(18 days)
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.
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.
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.
§ 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.