The MORCELLEX SIGMA™ Generator is used with the following ETHICON Morcellation Devices: GYNECARE X-TRACT™, GYNECARE MORCELLEX™, and MORCELLEX SIGMA™. The MORCELLEX SIGMA™ Generator is used in conjunction with the ETHICON Morcellation Devices for gynecologic, urologic, and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers. The MORCELLEX SIGMA™ Generator is used in conjunction with ETHICON Morcellation Devices for cutting, coring, and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

Device Description

The MORCELLEX SIGMA™ Generator provides mechanical power to the ETHICON laparoscopic tissue morcellators via the morcellator's Flexible Drive Cable which connects the morcellator to the MORCELLEX SIGMA™ Generator. The MORCELLEX SIGMA™ Generator is equipped with a bi-directional motor that has a user-selectable speed range at which to rotate the ETHICON laparoscopic tissue morcellator. Activation buttons located on the Front Panel of the device allow the user to select the motor rotation direction and the speed of rotation.

AI/ML Overview

The provided text describes the MORCELLEX SIGMA™ Generator, a device used with laparoscopic tissue morcellators, and its 510(k) pre-market notification. The document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study results for novel acceptance criteria.

The acceptance criteria and study information is highly limited to bench testing for performance and electrical safety/EMC.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it describes characteristics that were evaluated and implies that the performance met the requirements for substantial equivalence to the predicate device.

Characteristic Evaluated	Reported Device Performance
Bench Studies:
Device Weight	Evaluated (Implied to be comparable or acceptable for intended use, given it's "same approximate weight" as predicate)
Speed	Evaluated (Stated to have "the same operational speed" as the predicate device, with a "user-selectable speed range")
Torque Output	Evaluated (Stated to provide "greater maximum torque output compared to the predicate device")
Activation/De-activation Pressure	Evaluated
Compatibility with ETHICON Laparoscopic Tissue Morcellators	Evaluated (Bench testing conducted to demonstrate compatibility)
Electrical Safety and EMC:
Electrical Safety	Conducted in accordance with IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General requirements for safety. (Implied compliance with standards)
Electromagnetic Compatibility	Conducted in accordance with IEC60601-1-2:2007 Medical electrical equipment – Part 1: General requirements for safety 2. Collateral standard: Electromagnetic compatibility - Requirements and tests. (Implied compliance with standards)
Other Comparisons:
Fundamental Technology	Same as predicate device
Basic Design	Same as predicate device
Principle of Operation	Same as predicate device
Bi-directional Motor Rotation	Both the MORCELLEX SIGMA™ Generator and the predicate device provide bi-directional motor rotation.
Rated Voltage	Essentially the same as the predicate device.
Rated Frequency	Identical to the predicate device.
Dimensions	Same as the predicate device.
Maximum Power Draw	Greater than the predicate device.

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

The document describes "bench studies" for performance evaluation and "Electrical safety and electromagnetic compatibility testing." There is no mention of a "test set" in the context of patient data or clinical imaging. These are laboratory-based tests. Therefore, specific sample sizes (e.g., number of devices tested for each characteristic) or data provenance (country of origin, retrospective/prospective) for a clinical test set are not applicable here.

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

Not applicable. This device is a mechanical generator, and the "ground truth" for its performance is established through engineering and electrical testing against design specifications and relevant standards, not through expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable, as there is no human-interpreted "test set" or clinical data mentioned.

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 device is a surgical generator and does not involve AI or human "readers" interpreting output.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical and electrical operation.

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

The "ground truth" for the device's performance is based on:

Engineering specifications and design requirements: for characteristics like speed, torque, weight, and dimensions.
International standards: IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility.
Comparison to the predicate device: to establish substantial equivalence in terms of fundamental technology, basic design, principle of operation, and functional characteristics.

8. The sample size for the training set

Not applicable. This is a medical device (generator), not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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MORCELLEX SIGMA™ Generator 510(k) Pre-Market Notification

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Sponsor:	ETHICON Women's Health and UrologyETHICON, Inc.P.O. Box 151Route 22 WestSomerville, New Jersey 08876
Contact:	Sarah McManusETHICON Women's Health and UrologyETHICON, Inc.P.O. Box 151Route 22 WestSomerville, New Jersey 08876Phone: 908-218-2954Fax: 908-218-2595Email: smcmanu3@its.jnj.com
Date of Submission:	5 June 2013
Proprietary Name:	MORCELLEX SIGMA™ Generator
Common Name:	Laparoscope, gynecologic (and accessories)
Regulation:	21 CFR 884.1720
Regulatory Class:	II
Product Codes:	HET, Gynecologic laparoscope and accessories.
Predicate Device:	GYNECARE X-TRACT Motor Drive Unit (FEMRX OPERASTAR SYSTEM) - K954648
Device Description:	The MORCELLEX SIGMA™ Generator provides mechanical power to theETHICON laparoscopic tissue morcellators via the morcellator's Flexible DriveCable which connects the morcellator to the MORCELLEX SIGMA™ Generator.The MORCELLEX SIGMA™ Generator is equipped with a bi-directional motorthat has a user-selectable speed range at which to rotate the ETHICON

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laparoscopic tissue morcellator. Activation buttons located on the Front Panel of the device allow the user to select the motor rotation direction and the speed of rotation.

Indications for Use The MORCELLEX SIGMA™ Generator is used with the following ETHICON Morcellation Devices: GYNECARE X-TRACT™, GYNECARE MORCELLEX™, and MORCELLEX SIGMA™. The MORCELLEX SIGMA™ Generator is used in conjunction with the ETHICON Morcellation Devices for gynecologic, urologic, and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers. The MORCELLEX SIGMA™ Generator is used in conjunction with ETHICON Morcellation Devices for cutting, coring, and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

Technological The MORCELLEX SIGMA™ Generator and the predicate device, the GYNECARE Characteristics X-TRACT Motor Drive Unit, have the same fundamental technology, the same basic design, and use the same principle of operation.

The MORCELLEX SIGMA™ Generator and the predicate device, the GYNECARE X-TRACT Motor Drive Unit, provide mechanical power to the ETHICON laparoscopic tissue morcellators. This pre-market notification is for modifications to the currently-marketed GYNECARE X-TRACT Motor Drive Unit. Minor modifications were made to the Front Panel user interface to identify the purpose of the activation buttons and to add Motor Status indicator LED's. Internal component changes include a new Power Supply component, a new Printed Circuit Board Assembly and the addition of an audible alert buzzer to alert the user of the motor status.

MORCELLEX SIGMA™ Generator and the predicate device, the GYNECARE X-TRACT Motor Drive Unit, both provide bi-directional motor rotation (clockwise/counter-clockwise) and the same operational speed. The rated voltage is essentially the same for both devices. The rated frequency is identical. Both devices are the same dimensions and same approximate weight. The proposed device, the MORCELLEX SIGMA™ Generator, provides greater maximum power draw and greater maximum torque output compared to the predicate device, GYNECARE X-TRACT Motor Drive Unit.

Performance Data

Bench studies were conducted to demonstrate the performance of the MORCELLEX SIGMA™ Generator. The bench studies consisted of evaluating the following device characteristics: device weight, speed, torque output, and activation/de-activation pressure. Bench testing was also conducted to evaluate the compatibility of the MORCELLEX SIGMA™ Generator with the ETHICON laparoscopic tissue morcellators.

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Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General requirements for safety and IEC60601-1-2:2007 Medical electrical equipment – Part 1: General requirements for safety 2. Collateral standard: Electromagnetic compatibility - Requirements and tests.

Conclusions

The data provided in this premarket notification demonstrate that the MORCELLEX SIGMA™ Generator is substantially equivalent to the predicate device, the GYNECARE X-TRACT Motor Drive Unit. Both devices have the same intended use, the same fundamental technology and the same principle of operation.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

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

September 27, 2013

ETHICON. Inc. % Sarah McManus Manager, Regulatory Affairs P.O. Box 151, Route 22 West Somerville. NJ 08876

Re: K131656

Trade/Device Name: MORCELLEX SIGMA™ Generator Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: August 28. 2013 Received: August 29, 2013

Dear Sarah McManus,

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 1 ou may, mererers, minists 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 four a 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

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Page 2 - Sarah McManus

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 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,

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 Statement

510(k) Number (if known): K131656

Device Name: MORCELLEX SIGMA™ Generator

Indications for Use:

The MORCELLEX SIGMA™ Generator is used with the following ETHICON Morcellation Devices: GYNECARE X-TRACT™, GYNECARE MORCELLEX™, and MORCELLEX SIGMA™. The MORCELLEX SIGMA™ Generator is used in conjunction with the ETHICON Morcellation Devices for gynecologic, and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers. The MORCELLEX SIGMA™ Generator is used in conjunction with ETHICON Morcellation Devices for cutting, coring, and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

Prescription Use______________________________________________________________________________________________________________________________________________________________ V 21 CFR Part 801 Subpart D and/or

Over-the-Counter Use_ 21 CFR Part 801 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

Confidential & Proprietary

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.