(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.
§ 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.