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 and deactivated 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 4 mm working channel.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate Device K100559)	Reported Device Performance (MyoSure XL - K122498)	Pass/Fail
Tissue Cutting Performance	Equivalent to predicate device K100559	Equivalent to predicate device	Pass
Cutter Durability over time	Equivalent to predicate device K100559	Equivalent to predicate device	Pass
Heat Generation over time	Equivalent to predicate device K100559	Equivalent to predicate device	Pass

2. Sample Size and Data Provenance for Test Set

The provided text does not specify the exact sample sizes used for the performance testing. It states that the testing "evaluated cutting functionality and heat generation over the test interval" but does not give numerical values for the number of tests performed or the duration.

The data provenance is not explicitly stated as "country of origin," but given that Hologic, Inc. is based in Marlborough, MA, USA, and the submission is to the FDA, it is highly probable that the testing, or at least the data collection, occurred in the United States. The study is retrospective in the sense that it compares the modified device to a previously cleared predicate device (K100559) and uses the same methodology as the prior submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable to this submission. The device is a medical instrument (tissue removal system), and its performance testing focuses on objective, measurable physical characteristics (cutting performance, durability, heat generation) rather than diagnostic accuracy or interpretation, which would typically involve expert ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Adjudication methods are relevant for studies where subjective assessments (e.g., image interpretation) are made by multiple readers and a consensus or tie-breaking process is needed to establish "ground truth." This is a performance verification study for a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as per the provided information. This type of study is typically performed for diagnostic imaging algorithms or tools that involve human interpretation, to assess the impact of AI assistance on human reader performance. The MyoSure XL is a surgical tissue removal device, not an AI-powered diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The "Performance Testing" section states: "Performance verification testing of the modified MyoSure Hysteroscopic Tissue Removal System was completed... The testing evaluated cutting functionality and heat generation over the test interval for the modified MyoSure System." This indicates that the device's performance was assessed independently to ensure it met certain criteria, even if those criteria were based on equivalence to a predicate device. The comparison to the predicate device was done using the results of these standalone tests for both the modified and predicate systems.

7. Type of Ground Truth Used

The "ground truth" for this performance study was based on objective physical measurements and functional performance criteria. Instead of expert consensus, pathology, or outcomes data, the ground truth here is the established and verified performance of the predicate device (K100559) against which the modified device's performance was compared for equivalence in:

Tissue cutting performance
Cutter durability over time
Heat generation over time

8. Sample Size for the Training Set

This information is not applicable. The MyoSure XL Tissue Removal Device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. Its performance is based on its engineering design and manufacturing, tested through physical performance verification.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8. There is no training set for a physical device.

Summary

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HOLOGIC, Inc.

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Premarket Notification

న. 510(k) SUMMARY

SEP 10 2012

1. Submitter:

Hologic, Inc. 250 Campus Dr. Marlborough, MA 01752 Telephone: 508.263.8857

Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist

2. Device:

Trade Name: MyoSure XL Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System) Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II

3. 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 o
Myosure Tissue Removal Device 0
Myosure Foot Pedal 0

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Premarket Notification

5. Intended Use:

6. 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, K100559.

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

. To target larger uterine pathologies the diameter of the morcellator has been increased

7. 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 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 O equivalent to that of the predicate device
cutter durability over time is equivalent for the modified and o predicate Myosure Systems
heat generation over time is equivalent for the modified and predicate 0 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.

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Premarket Notification

8. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Ms. Sarah Fairfield Senior Regulatory Affairs Specialist Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752

SEP 10 2012

Re: K122498

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

Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: August 15, 2012 Received: August 16, 2012

Dear Ms. 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 for use sualod in the encreating to 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 I ou may) ateres 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 I tease be advisod that I Dr renation that your device complies with other requirements of the Act that 1 Dr. Has made a colorizantions administered by other Federal agencies. You must of any I outhal battler the requirements, including, but not limited to: registration and listing Comply with an the Free Prequirements and ) == 01 ) == 0 == 0 == 0 == 0 == 0 == 0 == 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0

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Page 2 -

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Evanko

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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HOLOGIC, Inc.

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Қ ( 2 2 498

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

Indications For Use:

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

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)

Arne W. Zitz

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122498

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.