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 3 mm working channel.

AI/ML Overview

Here's an analysis of the provided text regarding the MyoSure Hysteroscopic Tissue Removal System, extracting the requested information about acceptance criteria and the supporting study:

The provided text (K120593 Premarket Notification) describes a modification to an existing device, the MyoSure Hysteroscopic Tissue Removal System. The modification specifically concerns the motor within the control unit, which now rotates bidirectionally. The submission aims to demonstrate substantial equivalence to the predicate device (K100559).

Acceptance Criteria and Device Performance

The core of the performance testing is to demonstrate equivalence to the predicate device. The acceptance criteria are implicitly tied to the performance characteristics of the predicate device, K100559. The study's outcome is that the modified device meets or is equivalent to these established characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit from Predicate Device)	Reported Device Performance (MyoSure K120593)
Fibroid cutting performance equivalent to predicate	Modified MyoSure System's fibroid cutting performance is equivalent to that of the predicate device.
Cutter durability over time equivalent to predicate	Cutter durability over time is equivalent for the modified and predicate MyoSure Systems.
Heat generation over time equivalent to predicate	Heat generation over time is equivalent for the modified and predicate MyoSure Systems.
Meets predicate's functional specifications	Modified MyoSure System meets the same functional and performance specifications as the predicate MyoSure System.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes (e.g., number of fibroids tested, number of cutting cycles, duration of heat generation tests) used for the performance verification testing.

Sample Size: Not explicitly stated. The testing methodology used was the same as for the predicate device (K100559), implying similar rigor but not detailing specific numbers.
Data Provenance: Not explicitly stated, but it would have been generated internally by Hologic, Inc. as part of product development and regulatory submission. The study is described as "Performance verification testing" and "Verification/validation testing," which are typically prospective tests conducted on the modified device under controlled laboratory or simulated conditions. There is no mention of retrospective patient data.

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

This type of information is not applicable to this submission. The tests described are engineering performance tests of a mechanical device (cutting efficacy, durability, heat generation), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" here is objective physical measurement or operational equivalence.

4. Adjudication Method for the Test Set:

This is not applicable. As mentioned above, the testing involves objective engineering measurements and comparisons, not subjective interpretations requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on the device's mechanical and functional performance, not the diagnostic or interpretative performance of human readers, with or without AI assistance. The device is a surgical tool, not an AI diagnostic system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable in the context of AI. This device is hardware with an embedded software controller for its motor. The "standalone" performance here refers to the device operating according to its design specifications. The testing performed is essentially "standalone performance" in the sense that the device's cutting, durability, and heat generation were tested independently to ensure they met the established benchmarks (i.e., equivalence to the predicate).

7. The Type of Ground Truth Used:

The "ground truth" for this engineering study is based on:

Objective Engineering Measurements: Direct measurements of cutting performance (e.g., speed, efficacy on tissue simulants), durability (e.g., number of cycles before failure), and heat generation (e.g., temperature readings).
Functional Equivalence to Predicate Device: The established performance characteristics and specifications of the legally marketed predicate device (K100559) serve as the benchmark for comparison.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI that would require a "training set" in the conventional sense. The "training" for such a device would be its engineering design and manufacturing processes.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as point 8.

Summary

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

KIZD693

Premarket Notification

MAR 2 3 2012

HOLOGIC、Inc.

510(k) SUMMARY 5.

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™ 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
o Myosure Tissue Removal Device
o Myosure Foot Pedal

ﺗﯿﺮﯾ

ર- I

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

K120593 page. 2 of 3

Premarket Notification

న. 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:

. The motor within the control unit now rotates bidirectionally

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). 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 fibroid cutting performance is ಂ equivalent to that of the predicate device
cutter durability over time is equivalent for the modified and 0 predicate Myosure Systems
O 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.

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

K120593 page 3 of 3

HOLOGIC, Inc.

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.

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

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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design. The logo is commonly used to represent the department and its various agencies.

Public Health Service

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

MAR 2 3 2012

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

Re: K120593

Trade/Device Name: Myosure Hysteroscopic Tissue Removal System Regulation Number: 21 CFR8 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: February 27, 2012 Received: February 29, 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 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

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

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/CDRHOffices/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. Eick, Ph.D.

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

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

HOLOGIC, Inc.

Premarket Notification

4. INDICATIONS FOR USE STATEMENT

K120593 510(k) Number (if known):

Device Name: 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)

Norin R. Whin

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

CONFIDENTIAL

4-1

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.