(13 days)
Not Found
Not Found
No
The description focuses on mechanical and manual functions of a suction/irrigation system, with no mention of AI or ML capabilities.
No
The device is described as a suction/irrigation system for rinsing liquid in the operating area, which is a procedural tool rather than a device intended to treat a disease or condition.
No
The device is described as a suction/irrigation system used for irrigation and aspiration of rinsing liquid in the operating area. Its function is to manage fluids during surgery, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly details a physical suction/irrigation system with handles, tubes, and an instrument channel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "suction/irrigation Systems for irrigation and aspiration of rinsing liquid in the operating area." This describes a surgical tool used during a procedure to manage fluids.
- Device Description: The description details a system for delivering and removing liquids from a surgical site. It mentions features like handles, tubes, valves, and an instrument channel. These are all consistent with surgical instruments.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The provided description does not mention any analysis of specimens or diagnostic purposes.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
suction/irrigation
Systems for irrigation and aspiration of rinsing liquid in the operating area.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Oenchal modular multifunction suction/irrigation system with pistol handle, maintenance i he Fajant modular many different adaptable tubes and lockable instrument channel for iree & way varro, marry af rinsing liquid in the laparoscopic operating area. The instrument imgation and aspliation of this instruments are inserted and closes when they are channel adomatioally opene would the instrument channel can be opened manually by removed. Allemativery "are xample to remove a hook-type instrument or a biopsy. The prossing a pachbutter.inted/ assembled for cleaning without any tools needed.
Modular Valve fiction handles with trumpet valves or maintenance-free 2-way valves The T ajurit Suchon inigation hardison her in the dismounted without any tools. Each handle can be used with any tube having a M8x1 mm connector; i.e. all handles of the series 1298-XX-00 are completely interchangeable.
The Pajunk adaptable suction/irrigation tubes with connector M8x1 mm can be used with any handle having a M8x1 mm connector. Adaptable suction/irrigation tubes with large LuerLock connector female can be used with any handles of series 1295-XX-00.
Modular multifunction suction/irrigation system with pistol handle, maintenance-free 2-way walve, many different adaptable tubes and lockable instrument channel Ø 5mm for irrigation valve, many direront adaptable the laparoscopic operating area. The instrument channel automatically opens when instruments are inserted and closes when they are removed. automativally the closure of the instrument channel can be opened manually by pressing a Akerhutton for example to repove a hook-type instrument or a biopsy. The system can be dismounted/assembled for feaning without any tools need
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laparoscopic operating area
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.
Not Found
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
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Applicant: | Pajunk GmbH
Am Holzplatz 5 - 7
D-78187 Geisingen
Germany
Tel. 07704 9291-0 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Martin Hauger
Technical Director |
| Device Identification: | Common Name:
modular valve handles for adaptable tubes, adaptable
suction/irrigation tubes
Trade Name:
modular valve handles for adaptable tubes, adaptable
suction/irrigation tubes |
Indication and Device Description:
General
Oenchal modular multifunction suction/irrigation system with pistol handle, maintenance i he Fajant modular many different adaptable tubes and lockable instrument channel for iree & way varro, marry af rinsing liquid in the laparoscopic operating area. The instrument imgation and aspliation of this instruments are inserted and closes when they are channel adomatioally opene would the instrument channel can be opened manually by removed. Allemativery "are xample to remove a hook-type instrument or a biopsy. The prossing a pachbutter.inted/ assembled for cleaning without any tools needed.
Modular valve handles for adaptable tubes
Modular Turve fiction handles with trumpet valves or maintenance-free 2-way valves The T ajurit Suchon inigation hardison her in the dismounted without any tools. Each handle can be used with any tube having a M8x1 mm connector; i.e. all handles of the series 1298-XX-00 are completely interchangeable.
Adaptable suction/irrigation tubes
The Pajunk adaptable suction/irrigation tubes with connector M8x1 mm can be used with any handle having a M8x1 mm connector. Adaptable suction/irrigation tubes with large LuerLock connector female can be used with any handles of series 1295-XX-00.
Modular multifunction suction/irrigation system with instrument channel
Modular multifunction suction/irrigation system with pistol handle, maintenance-free 2-way walve, many different adaptable tubes and lockable instrument channel Ø 5mm for irrigation valve, many direront adaptable the laparoscopic operating area. The instrument channel automatically opens when instruments are inserted and closes when they are removed. automativally the closure of the instrument channel can be opened manually by pressing a Akerhutton for example to repove a hook-type instrument or a biopsy. The system can be dismounted/assembled for feaning without any tools need
Signed:
Mr. Horst Pajunk
General Manager
tools needed.
Mr.Heinrich Rajunk
General Manager
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2001
Pajunk GmbH c/o Mr. Mark Job TÜV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K011997
Trade/Device Name: Modular Valve Handles for Adaptable Tubes Regulation Number: 876.1500 Regulatory Class: II Product Code: GCJ Dated: June 13, 2001 Received: June 27, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Mark Job
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. THE I Drivin 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 and IT you desire specific arriver Jamostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (2017) 594-1639. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsive at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerety yours,
Mark N Melkinn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Medizintechnologie
Page_1_of_i
510(k) Number (if known): KO 11997
Device Name: _modular valve handles for adaptable tubes
Indications For Use: _suction/irrigation
Systems for irrigation and aspiration of rinsing liquid in the operating area.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
le Mark n. Melleker
Restorative d Neurologic
510(k) Number K011497
(Optional Format 3-10-98)