(56 days)
Not Found
No
The description focuses on manually operated surgical devices and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The trochlear system is described as a surgical device for making incisions, not for treating a disease or condition.
No
The device is a manually operated surgical device used for making incisions to allow the insertion of endoscopes and accessories, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components like disposable trocar sleeves, trocars, obturators, and valves, and is a manually operated surgical device.
Based on the provided information, the Pajunk TrocaSys is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "manually operated surgical device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures." This describes a surgical tool used on the patient's body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description reinforces its function as a surgical instrument for creating access points during procedures. It discusses components like trocar sleeves, trocars, obturators, and valves, all of which are physical tools for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, the Pajunk TrocaSys falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Pajunk TrocaSys consists of disposable trocar sleeves, disposable trocars and obturators and disposable valves (i.e. TrocaTec, TrocaPort, Hasson system for example for insufflation). The system is based on Pajunks reusable Trokars, Trokar sleeves and Accessories already cleared in K012771. The technical description remains unchanged.
The systems and its accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and end propio accessories during general endoscopic and laparoscopic procedures.
The devices follow the FDA Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology, dated 3/17/95.
The trocars and obturators are used together with the trocar sleeves for puncture of the patient's body. After having made the incision, the trocar is removed to allow insertion of end scope and endoscopic accessories.
The Disposable Hasson Cone, Disposable obturators/ trocars, Disposable Trocar valve, Disposable TrocaTec and Disposable TrocaPort are available seperately.
For a detalied device description please refer to section 11.0 of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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.
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
Premarket Notification Submission
TrocaSys
Image /page/0/Picture/2 description: The image shows the number K063528 at the top. Below that is the word PAJUNK in a bold, sans-serif font. Underneath that is the word MEDIZINTECHNOLOGIE in a smaller, sans-serif font.
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: November 6th 2006
Submitter Information/ production site:
Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605
Contact:
Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com
Establishment Registration Number:
9611612
Device Information:
| Device Name: | Disposable Trocar System |
|---|---|
| Trade Names: | TrocaSys |
| Common Name: | Laparoscope, General and Plastic surgery |
| Classification Name: | Endoscope and accessories |
| Classification Reference: | 21 CFR §876.1500, April 1, 2005 |
| Establishment Registration Number: | 9611612 |
| Classification: | Regulatory Class: II |
| Product Code: | GCJ |
| Panel: | General & Plastic Surgery |
| Predicate Devices: | K012771: Pajunks reusable Trocars, trocar sleeves, dilation balloons and trocar Systems |
Contract Sterilizer:
SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Moerfelden-Walldorf Germany
JAN 1 7 2007
1
Premarket Notification Submission
TrocaSys
MEDIZINTECHNOLOGIE
Device Description:
The Pajunk TrocaSys consists of disposable trocar sleeves, disposable trocars and obturators and disposable valves (i.e. TrocaTec, TrocaPort, Hasson system for example for insufflation). The system is based on Pajunks reusable Trokars, Trokar sleeves and Accessories already cleared in K012771. The technical description remains unchanged.
The systems and its accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and end propio accessories during general endoscopic and laparoscopic procedures.
The devices follow the FDA Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology, dated 3/17/95.
The trocars and obturators are used together with the trocar sleeves for puncture of the patient's body. After having made the incision, the trocar is removed to allow insertion of end scope and endoscopic accessories.
The Disposable Hasson Cone, Disposable obturators/ trocars, Disposable Trocar valve, Disposable TrocaTec and Disposable TrocaPort are available seperately.
For a detalied device description please refer to section 11.0 of this submission.
Disposable TrocaPort
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient´s body to allow the insertion of endoscopes and endoscopic accessories around general endoscopic and laparoscopic procedures. The TracePort is a component of the system available seperately.
Disposable TrocaTec
IThe Pajunk TrocaSys is a manually operated surgical! device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures. The TrocaTec is a component of the system available seperately.
Disposable Trocar valve
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories aring general endoscopic and laparoscopic procedures. The disposable Trocar value is a component of the system available seperately. It may be used with Pajunks dilation balloon systems also.
Disposable obturators/ trocars
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures. The obturators and trocars are components of the system available seperately. They may be used with Pajunks dilation balloon systems also.
Disposable Hasson Cone
PMN
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparosiser enable procedures. The Hasson Cone is a component of the system available seperately.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around the perimeter. Inside the circle is a stylized image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2007
Pajunk GmbH Medizintechnologie % Christian Quass Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany
Re: K063528
Trade/Device Name: TrocaSys disposable Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 4, 2007 Received: January 8, 2006
Dear Christian Quass:
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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Christian Quass
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,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Submission
TrocaSys
MEDIZINTECHNOLOGIE
Indications for use
510(k) Number:
Device Name:
TrocaSys disposable Trocar System
Indications for Use:
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
Prescription Use (Per 21 CFR 801.109) 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 General, Restorative, and Neurological Devices
510(k) Number /