(113 days)
Not Found
No
The description focuses on mechanical power, user-selectable speed, and basic electrical/EMC testing. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is a generator that provides mechanical power for tissue morcellation, which is a surgical procedure for tissue removal, not a therapeutic treatment itself.
No
The device is described as a "Generator" that provides mechanical power for "cutting, coring, and extracting tissue" during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is a "Generator" that provides "mechanical power" via a "Flexible Drive Cable" and has a "bi-directional motor" with "activation buttons". This clearly indicates a hardware component that generates power and controls a motor, which is not a software-only device.
Based on the provided information, the MORCELLEX SIGMA™ Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in conjunction with morcellation devices for cutting, coring, and extracting tissue during operative laparoscopy. This is a surgical procedure performed on the patient, not a test performed on a sample of tissue or body fluid outside the body.
- Device Description: The description details a mechanical generator that provides power to surgical tools. This aligns with surgical equipment, not diagnostic equipment.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of substances, or diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MORCELLEX SIGMA™ Generator's function is purely mechanical and surgical.
N/A
Intended Use / 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.
Product codes
HET
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals in hospital environments and ambulatory surgery centers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MORCELLEX SIGMA™ Generator 510(k) Pre-Market Notification
.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
·
.
| Sponsor: | ETHICON Women's Health and Urology
ETHICON, Inc.
P.O. Box 151
Route 22 West
Somerville, New Jersey 08876 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah McManus
ETHICON Women's Health and Urology
ETHICON, Inc.
P.O. Box 151
Route 22 West
Somerville, New Jersey 08876
Phone: 908-218-2954
Fax: 908-218-2595
Email: 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 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 |
1
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.
2
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.
3
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
4
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
5
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