COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES

K980079 · Lumenis, Inc. · GCJ · Apr 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980079
• Device Name: COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
• Applicant: Lumenis, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coherent Tissue Morcellator Kit 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

The Coherent Tissue Morcellator Kit is a surgical instrument system used for tissue morcellation and removal. It consists of a handpiece, cutting blade sets, an aspiration pump, a variable speed control unit, and a footswitch. The device is used by surgeons during pelviscopic, laparoscopic, percutaneous, and open surgical procedures to facilitate tissue removal through limited access sites under direct or endoscopic visualization. The system operates via a motor-driven handpiece that powers the cutting blades to morcellate tissue, while the aspiration pump assists in the removal of the morcellated material. The surgeon controls the speed of the device via the control unit and footswitch. The device is provided non-sterile (handpiece/drive units) or as sterile/non-sterile components (blades), requiring sterilization before use. By enabling efficient tissue removal through small incisions, the device reduces the need for larger surgical openings, potentially minimizing patient trauma and recovery time.

Clinical Evidence

Bench testing only. Physical testing was conducted to demonstrate performance in accordance with product specifications. Biocompatibility testing was performed on component materials with expected or potential patient contact.

Technological Characteristics

System includes a motor-driven handpiece, variable speed control unit, aspiration pump, footswitch, and cutting blade sets. Components are designed for sterilization. Materials were tested for biocompatibility. The device is an electrosurgical-style mechanical morcellator used under endoscopic or direct visualization.

Indications for Use

Indicated for patients undergoing pelviscopic, laparoscopic, percutaneous, or open surgical procedures requiring morcellation and removal of dissected tissue 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

• Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939)
• Lasersonics Tissue Morcellator Set manufactured by Heraeus Surgical, Inc. (K935604)

Submission Summary (Full Text)

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g80079

# Attachment 14 510(k) Summary Statement for the Coherent Tissue Morcellator Kit

APR - 9 1998

#### I. General Information

| Submitter: | Coherent Medical Group |
|------------|-------------------------|
| | 3270 West Bayshore Road |
| | Palo Alto, CA 94303 |

Contact Person: Anne C. Worden V

> January 8, 1998 Summary Preparation Date:

#### II. Names

Coherent Tissue Morcellator Kit > Device Names:

Primary Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories

#### III. Predicate Devices

- · Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939)
- · Lasersonics Tissue Morcellator Set manufactured by Heraeus Surgical, Inc. (K935604)

## IV. Product Description

The Coherent Tissue Morcellator Kit 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.

Coherent Tissue Morcellator Kits are comprised of the following main components:

- · a Morcellator handpiece;
- · a variety of cutting blade sets;
- · an aspiration pump;
- · a variable speed control unit;
- · a footswitch;
- · a sterilization tray

The Coherent Morcellator Handpiece/Drive Units are provided as non-sterile, ready to be sterilized devices. The Cutting Blade Sets are provided either as sterile, single-use items, or as non-sterile, limited reuse, ready to be sterilized items. An optional sterilization tray may be used to sterilize the Morcellator Handpiece/Drive Units and the limited reuse cutting blade sets.

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#### V. Indications for Use

The Coherent Tissue Morcellator Kit 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 VI.

The Coherent Tissue Morcellator Kit shares the same indications for use, and therefore is substantially equivalent to both the Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939) and the Lasersonics Tissue Morcellator Set manufactured by Heraeus Surgical, Inc. (K935604). In addition the Coherent Tissue Morcellator Kit shares similar design features, components and materials as the Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939).

# VII. Safety and Effectiveness Information

Physical testing was conducted to demonstrate performance of the Coherent Tissue Morcellator Kit in accordance with product specifications. The component materials with expected and potential patient contact were tested to demonstrate acceptable biocompatibility. Cleaning and sterilization will be conducted prior to commercial distribution.

## VIII. Conclusion

The Coherent Tissue Morcellator Kit was found to be substantially equivalent to the Tissue Morcellator marketed by Cook Urological/Cook OB/GYN, Inc. (K925851 and K910939) and to the Lasersonics Tissue Morcellator Set manufactured by Heraeus Surgical, Inc. (K935604). The Coherent Tissue Morcellator Kit shares the same indications for use as the predicate Cook and Lasersonics tissue morcellators. In addition, the Coherent Tissue Morcellator shares similar design features, and similar functional features as the currently marketed Cook Tissue Morcellator. Physical and biocompatibility test results demonstrated that the Coherent Tissue Morcellator Kit has acceptable performance characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the emblem. The logo is simple, clean, and uses a monochromatic color scheme.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Anne C. Worden ·Senior Manager, Regulatory Affairs Coherent Medical Group 3270 West Bayshore Road Palo Alto, California 94303

APR - 9 1998

K980079 Re : Coherent Tissue Morcellator Kit Regulatory Class: II Product Code: GCJ Dated: January 8, 1998 Received: January 9, 1998

Dear Ms. Worden:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with =============================================================================================================== the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Anne C. Worden

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment 2 Indications For Use Statement as Requested by FDA

510(k) Number (if Known): k980079

Device Name : Coherent Tissue Morcellator Kit

Indications For Use:

The Coherent Tissue Morcellator Kit 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

coQlo

Prescription Use (Per 21 CFR 801.10

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

510(k) Submission: Coherent Tissue Morcellator Kit

Attachment 2 - Page 1