MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)

K122498 · Hologic, Inc. · HIH · Sep 10, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K122498
• Device Name: MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
• Applicant: Hologic, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Sep 10, 2012
• 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 XL Tissue Removal Device is a component of the MyoSure Hysteroscopic Tissue Removal System; used for hysteroscopic resection of intrauterine tissue (submucous myomas, endometrial polyps). System comprises a control unit, foot pedal, and tissue removal device (morcellator). Control unit contains an electric motor and software controller; activated by foot pedal. Morcellator connects to control unit via flexible drive cable; cutter blade performs simultaneous rotation and reciprocation. Vacuum source aspirates resected tissue through side-facing cutting window; tissue and distension fluid transported to external trap/canister. Used by gynecologists in clinical settings; compatible with standard fluid management systems and hysteroscopes with 4 mm working channels. Increased morcellator diameter in XL version targets larger uterine pathologies. Provides efficient tissue removal; benefits patient through minimally invasive intrauterine surgery.

Clinical Evidence

Bench testing only. Performance verification compared the modified MyoSure XL system to the predicate MyoSure system. Testing evaluated tissue cutting performance, cutter durability, and heat generation over time. Results demonstrated that the modified system is equivalent to the predicate device in all tested functional and performance specifications.

Technological Characteristics

Tissue morcellator with electric motor-driven cutter; simultaneous rotation and reciprocation. Vacuum-assisted aspiration. Compatible with 4 mm working channel hysteroscopes. Software controller manages motor activation. Sterilization and material specifications not detailed in provided text.

Indications for Use

Indicated for hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue, including submucous myomas and endometrial polyps.

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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### HOLOGIC, Inc.

PAGE IOF 3

Premarket Notification

#### న. 510(k) SUMMARY

SEP 10 2012

#### 1. Submitter:

Hologic, Inc. 250 Campus Dr. Marlborough, MA 01752 Telephone: [phone]

Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist

#### 2. Device:

Trade Name: MyoSure XL 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 o
- Myosure Tissue Removal Device 0
- Myosure Foot Pedal 0

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 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 4 mm working channel.

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Premarket Notification

#### 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.

#### 6. 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, K100559.

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

- . To target larger uterine pathologies the diameter of the morcellator has been increased
#### 7. 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 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 O equivalent to that of the predicate device
- cutter durability over time is equivalent for the modified and o predicate Myosure Systems
- heat generation over time is equivalent for the modified and predicate 0 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.

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Premarket Notification

#### 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

### Public Health Service

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

Ms. Sarah Fairfield Senior Regulatory Affairs Specialist Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752

SEP 10 2012

Re: K122498

Trade/Device Name: MyoSure XL Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System)

Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: August 15, 2012 Received: August 16, 2012

Dear Ms. 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 for use sualod in the encreating to 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 I ou may) ateres 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 I tease be advisod that I Dr renation that your device complies with other requirements of the Act that 1 Dr. Has made a colorizantions administered by other Federal agencies. You must of any I outhal battler the requirements, including, but not limited to: registration and listing Comply with an the Free Prequirements and ) == 01 ) == 0 == 0 == 0 == 0 == 0 == 0 == 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0

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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/CDRHQffices/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,

Benjamin R. Evanko

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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HOLOGIC, Inc.

# 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Қ ( 2 2 498

Device Name: MyoSure XL 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 (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)

Arne W. Zitz

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122498