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510(k) Data Aggregation
(231 days)
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
The Catheter Clamping Adapter, a connection device, is used to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics.
The connector is used in conjunction with catheters for continuous administration of anesthetic agents.
The Catheter Clamping Adapter with either NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. The device is intended to provide a specified connection (either NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7) to an unspecified proximal end of a 20G anesthesia conduction catheter (epidural or peripheral). Therefore it may also be considered an accessory for epidural and peripheral anesthesia conduction catheters. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers.
The PAJUNK Catheter Clamping Adapter NRFit (ISO80369-6) and Catheter Clamping Adapter LUER (ISO80369-7) have been determined to be substantially equivalent to a legally marketed predicate device (BBraun Perifix Catheter Connector, K022019) based on a detailed comparison and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Detail) | Standard | Required Performance (Acceptance Criteria) | Reported Device Performance | Result |
|---|---|---|---|---|
| Sterilization | ISO 11135 | SAL of 10⁻⁶ | SAL of 10⁻⁶ | Pass |
| Residuals (EO and ECH) | ISO 10993-7 | Compliance with limits | Limits met | Pass |
| Biocompatibility | ISO 10993-1 | Evaluated (external communicating device) | Evaluated and considered biocompatible | Pass |
| Liquid Leakage (ISO 80369-7) | ISO 80369-7, 6.1 | Pass | Pass | Pass |
| Air Leakage (ISO 80369-7) | ISO 80369-7, 6.2 | Pass | Pass | Pass |
| Stress Cracking (ISO 80369-7) | ISO 80369-7, 6.3 | Pass | Pass | Pass |
| Axial Load (ISO 80369-7) | ISO 80369-7, 6.4 | Pass | Pass | Pass |
| Unscrewing torque (ISO 80369-7) | ISO 80369-7, 6.5 | Pass | Pass | Pass |
| Overriding (ISO 80369-7) | ISO 80369-7, 6.6 | Pass | Pass | Pass |
| Liquid Leakage (ISO 80369-6) | ISO 80369-6, 6.1 | Pass | Pass | Pass |
| Air Leakage (ISO 80369-6) | ISO 80369-6, 6.2 | Pass | Pass | Pass |
| Stress Cracking (ISO 80369-6) | ISO 80369-6, 6.3 | Pass | Pass | Pass |
| Axial Load (ISO 80369-6) | ISO 80369-6, 6.4 | Pass | Pass | Pass |
| Unscrewing torque (ISO 80369-6) | ISO 80369-6, 6.5 | Pass | Pass | Pass |
| Overriding (ISO 80369-6) | ISO 80369-6, 6.6 | Pass | Pass | Pass |
| Leak Tightness | Internal Protocol | Leak tight under normal conditions | Complies with internal protocol | Pass |
| Security of connection | Internal Protocol | Secure connection | Complies with internal protocol | Pass |
| Tensile Force | Predicate device criterion | > 8N | > 8N | Pass |
| Pyroburden/Endotoxin | Not specified | Limit met | Limit met | Pass |
| Shelf Life (5 years) | Internal Protocol | No decrease in performance after 5 years (real-time aged & accelerated aged) | No decrease in performance after 5 years | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., liquid leakage, axial load). It indicates that tests were conducted according to the specified ISO standards (ISO 80369-6, ISO 80369-7) and internal protocols. The standards themselves typically outline sample size requirements.
The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective." However, the testing was performed by PAJUNK® GmbH Medizintechnologie (based in Germany) and its contract sterilizer (Sterigenics Germany GmbH). The testing would be considered prospective for the purpose of demonstrating substantial equivalence for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The device is a medical connector, and its performance is evaluated against engineering and material standards (e.g., ISO for connectivity, leakage, tensile strength, biocompatibility), not against a diagnostic "ground truth" established by experts.
4. Adjudication Method for the Test Set
This section is not applicable for this type of device and testing. Performance is measured objectively against predefined engineering standards and specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic devices involving human interpretation of data (e.g., medical images), which is not relevant for this device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The device's performance (e.g., leak tightness, tensile strength, connectivity) was tested directly against established physical and material standards without human intervention in its function. The "algorithm" in this context is the physical design and manufacturing process of the device, and its performance was evaluated inherently without human-in-the-loop.
7. The Type of Ground Truth Used
The "ground truth" used for this device's evaluation is based on established international and internal engineering standards and specifications. This includes:
- ISO 80369-6 (for NRFit connectors)
- ISO 80369-7 (for LUER connectors)
- ISO 11135 (for sterilization)
- ISO 10993-7 (for residuals)
- ISO 10993-1 (for biocompatibility)
- Internal protocols for leak tightness and security of connection.
These standards define the objective, measurable criteria for acceptable device performance for safety and effectiveness.
8. The Sample Size for the Training Set
This section is not applicable. This device is a manufactured medical product, not an AI or algorithm-based system that requires a "training set" in the computational sense. The "development" and "refinement" of the product involve engineering design, material selection, and manufacturing processes, culminating in validation testing.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the reasons stated in point 8.
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