K131656 · ETHICON, Inc. · HET · Sep 27, 2013 · Obstetrics/Gynecology
Device Facts
Record ID
K131656
Device Name
MORCELLEX SIGMA GENERATOR
Applicant
ETHICON, Inc.
Product Code
HET · Obstetrics/Gynecology
Decision Date
Sep 27, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.1720
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
The MORCELLEX SIGMA™ Generator is an electromechanical power unit providing rotational energy to ETHICON laparoscopic tissue morcellators via a flexible drive cable. Operated by surgeons in hospital or ambulatory settings, the device features a front panel interface allowing selection of motor rotation direction (clockwise/counter-clockwise) and speed. Internal components include a power supply, printed circuit board, and an audible alert buzzer for motor status. The device provides mechanical power for cutting, coring, and extracting tissue during endoscopic procedures. It improves upon the predicate by offering increased maximum power draw and torque output. Healthcare providers use the device to facilitate tissue removal during minimally invasive surgery, potentially reducing procedure time and improving surgical efficiency.
Clinical Evidence
Bench testing only. Evaluations included device weight, speed, torque output, and activation/de-activation pressure. Compatibility with ETHICON laparoscopic tissue morcellators was verified. Electrical safety and electromagnetic compatibility testing were conducted per IEC 60601-1 and IEC 60601-1-2 standards.
Technological Characteristics
Electromechanical generator providing bi-directional motor rotation. Features front panel user interface with speed/direction controls and LED status indicators. Includes internal power supply, PCB, and audible alert buzzer. Provides mechanical power via flexible drive cable. Complies with IEC 60601-1 and IEC 60601-1-2 standards. Dimensions and weight are identical to the predicate device.
Indications for Use
Indicated for trained professionals in hospital or ambulatory surgery centers performing operative laparoscopic procedures (gynecologic, urologic, general surgery) requiring tissue cutting, coring, and extraction using compatible ETHICON morcellation devices.
Regulatory Classification
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.
Predicate Devices
GYNECARE X-TRACT Motor Drive Unit (FEMRX OPERASTAR SYSTEM) (K954648)
Submission Summary (Full Text)
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### MORCELLEX SIGMA™ Generator 510(k) Pre-Market Notification
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### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
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| Sponsor: | ETHICON Women's Health and Urology<br>ETHICON, Inc.<br>P.O. Box 151<br>Route 22 West<br>Somerville, New Jersey 08876 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah McManus<br>ETHICON Women's Health and Urology<br>ETHICON, Inc.<br>P.O. Box 151<br>Route 22 West<br>Somerville, New Jersey 08876<br>Phone: 908-218-2954<br>Fax: 908-218-2595<br>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<br>ETHICON laparoscopic tissue morcellators via the morcellator's Flexible Drive<br>Cable which connects the morcellator to the MORCELLEX SIGMA™ Generator.<br>The MORCELLEX SIGMA™ Generator is equipped with a bi-directional motor<br>that 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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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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
