MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)

K131581 · Hologic, Inc. · HIH · Aug 22, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K131581
• Device Name: MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
• Applicant: Hologic, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Aug 22, 2013
• 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 is a mechanical tissue morcellator used during hysteroscopic intrauterine procedures. System components include a control unit with an electric motor and software controller, a foot pedal, and a tissue removal device. The morcellator features a cutter blade that rotates and reciprocates simultaneously, driven by a flexible cable connected to the control unit. A vacuum source aspirates resected tissue through a side-facing cutting window in the outer tube into a tissue trap and vacuum canister. The device is operated by a trained gynecologist in a clinical setting. The system is compatible with standard fluid management systems and hysteroscopes with a 3 mm working channel. The modification allows for continuous aspiration of the uterine cavity during the procedure. The device benefits patients by enabling efficient removal of submucous myomas and endometrial polyps.

Clinical Evidence

Bench testing only. Performance verification testing compared the modified MyoSure system to the predicate (K100559). Results demonstrated equivalent tissue cutting performance, cutter durability, and heat generation over the test interval.

Technological Characteristics

Mechanical tissue morcellator; electric motor-driven rotation and reciprocation; vacuum-assisted aspiration; compatible with 3 mm working channel hysteroscopes; software-controlled motor; continuous aspiration capability.

Indications for Use

Indicated for hysteroscopic intrauterine tissue resection and removal, including submucous myomas and endometrial polyps, in patients requiring such procedures performed 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 (K100559)

Submission Summary (Full Text)

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### 510(k) SUMMARY

- l . Submitter:
Hologic, Inc.

AUG 2 2 2013

250 Campus Dr. Marlborough, MA 01752

Telephone: [phone]

Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist

- 2. Device:
Trade Name: MyoSure Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System)

Common Name: Hysteroscope and accessories

Classification Name: Hysteroscope and accessories

Class: II

- 3. Predicate Device:
MyoSure™ Hysteroscopic Tissue Removal System (K100559)

#### 4. Device Description:

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 .
- . Myosure Tissue Removal Device
- . Myosure Foot Pedal

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The Myosure Control Unit contains an electric motor and software controller that drives the Myosure Tissue Removal Device. The Control Unit motor is activated 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 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.

#### 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:

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. K 100559.

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

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

- . To allow for continuous aspiration of the uterine cavity throughout the Myosure procedure.
## Performance Testing:

Performance verification testing of the modified Myosure Hysteroscopic Tissue Removal System was completed using the same methodology as was used in support of the predicate Myosure System 510(k) submission (K100559). The testing evaluated cutting functionality and heat generation over

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the test interval for the modified Myosure System. Test results for the predicate and modified Myosure Hysteroscopic Tissue Removal Systems were then compared. Results from this testing demonstrated that:

- the modified Myosure System's tissue cutting performance is equivalent to that of the predicate . device
- cutter durability over time is equivalent for the modified and predicate Myosure Systems .
- heat generation over time is equivalent for the modified and predicate Myosure Systems .

Verification/validation testing of the modified Myosure System was completed and confirmed that the modified Myosure System meets the same functional and performance specifications as the predicate Myosure System.

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

August 22, 2013

Hologic, Inc. % Sarah Fairfield Senior Regulatory Affairs Specialist 250 Campus Drive Marlborough, MA 01752 US

Re: K131581

> Trade/Device Name: MyoSure Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: July 24, 2013 Received: July 25, 2013

Dear Sarah Fairfield,

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

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Page 2 - Sarah Fairfield

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known):K131581

Device Name: MyoSure Tissue Removal Device (part of the 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 ___________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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)

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131581 510(k) Number_