The MyoSure MANUAL Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.

Device Description

The MyoSure MANUAL Tissue Removal Device is a single-use device that is intended for the resection and removal of tissue under hysteroscopic visualization. It is sterile, non-powered, and hand-actuated. It is compatible with the MyoSure hysteroscope and can be used in either an office or an operating room setting. The MyoSure MANUAL Tissue Removal Device is packaged with an accessory inflow tube to facilitate delivery of distention media. The inflow tube contains a bag spike, a tube and a luer connection to the hysteroscope. The MyoSure MANUAL Tissue Removal Device incorporates a rotating outer tube with a side facing cutting window and inner reciprocating cutting blade. A removable in-line tissue trap collects the excised tissue. An Outflow tube transfers and directs the waste fluid into a buttock drape.

AI/ML Overview

The provided text describes a 510(k) summary for the MyoSure MANUAL Tissue Removal Device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics in the way a clinical trial report would.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, MRMC study, training set details) are not explicitly provided or are not applicable to this type of regulatory submission.

However, I can extract the information available regarding acceptance criteria and performance testing for design verification and validation.

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

The document states that "All testing met the acceptance criteria" for a list of performance tests. However, the specific numerical acceptance criteria for each test are not explicitly stated in this summary. Instead, it lists the types of tests performed.

Test Type	Reported Device Performance	Acceptance Criteria (Not explicitly stated in document)
Visual Inspection	Met acceptance criteria	(e.g., No visible defects, proper assembly)
Dimensional Measurements	Met acceptance criteria	(e.g., Within specified tolerances for OD, cutting window, cutting depth)
Outer tube rotation	Met acceptance criteria	(e.g., Smooth rotation, within specified torque)
Device/Scope/Camera Clearance	Met acceptance criteria	(e.g., Adequate clearance for visualization and operation)
Tissue trap is removable	Met acceptance criteria	(e.g., Easily removable and reattachable)
Inflow spike to tubing tensile strength	Met acceptance criteria	(e.g., Withstands specified tensile load without separation)
¼" Luer to tubing tensile strength	Met acceptance criteria	(e.g., Withstands specified tensile load without separation)
Trigger force test	Met acceptance criteria	(e.g., Within specified force range for actuation)
Outer tube/blade tensile test	Met acceptance criteria	(e.g., Withstands specified tensile load without failure)
Drain tube to connector tensile test	Met acceptance criteria	(e.g., Withstands specified tensile load without separation)
Tissue trap volume	Met acceptance criteria	(e.g., Meets specified volume capacity)
Cutting Rate	Met acceptance criteria	(e.g., Achieves a certain rate of tissue removal)
Fluid Usage	Met acceptance criteria	(e.g., Within acceptable range for distention media)
Tissue Trap Efficiency	Met acceptance criteria	(e.g., Retains a specified percentage of resected tissue)

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

The document mentions "Usability and human factors were addressed through Voice of Customer (VOC) studies and design validation."

Sample size for test set: 15 active physicians.
Data provenance: Not explicitly stated, but the VOC studies and design validation were conducted within the context of product development and regulatory submission, likely at the manufacturer's location (Marlborough, MA, USA) or through contracted facilities. It's a prospective design validation study.

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

Number of experts: 15 physicians.
Qualifications of experts: The document states "15 physicians with a range of experience." Specific specializations or years of experience are not detailed, but given the device's indication for use, they would be gynecologists.

4. Adjudication method for the test set

The document describes "Usability and human factors" testing with physicians using a simulated uterine model. This type of testing typically involves direct observation of device use and participant feedback, rather than a formal adjudication method for ground truth in the sense of comparing multiple expert interpretations to establish a single "correct" answer. Since the goal was to demonstrate usability and that the device meets user needs, the "ground truth" would be the direct experience and feedback from each of the 15 participating physicians. There is no mention of a formal adjudication process.

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

There is no mention of an MRMC study or any AI component in this device. The MyoSure MANUAL Tissue Removal Device is a physical, hand-actuated surgical instrument, not an imaging or diagnostic AI device.

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, hand-actuated manual surgical instrument, not an algorithm or AI product.

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

For the performance testing: The "ground truth" for the engineering performance tests (e.g., dimensions, tensile strength, cutting rate, fluid usage, tissue trap efficiency) would be established by engineering specifications and validated measurement methods. The document states that a simulated uterine model with pieces of chicken breast was used to simulate target tissue for the usability testing. The "ground truth" for the usability aspects was the direct experience and feedback from the 15 physicians regarding device performance and user needs.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device would refer to its design and development iterations, not a data-driven training set.

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

This question is not applicable for the same reason as above.

Summary

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May 8, 2018

Hologic, Inc. Anne-Marie Keefe Senior Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752

Re: K173901

Trade/Device Name: MyoSure MANUAL Tissue Removal Device Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: April 2, 2018 Received: April 3, 2018

Dear Anne-Marie Keefe:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K173901

Device Name MyoSure MANUAL Tissue Removal Device

Indications for Use (Describe)

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)

Description (i.e. street, company, etc.)

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

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K173901 510(K) SUMMARY

Date: May 7, 2018

510(k) Submitter:

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Anne-Marie Keefe 508.263.8851 F: 866.523.8663

Establishment Registration Number: 1222780

Trade Name: MyoSure MANUAL Tissue Removal Device

Common/Usual Name: Hysteroscopic Tissue Removal Device

Regulation Name: Hysteroscope and Accessories

Regulation Number: 21.CFR.Reg 884.1690

Product Code: HIH, Hysteroscope and Accessories

Classification: Class II

Panel: Obstetrics/Gynecology

PREDICATE DEVICES

Tradename: MyoSure LITE Tissue Removal Device Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K142029 Product Code: HIH Regulation: 21.CFR.884.1690

The MyoSure LITE Tissue Removal Device has not been subject to a design-related recall.

DEVICE DESCRIPTION

The MyoSure MANUAL Tissue Removal Device is packaged with an accessory inflow tube to facilitate delivery of distention media. The inflow tube contains a bag spike, a tube and a luer connection to the hysteroscope.

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The MyoSure MANUAL Tissue Removal Device incorporates a rotating outer tube with a side facing cutting window and inner reciprocating cutting blade. A removable in-line tissue trap collects the excised tissue. An Outflow tube transfers and directs the waste fluid into a buttock drape.

INDICATIONS FOR USE:

The MyoSure MANUAL Tissue Removal Device indications for use are similar to the predicate MyoSure LITE device. The primary difference between the subject MyoSure MANUAL Tissue Removal Device and the predicate MyoSure LITE is as follows:

Resection and removal of tissue for the MyoSure MANUAL device includes focal lesions such . as endometrial polyps and retained products of conception. Resection and removal of tissue for the MyoSure LITE includes submucous myomas. Both the MyoSure MANUAL and MyoSure LITE devices are intended for removal of endometrial polyps and retained products of conception.
The MyoSure MANUAL Tissue Removal Device intended use is identical to the predicate MyoSure LITE device.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Primary specifications including morcellator dimensions (including OD, cutting window and cutting depth) cutting blade configuration, fluid distention media, visualization and access route to targeted tissue are identical to the predicate MyoSure LITE device.

The mode of operation including method of use and mechanism of action, material composition, and aspiration pressure are similar to the predicate MyoSure LITE device.

The primary difference between the subject MyoSure MANUAL Tissue Removal Device and the predicate MyoSure LITE is as follows:

. The MyoSure MANUAL Tissue Removal Device is a hand actuated device while the predicate MyoSure LITE is motor actuated.
. The MyoSure MANUAL Tissue Removal Device consists of a rotatable outer sheath while the MyoSure LITE consists of a stationary outer sheath.
The MyoSure MANUAL Tissue Removal Device contains an Inflow Tube Assembly ● while the MyoSure LITE is not packaged with this assembly.
. The MyoSure LITE requires an external vacuum source while the MyoSure MANUAL Tissue Removal Device does not.

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

PERFORMANCE TESTING

Performance verification and validation testing of the MyoSure MANUAL Tissue Removal Device evaluated the following:

Visual Inspection ●
Dimensional Measurements ●
Outer tube rotation
Device/Scope/Camera Clearance
Tissue trap is removable
Inflow spike to tubing tensile strength
¼" Luer to tubing tensile strength ●
Trigger force test ●
Outer tube/blade tensile test
Drain tube to connector tensile test
Tissue trap volume ●
Cutting Rate ●
Fluid Usage ●
. Tissue Trap Efficiency

All testing met the acceptance criteria.

Usability and human factors were addressed through Voice of Customer (VOC) studies and design validation. Testing was done to demonstrate that the MyoSure MANUAL Tissue Removal Device meets user needs and intended use. The testing included 15 physicians with a range of experience. Testing was conducted with a simulated uterine model that included pieces of chicken breast to simulate the target tissue. Design verification. validation testing and usability testing confirmed that the device performs as intended.

CONCLUSION

Based on the intended use, descriptive information and performance provided in this submission, the MyoSure MANUAL Tissue Removal Device has been shown to be substantially equivalent to the predicate MyoSure LITE Tissue Removal Device.

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.