SURGISURE TISSUE REMOVAL SYSTEM

K103741 · Interlace Medical, Inc. · GCJ · Mar 2, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103741
• Device Name: SURGISURE TISSUE REMOVAL SYSTEM
• Applicant: Interlace Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SurgiSure™ Tissue Removal 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

SurgiSure Tissue Removal System consists of a control unit, foot pedal, and tissue removal device. Device functions as a tissue morcellator for use during surgery under direct or endoscopic visualization. Input: physical tissue at surgical site. Operation: electric motor in control unit drives a rotating/reciprocating inner cutter blade (2mm OD) encased in a stationary outer tube (3mm OD). Vacuum source aspirates resected tissue through a side-facing cutting window in the outer tube into a collection canister. Operated by surgeon via foot pedal. Output: physical removal of tissue from operative site. Benefits: facilitates tissue removal in procedures with limited access. Healthcare provider uses device to clear surgical site; output directly affects surgical progress by enabling tissue extraction.

Clinical Evidence

Bench testing only. In-vitro testing demonstrated performance equivalent to the predicate VersaCut device. Biocompatibility testing performed per ISO 10993-1. Electrical safety and EMC testing conducted.

Technological Characteristics

System includes control unit with electric motor, foot pedal, and disposable morcellator. Morcellator features rotating/reciprocating inner cutter (2mm OD) within stationary outer tube (3mm OD) with side-facing cutting window. Vacuum-assisted aspiration. Biocompatibility per ISO 10993-1. Electrical safety/EMC compliant. Firmware-based motor control.

Indications for Use

Indicated for morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures with limited access to the surgical site.

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

• MyoSure™ Hysteroscopic Tissue Removal System (K091100 & K100559)
• VersaCut™ Tissue Morcellator System (K050639)

Submission Summary (Full Text)

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## MAR - 2 2011

#### 5. 510(k) SUMMARY

#### 1. Submitter:

Interlace Medical Inc. 135 Newbury St Framingham, MA 01701 Telephone: [phone], ext. 112

Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: December 17, 2010

#### 2. Device:

Trade Name: SurgiSure™ Tissue Removal System Common Name: Endoscope and accessories Classification Name: Endoscope and accessories Class: II

#### Predicate Device: 3.

MyoSure™ Hysteroscopic Tissue Removal System (K091100 & K100559). VersaCut™ Tissue Morcellator System (K050639)

#### Device Description: 4.

The SurgiSure™ Hysteroscopic Tissue Removal System consists of the following procedural components:

- SurgiSure™ Tissue Removal Device o
- SurgiSure™ Control Unit o
- SurgiSure™ Foot Pedal O

The SurgiSure™ Control Unit contains an electric motor and firmware motor controller that drives the SurgiSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the SurgiSure Foot Pedal. The SurgiSure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The SurgiSure Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube. The device's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the SurgiSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The SurgiSure Tissue Removal System is compatible with commercially available fluid management systems and may be used with endoscopes that have a straight ≥3 mm working channel.

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#### 5. Intended Use:

The SurgiSure™ Tissue Removal 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.

k 103741

#### 6. Comparison of Characteristics:

The principles of operation and primary functional specifications of the SurgiSure™ Tissue Removal System are identical to those of the predicate MyoSure™ Hysteroscopic Tissue Removal System, K091100 & K100559 and similar to those of the predicate VersaCut™ Morcellator System, K050639. Each device employs a sterile, straight surgical morcellator for tissue removal. A foot pedal controls activation and deactivation of the motor which powers the morcellator in all three devices. All three devices access the target treatment site through a sheath or endoscope with a straight working channel and all devices simultaneously morcellate and aspirate tissue from the operative site.

The SurgiSure™ morcellator is identical to the predicate MyoSure™ morcellator in that it consists of a single use, disposable rotating and reciprocating inner tube or cutter that is totally contained within a stationary outer tube and has a vacuum tube fitting at its proximal end to enable aspiration of resected tissue. The SurgiSure inner tube or cutter rotates and reciprocates at a fixed rate that is identical to the predicate MyoSure device. The SurgiSure cutter blade tip design is identical to that of the predicate MyoSure device and the outer tube design of both devices incorporates a side-facing "cutting window" through which targeted tissue is pulled, cut, and moved back through the inner tube to a collection canister.

The SurgiSure™ Tissue Removal System's intended use is identical to that of the predicate VersaCut™ Morcellator System and similar to that of the predicate MyoSure Hysteroscopic Tissue Removal System.

The SurgiSure™ Tissue Removal System is different from the predicate MyoSure™ Hysteroscopic Tissue Removal System and VersaCut Morcellator System as follows:

- The SurgiSure Control Unit's electric motor, motor control firmware and o electronic circuitry components are identical to those found in the predicate MyoSure device, but are different from those found in the VersaCut device.
- The SurgiSure Tissue Removal Device is dimensionally identical to the o predicate MyoSure device except that it is longer than the MyoSure device to facilitate access of the cutter blade to target tissue. The SurgiSure Tissue Removal Device is smaller in diameter and lighter than the predicate VersaCut Morcellator System.

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- Instructions for use for the SurgiSure™ Tissue Removal System have o been changed from the predicate MyoSure™ Hysteroscopic Tissue Removal System instructions for use to reflect the SurgiSure device's intended use.
k 10274

- Because the SurgiSure Tissue Removal Device is smaller in diameter than o the predicate VersaCut Morcellator System, it's tissue cutting rate is similar to but slightly slower than the VersaCut Morcellator System.
#### 7. Performance Testing:

The SurgiSure™ Tissue Removal System meets electrical safety and EMC standards. Patient contact materials in the SurgiSure device meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. In addition, in-vitro testing demonstrated that the SurgiSure™ Tissue Removal System performs equivalent to the predicate VersaCut™ device.

#### 8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the SurgiSure™ Tissue Removal System has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicate MyoSure™ Hysteroscopic Tissue Removal System and VersaCut™ Morcellator System.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

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

Interlace Medical, Inc. % Mr. John J. Vozella Vice President, Clinical & Regulatory Affairs 135 Newbury Street Framingham, Massachusetts 01701

MAR - 2 2511

Re: K103741

Trade/Device Name: SurgiSure™ Tissue Removal System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 22, 2010 Received: December 23, 2010

Dear Mr. Vozella:

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

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### Page 2 - Mr. John J. Vozella

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 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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Az. B. nh

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Interlace Medical Inc.

# 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k | v 374 |

Device Name: SurgiSure™ Tissue Removal System

Indications For Use:

The SurgiSure™ Tissue Removal 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.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K103741

CONFIDENTIAL