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510(k) Data Aggregation
(104 days)
E-Cath STIM acc. Tsui
The E-Cath STIM acc. Tsui System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle removal, to assist the physician pinpoint conduction catheter placement, an electrical stimulus can be applied to the conduction catheter tip via the catheter adapter.
The E-Cath STIM acc. Tsui System is contraindicated for the epidural space.
The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula, E-Cath catheter, locking cap.
The provided document is a 510(k) premarket notification for a medical device (E-Cath STIM acc. Tsui). It is a special 510(k) for a device modification, intending to combine features from previously cleared devices. The document mainly focuses on demonstrating substantial equivalence to predicate devices through bench testing and compliance with recognized standards, rather than clinical studies with human participants. Therefore, several of the requested categories, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "sample size for the test set," "number of experts," "adjudication method," and "standalone (i.e., algorithm only) performance" are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Needle: Bending Rigidity | According to EN ISO 9626: ≤ 0.48mm under an applied force of 15N by a span width of 17.5mm. | The bending rigidity of the subject/predicate/reference device's needles is less than 0.46mm. Conclusion: In compliance. |
| Needle: Breaking Resistance | According to EN ISO 9626: Not to break during a bending test for 20 periods at an angle defined by cannula size. | The tested cannulas did not break during the test. Conclusion: In compliance. |
| Needle: Bonding to Hub | According to EN ISO 7864: Pull-off force ≥ 44N. | For the subject/predicate/reference device's needles, a force significantly higher than the target value has to be applied. Conclusion: In compliance. |
| Needle: Penetration Force | EN 13097: No specific pass/fail criteria; objective comparison only. | The subject/predicate/reference device's needles show appropriate penetration/insertion forces. Compared to the predicate device, PAJUNK's needles are in compliance. Conclusion: In compliance. |
| Catheter: Leak Tightness | Internal protocols based on risk assessment and clinical evaluation (standard DIN EN 1618 does not define criteria). Catheter system must be tight for a defined period and pressure. | All systems are tight during the test for both the subject device and the predicate/reference devices. Conclusion: In compliance. The subject/predicate/reference device's catheters meet the acceptance criterion. |
| Catheter: Tensile Strength | Internally defined acceptable value to be met without tear-off (standard DIN EN 10555-1 and DIN EN 1618 do not define criteria). | The catheters of the E-Cath Systems meet the acceptance criterion (without tear-off). Conclusion: In compliance. The subject/predicate/reference device's catheters meet the acceptance criterion. |
| Catheter: Flow Rate | Internally defined by the sponsor based on risk management and clinical evaluation (standard DIN EN 10555-1 and DIN EN 1618 do not define criteria). | The flow rate of the tested E-Cath catheter meets the acceptance criterion. The subject/predicate/reference device's catheters meet the acceptance criterion and have proven to supply appropriate flow rates. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with the referenced ISO/EN standards for medical device components. The tests refer to "tested cannulas" and "tested catheters."
- Data Provenance: Bench testing, compliance with international standards (ISO, EN, DIN). Results are compared against predicate and reference devices, implying these are internal company data.
- Retrospective/Prospective: Not applicable in the context of bench testing for a device modification. The tests are performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. The ground truth for these tests is defined by international standards (e.g., ISO 9626, ISO 7864, DIN EN 1618, DIN EN 10555-1) and internal protocols for performance criteria where standards are not specific. This does not involve expert medical opinion for "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set:
- Not applicable. Performance is measured against predefined, objective, quantifiable acceptance criteria established by international standards or internal engineering/risk assessment protocols.
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 is a medical device (anesthesia conduction kit), not an AI diagnostic or image analysis system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is established by compliance with recognized international standards for medical device components (e.g., mechanical properties, sterility, biocompatibility) and internal engineering/risk assessment protocols where standards allow for manufacturer-defined criteria (e.g., leak tightness, tensile strength, flow rate).
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, this is not a machine learning model.
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