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 Trocars, 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 The devices follow the FDA Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology, dated 3/17/95.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.

AI/ML Overview

This document is a 510(k) Premarket Notification Submission for a medical device called "TrocaSys disposable Trocar System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria for device performance. Therefore, the information you've requested regarding acceptance criteria and performance studies in the way one might evaluate AI/ML-based devices or other novel technologies is not applicable within this document.

Here's why and what information can be extracted:

510(k) Submissions: These submissions establish that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or has different technological characteristics but does not raise new questions of safety and effectiveness.
Focus on Equivalence: The primary "proof" in a 510(k) is the comparison to the predicate device, showing that the new device performs as safely and effectively as the predicate. This typically involves engineering tests, material compatibility, sterilization validation, and often a functional comparison, but not necessarily a clinical study with detailed performance metrics against specific acceptance criteria.

Therefore, your direct questions regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics are not directly addressed in this type of submission.

However, I can extract information related to the device and its regulatory context:

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

As explained above, this 510(k) submission does not present acceptance criteria and reported device performance in the typical manner of a novel device proving its efficacy or diagnostic accuracy. The "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to a predicate device.

The document states: "The system is based on Pajunks reusable Trokars, Trokar sleeves and Accessories already cleared in K012771. The technical description remains unchanged." This implies that the performance characteristics should be equivalent to the predicate device.

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

Not applicable. This submission doesn't detail a clinical study with a "test set" in the sense of patient data for performance evaluation. The "data provenance" would relate to the technical specifications and testing against standards for the device itself (e.g., material testing, sterilization validation), not patient data.

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)

Not applicable. There is no mention of a "test set" requiring expert ground truth establishment for clinical performance in this 510(k) submission.

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

Not applicable. No such adjudication method is mentioned as there is no clinical test set for performance evaluation 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

Not applicable. This device is a manual surgical tool (trocar system), not an AI-assisted diagnostic or therapeutic system. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is a manual surgical tool, not an algorithm.

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

Not applicable in the context of clinical performance evaluation. The "ground truth" for this device would be its ability to physically perform its function safely and effectively as a surgical tool, which is assessed through engineering principles, material science, and comparison to the predicate.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of machine learning or AI described for this manual surgical device.

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

Not applicable. As there is no training set, this question is not relevant.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a new manual surgical device to a predicate device, rather than a report on a clinical study with specific performance acceptance criteria for a novel technology.

Summary

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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

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Premarket Notification Submission

TrocaSys

MEDIZINTECHNOLOGIE

Device Description:

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.

K063582

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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.

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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

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Premarket Notification Submission

TrocaSys

MEDIZINTECHNOLOGIE

Indications for use

510(k) Number:

Device Name:

TrocaSys disposable Trocar System

Indications for Use:

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 /<063528

Page 1 of 1

K063582

PMN

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.