(77 days)
Pajunks HF 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.
Pajunks MIS-Instruments and HF-electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions for use. The Pajunk adaptable and retractable HF electrodes are multiple uses, non-sterile delivered and latex free medical devices. They are intended for transient delivery of energy required for coaqulation of tissue. The modular system for optional monopolar coagulation enables a surgeon to manipulate, The mound by commer of of on coagulate internal tissue or organs while performing laparoscopic procedures. The instruments are insulated for optional monopolar coagulation. The Pajunk MIS-System contains but is not limited to HF-electrodes for comfortable and safe rne i ajain with and without suction/ irrigation and microsurgical instruments with and without suction/irrigation. Pajunk provides electrodes with and without suction and irrigation element and electrodes with r ajurik provides ticonooo with retractable/ extendable tips. Tubes for suction/irrigation are available seperately also. Pajunks electrodes consist of a stainless steel guidance rod, insulated tube, ceramic or polyamide insulation at tip and stainless steel electrode tip for coagulation. Isolation at tip is made by ceramic or poly amid and already cleared for market. The electrodes are fixed to handle via click-screw, Luer or Pajunks M8x1 connector. Pajunks electrode and instrument series are modular and interchangeable as stated in the user instructions. Disposable inserts are also available.
This appears to be a 510(k) Premarket Notification Summary for a medical device (Pajunks HF Electrodes), which focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The document does not describe:
- Specific acceptance criteria in a quantifiable way for the device's performance (e.g., accuracy, sensitivity, specificity).
- A formal study designed to prove the device meets such criteria.
- Details about sample sizes for test sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies, as these types of studies are typically associated with performance validation of novel AI/diagnostic devices.
Instead, the submission relies on demonstrating:
- Substantial Equivalence: That the new device is as safe and effective as previously cleared predicate devices. This is done by comparing its design, materials, intended use, and technology to the predicates.
- No Changes in Material or Technique (Fundamentally): The primary change in the subject device is the combination of existing, cleared technologies (HF electrodes with suction/irrigation, and a retraction/extension feature). The document explicitly states, "There are no changes in material or technique in fact; the subject of this PMN is a combination of two already cleared technologies available in the predicates."
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this document. The document's purpose is to establish equivalence, not to present a de novo performance study.
However, based on the provided text, I can infer some "acceptance criteria" from the basis of the submission and the technological equivalence table, and comment on the "study" (which is effectively the comparison to predicate devices).
Here's an attempt to structure the information, acknowledging the limitations of a 510(k) summary for these specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Material Equivalence: No new materials are introduced. | All materials (stainless steel, ceramic, polyamide) are identical to those used in the predicate devices K053282, K033249. |
| Dimensional Equivalence: Physical dimensions are comparable. | Physical dimensions are equivalent to predicate devices K053282, K033249. |
| Fixation Specifications Equivalence: Similar connection methods. | Fixation methods (click-screw, Luer, M8x1 connector) are identical to those used with predicate modular valve handles K011997. |
| Intended Use Equivalence: Same indications for use. | Indications for use (grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue/organs during laparoscopic procedures) are identical to predicate devices. |
| Technological Equivalence (Core Function): The new feature (retraction/extension with suction/irrigation and coagulation) combines existing cleared technologies. | The device combines HF Electrodes (from K033249, K053282) with a suction/irrigation channel and optional retraction-extension, merging functions already present in predicate devices. The core coagulation and suction/irrigation functionalities are maintained. |
| Biocompatibility: Device materials are biocompatible. | Biocompatibility information is located in Section 15.0 of the submission (not provided here, but stated to exist). |
| Sterilization: Device can be sterilized effectively as a reusable device. | Supplied non-sterile, can be sterilized up to five times (validation report in section 14 of this submission – not provided here). |
2. Sample Size Used for the Test Set and Data Provenance
- This document does not describe a test set in the context of a performance study with a sample size for data analysis. The "test" is a comparison to predicate devices, not a new clinical or algorithmic performance evaluation.
- Data Provenance: Not applicable in the sense of patient data. The provenance of the device information itself is from Pajunk GmbH, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission does not involve establishing ground truth from expert readings for a test set. The "ground truth" for the substantial equivalence claim relies on the FDA's prior clearance of the predicate devices and the manufacturer's engineering comparison.
4. Adjudication Method for the Test Set
- Not applicable. There is no described test set requiring adjudication in this 510(k) summary.
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 an electrosurgical tool, not an AI or diagnostic imaging device that would typically undergo an MRMC study related to human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is an instrument for surgical use, not a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearances (K053282, K033249, K011997). The new device's ground is established by demonstrating its equivalence to these already cleared devices, not by new clinical outcomes data or pathology reviews for a novel diagnostic.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below the word "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, white letters.
MEDIZINTECHNOLOGIE
page 1 of 4
Special 510(k) Premarket Notification Submission: Summary of Safety and Effectiveness
Date of Preparation: September 19th, 2006
OC7 - 5 2006
| Submitter Information/ production site: | USA Contact: |
|---|---|
| Pajunk GmbH | Pajunk USA |
| Karl-Hall-Strasse 01 | German American Trade Center |
| 78187 Geisingen | 5126 South Royal Atlanta Drive |
| Germany | 30084 Tucker, Georgia |
| Fon: +49(0)7704-9291-0 | USA |
| Fax: +49(0)7704-9291-610 | |
| Establishment Registration Number: 9611612 | |
| Contact: | Contact |
| Christian Quass, Director Regulatory Affairs | Stefan Dayagi |
| Fon: +49(0)7704-9291-586 | Fon: +01(0)770-493-9305 |
| Fax: +49(0)7704-9291-605 | |
| E-Mail: christian.quass@pajunk.com | E-Mail: stefan.dayagi@pajunk-usa.com |
Device Information:
| Trade Names: | Pajunks HF Electrodes |
|---|---|
| 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. Pajunks monopolar Ceramic Tip electrodes K0532822. Pajunks Modular valve handles for adaptable tubes K0119973. Pajunks monopolar electrodes marketed under K033249 |
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PAJUNK
MEDIZINTECHNOLOGIE
Page 2 of 4
Device Description:
Pajunks MIS-Instruments and HF-electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions for use.
The Pajunk adaptable and retractable HF electrodes are multiple uses, non-sterile delivered and latex free medical devices. They are intended for transient delivery of energy required for coaqulation of tissue.
The modular system for optional monopolar coagulation enables a surgeon to manipulate, The mound by commer of of on coagulate internal tissue or organs while performing laparoscopic procedures. The instruments are insulated for optional monopolar coagulation.
The Pajunk MIS-System contains but is not limited to HF-electrodes for comfortable and safe rne i ajain with and without suction/ irrigation and microsurgical instruments with and without suction/irrigation.
Pajunk provides electrodes with and without suction and irrigation element and electrodes with r ajurik provides ticonooo with retractable/ extendable tips. Tubes for suction/irrigation are available seperately also.
Pajunks electrodes consist of a stainless steel guidance rod, insulated tube, ceramic or polyamide insulation at tip and stainless steel electrode tip for coagulation. Isolation at tip is made by ceramic or poly amid and already cleared for market.
The electrodes are fixed to handle via click-screw, Luer or Pajunks M8x1 connector.
Pajunks electrode and instrument series are modular and interchangeable as stated in the user instructions. Disposable inserts are also available.
Substantial equivalenve: basis for submission
The subject of Pajunks K011997 are Pajunks multipurpose handles (Modular valve handles) already designed for use with the HF Electrodes subject of this submission.
In K033249 FDA cleared HF Electrodes and instruments for either coagulation, grasping and so on or suction/irriragtion (channel only). The subject of this PMN is the combination of both: HF Electrodes within a suction/irrigation channel and optional retraction-extension.
There are no changes in material or technique in fact; the subject of this PMN is a rners are no onarges in the predicates. Pajunks HF electrodes subject of this PMN optionally are for suction/irrigation and coagulation at the same time with the same electrode enabled by retraction-extension feature.
The electrode can be drawn back into the tube – re-tracted – for suction/irrigation procedures. Afterwards it can be comfortably extended to go on coagulating (or whatever the surgical intervention is intended to).
The combination of this two cleared technologies does increase safety and comfortability of the rne odminitiation it it is weriod the surgical intervention takes place. Insttead of employing two different instrument or an instrument inside a working channel The retractable electrode combine both, suction/irrigation and surgical intervention.
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Page 3 of 4
Pajunk's adaptable and retractable HF electrodes are substantially equivalent to Pajunk's r guilk o additional and rotratia under 510(k) number K033249. All materials, dimensions, fixation specifications and intended use are identical. A retraction/extension feature has been added.
Pajunk's monopolar adaptable and retractable HF electrodes are equivalent in design, physical dimensions, metal and plastics materials, to Pajunks monopolar ceramic/ polyamid tip electrodes marketed under 510(k) number K053282, K033249 and are intended to be used with Pajunks Modular Valve handle system with different interchangeble fixation methods (click-screw, Luer, M8x1) cleared for market under K011997.
Technological Equivalence
| Predicate device | Subject device | Predicate device | |
|---|---|---|---|
| K033249, K053282 | K062047 | K011997 | |
| Shape of electrode tiptip | grasping forceps,biopsy, clamps andscissors, hook, right-angle, spatula, knife,45°, needle | Retractable/ extendable:hook, right-angle,spatula, knife. 45°,needleSuction/ Irrigation:grasping forceps,biopsy, clamps andscissors, hook, right-angle, spatula, knife,45°, needle | Not applicable |
| Connector | M8 x 1 or Luer or click-screw | M8 x 1 or Luer or click-screw | M8 x 1 or Luer or click-screw |
| Features | CoagulationSuction/ irrigation | Suction/ IrrigationCoagulationRetraction/ Extension | Suction/ IrrigationCoagulation |
Sterilization
Pajunks HF Electrodes are supplied non-sterile. They have to be sterilized before initial use and before each further use. They can be sterilized up to five times (validation report in sect. 14 of this submission).
Biocompatibility
Biocompatibility information for Pajunk's adaptable and retractable HF is located in Section 15.0 of this submission.
Indications for use
Pajunks HF 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.
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Kob2047
Image /page/3/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, black letters. Below the company name is the word "MEDIZINTECHNOLOGIE" in a smaller font size. The logo appears to be extracted from a document.
ﺮ
Conclusion:
The comparison between the predicate devices and the proposed device demonstrates that The companson between the predicate devices and the proposed and substantially equivalent to Pajunks predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 5 2006
Pajunk GmbH % Mr. Christian Quass Director Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen Germany
Re: K062047
Trade/Device Name: Pajunks HF Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 25, 2006 Received: September 27, 2006
Dear Mr. 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. Iisting 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 Codc 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 FIDA '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
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Page 2 - Mr. Christian Quass
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.
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 vours.
Barbave Buchum
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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| Indications for use |
|---|
| --------------------- |
| 510(k) Number: | K062047 |
|---|---|
| Device Name: | Pajunks HF Electrodes |
| Indications for Use: |
|---|
| ---------------------- |
Pajunks HF 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.
| Prescription Use(Per 21 CFR 801.109) | X 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 | K062047 |
|---|---|
| --------------- | --------- |
| Page 1 of 1 |
|---|
| ------------- |
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§ 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.