MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

K091100 · Interlace Medical, Inc. · HIH · Oct 23, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K091100
• Device Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Applicant: Interlace Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Traditional
• 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; consists of control unit, tissue removal device (morcellator), and foot pedal. Used by gynecologists during hysteroscopic intrauterine procedures. Device inputs: mechanical activation via foot pedal. Operation: electric motor in control unit drives rotating/reciprocating cutter blade within stationary outer tube via flexible drive cable; side-facing window aspirates resected tissue via vacuum source to collection canister. Output: physical removal of intrauterine tissue (myomas, polyps). Benefits: ergonomic handpiece, disposable design, efficient tissue resection. Clinical decision-making: enables minimally invasive removal of intrauterine pathology.

Clinical Evidence

Bench testing only. In-vitro testing demonstrated performance equivalent to or better than the predicate Interlace Morcellator. Electrical safety and EMC standards met. Biocompatibility of new patient-contact materials confirmed per ISO 10993-1.

Technological Characteristics

System includes control unit with electric motor and software controller, foot pedal, and disposable morcellator. Morcellator features 2mm OD rotating/reciprocating cutter inside 3mm OD outer tube. Outer tube coated with Titanium Nitride (TiN). Connectivity: compatible with standard fluid management systems and hysteroscopes with 3mm working channel. Power: electric motor. Sterilization: disposable device. Software: motor control.

Indications for Use

Indicated for hysteroscopic intrauterine tissue resection and removal, including submucous myomas and endometrial polyps, in patients undergoing gynecological procedures.

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

• Interlace Medical Hysteroscopic Morcellation System (K073690)
• Gynecare Morcellex Tissue Morcellator (K061050)

Submission Summary (Full Text)

{0}------------------------------------------------

Interlace Medical Inc.

# 5. 510(k) SUMMARY

OCT 2 3 2009

#### Submitter: 1.

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

Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: March 30, 2009

#### 2. Device:

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

### Predicate Device: 3.

Interlace Medical Hysteroscopic Morcellation System (K073690) Gynecare Morcellex Tissue Morcellator (K061050)

### 4. Device Description:

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

- MyoSURE Control Unit O
- 0 MyoSURE Tissue Removal Device
- 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 (2mm 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 sidefacing 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

ર-1

{1}------------------------------------------------

compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.

### ડ. 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.

# 6. Comparison of Characteristics:

The principles of operation and primary functional specifications of the MyoSURE Hysteroscopic Tissue Removal System are identical to those of the predicate Interlace Medical Hysteroscopic Morcellation System device, K073690. Each device employs a sterile, single use, disposable straight surgical morcellator for tissue removal. A foot pedal controls activation and deactivation of the motor which powers the morcellator in both devices. The MyoSURE morcellator is identical to the predicate morcellator in that it consists of a 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 MyoSURE inner tube or cutter rotates and reciprocates at a fixed rate that is identical to the predicate device. The MyoSURE cutter blade tip design is identical to that of the predicate 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 MyoSURE Hysteroscopic Tissue Removal System's intended use is identical to that of the predicate Interlace Medical Hysteroscopic Morcellation System.

The MyoSURE Hysteroscopic Tissue Removal System is different from the predicate Interlace Medical Hysteroscopic Morcellation System device as follows:

- The MyoSURE Control Unit's electric motor control software and o electronic circuitry components have been modified from those found in the predicate device.
- The MyoSURE Tissue Removal Device is smaller, lighter and completely o disposable and also features a more ergonomic hand piece design than the predicate device.
- The MyoSURE Tissue Removal Device's morcellator features a 0 mechanical drive mechanism in the handle which is connected via a flexible drive shaft to an electric motor in the MyoSURE Control Unit while the predicate Interlace morcellator is driven by a mechanical drive mechanism and two separate electric motors, all of which are located in the handle of the device.

The electric motor in the MyoSURE Control Unit is software-controlled. o

5-2

{2}------------------------------------------------

- The MyoSURE Tissue Removal Device morcellator's cutting tube outer ಂ surface is now coated with Titanium Nitride (TiN) to mitigate galling potential of the cutter tube and outer tube; the predicate Interlace device's cutting tube outer surface is not coated.
- A vacuum sensor present in the predicate device has been eliminated in 0 the MyoSURETM Hysteroscopic Tissue Removal System.
- Instructions for use for the MyoSURE™ Hysteroscopic Tissue Removal o System have been changed from the predicate instructions for use to reflect the new device's ergonomic design modifications.

# 7. Performance Testing:

The MyoSURE Hysteroscopic Tissue Removal System meets electrical safety and EMC standards. New patient contact materials in the MyoSURE device meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. In addition, in-vitro testing demonstrated that the MyoSURE device performs equivalent to or better than the predicate Interlace Morcellator device.

### 8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the MyoSURE Hysteroscopic Tissue Removal System has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicate Interlace Medical Hysteroscopic Morcellation System device.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

# OCT 2 3 2009

Interlace™ Medical, Inc. c/o Jonathan S. Kahan Hogan & Hartson, LLP 555 Thirteenth Street, N.W. WASHINGTON DC 20010

Re: K091100

Trade/Device Name: MyoSURE™ Hysteroscopic Tissue Removal System Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: October 6, 2009 Received: October 6, 2009

Dear Mr. Kahan:

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.

If vour 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 (reporting of medical

{4}------------------------------------------------

Page 2 -

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/Resourcesfor You/Industry/default.htm.

Singerely yours.

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

Enclosure

{5}------------------------------------------------

Interlace Medical Inc.

# 4. INDICATIONS FOR USE STATEMENT

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)

lun

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

CONFIDENTIAL