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 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.

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

AI/ML Overview

This is a 510(k) premarket notification for a medical device, not a study report. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for a performance study is not present in the provided text.

The document describes the device, its indications for use, and confirms that the FDA has found it substantially equivalent to legally marketed predicate devices. It does not contain a study demonstrating how the device meets specific acceptance criteria based on performance metrics.

Here's an attempt to answer the questions based on the available information, noting what cannot be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. The 510(k) submission is about demonstrating substantial equivalence to a predicate device, not typically about reporting specific performance metrics against pre-defined acceptance criteria in the format of a clinical or technical study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available. The document focuses on the description of the device itself and its equivalence to other devices, not on a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not available. The device is a "modular valve handles for adaptable tubes" and an "adaptable suction/irrigation system." It is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study or AI-related effectiveness is irrelevant and not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not available and is not applicable. The device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available. No ground truth for performance evaluation is mentioned.

8. The sample size for the training set

This information is not available. The document is not about a machine learning or AI device that would require a training set.

9. How the ground truth for the training set was established

This information is not available. Not applicable to this type of device.

Summary of what is present:

Indications for Use: "suction/irrigation Systems for irrigation and aspiration of rinsing liquid in the operating area."
Device Description: Modular valve handles, adaptable suction/irrigation tubes, and a modular multifunction suction/irrigation system with a pistol handle, 2-way valve, and lockable instrument channel.
Regulatory Classification: Class II, Product Code GCJ, Regulation Number 876.1500.
Outcome: The FDA found the device "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

This document serves as an FDA clearance letter based on substantial equivalence, which is a different type of submission than a detailed performance study with defined acceptance criteria and experimental results.

Summary

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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 GmbHAm Holzplatz 5 - 7D-78187 GeisingenGermanyTel. 07704 9291-0
Contact:	Martin HaugerTechnical Director
Device Identification:	Common Name:modular valve handles for adaptable tubes, adaptablesuction/irrigation tubesTrade Name:modular valve handles for adaptable tubes, adaptablesuction/irrigation tubes

Indication and Device Description:

General

Modular valve handles for adaptable tubes

Adaptable suction/irrigation tubes

Modular multifunction suction/irrigation system with instrument channel

Signed:

Mr. Horst Pajunk
General Manager

tools needed.

Mr.Heinrich Rajunk
General Manager

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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

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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)

Regulation Number and Section

§ 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.