(691 days)
Not Found
No
The summary describes a mechanical device for tissue morcellation and extraction, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for morcellating and extracting tissue, which is a surgical procedure, not a therapeutic treatment.
No
The device description indicates that it is used for "morcellating and extracting tissue," which is a surgical procedure, not a diagnostic one. There is no mention of it being used to identify or analyze a disease or condition.
No
The device description explicitly lists multiple hardware components including a control unit, grip module, foot pedals, power cord, control cable, flexible shaft, cutting modules, trocar sheaths, trocars, and forceps. This indicates it is a physical medical device with software components, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "morcellating and extracting tissue during laparoscopic procedures." This is a surgical procedure performed on the patient, not a test performed on a sample of the patient's body outside of the body.
- Device Description: The description details a surgical instrument with components like a control unit, grip module, foot pedals, and cutting modules. These are tools used in surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples in vitro), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for tissue removal during a procedure.
N/A
Intended Use / Indications for Use
The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
Product codes (comma separated list FDA assigned to the subject device)
HET, GCJ
Device Description
The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps.
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
Not Found
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 device complies with applicable requirements of recognized consensus standards IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility) and Medical Device Directive 93/42/EEC, and is manufactured at an ISO 13485 facility.
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.
K993801, K061180, K041610, K960640
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
K09101C page 1 of 2
ーで
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR - 1 20il
| Date: | February 9, 2011 |
|---|---|
| Submitter: | |
| Name: | Trokamed GmbH |
| Address: | Kleine Breite 17 |
| 78187 Geisingen | |
| Germany | |
| Contact Person: | Harald Merkt |
| Telephone: | +49.7704.92440 |
| Fax: | +49.7704.924444 |
| Product: | |
| Trade Name: | TROKAMED MORCELLATOR |
| Classification: | HET, GCJ (Class II) |
| Common Names: | Morcellator |
| Classification Names: | Endoscopic Cutting Accessory |
| Predicate Device: | K993801, Gynecare Laparoscopic MorcellatorK061180, Storz KSEA Rotocut GIK041610, Morce Scope Set - MorcellatorK960640, SEMM Set for Moto Drive WISAP |
| Device Description: | The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps. |
| Intended Use: | The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy. |
| Performance Data: | The device complies with applicable requirements of recognized consensus standards IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility) and Medical Device Directive 93/42/EEC, and is manufactured at an ISO 13485 facility. |
| Sterilization | The control unit, power cable and foot pedals are provided non-sterile for disinfection only. |
| The flexible shaft, control cable, grip module, trocar sheaths, trocars, and forceps are provided non-sterile for steam sterilization. | |
| The cutting modules and the valve unit are provided sterile for single use only. |
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KD91010 page 2 of 2
Conclusion: The basic features, design and intended uses of the TROKAMED MORCELLATOR are similar or identical to those of the predicate devices. The minor differences in design and dimensions have no effect on the performance, function or intended use of the device and do not raise any new issues of safety and effectiveness. In summary, the applicant considers the TROKAMED MORCELLATOR to be substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Trokamed GmbH % Ms. Angelika Scherp Regulatory Affairs Consultant Business Support International Amstel 320-I 1017 AP Amsterdam NH 1017AP THE NETHERLANDS
- 1 2011
Re: K091010
Trade Name: Trokamed Morcellator Regulation Number: 21 CFR 8884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET and GCJ Dated: August 9, 2010 Received: August 19, 2010
Dear Ms. Scherp:
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
Page 2
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/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.
Sincerely yours,
Hichard Lemmer us
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K091010
Device Name: TROKAMED MORCELLATOR
Indications for Use: The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tom K. Whing
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K091010.
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