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

The provided text describes the MyoSure LITE Tissue Removal Device and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way a clinical performance study for an AI/CADe device would.

The document is a 510(k) summary for a medical device which focuses on demonstrating substantial equivalence to a predicate device based on functional and performance specifications and biocompatibility, rather than clinical performance metrics like sensitivity or specificity.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is missing:

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

Missing. The document states, "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." However, it does not specify what those functional and performance specifications (acceptance criteria) are, nor does it quantify the reported device performance against them (e.g., specific thresholds or measurements). It only states they were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. This type of information is not relevant for the type of device and submission described. There is no "test set" in the context of clinical data for an AI/CADe device. The testing mentioned refers to engineering verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. Not applicable to this type of device and submission. There is no concept of "ground truth" established by experts for engineering verification and validation of a tissue removal device in this context.

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

Missing. Not applicable.

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

Missing. Not applicable. This device is a surgical instrument, not an AI or CADe system for diagnostic imaging interpretation.

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

Missing. Not applicable.

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

Missing. Not applicable.

8. The sample size for the training set

Missing. Not applicable. The device does not involve a "training set" in the AI/machine learning sense.

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

Missing. Not applicable.

Summary of what the document does provide regarding "studies":

The "study" mentioned is "Verification/validation testing of the modified Myosure System," which is described as confirming that the modified system "meets the same functional and performance specifications as the predicate Myosure System." Additionally, it states that "The new patient contact materials... meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical devices." This indicates engineering and biocompatibility testing, not clinical performance studies with diagnostic metrics.

Summary

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510(k) SUMMARY 5.

JUL 1 9 2012

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 LITE 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)

Device Description: 4.

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 o
Myosure Foot Pedal O

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.

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5-3

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.

The new patient contact materials in the proposed new sized morcellator for the Myosure System meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical devices.

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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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 19 2012

K121868 Re:

Trade/Device Name: MyoSure LITE 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: June 26, 2012

Received: June 26, 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 (reporting of medical

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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 K. Twitchell

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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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): |(121868

Device Name: MyoSure LITE 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)

	18 July 2012
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and

Drision of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120868

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.