Ceramic tip electrodes are instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.

Device Description

The Pajunk ceramic tip electrodes are multiple uses, non-sterile delivered and latex free medical devices. They are intended for transient delivery of energy required for coagulation of tissue.

The Pajunk MIC-System contains but is not limited to HF-electrodes for comfortable and safe coagulation. Pajunk provides electrodes with and without suction and irrigation element and electrodes with suction and irrigation capacity with retractable/ extendable tips. Isolation at tip is made by ceramic.

The Modular system for optional monopolar coagulation enables a surgeon to manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures. The instruments are insulated for optional monopolar coagulation.

The electrode-tips are retractable for comfortable suction and irrigation performance.

The Pajunk ceramic tip electrodes are intended for transient delivery of energy required for coagulation of tissue. Ceramic tip electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions for use. The ceramic tip electrodes consist of a medical grade steel tube, ceramic tip and stainless steel electrode tip.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for a device called "Pajunk ceramic tip electrodes." This submission is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a clinical or technical validation study.

Therefore, an acceptance criteria table and details of a performance study as would be seen for novel devices with specific performance claims are not explicitly present in the provided document. The "study" here is the comparison to predicate devices to establish substantial equivalence.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the submission focuses on substantial equivalence to predicate devices. The "acceptance criteria" are implied by the regulatory definition of substantial equivalence, meaning the new device has the same intended use and technological characteristics as the predicate, or if there are differences, they do not raise different questions of safety and effectiveness.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary from Submission)
Intended Use: Same as predicate device.	Same: "Pajunk ceramic tip electrodes are intended for transient delivery of energy required for coagulation of tissue. Ceramic tip electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions for use." This matches the general intended use of electrosurgical cutting and coagulation devices and accessories. (The predicate device (K033249) has an identical intended use).
Technological Characteristics: Same as predicate device OR differences do not raise new questions of safety and effectiveness.	Similar with one key difference (ceramic tip vs. polyamide): "Pajunk's monopolar ceramic tip electrodes have the same technological characteristics as the predicate device identified below. Pajunk's monopolar ceramic tip electrodes are substantially equivalent to Pajunk's monopolar electrodes marketed under 51000) number K033249. All materials, dimensions and intended use are identical. There is one exception, which is the electrical insulation at the electrode tip. The polyamide (Nylon) coating is substituted by a ceramic tip." "Equivalent in design, physical dimensions, ceramic, metal and plastics materials," to another predicate (Aesculap K970541). The only design difference mentioned for the Aesculap predicate is that "Aesculap's monopolar ceramic tips can be unlocked from the electrode shaft. Pajunk's monopolar ceramic tips are fixed to the electrode shaft and can not be removed, nor lost during a surgical procedure." This is presented as a safety improvement, not a new risk.
Biocompatibility: Device materials are biocompatible.	Biocompatibility testing performed: "Biocompatibility testing of Pajunk's monopolar ceramic tip electrodes is located in Section 7 of this submission." (Details of the results are not in the provided text, but the statement indicates it was addressed).
Safety and Effectiveness: Demonstrated through comparison to predicate.	Conclusion: "The comparison between the predicate device and the proposed device demonstrates that the proposed device is safe and effective, as well as substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

No specific "test set" and sample size are mentioned for performance assessment in the provided text.
Data Provenance: The "study" is a comparison to predicate devices, drawing upon their established safety and effectiveness. The predicate devices are Pajunk's monopolar electrodes (K033249) and Aesculap's modular monopolar ceramic tip electrodes (K970541), which would have undergone their own regulatory approval processes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of expert review for "ground truth" establishment is not applicable to this 510(k) submission. The submission relies on demonstrating similarity to already cleared devices.

4. Adjudication Method

Not applicable. There is no clinical or performance data requiring adjudication by experts described in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is typically performed to assess human reader performance, often with and without AI assistance. This submission does not involve AI or a complex interpretive task requiring such a study.

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

No. This device is a physical medical instrument (electrosurgical electrode), not an algorithm or software-driven device.

7. The Type of Ground Truth Used

Not applicable in the typical sense. The "ground truth" for this 510(k) is essentially the established safety and effectiveness of the predicate devices as previously determined by the FDA's clearance decisions (K033249 and K970541). The entire premise of a 510(k) is that if a new device is "substantially equivalent" to a legally marketed predicate, then it is inherently safe and effective.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning/AI device.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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DEC 1 3 2005

MEDIZINTECHNOLOGIE

Ceramic Tip for Monopolar Electrodes - Premarket Notification Submission

Special 510(k) Premarke tification Submission: Summary of Safety and Effectiveness

Date of Preparation: October 27, 2005

Submitter Information/ production site:

Pajunk GmbH Karl-Hall-Straße 01 78187 Geisingen Germany Fon: +49(0)7704-9291-0 Fax: +49(0)7704-9291-610

Contact:

Christian Quaß, Regulatory Affairs Fon: +49(0)7704-9291-533 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com

Device Information:

Trade Names:	Monopolar Electrodes with Ceramic Tip
Common Name:	Monopolar Electrodes
Classification Name:	Electrosurgical cutting and coagulation device and accessories
Classification Reference:	21 CFR 878.4400, April 1. 2005
Proposed Classification:	Regulatory Class: II
Proposed Product Code:	GEI
Predicate Devices:	1. Pajunk's monopolar electrodes marketed under K033245

1. Aesculap's modular monopolar ceramic tip electrodes K970541

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K0 53 282

MEDIZINTECHNOLOGIE

Ceramic Tip for Monopolar Electrodes - Premarket Notification Submission

Device Description:

The Pajunk ceramic tip electrodes are multiple uses, non-sterile delivered and latex free medical devices. They are intended for transient delivery of energy required for coagulation of tissue.

The electrode-tips are retractable for comfortable suction and irrigation performance.

Technology Characteristics:

Pajunk's monopolar ceramic tip electrodes have the same technological characteristics as the predicate device identified below.

Pajunk's monopolar ceramic tip electrodes are substantially equivalent to Pajunk's monopolar electrodes marketed under 510(k) number K033249. All materials, dimensions and intended use are identical. There is one exception, which is the electrical insulation at the electrode tip. The polyamide (Nylon) coating is substituted by a ceramic tip.

Pajunk's monopolar ceramic tip electrodes are equivalent in design, physical dimensions, ceramic, metal and plastics materials, to Aesculap's monopolar ceramic tip electrodes marketed under 510(k) number K970541.

There is one design difference: Aesculap's monopolar ceramic tips can be unlocked from the electrode shaft. Pajunk's monopolar ceramic tips are fixed to the electrode shaft and can not be removed, nor lost during a surgical procedure.

Biocompatibility testing of Pajunk's monopolar ceramic tip electrodes is located in Section 7 of this submission.

Conclusion:

The comparison between the predicate device and the proposed device demonstrates that the proposed device is safe and effective, as well as substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form a wing-like shape, and two snakes that are wrapped around a staff.

Public Health Service

DEC 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I. A. Christian Quass MA Regulatory Affairs Pajunk GmbH Karl-Hall-StraBe 01 78187 Geisingen Germany

Re: K053282

Trade/Device Name: Pajunk ceramic tip electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Eye pad Regulatory Class: II Product Code: GEI Dated: November 21, 2005 Received: November 25, 2005

Dear Mr. Quass:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications forcronood above and haves sure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered province that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls profisions of vactice, 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 rr your device is elasbined (on as controls. Existing major regulations affecting your device can may ou subjoct to back academa, 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 I toase be determination that your device complies with other requirements of the Act that I DA has made a aved regulations administered by other Federal agencies. You must or any I odean statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It 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- I. A. Christian Quass

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieing of substantial equivalence of your device to a legally promatics notification: "The President 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 If you desire specific advice for your at (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Compullier and (21 ) = ) = = (807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respenser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

barbara Boehm

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

510(k) Number:

K053282

Device Name:

Pajunk ceramic tip electrodes

Indications for Use:

Ceramic tip electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions 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)

Barbara Brielm for Myron

Division of Gen al. Restorative, and Neurological Devices

510(k) Number K053282

Page 1 of 1

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.