(63 days)
Pajunks disposable inserts 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.
The Pajunk MIS-System contains but is not limited to electrode-inserts for comfortable and safe coagulation. PAJUNK has extended its range of instruments for MIS by a reuseable, modular system with disposeable inserts, which permits the economic replacement of the sensitive inserts. The instrument inserts consist of four basic types: Grasping Forceps, Scissors, Biopsy Punches and Clamps /Needle Holders. All handles can be combined with all insulated shafts and instrument inserts, regardless of their size and shape. The shaft screws onto the handle tightly, and it ensures the safe and secure connection of the two elements. Every module of the handle-instrument is kept in its bracing future, secured against distortion. A snap-on mechanism locks the instrument insert in the shaft: This whole element can then in turn be latched onto the handle by a special locking device. This latching of the connecting rod and the shaft minimizes the torsion stress exerted upon the instrument insert; the double security against distortion transfers the torque also to the entire shaft. For the 1293- and 1292- Combination Handle an ergonomically placed switch allows the ratchet to be easily switched on or off during usage. Jacketed with glass fiber-reinforced plastic, the precise mechanical construction of the PAJUNK handle ensures maximum stability. Designed for left and right handed use, the ergonomically shaped handles are simple and comfortable to operate. The rotary wheel can be adjusted with a little pressure applied by the index finger. A built-in rotation stop secures the desired position when grasping. And with that, PAJUNK® has created the option to always work and also to coagulate with new, guaranteed sharp scissors at every intervention. Three different sizes are available: micro, medium and large. They are packed individually, sterile, and they can be replaced very easily. The fast and easy assembly is based on the ingenious locking mechanism. The scissor-insert is clicked into the connecting rod and tightly screwed together with the guidance tube. Please observe, that the replacement can only be carried out if the scissors are closed.
The provided document is a 510(k) Premarket Notification for "Pajunks disposable inserts for Handle instruments and HF Electrodes." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials with acceptance criteria and formal studies as described in the request.
Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document because they are generally not required for a 510(k) submission that relies on demonstrating substantial equivalence to a previously cleared device.
However, I can extract the relevant information from the document to address the user's request as much as possible:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report performance data derived from a formal study against such criteria. Instead, it makes a qualitative claim of "Substantial Equivalence" to a predicate device (Pajunk's monopolar electrodes marketed under K033249).
The "performance" claimed is that the proposed device is "at least as safe and effective as, as well as substantially equivalent to Pajunks predicate device."
Therefore, a table cannot be constructed as requested.
2. Sample sized used for the test set and the data provenance
No test set or associated data provenance (country of origin, retrospective/prospective) is described in the document. The submission relies on a comparison to a predicate device, not empirical testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
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. An MRMC study is not mentioned as this device is a surgical instrument, not an AI-assisted diagnostic tool for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth for a study is not mentioned. The regulatory decision is based on a demonstration of substantial equivalence.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
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Special Premarket Notification Submission - Djsposable inserts
Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-0 Fax: +49(0)7704-9291-610 Establishment Registration Number: 9611612
Submitter Information/ production site:
Contact:
Christian Quass, Director Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605
E-Mail: christian.quass@pajunk.com
E-Mail: stefan.dayagi@pajunk-usa.com
German American Trade Center
5126 South Royal Atlanta Drive
30084 Tucker, Georgia
Fon: +01(0)770-493-9305
Contract Sterilizer
SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Mörfelden Tel +49 6105 23091 or +49 (0) 6105 93470 Fax +49 6105 24760 Germany
Device Information:
Pajunks disposable inserts for Handle instruments and HF Trade Names: Electrodes
Common Name: Disposable Modular Inserts for Handle instruments
Classification Name: Disposable monopolar surgical instrument
Classification Reference: 21 CFR 876.1500, April 1. 2005
Poposed Classification: Regulatory Class: II
Proposed Product Code: GEI, GCJ
Predicate Devices: Pajunks monopolar electrodes marketed under K033249
Page 1 of 3
Special 510(k) Premarket Notification Submissio Summary of Safety and Effectiveness
Date of Preparation: August 29th, 2006
USA Contact:
Pajunk USA
USA
Contact
Stefan Dayagi
SEP 2 2 2006
Image /page/0/Picture/22 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters on a black background. Below that, in smaller, white letters, is the word "MEDIZINTECHNOLOGIE".
{1}------------------------------------------------
Special Premarket Notification Submission - Disposable inserts
Image /page/1/Picture/2 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters on a black background. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, black letters on a white background.
Device and Technology Description:
The Pajunk MIS-System contains but is not limited to electrode-inserts for comfortable and safe coagulation. PAJUNK has extended its range of instruments for MIS by a reuseable, modular system with disposeable inserts, which permits the economic replacement of the sensitive inserts.
The instrument inserts consist of four basic types: Grasping Forceps, Scissors, Biopsy Punches and Clamps /Needle Holders. All handles can be combined with all insulated shafts and instrument inserts, regardless of their size and shape.
The shaft screws onto the handle tightly, and it ensures the safe and secure connection of the two elements. Every module of the handle-instrument is kept in its bracing future, secured against distortion. A snap-on mechanism locks the instrument insert in the shaft: This whole element can then in turn be latched onto the handle by a special locking device. This latching of the connecting rod and the shaft minimizes the torsion stress exerted upon the instrument insert; the double security against distortion transfers the torque also to the entire shaft.
For the 1293- and 1292- Combination Handle an ergonomically placed switch allows the ratchet to be easily switched on or off during usage. Jacketed with glass fiber-reinforced plastic, the precise mechanical construction of the PAJUNK handle ensures maximum stability. Designed for left and right handed use, the ergonomically shaped handles are simple and comfortable to operate. The rotary wheel can be adjusted with a little pressure applied by the index finger. A built-in rotation stop secures the desired position when grasping.
And with that, PAJUNK® has created the option to always work and also to coagulate with new, guaranteed sharp scissors at every intervention. Three different sizes are available: micro, medium and large. They are packed individually, sterile, and they can be replaced very easily.
The fast and easy assembly is based on the ingenious locking mechanism. The scissor-insert is clicked into the connecting rod and tightly screwed together with the guidance tube. Please observe, that the replacement can only be carried out if the scissors are closed.Biocompatibility information for Pajunk's adaptable disposable inserts is located in Section 15.0 of this submission.
Intended Use
Pajunks disposable inserts 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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[062072
Special Premarket Notification Submisston - Disposable inserts
Image /page/2/Picture/2 description: The image shows the logo for PAJUNK, a company specializing in medical technology. The logo consists of the company name in bold, uppercase letters, with the word "MEDIZINTECHNOLOGIE" written in a smaller font size below it. There is a horizontal line below the text.
Substantial Equivalence
Based on the information within this submission, it is our conclusion that Pajunk's reusable inserts marketed under 510(k) number K033249, and disposable inserts (subject device) are substantially equivalent.
Pajunk's electrodes are as safe and effective as the predicate devices when used by professional surgeons in accordance with the instructions for use supplied with these medical devices.
Conclusion:
The comparison between the predicate device and the proposed device demonstrates that the proposed Pajunk devices are at least as safe and effective as, as well as substantially equivalent to Pajunks predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2006
Pajunk GmbH Medizintechnologie % Christian Quass Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany
Re: K062072
Trade/Device Name: Pajunks disposable inserts for Handle instruments and HF Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 29, 2006 Received: September 1, 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 (OS) 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 Contsumer assistance at its will 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,
Jarbare Buent
N.N. Motes
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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Special Premarket Notification Schmission - Disposable inserts
Image /page/5/Picture/1 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, white letters. The logo appears to be for a medical technology company.
Indications for use
510(k) Number:
Device Name:
Pajunks disposable inserts for Handle instruments and HF Electrodes
Indications for Use:
Pajunks disposable inserts 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.
Image /page/5/Picture/8 description: The image shows the words "Prescription Use" in bold font. Below that, in a smaller font, is the text "(Per 21 CFR 801.109)". The text is left-aligned and appears to be part of a document or label.
Image /page/5/Picture/9 description: The image contains a large, bold letter 'X'. The letter is black and stands out against a white background. There are short, horizontal lines extending from the bottom of each leg of the 'X', giving the impression that it is underlined or emphasized. The overall impression is simple and graphic.
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)
Sunbare Mnchum
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number K060272
Page 1 of 1
§ 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.