(170 days)
K 991718, K 051610, K 974382
Not Found
No
The document describes standard endoscopes and surgical instruments without mentioning any AI/ML capabilities or image processing beyond basic visualization.
Yes
The cystoscopes are indicated for therapy in conjunction with endoscopic accessories/auxiliary instruments through the scope's working channel.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are intended for "diagnosis of joint disease" and for "examination, diagnosis and for therapy." This directly indicates a diagnostic purpose.
No
The device description explicitly lists physical hardware components such as surgical instruments, trocar sleeves, cannulas, suction-irrigation systems, and endoscopes (arthroscope, cystoscope). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used for visualization and surgical procedures within the body. This is the definition of an in-vivo device.
- Device Description: The description lists surgical instruments, trocar sleeves, and endoscopes, all of which are used for direct interaction with the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples outside of the body (in vitro), such as blood, urine, or tissue samples. IVDs are typically used in laboratories or point-of-care settings to analyze biological specimens.
Therefore, the described devices are surgical endoscopes and accessories intended for in-vivo use, not in-vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical nrocedures .
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The cystoscopes and accessories are used for visualizing body cavities and organs (via natural pessages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope s working channel.
The instruments are reusable; they are intended to be cleaned, sterilized and reused.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Trokamed GmbH Endoscopes and accessories consist of:
- A Various manually operated surgical instruments
- A Several Trocar sleeves and accessories, Verres insufflation cannula and suction-firrigation systems
-
Several Endoscopes (Arthroscope, Cystoscope)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, organs, canals, joint (knee, shoulder, wrist, temporal mandibular joint, ankle, elbow)
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)
Not Found
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.
K 991718, K 051610, K 974382
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
JUL 1 9 2006
Image /page/0/Picture/2 description: The image shows the logo for TROKAMED GmbH. The logo is black and white and features the word "TROKAMED" in bold letters. 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 abbreviation "GmbH" in smaller letters.
K .06.02 3.3. ........
Page 1 of 2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN Accordance with SMDA of 1990
DATE OF APPLICATION: 2006-01-26
Submitted by: Trokamed GmbH 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
Trade Name: Edoscopes and accessories
Common Name: Endoscopes
The Trokamed GmbH Endoscopes and accessories consist of:
- A Various manually operated surgical instruments
- A Several Trocar sleeves and accessories, Verres insufflation cannula and suction-firrigation systems
-
Several Endoscopes (Arthroscope, Cystoscope)
1
Trokamed GmbH
Kob0233
Image /page/1/Picture/2 description: The image shows the logo for TROKAMED GmbH. The logo is black and white and features the company name in bold, sans-serif font. The "O" in TRO is stylized as a semi-circle, and the "GmbH" is written in a smaller font size to the right of the word "KAMED".
2. Classification
| Device: | Endoscope and accessories |
|---|---|
| Panel: | 876 |
| Product Code: | GCJ |
| Device Class: | 2 |
| Regulation Number: | 876.1500 |
3. Intended Use
The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures. The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The cystoscopes and accessories are used for visualizing body cavities and organs (via natural passages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the schope's working channel.
The instruments are reusable; they are intended to be cleaned, sterilized and reused,
4. SUBSTANTIAL EQUIVALENCE
| Manufacturer | 510(k) Number | Device name |
|---|---|---|
| A Richard Wolf | K 991718 | Operating Laparoscope, 10-5mm, angeled... |
| B Hans Hermann | K 051610 | Laparoscopes and accessories |
| C Ackermann | K 974382 | Ackermann surgical instruments |
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 endoscopes and accessories 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2006
Trokamed GmbH % Karhlheinz Trondle President Kleine Breite 17 Geisingen, Germany 78187
Re: K060233
Trade/Device Name: Endoscopes and accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 21, 2006 Received: June 28, 2006
Dear Karhlheinz 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 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Karhlheinz Trondle
This letter will allow you to begin marketing your device as described in your Section 510(k) rremarket notification. The FDA finding of substantial equivalence of your device to a legally premaince no licate 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 11 you attent 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,
Ваваевичем
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): кобог33
Device Name: Endoscopes and accessories
Indications For Use:
The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical nrocedures .
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The cystoscopes and accessories are used for visualizing body cavities and organs (via natural pessages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope s working channel.
The instruments are reusable; they are intended to be cleaned, sterilized and reused.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehum for MKM
and Neurological Devices
Page 1 of _ 1
510(k) Number K060233