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

The provided text describes a 510(k) summary for the Hologic MyoSure Tissue Removal Device. This submission is for a modified version of an existing device, and therefore the performance testing focuses on demonstrating equivalence to the predicate device, rather than establishing novel performance metrics.

Here's an analysis of the provided information against your requested criteria:

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

Acceptance Criteria (Implicit)	Reported Device Performance
Tissue cutting performance equivalent to the predicate device.	"the modified MyoSure System's tissue cutting performance is equivalent to that of the predicate device"
Cutter durability over time equivalent to the predicate device.	"cutter durability over time is equivalent for the modified and predicate MyoSure Systems"
Heat generation over time equivalent to the predicate device.	"heat generation over time is equivalent for the modified and predicate MyoSure Systems"
Meets the same functional and performance specifications as the predicate device.	"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. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. The document mentions "performance verification testing" and "test interval" but does not quantify the number of devices, tests, or tissue samples used.
Data Provenance: Not explicitly stated. It refers to "the same methodology as was used in support of the predicate MyoSure System 510(k) submission (K122498)." This suggests in-house lab testing rather than human clinical data. No country of origin is mentioned. The testing appears to be prospective lab testing.

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)

This is a device equivalence study based on functional performance, not an AI or diagnostic tool where expert ground truth is typically established. Therefore, this question is not applicable in the context of this 510(k) submission.

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

Not applicable. This is a device performance study, not a study where human reader adjudication of results is relevant.

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

Not applicable. This is a device equivalence study for a hysteroscopic tissue removal system, not an AI or diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm, and its performance is evaluated in direct comparison to a predicate device's functional characteristics.

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

The "ground truth" in this context is the established performance and specifications of the predicate MyoSure Hysteroscopic Tissue Removal System (K122498). The study aims to prove that the modified device's performance aligns with these established benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning device.

Summary

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510(k) SUMMARY

l . Submitter:
Hologic, Inc.

250 Campus Dr. Marlborough, MA 01752

AUG 2 2 2013

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: Il

1. Predicate Device:
  MyoSure™ Hysteroscopic Tissue Removal System (K122498)

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 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.

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 122498.

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 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 (K122498). 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 0903 New Hampshire Avenue cument 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

K131736 Re:

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 Fairficid

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/ResourcesforYou/Industry/default.hum. 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/Reportal?roblem/delault.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.hum.

Sincerely yours,

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):K131736

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 K131736 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.