(504 days)
The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gyrocological procedures to morcellate and remove tissue.
The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.
The Morce Power Plus / VarioCarve is the drive control unit for the morcellator. With a cutting blade on the distal end, a rotating cylindrical tube is inserted in the abdominal cavity.
This document is a 510(k) summary for the NOUVAG AG Morcellator (Morce Power Plus / VarioCarve). The device is a surgical morcellator used in laparoscopic procedures.
Here's an analysis of the provided text in relation to acceptance criteria and device performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics explicitly stated for the NOUVAG AG Morcellator. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against predefined criteria.
The general statement regarding performance is:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety & Effectiveness | "The Morcellator has been designed and tested to applicable safety standards. The Morcellator does not raise any new issues of safety, effectiveness, or performance of the product." (Implicitly, it meets the safety, effectiveness, and performance standards of the predicate devices based on substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe any specific test set or clinical study with a defined sample size. The substantial equivalence claim is made based on the device's technological characteristics being similar to already legally marketed devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as there is no described test set requiring ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not applicable as there is no described test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on comparative effectiveness with or without AI assistance (which is not relevant to this type of device).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm-only) performance study was not conducted or reported. This device is a mechanical surgical instrument, not an AI or diagnostic algorithm, so this type of study is not relevant.
7. The Type of Ground Truth Used
This information is not applicable as there is no described test set requiring ground truth. The basis for clearance is substantial equivalence to predicate devices, implying that the established safety and effectiveness of the predicates serve as a "ground truth" for the new device's similar characteristics and intended use.
8. The Sample Size for the Training Set
There is no mention of a training set in this 510(k) summary. This type of device (surgical instrument) does not typically involve AI models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set.
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NOUVAG AG Morcellator
K080365 510(k) Notification June 25, 2009
SECTION 10
510(k) Summary
JUN 29 2009
Submitter:
NOUVAG AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland
Contact Person:
Erich Forster (INTRATest GmbH) Consultant Phone +41 56 201 95 00 Fax +41 56 201 95 05
Date Summary Prepared: June 25, 2009
Device Name:
Proprietary Name
Morce Power Plus Morcellator (Distributed by Richard Wolf) VarioCarve Morcellator (Distributed by Olympus)
Common Name Morcellator
Classification Name Gynecologic laparoscope and accessories (per 21 CFR section 884.1720)
Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
ETHICON, Inc. GYNECARE X-TRACT Tissue Morcellator K993801, Cleared on 02/07/2000
WISAP Gesellschaft für wissenschaftl. App.bau SEE*M SET K960640, cleared on 02/14/1997
WISAP Gesellschaft für wissenschaftl. App.bau POWER-DRIVE,WISAP Model 7688PD/7688PD1 K982515, cleared on 01/19/1999
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K080365 510(k) Notification June 25, 2009
Device Description:
The Morce Power Plus / VarioCarve is the drive control unit for the morcellator. With a cutting blade on the distal end, a rotating cylindrical tube is inserted in the abdominal cavity.
Sterility:
Motor, motorcable, and morcellator: Sterility by user up to 134℃.
Intended use of the Devices:
Morce Power Plus Morcellator (Distributed by Richard Wolf) The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gynerological procedures to morcellate and remove tissue.
VarioCarve Morcellator (Distributed by Olympus)
The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surger y and gynecology.
Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:
The Morcellator is substantially equivalent to other legally marketed devices in the United States. The Morcellator functions in a manner similar and are intended for the same use as the Devices designed by Ethicon, Inc. and WISAP Gesellschaft für wissenschaftl.18 probau
Brief summary of nonclinical tests and results:
The Morcellator has been designed and tested to applicable safety standards. The Morcellator does not raise any new issues of safety, effectiveness, or performance of the product.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration . 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2009
Nouvag AG c/o Mr. Erich Forster INTRATest Systems GmbH Reusswehrstrasse 1 Gebenstorf SWITZERLAND CH-5412
K080365 Re:
Trade/Device Name: Morce Power Plus Morcellator (Distributed by Richard Wolf) VarioCarve Morcellator (Distributed by Olympus) Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: June 8, 2009 Received: June 16, 2009
Dear Mr. Forster:
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. Isting 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 (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 (reporting of medical
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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda:gov/cdrh/industry/support/index.html.
Sincerely yours,
Jayne M. Morris
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
510(k) Number (if known): K080365
Device Name:__ Morce Power Plus Morcellator (Distributed by Richard Wolf)
Indications For Use:
The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gyrocological procedures to morcellate and remove tissue.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
Page 1 of 1
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Indications for Use
510(k) Number (if known):__K080365
Device Name:__VarioCarve Morcellator (Distributed by Olympus)
Indications For Use:
The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hullem
Divisid Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Page 1 of 1
§ 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.