(18 days)
No
The provided text describes a physical surgical instrument (ceramic tip electrodes) used for manipulation, dissection, and coagulation during laparoscopic procedures. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The device's function is based on the physical properties of the instrument and the delivery of energy for coagulation, controlled by the surgeon.
No.
The device is used to perform surgical actions like grasping, manipulating, dissecting, cutting, or coagulating tissue, which are interventions, not therapeutic treatments.
No
This device is described as an instrument for surgical procedures (grasp, manipulate, dissect, retrieve, biopsy, cut, coagulate) involving energy delivery for coagulation, not for diagnosing conditions.
No
The device description clearly states it is a physical medical device consisting of a steel tube, ceramic tip, and stainless steel electrode tip, used for surgical procedures. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Device function: The description clearly states that this device is used during minimal invasive surgery to manipulate, dissect, retrieve, biopsy, cut, or coagulate internal tissue or organs within the body. It's an surgical instrument used directly on the patient.
The device's function and intended use are entirely focused on surgical procedures performed in vivo (within the living body), not on analyzing samples in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
Indications for Use:
Ceramic tip electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions for use.
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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal tissue or organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
-
- Aesculap's modular monopolar ceramic tip electrodes K970541
1
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 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.
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.
2
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.
3
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
4
Image /page/4/Picture/1 description: The image shows the logo for PAJUNK. The logo consists of the word "PAJUNK" in large, bold, white letters against a black rectangular background. Below the logo is the word "MEDIZINTECHNOLOGIE" in smaller, white letters.
Indications for use
510(k) Number:
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.
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.
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
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