(90 days)
Gynecare Laparoscopic Morcellator
Not Found
No
The device description focuses on mechanical components and user-controlled functions (foot pedal, speed/direction control). There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is described as a surgical instrument for cutting, coring, and extracting tissue, which are mechanical actions, not therapeutic ones aimed at treating a disease or disorder.
No
The device is described as a surgical tool used for cutting, coring, and extracting tissue, primarily for operative laparoscopy. Its function is to perform a physical action on tissue, not to diagnose or identify medical conditions.
No
The device description clearly outlines physical hardware components including a disposable morcellator, a motor drive unit, a flexible drive cable, and a foot pedal.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cutting, coring, and extracting tissue during surgical procedures (laparoscopy). This is a surgical tool used on the patient, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details a mechanical device with a rotating blade for tissue removal. This aligns with a surgical instrument, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples after removal for testing), reagents, or diagnostic assays.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely mechanical tissue removal during surgery.
N/A
Intended Use / Indications for Use
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures such as nephrectomy, and laparoscopic gynecologic procedures such as myomectomy and hysterectomy.
The Gynecare Laparoscopic Morcellator is intended for gynecologic, urologic, and general surgical endoscopic use by trained professionals in hospital environments.
Product codes (comma separated list FDA assigned to the subject device)
85 HET
Device Description
The modified Laparoscopic Morcellator is comprised of two major components: the Laparoscopic Morcellator and the Motor Drive Unit (MDU). The Gynecare Laparoscopic Morcellator is a disposable device which is provided sterile. It is essentially a rotating, cylindrical (tubular) razor blade, with a blade guard, which allows tissue to be grasped with a standard grasper type instrument extending through the central lumen of the device and then drawn up inside the rotating cutter as the cutter cuts with a coring action. The cutting is powered by the Gynecare Laparoscopic Motor Drive Unit (MDU) via a flexible drive cable (see drawing). The physician can turn the Gynecare Laparoscopic Morcellator on and off via a foot pedal. The direction and speed of rotation are controlled on the face of the MDU by a nurse outside the sterile field.
The variable-speed, reversible MDU is an integral part of the Gynecare Laparoscopic Morcellator since it drives the rotation of the cutter/Morcellator at a controlled speed and torque. The Gynecare Motor Drive Unit provides a user-selectable speed range at which to drive (rotate) the cutter/Morcellator. The torsional output of the motor is sufficient at all speeds to drive the cutter while cutting tough tissue. The direction of rotation of the motor is user-selectable.
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.
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)
Nonclinical laboratory was deemed unnecessary.
No clinical data was deemed necessary to support this premarket notification; however, published literature is available to support the use of a laparoscopic morcellation device for laparoscopic hysterectomies.
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.
Gynecare Laparoscopic Morcellator
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
FEB 7 2000
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness
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 Laparoscopic Morcellator |
|---|---|
| PREDICATE DEVICE NAME: | Gynecare Laparoscopic Morcellator |
510(k) SUMMARY
Device Description
The modified Laparoscopic Morcellator is comprised of two major components: the Laparoscopic Morcellator and the Motor Drive Unit (MDU). The Gynecare Laparoscopic Morcellator is a disposable device which is provided sterile. It is essentially a rotating, cylindrical (tubular) razor blade, with a blade guard, which allows tissue to be grasped with a standard grasper type instrument extending through the central lumen of the device and then drawn up inside the rotating cutter as the cutter cuts with a coring action. The cutting is powered by the Gynecare Laparoscopic Motor Drive Unit (MDU) via a flexible drive cable (see drawing). The physician can turn the Gynecare Laparoscopic Morcellator on and off via a foot pedal. The direction and speed of rotation are controlled on the face of the MDU by a nurse outside the sterile field.
Continued on next page
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Device Description,
Continued | The variable-speed, reversible MDU is an integral part of the
Gynecare Laparoscopic Morcellator since it drives the rotation of
the cutter/Morcellator at a controlled speed and torque. The
Gynecare Motor Drive Unit provides a user-selectable speed range
at which to drive (rotate) the cutter/Morcellator. The torsional
output of the motor is sufficient at all speeds to drive the cutter
while cutting tough tissue. The direction of rotation of the motor is
user-selectable. | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications For Use | Indicated for cutting, coring and extracting tissue in operative
laparoscopy, including laparoscopic general surgical procedures,
laparoscopic urologic procedures such as nephrectomy, and
laparoscopic gynecologic procedures such as myomectomy and
hysterectomy. | |
| Intended Use | The Gynecare Laparoscopic Morcellator is intended for
gynecologic, urologic, and general surgical endoscopic use by
trained professionals in hospital environments. | |
| Technological
Characteristics | The modified device has identical technological characteristics to
the predicate device. | |
| Performance Data | Nonclinical laboratory was deemed unnecessary. | |
| Clinical Data | No clinical data was deemed necessary to support this premarket
notification; however, published literature is available to support
the use of a laparoscopic morcellation device for laparoscopic
hysterectomies. | |
| | Continued on next page | |
の 2007年の1000年の1000年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に1000
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.
.
Contact
Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
November 8, 1999
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc., a Johnson & Johnson Co. P.O. Box 151 Somerville, NJ 08876-0151
Re: K993801
Gynecare Laparoscopic Morcellator Dated: November 8, 1999 Received: November 9, 1999 Requlatory Class: II 21CFR §884.1720/Procode: 85 HET
Dear Mr. Jones:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions, Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE
K993801 510(k) Number (if known):
Device Name:
Laparoscopic Morcellator
Indications For Use:
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures such as nephrectomy, and laparoscopic gynecologic procedures such as myomectomy and hysterectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use _
David G. Elynn
(Divisio): ... . . . - Off) 'eproductive, Abdominal, ENT. Division ! and Radiolo leal I 510(k) Number
Modified Laparoscopic Morcellator Gynecare/ETHICON, Inc.
(Optional Format 1-2-9G)
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