(88 days)
HET
Not Found
No
The description focuses on mechanical operation and control via foot pedal or trigger, with no mention of AI or ML capabilities.
No.
The provided text describes a surgical device used for cutting, coring, and extracting tissue, not a device intended to treat a disease or condition.
No
The device is described as a tissue morcellator used for cutting, coring, and extracting tissue during surgical procedures. It is an operative device, not a diagnostic one.
No
The device description clearly details a physical, single-patient-use device with mechanical components (blade, sheath, handle, foot pedal, motor drive unit, flexible drive cable) used for cutting and extracting tissue. It is not solely software.
Based on the provided information, the GYNECARE Morcellex Tissue Morcellator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cutting, coring, and extracting tissue during operative laparoscopy within the patient's body. This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is described as being inserted into the patient and used to physically manipulate and remove tissue. This aligns with a surgical instrument, not a diagnostic test that analyzes samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect markers, or provide diagnostic information about a patient's condition.
IVD devices are typically used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The GYNECARE Morcellex Tissue Morcellator is a surgical tool used for tissue removal during a procedure.
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
HET
Device Description
The GYNECARE Morcellex Tissue Morcellator is a singlepatient-use device. The device is inserted into the patient with the use of the provided single-patient-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-patient-use reducer cap to allow the optional use of a 5mm instrument.
The variable-speed, reversible GYNECARE Motor Drive Unit (MDU) drives the rotation of the blade of the GYNECARE Morcellex Tissue Morcellator at a controlled speed and torque after connection of the device to the MDU via the Flexible Drive Cable. An operating room staff member outside of the sterile field controls the direction and speed of rotation on the MDU.
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 provided in this 510(k) shows that there is less force required to pull simulated tissue through the Morcellex device than is required for the existing device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GYNECARE X-TRACT* Tissue Morcellator
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.
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K061050 page 1 of 2
Section 5
JUL 1 4 2006
510(k) SUMMARY
Statement
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " .... 510(k) Summaries and 510(k) Statements ...." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
MODIFIED DEVICE NAME:
GYNECARE MORCELLEX* Tissue Morcellator
PREDICATE DEVICE NAME:
GYNECARE X-TRACT* Tissue Morcellator
Device Description
The GYNECARE Morcellex Tissue Morcellator is a singlepatient-use device. The device is inserted into the patient with the use of the provided single-patient-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-patient-use reducer cap to allow the optional use of a 5mm instrument.
The variable-speed, reversible GYNECARE Motor Drive Unit
1
| | (MDU) drives the rotation of the blade of the GYNECARE
Morcellex Tissue Morcellator at a controlled speed and torque after
connection of the device to the MDU via the Flexible Drive Cable.
An operating room staff member outside of the sterile field
controls the direction and speed of rotation on the MDU. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Statement | 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 modified device has the same technological characteristics as
the predicate device. The form, fit, function and method of
operation are similar. |
| Performance Data | The bench testing provided in this 510(k) shows that there is less
force required to pull simulated tissue through the Morcellex
device than is required for the existing device. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR
807) 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. |
| Contact | Bryan Lisa
Senior Regulatory Associate
ETHICON, INC.
Rt. 22 West
Somerville, NJ 08876-0151
Phone: (908) 218-3392
Fax: (908) 218-2595 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing the department's mission to protect the health of all Americans and provide essential human services. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 4 2006
Mr. Bryan Lisa Senior Regulatory Affairs Associate Ethicon, Inc. Ethicon Women's Health & Urology P.O. Box 151, Route 22 West SOMERVILLE NJ 08876
Re: K061050
Trade/Device Name: GYNECARE MORCELLEX* Tissue Morcellator Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: April 14, 2006 Received: April 17, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. Underneath "FDA" is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text.
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Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): --
Koblo50 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use __ | OR | Over-The Counter Use _ |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Eormat 1-2-9G) | |
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, | ||
| and Radiological Devices | ||
| 510(k) Number _ | ||