(267 days)
The PORTEX® Tuohy and Hustead Needles with NRFif™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.
The sterile, single use Tuohy and Hustead needles with NRFit™ connector are for insertion into the epidural space for either single shot doses of anesthetic or narcotics or as an introducer for epidural catheters or spinal needles. The Tuohy needles are marked at 10 mm graduations to enable the depth of needle insertion to be determined. The Tuohy needles are supplied with a removable wing which allow the needle to be used as a winged or non-winged needle. The stylet hub is color-coded for ease of identification. The intended target population is pediatrics and adults.
The provided text describes the non-clinical testing performed on the PORTEX® NRFit™ Epidural Needles to demonstrate their substantial equivalence to predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Evaluation | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional Performance | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications (Specific criteria within standard not provided) | All testing met pre-established specifications. |
| Resistance to separation from axial load | ISO 80369-6 | All testing met pre-established specifications. | |
| Resistance to separation from unscrewing | ISO 80369-6 | All testing met pre-established specifications. | |
| Leakage by Pressure Decay | ISO 80369-6 | All testing met pre-established specifications. | |
| Subatmospheric Pressure | ISO 80369-6 | All testing met pre-established specifications. | |
| Stress Cracking | ISO 80369-6 | All testing met pre-established specifications. | |
| Verifying Non-interconnectable characteristics | ISO 80369-6 | All testing met pre-established specifications. | |
| Stiffness Characteristics | ISO 9626-2016, 5.8- Stiffness (Annex B) | All testing met pre-established specifications. | |
| Bending Force | ISO 9626:2016, 5.8- Stiffness (Annex B) | All testing met pre-established specifications. | |
| Penetration Force | PWI-10005073-Test Method for Needle Penetration Force for Epidural, Spinal and Peripheral Nerve Block (Specific criteria within method not provided) | All testing met pre-established specifications. | |
| Deflection Force | ISO 9626:2016, 5.8-Stiffness (Annex B) | All testing met pre-established specifications. | |
| Packaging | Package integrity, sterile barrier | ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | All testing met pre-established specifications. |
| Sterilization | Sterility | ISO 11135, Sterilization of health care products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. | All testing met pre-established specifications. |
| Residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | All testing met pre-established specifications. | |
| Biocompatibility | Intracutaneous Reactivity | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | All testing met pre-established specifications. |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | All testing met pre-established specifications. | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | All testing met pre-established specifications. | |
| Hemocompatibility | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | All testing met pre-established specifications. | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | All testing met pre-established specifications. | |
| Genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | All testing met pre-established specifications. | |
| Leachable substances | ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances. | All testing met pre-established specifications. | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | All testing met pre-established specifications. | |
| Other | Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | All testing met pre-established specifications. |
| Particulate matter | USP 788, Particulate Matter in Injections | All testing met pre-established specifications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test. It broadly states that "All testing met pre-established specifications."
The data provenance is from non-clinical performance testing, meaning these are laboratory tests on the device itself, not clinical data from patients. There's no information about country of origin for the data or whether it's retrospective or prospective, as it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The "ground truth" in this context refers to established standards (e.g., ISO, ANSI/AAMI, USP) and the physical properties and performance of the device. There were no human experts establishing ground truth for a diagnostic outcome, as this is a device for fluid delivery and catheter placement, not a diagnostic imaging device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed for ambiguous cases. These were non-clinical, objective tests against established standards.
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
This section is not applicable. This document describes the testing for an epidural needle, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This document describes the testing for a physical medical device (epidural needle), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing was established by recognized international and national standards and test methods. These include:
- ISO 80369-6 (for connectors for neuraxial applications)
- ISO 9626-2016 (for stiffness and bending force of needles)
- PWI-10005073-Test Method for Needle Penetration Force
- ISO 11607 (for packaging)
- ISO 11135 (for sterilization)
- ISO 10993 series (for biocompatibility)
- ANSI/AAMI ST72 (for bacterial endotoxins)
- USP 788 (for particulate matter)
These standards define the acceptable performance parameters and methodologies for testing.
8. The sample size for the training set
This section is not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply here.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).