(51 days)
Not Found
No
The device description focuses on mechanical cutting and extraction of tissue, with no mention of AI/ML capabilities or data processing.
No
The device is described as a "Tissue Morcellator" used for cutting, coring, and extracting tissue during surgical procedures, not for treating or curing a disease or condition.
No
This device is a surgical tool used for cutting, coring, and extracting tissue during laparoscopic procedures. It is designed for tissue removal, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, single-use surgical instrument with mechanical components (blade, sheath, obturator, handle, foot pedal, trigger, coreguard, reducer cap) used for cutting and extracting tissue. It is not software-only.
Based on the provided text, the GYNECARE MORCELLEX Tissue Morcellator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "cutting, coring, and extracting tissue during operative laparoscopy." This describes a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a surgical instrument used for tissue manipulation and removal within the body. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples outside the body).
- Providing diagnostic information based on the analysis of these samples.
- Reagents, calibrators, or controls used in laboratory testing.
Therefore, the GYNECARE MORCELLEX Tissue Morcellator is a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GYNECARE MORCELLEX™ Tissue Morcellator is intended for gynecologic, urologic and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers.
The GYNECARE MORCELLEX™ Tissue Morcellator is indicated for cutting, coring, and extracting tissue during operative laparoscopy including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HET
Device Description
The GYNECARE MORCELLEX™ Tissue Morcellator is a single-use device. The device is inserted into the patient with the use of the provided single-use obturator. The device allows tissue to be grasped with a standard grasping instrument extended through its central lumen. The tissue can be drawn up inside the device's central lumen into the inner stationary sheath as the exposed blade cuts the tissue. The physician can activate the GYNECARE MORCELLEX™ Tissue Morcellator via a foot pedal or via the dual-function Blade Guard / Activation Trigger on the device's detachable handle. The device can operate in either coring or peeling mode based on the degree of exposure of the blade and placement of the rotatable coreguard. The device is packaged with a single-use reducer cap to allow the optional use of a 5mm instrument.
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)
The bench testing data, including insertion and extraction forces, provided in this 510(k) demonstrates that the corrective action on the device design addresses the root cause of device failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a black and white abstract shape. The shape is irregular and has a jagged edge. The shape is isolated on a white background. The shape is dark and has no visible texture.
Image /page/0/Picture/1 description: The image contains two lines of alphanumeric characters. The first line reads 'K160280'. The second line reads 'pgiuf2'. The characters are handwritten and appear to be in black ink on a white background.
FILI
Johnon company
MAR 2 4 2010
510k Summary
| 510(k) Owner | ETHICON, Inc. |
|---|---|
| Contact Information | Bryan A. Lisa |
| Associate Director, Regulatory Affairs | |
| ETHICON Inc. | |
| PO Box 151 | |
| Route 22 West | |
| Somerville, NJ 08876 | |
| Telephone: 908.218.3392 | |
| Facsimile: 908.218.2595 | |
| Email: blisa@its.jnj.com | |
| Date of Preparation | 29 January 2010 |
| Device Classification | Trade Name: GYNECARE MORCELLEX™ Tissue Morcellator |
| Common Name: Laparoscope, gynecologic (and accessories) | |
| Classification Name/Number: | |
| Gynecologic laparoscope and accessories | |
| Regulation Number: 884.1720 | |
| Product code: HET | |
| Predicate Device | GYNECARE MORCELLEX™ Tissue Morcellator: K061050 |
| Device Description | The GYNECARE MORCELLEX™ Tissue Morcellator is a single-use |
| device. The device is inserted into the patient with the use of the | |
| provided single-use obturator. The device allows tissue to be | |
| grasped with a standard grasping instrument extended through its | |
| central lumen. The tissue can be drawn up inside the device's | |
| central lumen into the inner stationary sheath as the exposed blade | |
| cuts the tissue. The physician can activate the GYNECARE | |
| MORCELLEX™ Tissue Morcellator via a foot pedal or via the dual- | |
| function Blade Guard / Activation Trigger on the device's | |
| detachable handle. The device can operate in either coring or | |
| peeling mode based on the degree of exposure of the blade and | |
| placement of the rotatable coreguard. The device is packaged with | |
| a single-use reducer cap to allow the optional use of a 5mm | |
| instrument. | |
| Intended Use | The GYNECARE MORCELLEX™ Tissue Morcellator is intended for |
| gynecologic, urologic and general surgical endoscopic use by | |
| trained professionals in hospital environments and ambulatory | |
| surgery centers. | |
| Indications for Use | The GYNECARE MORCELLEX™ Tissue Morcellator is indicated for |
| cutting, coring, and extracting tissue during operative laparoscopy | |
| including laparoscopic general surgical procedures, laparoscopic | |
| urologic procedures, and laparoscopic gynecologic procedures. | |
| Technological | |
| Characteristics | The technological characteristics of GYNECARE MORCELLEX™, |
| including design and materials, are identical to the predicate | |
| device, GYNECARE MORCELLEX™. | |
| Performance Data | The bench testing data, including insertion and extraction forces, |
| provided in this 510(k) demonstrates that the corrective action on | |
| the device design addresses the root cause of device failure. | |
| Clinical Data | This 510(k) does not rely on clinical data to demonstrate |
| substantial equivalence. | |
| Conclusion | Based on the 510(k) summary and the information provided herein, |
| we conclude that the subject device is substantially equivalent to | |
| the predicate devices under the Federal Food, Drug, and Cosmetic | |
| Act. |
1
Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The first line reads 'K100280', with the 'z' possibly being a '2'. The second line reads 'pg 2uf2', where 'pg' is lowercase and the 'u' and 'f' are connected in a cursive style.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MAR 2 4 2010
Brian A. Lisa Associate Director, Regulatory Affairs ETHICON, Inc. Route 22 West, P.O. Box 151 SOMERVILLE NJ 08876
Re: K100280
Trade/Device Name: GYNECARE MORCELLEX™ Tissue Morcellator Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparascope and accessories Regulatory Class: II Product Code: HET Dated: January 29, 2010 Received: February 1, 2010
Dear Mr. Lisa:
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 of medical device-related
3
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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): _ K ) vo 2 8 C
Device Name: GYNECARE MORCELLEX™ Tissue Morcellator
Indications for Use:
The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.
Prescription Use X . Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number