Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

K152723 · Hologic, Inc. · HIH · Nov 13, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K152723
• Device Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
• Applicant: Hologic, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Nov 13, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MyoSure Tissue Removal System and Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception

Device Story

The MyoSure Hysteroscopic Tissue Removal System is a mechanical resection device used by gynecologists in a clinical setting to remove intrauterine tissue. The system consists of a tissue removal drive system, a tissue removal device (TRD), and a foot pedal. During a hysteroscopic procedure, the device uses suction to draw targeted tissue into a cutting window at the distal end of the morcellator, where an inner blade performs mechanical resection. The system allows surgeons precise control over the location and extent of tissue removal. The device is used to treat conditions such as submucous myomas, endometrial polyps, and retained products of conception, potentially benefiting patients by providing a minimally invasive surgical option for tissue removal.

Clinical Evidence

Bench testing only. The system was tested using beef tongue tissue over 30-minute intervals to evaluate cutting functionality, durability, and heat generation. Results demonstrated equivalence to the predicate device in all metrics, with thermal output meeting IEC 60601-1 safety requirements.

Technological Characteristics

Mechanical tissue resection system. Components include a drive unit, foot pedal, and TRD. Features a modified distal cutting window and helix design. Operates via mechanical cutting and suction. Thermal safety complies with IEC 60601-1. Firmware controls motor movement and cutting parameters.

Indications for Use

Indicated for trained gynecologists to hysteroscopically resect and remove intrauterine tissue, including submucous myomas, endometrial polyps, and retained products of conception.

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 and Myosure Tissue Removal Devices (K142029)

Submission Summary (Full Text)

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

November 13, 2015

Hologic, Inc Catherine Eaton Regulatory Affairs Specialist 250 Campus Drive Marlborough, MA 01752

Re: K152723

> Trade/Device Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: October 29, 2015 Received: October 30, 2015

Dear Catherine Eaton,

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 (reporting of medical device

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Benjamin R. Fisher -S

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) K152723

Device Name

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

Indications for Use (Describe)

The MyoSure Tissue Removal System and Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:

Submucous myomas Endometrial Polyps Retained products of conception

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Hologic, Inc. Special 510(k) Submission November 12th, 2015

## 510(k) SUMMARY

Date: November 12th, 2015

#### 510(k) Submitter:

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Catherine Eaton P: 508.263.8604 F: 508.263.2403

#### Establishment Registration Number: 1222780

Trade Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

Common/Usual Name: Hysteroscope and Accessories, 21.CFR.Reg 884.1690

## Product Code: HIH

Classification: Class II

Panel: Obstetrics/Gynecology

## Predicate Device:

Trade name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Submitter / 510(k) Holder: Hologic, Inc. 510(k) #: K142029 Classification code: HIH and Regulation: 21.CFR.884.1690

## DEVICE DESCRIPTION

The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the sponsor's previously cleared device:

- Tissue Removal Drive System O
- o Tissue Removal Device (TRD)
- o Foot Pedal

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Hologic. Inc. Special 510(k) Submission November 12th, 2015

The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps, submucous myomas, and retained products of conception hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue.

# Indications for Use:

The Myosure Hysteroscopic Tissue Removal System and Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:

> Submucous myomas Endometrial Polyps Retained products of conception

# Comparison of Characteristics:

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 change to the Myosure Hysteroscopic Tissue Removal System is the modification of the Myosure Tissue Removal Device (TRD) used with the system (to be named Myosure Reach TRD). The MyoSure Reach TRD will be part of the family of the MyoSure TRDs utilized with the Myosure Hysteroscopic Tissue Removal System.

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

- Cutting window has been shifted farther down the distal end of the morcellator.
- . The tolerance within the firmware has been tightened to coincide with the dimensional change made by shifting the window farther down the distal tip
- The helix within the TRD has been modified to improve manufacturability and optimize ● the bidirectional movement of the motor.

The differences between the subject device and predicate do not raise any new types of safety and effectiveness questions. The difference in cutting window placement and helix design were evaluated by performance bench testing

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Hologic. Inc. Special 510(k) Submission November 12th, 2015

The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K142029):

- Has the same mechanism of action and mode of operation, .
- Is manufactured using the same materials, ●
- Is packaged and sterilized using the same process,
- Has the same shelf life.

## 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. The Myosure Tissue Removal Devices and modified Control Units were used to cut beef tongue tissue; each device was tested for a 30 minute duration test interval. 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 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 ● and meets IEC 60601-1 thermal safety requirements.

The modified device software/firmware was assessed per the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. 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:

The proposed Myosure Tissue Removal System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The proposed Myosure Tissue Removal System is substantially equivalent to the legally marketed predicate device (Hologic's Myosure Tissue Removal Device System and Tissue Removal Devices).