endoscope adapters are to be cleaned and sterilized.

#### Intended Use Statement:

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

VersaCut + Tissue Morcellator - Traditional 510k Notification

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# દાતારા

Substantial equivalence to the following predicate device is Predicate Devices: claimed:

| Device Name | 510k No | Date of Clearance |
|------------------------------------|---------|-------------------|
| VersaCut Tissue Morcellator system | K050639 | March 14, 2005 |

### Performance Standards

VersaCut + Tissue Morcellator was tested and complies with the following standards:

- AAMI TIR30:2011 A compendium. of processes, materials, . test methods, and acceptance criteria for cleaning reusable , medical devices;
- AAMI TIR12:2010 Designing, testing, and labeling reusable . medical devices for reprocessing in health care facilities: A guide for medical device manufacturers;
- ISO 14971-1:2009 Risk management for medical devices; ●
- . ISO 10993-1:2009 Biological Evaluation of Medical devices Part1: Evaluation and testing;
- ISO 13485:2003 Medical device- Quality management system-. Requirement for regulatory purpose;
- IEC 60601-1:2005 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential. performance Electromagnetic compatibility - Requirements and tests
- ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care . products - Moist Heat.

### 2-3 VersaCut + Tissue Morcellator - Traditional 510k Notification

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# NEWILE.

#### Performance Bench Testing

Performance testing demonstrated that the VersaCut + Tissue Morcellator is as safe and effective as the cleared predicate device.

### Summary of Pre-Clinical and clinical study

The safety and efficacy of the VersaCut + Tissue Morcellator was shown by performance bench testing.

Lumenis believes that clinical studies are not needed to claim safety and efficacy of the device

### Substantial Equivalence to Predicate Devices

The VersaCut + Tissue Morcellator is a modification of the Lumenis VersaCut Tissue Morcellator System (K050639).

The intended use of the VersaCut + Tissue Morcellator is identical to the intended use of its predicate.

Both the VersaCut + Tissue Morcellator and the FDA-cleared Lumenis VersaCut Tissue Morcellator System (K050639) are multiple-use electrosurgical cutting and aspiration device that provides rapid and efficient morcellation and removal of dissected soft tissue under direct or endoscopic visualization.

The structures, the materials and the dimensions of the VersaCut + Tissue Morcellator are identical to the predicate device.

The minor differences between the VersaCut + Tissue Morcellator and its predicate device are an addition of an Inverted Handpiece, addition of a disposable tissue collector container with a one way valve to prevent reverse direction aspiration and an additional warning and operating step in the Operation Manual (OP). These additions were done in order to avoid reverse direction aspiration. See the labeling section and the device Operator Manual (Attachment No. 2). Moreover, performance testing demonstrated that the VersaCut + Tissue

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Image /page/4/Picture/1 description: The image shows the word "LUMENIS" in a bold, sans-serif font. To the left of the word is a stylized letter "L" that is also in bold. A small registration mark is located to the right of the word.

Morcellator is as safe and effective as the predicate device. Thus, the VersaCut + Tissue Morcellator is substantially equivalent to Lumenis VersaCut Tissue Morcellator System (K050639).

2-5 VersaCut + Tissue Morcellator – Traditional 510k Notification

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 13, 2014

Lumenis Ltd. % Mr. Yoram Levy Mr. Yoram Levy, Qsite 31 Haavoda Street Binyamina, Israel 30500

Re: K133272

Trade/Device Name: Versacut + Tissue Morcellator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 19, 2014 Received: April 2, 2014

Dear Mr. Levy:

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 for associated an the 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 r ou may, merels 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 that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I carates and 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Yoram Levy

forth.in the quality systems (OS) 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/ResourcesforYou/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,

### David Krause -S

for

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

Enclosure

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### INDICATIONS FOR USE STATEMENT

K133272 510(k) Number (if known):

Device Name:

VersaCut + Tissue Morcellator

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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