(269 days)
The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
The PORTEX® Lancet Point Spinal Needle with NRFit™ connectors and PORTEX® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
The NRFit ™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.
The PORTEX® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.
This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors.
The provided text details the non-clinical testing performed to demonstrate substantial equivalence for the Portex® Lancet Point Spinal Needles and Portex® Pencil Point Spinal Needles with NRFit™ connectors to their predicate devices. This is a premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence rather than proving device efficacy from scratch.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for functional performance tests are primarily based on ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. While specific numerical acceptance criteria are not explicitly detailed in the summary, the document states that "All testing met pre-established specifications," implying adherence to the pass/fail criteria outlined in the referenced ISO standards.
| Category | Evaluation | Test Criteria (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 | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted overriding according to the ISO standard. |
| Resistance to separation from axial load | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted separation from axial load according to the ISO standard. | |
| Resistance to separation from unscrewing | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted separation from unscrewing according to the ISO standard. | |
| Leakage by Pressure Decay | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the leakage by pressure decay requirements of the ISO standard. | |
| Subatmospheric Pressure | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the subatmospheric pressure requirements of the ISO standard. | |
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted stress cracking according to the ISO standard. | |
| Verifying Non-interconnectable characteristics (physical force) | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully demonstrated non-interconnectable characteristics according to the ISO standard. | |
| 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, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the sterile barrier and packaging integrity requirements of ISO 11607. |
| 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, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the sterility requirements of ISO 11135. |
| Residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the ethylene oxide sterilization residuals requirements of ISO 10993-7. | |
| 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, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable intracutaneous reactivity as per ISO 10993-10. |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable systemic toxicity as per ISO 10993-11. | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable sensitization as per ISO 10993-10. | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable cytotoxicity as per ISO 10993-5. | |
| 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, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable genotoxicity, carcinogenicity, and reproductive toxicity as per ISO 10993-3. | |
| 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, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable leachable substances as per ISO 10993-17. | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable chemical characterization as per ISO 10993-18. | |
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable bacterial endotoxins levels as per ANSI/AAMI ST72. | |
| Particulate matter | USP 788, Particulate Matter in Injections | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable particulate matter levels as per USP 788. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests as summarized in "Table 2: Summary of Non-Clinical Testing" and described in Section 7 of the document. These tests evaluated the functional performance of the NRFit™ connectors, packaging integrity, sterilization effectiveness, and biocompatibility of the materials.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests. It states that "various configurations" of the spinal needles were included. The data provenance is also not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given it's non-clinical testing (bench testing, lab tests), these details are typically less relevant than for clinical trials. The tests were performed in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The ground truth for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., ISO, ANSI/AAMI, USP). There are no "experts" in the sense of clinicians establishing a "ground truth" on patient data for this kind of engineering and laboratory testing.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on objective measurements against pre-defined engineering and biological standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tools where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission concerns spinal needles, which are physical medical devices, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical instrument (spinal needle), not a software algorithm or an AI.
7. The Type of Ground Truth Used
For this submission, the "ground truth" is defined by established international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). The device's performance is compared against the requirements and specifications outlined in these standards.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this device and its non-clinical testing. Training sets are used in machine learning and AI development, which is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 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).