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 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, Myosure Tissue Removal Device, Myosure Foot Pedal. The Myosure Control Unit contains an electric motor and software controller that drives the Myosure Tissue Removal Device. The Control Unit motor is activated 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 3 mm working channel.

AI/ML Overview

This document describes a 510(k) summary for a modified MyoSure Tissue Removal Device. This is not a device that uses AI or machine learning. The performance testing described is for a physical medical device, specifically its cutting functionality and heat generation, compared to a predicate device. Therefore, many of the requested criteria related to AI/ML model evaluation (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.

Here's the information that can be extracted from the provided text, focusing on the mechanical and functional aspects of the device comparison:

Acceptance Criteria and Device Performance (for a Mechanical Medical Device)

Acceptance Criteria	Reported Device Performance
Tissue cutting performance equivalent to predicate device	The modified MyoSure System's tissue cutting performance is equivalent to that of the predicate device.
Cutter durability over time equivalent to predicate device	Cutter durability over time is equivalent for the modified and predicate MyoSure Systems.
Heat generation over time equivalent to predicate device	Heat generation over time is equivalent for the modified and predicate MyoSure Systems.
Meets same functional and performance specifications as predicate device	Verification/validation testing confirmed that the modified MyoSure System meets the same functional and performance specifications as the predicate MyoSure System.

Study Details (as applicable to a physical device modification)

Sample size used for the test set and the data provenance: Not explicitly stated as a number of subjects or samples. The testing methodology was "the same methodology as was used in support of the predicate Myosure System 510(k) submission (K100559)". This implies in-vitro or bench testing, comparing the performance characteristics of the modified device against the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this would be established through objective measurements (e.g., cutting efficiency metrics, temperature readings, durability cycles) rather than expert interpretation of images or data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As this is mechanical performance testing, there's no "adjudication" in the sense of reconciling subjective expert opinions.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. MRMC studies are used for evaluating the impact of diagnostic aids on human readers' performance, typically in imaging. This is a surgical tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical, user-operated device, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical capabilities.
The type of ground truth used: For cutting performance, it would be quantitative metrics of tissue resection rate or efficiency. For durability, it would be the number of cycles to failure or maintenance of performance over a specified number of uses. For heat generation, it would be temperature measurements at specific points. These are objective engineering measurements.
The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model that requires training data.
How the ground truth for the training set was established: Not applicable. As above, no training set for an AI/ML model.

Summary of the Study:
The study was a performance verification testing comparing a modified MyoSure Hysteroscopic Tissue Removal System to its predicate device (K100559). The "study" focused on mechanical performance characteristics such as tissue cutting, cutter durability, and heat generation. The primary goal was to demonstrate equivalence between the modified device and the previously cleared predicate device, rather than establishing absolute performance benchmarks. The testing methodology was identical to that used for the predicate, suggesting a rigorous engineering evaluation rather than a clinical trial or AI model validation.

Summary

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510(k) SUMMARY

l . Submitter:
Hologic, Inc.

AUG 2 2 2013

250 Campus Dr. Marlborough, MA 01752

Telephone: 508.263.8857

Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist

1. Device:
  Trade Name: MyoSure Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System)

Common Name: Hysteroscope and accessories

Classification Name: Hysteroscope and accessories

Class: II

1. 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 .
. Myosure Tissue Removal Device
. Myosure Foot Pedal

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The Myosure Control Unit contains an electric motor and software controller that drives the Myosure Tissue Removal Device. The Control Unit motor is activated 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 3 mm working channel.

Intended Use:

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. K 100559.

The principles of operation and primary functional specifications of the modified Mvosure 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 allow for continuous aspiration of the uterine cavity throughout the Myosure procedure.

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

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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 .

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:

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

August 22, 2013

Hologic, Inc. % Sarah Fairfield Senior Regulatory Affairs Specialist 250 Campus Drive Marlborough, MA 01752 US

Re: K131581

Trade/Device Name: MyoSure Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: July 24, 2013 Received: July 25, 2013

Dear Sarah 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 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

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Page 2 - Sarah Fairfield

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-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

Sincerely vours.

Herbert P. Lerner -S

for

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):K131581

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

Indications For Use:

Prescription Use X ___________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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)

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131581 510(k) Number_

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.