(51 days)
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.
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.
The provided text describes a 510(k) summary for the GYNECARE MORCELLEX™ Tissue Morcellator, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a dedicated study proving a device meets specific performance criteria.
The "Performance Data" section explicitly states: "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." This indicates testing was done related to a "root cause of device failure" for a previous version of the device (K061050), and not necessarily to establish new performance criteria for the current device's intended use in comparison to a defined clinical or performance benchmark.
Furthermore, the "Clinical Data" section states: "This 510(k) does not rely on clinical data to demonstrate substantial equivalence."
Therefore, based solely on the provided text, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study with the specified details (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance) is not described.
The document primarily focuses on demonstrating that the technological characteristics of the current device are identical to its predicate, and that previous bench testing (related to a corrective action) was sufficient for the 510(k) clearance process.
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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. LisaAssociate Director, Regulatory AffairsETHICON Inc.PO Box 151Route 22 WestSomerville, NJ 08876Telephone: 908.218.3392Facsimile: 908.218.2595Email: blisa@its.jnj.com |
| Date of Preparation | 29 January 2010 |
| Device Classification | Trade Name: GYNECARE MORCELLEX™ Tissue MorcellatorCommon Name: Laparoscope, gynecologic (and accessories)Classification Name/Number:Gynecologic laparoscope and accessoriesRegulation Number: 884.1720Product code: HET |
| Predicate Device | GYNECARE MORCELLEX™ Tissue Morcellator: K061050 |
| Device Description | The GYNECARE MORCELLEX™ Tissue Morcellator is a single-usedevice. The device is inserted into the patient with the use of theprovided single-use obturator. The device allows tissue to begrasped with a standard grasping instrument extended through itscentral lumen. The tissue can be drawn up inside the device'scentral lumen into the inner stationary sheath as the exposed bladecuts the tissue. The physician can activate the GYNECAREMORCELLEX™ Tissue Morcellator via a foot pedal or via the dual-function Blade Guard / Activation Trigger on the device'sdetachable handle. The device can operate in either coring orpeeling mode based on the degree of exposure of the blade andplacement of the rotatable coreguard. The device is packaged witha single-use reducer cap to allow the optional use of a 5mminstrument. |
| Intended Use | The GYNECARE MORCELLEX™ Tissue Morcellator is intended forgynecologic, urologic and general surgical endoscopic use bytrained professionals in hospital environments and ambulatorysurgery centers. |
| Indications for Use | The GYNECARE MORCELLEX™ Tissue Morcellator is indicated forcutting, coring, and extracting tissue during operative laparoscopyincluding laparoscopic general surgical procedures, laparoscopicurologic procedures, and laparoscopic gynecologic procedures. |
| TechnologicalCharacteristics | The technological characteristics of GYNECARE MORCELLEX™,including design and materials, are identical to the predicatedevice, GYNECARE MORCELLEX™. |
| Performance Data | The bench testing data, including insertion and extraction forces,provided in this 510(k) demonstrates that the corrective action onthe device design addresses the root cause of device failure. |
| Clinical Data | This 510(k) does not rely on clinical data to demonstratesubstantial equivalence. |
| Conclusion | Based on the 510(k) summary and the information provided herein,we conclude that the subject device is substantially equivalent tothe predicate devices under the Federal Food, Drug, and CosmeticAct. |
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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
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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
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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
§ 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.