(163 days)
Not Found
No
The 510(k) summary describes standard electrosurgical instruments and accessories for prostate resection and does not mention any AI or ML capabilities.
Yes
The device is indicated for the resection of prostate tissue, which is a therapeutic intervention to treat a medical condition.
No
The device is described as an electrosurgical instrument indicated for resection of prostate tissue and for cutting and coagulation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states "electrosurgical instruments and accessories," indicating physical hardware components are involved. The intended use also describes a "Resectoscope & accessories" and "Monopolar Electrodes" and "Bipolar Electrodes," which are physical medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "resection of prostate tissue" and for "electrosurgical cutting and coagulation." These are procedures performed directly on the patient's body.
- Device Description: The device is described as "electrosurgical instruments and accessories." This aligns with surgical tools used in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body, not for direct surgical intervention.
N/A
Intended Use / Indications for Use
The Trokamed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.
The instruments are reusable; they are intended to be cleaned sterilized and reused.
Product codes
GEI
Device Description
electrosurgical instruments and accessories
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate tissue
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K 973341, K 964602, K 040699, K042077, K960757, K 971881
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo is black and white and features the word "TROKAMED" in a bold, sans-serif font. The "O" in TROKAMED is stylized as a circle with a break in the upper left quadrant. To the right of the word "TROKAMED" is the text "GmbH" in a smaller font, rotated 90 degrees clockwise, with a registered trademark symbol.
K 060232
Page 1 of 2
510(K) Summary of Safety and Effectiveness In Accordance with SMDA of 1990
JUL 1 2 2006
DATE OF APPLICATION: 2006-01-25
Trokamed GmbH Submitted by: Kleine Breite 17 78187 Geisingen Germany Tel.: +49 (0)7704/9244-0 Fax: +49 (0) 7704/9244-44 E-Mail: info@trokamed.de Homepage: www.trokamed.de
1. Device Description
electrosurgical instruments and accessories Trade Name: electrosurgical instruments and accessories Common Name:
2. Classification
| Device: | Electrosurgical cutting and coagulation device and accessories |
|---|---|
| Panel: | 878 General and Plastic surgery |
| Product Code: | GEI |
| Device Class: | 2 |
| Regulation Number: | 878.4400 |
C:\Documents and Settings\xc\Local Settings\Temporary Internet Files\OLK6F\510(k) Summary.doc Erstelldatum 21.09.2005 10:15:00 Seite 1 von 2
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Image /page/1/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo is in black and white and features the company name in a bold, sans-serif font. The "O" in TROKAMED is stylized with a circular design. The letters "GmbH" are smaller and vertically stacked to the right of the main name, with a registered trademark symbol next to them.
Kobo232
Page 2 of 2
3. Intended Use
The Trokamed GmbH Resectoscope & Accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used.
The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.
The instruments are reusable; they are intended to be cleaned, sterilized and reused.
| Manufacturer | 510(k) Number | Device name |
|---|---|---|
| A Richard Wolf | K 973341 | Unipolar electrodes |
| B Valleylab | K 964602 | Valleylab coated electrodes |
| C Megadyne | K 040699 | Leris |
| D Bissinger | K042077 | BiTech Bipolar Scissors |
| E Karl Storz | K960757 | Karl Storz Ureter Resectoscope |
| F COMEG Endoscopy | K 971881 | Comeg Resectoscope and... |
4. Substantial Equivalence
5. BIOCOMPATIBILITY
The biocompatibility has been approved based on ISO 10993 parts one, five and ten by the accredited Laboratory Bioservice.
6. Sterilization by User
Trokamed GmbH delivers all unipolar electrodes in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.
Trokamed GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.
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 circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trokamed GmbH % Karlheinz Trondle General Manager Kleine Breite 17 78187 Geisingen Germany
JUL 1 2 2006
Re: K060232
Trade/Device Name: Electrosurgical instruments and accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Class: II Product Code: GEI Dated: June 26, 2006 Received: June 28, 2006
Dear Mr. Trondle:
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 (PMA), 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal avencies. 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.
3
Page 2 – Mr. Karlheinz Trondle
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 (240) 276-0115. 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,
Hubert Humphrey
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 060232
Device Name: Electrosurgical instruments and accessories
Indications For Use:
The Trokemed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.
The instruments are reusable; they are intended to be cleaned sterilized and reused.
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)
(Division Sign-Off)
Division Sign-Off
Division of General, Restorative 1 of ________________________________________________________________________________________________________________________________________ and Neurological Devices
510(k) Number_1060232