Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent

K201756 · Stryker Sustainability Solutions · HIH · Sep 25, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K201756
• Device Name: Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
• Applicant: Stryker Sustainability Solutions
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Sep 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception. The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception. The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception. The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL) is indicated for intrauterine use by trained gyneologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception. The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-603XL) is indicated for intrauterine use by trained gynecologically resect and remove tissue such as: submucous myomas. endometrial polyps, and retain products of conception.

Device Story

Sterile, disposable, hand-held tissue removal device; used hysteroscopically to resect intrauterine tissue. Device connects via 6-foot flexible drive shaft to motorized control unit; foot pedal controls motor. Mechanical resection mechanism: tissue drawn through cutting window via suction; inner blade simultaneously rotates and reciprocates to cut tissue. Vacuum tubing connects to collection canister. Used in clinical settings by trained gynecologists. Enables minimally invasive removal of myomas, polyps, and retained products of conception; benefits patient by providing effective tissue resection during hysteroscopic procedures.

Clinical Evidence

Bench testing only. Evaluations included biocompatibility (ISO 10993-1), reprocessing validation (AAMI/TIR 30, ASTM D7225, AAMI/TIR 12, AAMI/ANSI ST35, ISO/TS 15883-5, ASTM F3208), sterilization (ISO 11135-1), electrical safety (IEC 60601-1), and functional performance (shaft deflection, leak decay, torque, RPM, reciprocation, and tissue cutting/removal efficacy). Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Mechanical tissue resection device; consists of hand-held probe with rotating/reciprocating inner blade, flexible drive shaft, and vacuum tubing. Materials evaluated per ISO 10993-1. Sterilized via Ethylene Oxide (ISO 11135-1). Electrical safety per IEC 60601-1. Dimensions vary by model (3mm or 4mm outer diameter; 32cm working length). Standalone device requiring external motorized control unit.

Indications for Use

Indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove 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 (K172566)
• MyoSure Hysteroscopic Tissue Removal System and MyoSure Tissue Removal Devices (K152723)
• MyoSure XL Tissue Removal Device for Fluent (K181974)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2020

Stryker Sustainability Solutions Scott English Senior Staff Regulatory Affairs Specialist 1810 W. Drake Drive Tempe, AZ 85283

#### Re: K201756

Trade/Device Name: Reprocessed MyoSure Tissue Removal Device (10-401/10-403), Reprocessed MyoSure REACH Tissue Removal Device (10-401FC/10-403FC), Reprocessed MyoSure LITE Tissue Removal Device (30-401LITE/30-403LITE), Reprocessed MyoSure XL Tissue Removal Device (50-501XL/50-503XL), Reprocessed MyoSure XL Tissue Removal Device for Fluent (50-601XL/50-603XL) Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: June 27, 2020 Received: June 29, 2020

Dear Scott English:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jason R. Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K201756

#### Device Name

Reprocessed MyoSure Tissue Removal Device (10-401/10-403). Reprocessed MyoSure REACH Tissue Removal Device (10-401FC/10-403FC), Reprocessed MyoSure LITE Tissue Removal Device (30-401LITE), Reprocessed MyoSure XL Tissue Removal Device (50-501XL), Reprocessed MyoSure XL Tissue Removal Device for Fluent (50-603XL)

#### Indications for Use (Describe)

The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL/50-503XL) is indicated for intrauterine use by trained gyneologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-601XL/50-603XL) is indicated for intrauterine use by trained gynecologically resect and remove tissue such as: submucous myomas. endometrial polyps, and retain products of conception.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.6 2.4L5.6 10.4L2.4 7.2L1.6 8L5.6 12L14.4 3.2L13.6 2.4Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(k) SUMMARY

#### Submitter:

Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283

### Contact:

Scott English Senior Staff Regulatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) [e-mail]

Date of Preparation: June 27, 2020

## Name of Device:

| Trade/Proprietary Name | Model Number |
|---------------------------------------------------------|-----------------------|
| Reprocessed MyoSure Tissue Removal Device | 10-401/10-403 |
| Reprocessed MyoSure REACH Tissue Removal Device | 10-401FC/10-403FC |
| Reprocessed MyoSure LITE Tissue Removal Device | 30-401LITE/30-403LITE |
| Reprocessed MyoSure XL Tissue Removal Device | 50-501XL/50-503XL |
| Reprocessed MyoSure XL Tissue Removal Device for Fluent | 50-601XL/50-603XL |

Common Name: Hysteroscope and Accessories

Classification Information: Hysteroscope and Accessories (21 CFR § 884.1690, HIH, Class II)

# Predicate Devices:

| Model<br>Number | 510(k)<br>Number | 510(k) Title | Original<br>Manufacturer |
|--------------------------|------------------|-----------------------------------------------------------------------------------|--------------------------|
| 10-401<br>10-403 | K172566 | MyoSure Hysteroscopic Tissue Removal System<br>and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 10-401FC<br>10-403FC | K152723 | MyoSure Hysteroscopic Tissue Removal System<br>and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 30-401LITE<br>30-403LITE | K172566 | MyoSure Hysteroscopic Tissue Removal System<br>and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 50-501XL<br>50-503XL | K172566 | MyoSure Hysteroscopic Tissue Removal System<br>and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 50-601XL<br>50-603XL | K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. |

The predicate devices have not been subject to a design-related recall.

### Device Description:

The Reprocessed MyoSure Tissue Removal Devices are sterile, disposable, hand-held tissue

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

removal devices that are used to hysteroscopically remove intrauterine tissue. The devices are connected via a 6-foot (1.8-meter) flexible drive shaft to a motorized control unit. A foot pedal allows the user to control the cutting action of the tissue removal device by turning the motor in the control unit on and off. The proximal end of the 10-foot (3-meter) vacuum tubing is connected to a collection canister. The devices use mechanical resection by drawing the tissue through the cutting window under suction, while the inner blade simultaneously rotates and reciprocates to cut the tissue.

| Device Specifications | | | | | |
|-------------------------------|-------------------|-------------------|------------------|-----------------|----------------|
| Model | Outer<br>Diameter | Working<br>Length | Window<br>Length | Window<br>Depth | Window<br>Size |
| Reprocessed MyoSure | 3 mm | 32 cm | 14.0 mm | 1.8 mm | 54 mm3 |
| Reprocessed MyoSure REACH | 3 mm | 32 cm | 14.0 mm | 1.8 mm | 54 mm3 |
| Reprocessed MyoSure LITE | 3 mm | 32 cm | 10.2 mm | 1.5 mm | 31 mm3 |
| Reprocessed MyoSure XL | 4 mm | 32 cm | 14.0 mm | 2.4 mm | 98 mm3 |
| Reprocessed MyoSure XL-Fluent | 4 mm | 32 cm | 14.0 mm | 2.4 mm | 98 mm3 |

# Indication for Use:

The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained qynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE/30-403LITE) is indicated for intrauterine use by trained qynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL/50-503XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-601XL/50-603XL) is indicated for intrauterine use by trained qynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The indications for use are the same as the predicate devices.

# Comparison of Technological Characteristics:

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

The principles of operation and primary functional specifications of the Reprocessed MyoSure Tissue Removal Devices are identical to those of the predicate MyoSure Tissue Removal Devices. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. The only differences between the Reprocessed MyoSure Tissue Removal Devices and the predicate devices MyoSure Tissue Removal Devices is that devices are reprocessed, and some device components are replaced with equivalent components during the reprocessing operation.

The differences in technological characteristics do not raise different questions of safety and effectiveness.

# Performance Data:

Bench and laboratory testing were conducted to demonstrate performance (safety and effectiveness) of the Reprocessed MyoSure Tissue Removal Device. This included the following tests:

# Biocompatibility

The biocompatibility evaluation for the Reprocessed MyoSure Tissue Removal Devices was conducted in accordance with FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" dated June 16, 2016, and International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Manaqement Process," as recognized by FDA. The battery of testing included the following tests:

- Cytotoxicity ●
- Sensitization
- Irritation
- Systemic Toxicity
- Materials Mediated Pyrogenicity ●
- Chemical Characterization .

The Reprocessed MyoSure Tissue Removal Devices are considered surface contacting, applied to breached surfaces for a duration of less than 24 hours.

# Validation of Reprocessing

The reprocessing validation was derived from the recommendations of AAMI/TIR 30:2011, "A Compendium of Processes, Materials. Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices"; ASTM D7225-13:2013, "Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors: AAMI/TIR 12:2010: Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers"; AAMI/ANSI ST35:2003, "Safe handling and biological decontamination of medical devices in health care facilities and in non-clinical settings"; ISO/TS 15883-5, "Washer-disinfectors – Part 5: Test soils and methods for demonstrating cleaning efficacy", and ASTM F3208-18, "Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices."

# Sterilization and Shelf Life

{6}------------------------------------------------

Sterility of the Reprocessed MyoSure Tissue Removal Devices was assessed in accordance with ANSI/AAMI/ISO 11135-1:2014, "Sterilization of Health Care Products - Ethylene oxide -Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices."

Shelf Life verification testing included assessment of package integrity and device functional performance following aging.

# Electrical Safety

Electrical safety testing was conducted on the Reprocessed MyoSure Tissue Removal Devices. The devices comply with the IEC 60601-1 standard for safety.

# Functional Performance

- Shaft deflection ●
- Leak decay ●
- Drive cable plug insertion
- Shaft insertion force ●
- Torque ●
- Linearity ●
- . Revolutions Per Minute
- Reciprocation ●
- Wear particulate ●
- Bend
- Tissue cutting and removal performance
- Reliability testing
- Device functional attribute tests ●
- . Equipment compatibility

The bench testing involved evaluation of the devices' performance and ability to cut and resect tissue. The results of the evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices effectively cut and resect tissue in accordance with the intended use.

# Conclusion:

The results of bench testing and laboratory evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices are at least as safe and effective and perform as well as the identified legally marketed predicate devices as described herein.