MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

K100559 · Interlace Medical, Inc. · HIH · Mar 30, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100559
• Device Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Applicant: Interlace Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Mar 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MyoSure™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

Device Story

MyoSure Hysteroscopic Tissue Removal System; electromechanical tissue morcellator for intrauterine procedures. System comprises control unit, foot pedal, and sterile single-use tissue removal device. Control unit motor drives rotating/reciprocating cutter blade (2.5 mm OD) within outer tube (3 mm OD). Vacuum source aspirates resected tissue through side-facing cutting window; transported to tissue trap/canister. Used in clinical setting by gynecologists; compatible with standard fluid management systems and hysteroscopes with 3 mm working channel. Firmware-controlled motor activation via foot pedal. Enables precise tissue resection; benefits include efficient removal of submucous myomas and endometrial polyps during hysteroscopy.

Clinical Evidence

Bench testing only. In-vitro testing demonstrated performance equivalence to the predicate device. Biocompatibility testing conducted per ISO 10993-1. Electrical safety and EMC standards met.

Technological Characteristics

Electromechanical morcellator; rotating/reciprocating cutter blade (2.5 mm OD) in 3 mm OD tube. Powered by electric motor in control unit. Firmware-based motor control. Biocompatible materials per ISO 10993-1. Sterile, single-use tissue removal device. Vacuum-assisted aspiration. Compatible with standard fluid management systems.

Indications for Use

Indicated for hysteroscopic intrauterine tissue resection and removal, including submucous myomas and endometrial polyps, in patients requiring such procedures by a trained gynecologist.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• MyoSure™ Hysteroscopic Tissue Removal System (K091100)

Submission Summary (Full Text)

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Interlace Medical Inc.

K100559

#### 510(k) SUMMARY 5.

#### Submitter: 1.

Interlace Medical Inc. 135 Newbury St Framingham, MA 01701 Telephone: [phone], ext. 112 MAR 3 0 2010

Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: February 26, 2010

#### 2. Device:

Trade Name: MyoSure™ Hysteroscopic Tissue Removal System Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II

#### Predicate Device: 3.

MyoSure™ Hysteroscopic Tissue Removal System (K091100)

### Device Description: 4.

The modified MyoSure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate MyoSure System:

- MyoSure Control Unit O
- MyoSure Tissue Removal Device o
- MyoSure Foot Pedal o

The MyoSure Control Unit contains an electric motor and software controller that drives the MyoSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSure Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSure Tissue Removal Device features a rotating/reciprocating (2.5 mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter-blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. 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 MyoSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.

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#### 5. Intended Use:

The MyoSure™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

## Comparison of Characteristics: 6.

The modified MyoSure Hysteroscopic Tissue Removal System's intended use and indicated use are identical to that of the predicate MyoSure Hysteroscopic Tissue Removal System, K091100.

The principles of operation and primary functional specifications of the modified MyoSure Hysteroscopic Tissue Removal System are identical to those of the predicate MyoSure Hysteroscopic Tissue Removal System.

The primary functional components of the modified MyoSure Hysteroscopic Tissue Removal System are identical to those of the predicate MyoSure Hysteroscopic Tissue Removal System, i.e.:

- each system employs a sterile, single use, Tissue Removal Device . (disposable straight surgical morcellator),
- a Foot Pedal controls activation and deactivation of a motor in the . Control Unit which powers the morcellator in both systems,
- the modified MyoSure cutter rotates and reciprocates at a fixed rate ● that is identical to the predicate device, and
- the modified MyoSure cutter blade tip design is identical to that of the . predicate device, and

The modified MyoSure Hysteroscopic Tissue Removal System is different · from the predicate MyoSure Hysteroscopic Tissue Removal System as follows:

- The modified MyoSure Control Unit's motor control software has been o changed to firmware and the controller component has been modified accordingly.
- The maximum running current limit and current limit has been decreased o in the modified MyoSure device.
- The modified MyoSure Tissue Removal Device morcellator's cutting tube O outer surface is now coated with a different material than was used in the predicate device.
- An O ring in the predicate device's fluid path has been changed to a o different material in the modified MyoSure™ Hysteroscopic Tissue Removal System.

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- The modified MyoSure™ Hysteroscopic Tissue Removal System utilizes o a lubricant on the device's gear mechanism and O ring while the predicate MyoSure device had no gear lubrication.
# Performance Testing: 7.

The modified MyoSure Hysteroscopic Tissue Removal System meets electrical safety and EMC standards. New patient contact materials in the modified MyoSure device meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. In addition, in-vitro testing demonstrated that the modified MyoSure device's performance is equivalent to the predicate MyoSure device.

## 8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the modified MyoSure Hysteroscopic 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.

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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 features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

Mr. John Vozella V.P. Clinical and Regulatory Affairs Interlace Medical, Inc. 135 Newbury Street FRAMINGHAM MA 01701

MAR 3 0 2010

Re: K100559

> Trade Name: MyoSure Hysteroscopic Tissue Removal System Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: February 26, 2010 Received: March 1, 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 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

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Interlace Medical Inc.

# 4. INDICATIONS FOR USE STATEMENT

KI00559 510(k) Number (if known):

Device Name: MyoSURE™ Hysteroscopic Tissue Removal System

Indications For Use:

The MyoSURE™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

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)

(Division Stan-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

CONFIDENTIAL