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 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 gynecologically resect and remove tissue such as: submucous myomas. endometrial polyps, and retain products of conception.

Device Description

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

AI/ML Overview

The provided text describes the regulatory clearance for reprocessed MyoSure Tissue Removal Devices (K201756). The clearance is based on demonstrating substantial equivalence to predicate devices, supported by performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative, pass/fail format. Instead, it lists general categories of performance testing and states that the devices comply or demonstrate effectiveness without providing specific numerical thresholds or outcomes for each test.

However, based on the listed "Functional Performance" tests, we can infer general performance areas. The reported device performance is broadly stated as: "The results of the evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices effectively cut and resect tissue in accordance with the intended use." and "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."

Here's an inferred table based on the functional performance tests and general statements:

Acceptance Criteria Category	Reported Device Performance
Shaft deflection	Performance demonstrated per testing.
Leak decay	Performance demonstrated per testing.
Drive cable plug insertion	Performance demonstrated per testing.
Shaft insertion force	Performance demonstrated per testing.
Torque	Performance demonstrated per testing.
Linearity	Performance demonstrated per testing.
Revolutions Per Minute	Performance demonstrated per testing.
Reciprocation	Performance demonstrated per testing.
Wear particulate	Performance demonstrated per testing.
Bend	Performance demonstrated per testing.
Tissue cutting and removal	Effectively cut and resect tissue.
Reliability	Performance demonstrated per testing.
Device functional attributes	Performance demonstrated per testing.
Equipment compatibility	Performance demonstrated per testing.
Biocompatibility	In accordance with FDA Guidance and ISO 10993-1.
Reprocessing Validation	Derived from recommendations of AAMI/TIR 30:2011, ASTM D7225-13:2013, AAMI/TIR 12:2010, AAMI/ANSI ST35:2003, ISO/TS 15883-5, ASTM F3208-18.
Sterilization	In accordance with ANSI/AAMI/ISO 11135-1:2014.
Shelf Life	Verification testing included package integrity and functional performance after aging.
Electrical Safety	Complies with IEC 60601-1 standard for safety.

Important Note: The document does not provide specific numerical acceptance thresholds (e.g., "Shaft deflection must be < X mm") nor quantitative results ("Shaft deflection observed was Y mm"). It only states that the device meets criteria "in accordance with" or "demonstrates effective" performance.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the tests conducted. It refers to "bench and laboratory testing" but provides no numerical count of devices tested.

The data provenance is implied to be from laboratory and bench testing conducted by Stryker Sustainability Solutions. Specific details regarding the country of origin of the data or whether it was retrospective or prospective are not mentioned, though "bench and laboratory testing" typically implies controlled, prospective testing in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily bench and laboratory performance tests, not clinical studies involving human patients or expert review of clinical data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis doesn't apply directly here. The "ground truth" for these engineering tests would be derived from the physical properties and performance metrics of the devices themselves, measured against engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method. This is expected as the studies are engineering/bench tests rather than clinical studies requiring expert consensus on subjective outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or mentioned. This device is a reprocessed tissue removal device, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical instrument, not an algorithm or AI. The tests conducted are "standalone" in the sense that they evaluate the device's intrinsic mechanical, material, and functional properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Functional Performance" tests (e.g., shaft deflection, torque, tissue cutting and removal), the ground truth is based on engineering specifications, physical measurements, and the device's ability to mechanically perform its indicated function (i.e., effectively cut and resect tissue). For biocompatibility, sterilization, and electrical safety, the ground truth is compliance with recognized international and national standards and guidance documents (e.g., ISO 10993-1, ANSI/AAMI/ISO 11135-1, IEC 60601-1).

8. The sample size for the training set

The document does not refer to a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for this device.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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

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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) scott.english@stryker.com

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:

ModelNumber	510(k)Number	510(k) Title	OriginalManufacturer
10-40110-403	K172566	MyoSure Hysteroscopic Tissue Removal Systemand MyoSure Tissue Removal Devices	Hologic, Inc.
10-401FC10-403FC	K152723	MyoSure Hysteroscopic Tissue Removal Systemand MyoSure Tissue Removal Devices	Hologic, Inc.
30-401LITE30-403LITE	K172566	MyoSure Hysteroscopic Tissue Removal Systemand MyoSure Tissue Removal Devices	Hologic, Inc.
50-501XL50-503XL	K172566	MyoSure Hysteroscopic Tissue Removal Systemand MyoSure Tissue Removal Devices	Hologic, Inc.
50-601XL50-603XL	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

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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	OuterDiameter	WorkingLength	WindowLength	WindowDepth	WindowSize
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 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 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:

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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

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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.

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.