(261 days)
The SPROTTE® NRFit™, Quincke NRFit™ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures.
The device is intended for adult and pediatric patients.
The SPROTTE® NRFit™ and Quincke NRFit™ lumbar puncture needles are disposable devices supplied sterile to the end user or non-sterile intended to be sterilized prior to use. The needles consist of a needle/cannula tubing made of Stainless Steel, a Hub made of Polycarbonate, and optionally Glue made of Epoxy resin. The introducer consists of Tubing made of Stainless Steel and a Hub made of Polycarbonate, and optionally Glue made of Epoxy resin. The stylet consists of Tubing made of Stainless Steel and a Knob made of Polycarbonate, and optionally Glue made of Epoxy resin. The SPROTTE® NRFit™ also includes a Retaining plate made of Polycarbonate. The Quincke NRFit™ also includes a Retaining plate and a Fixation Clip, both made of Polycarbonate. The primary difference between the subject devices and the predicate devices is the design of the hub.
Here's a breakdown of the acceptance criteria and study information for the SPROTTE® NRFit™ and Quincke NRFit™ lumbar puncture needles, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on demonstrating substantial equivalence to predicate devices, rather than setting distinct acceptance criteria for the new devices. The performance tests largely conform to existing standards, and the "acceptance criteria" are implied by compliance with these standards or by direct comparison to the predicate devices.
| Feature/Test | Acceptance Criteria (Implied/Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| Bending Rigidity (Needle) | Compliant with ISO/FDIS 9626:2016 | Compliant with the standard (identical to predicate device). |
| Bonding to Hub (Pull-off Force) | ≥ 22N (ISO 7864:2016) | Significantly higher than target value (identical to predicate device). |
| Penetration Force | Objective comparison only (EN 13097) - no normative criteria | Identical penetration/insertion forces to predicate device. |
| Sterilization (SAL) | 10^-6 (ISO 11135-1 Overkill Approach) | Achieved 10^-6 SAL with Ethylene Oxide. |
| Residuals of EO and ECH | In compliance with ISO 10993-7 | In compliance with ISO 10993-7. |
| Biocompatibility | Compliant with ISO 10993-1, 2nd and 3rd edition | Complies based on testing of a worst-case device (identical to predicate device). |
| Shelf Life | Efficacy of sterile product's lifecycle maintained for 5 years | Sterile and essential performance maintained after 5 years (real-time aged tests). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in the way an AI/ML study would. Instead, it discusses the devices under test for demonstrating substantial equivalence.
- SPROTTE® NRFit™: 9 different configurations (varying in Length and Gauge) were listed under "Devices under test".
- Quincke NRFit™: 5 different configurations (varying in Length and Gauge) were listed under "Devices under test".
- Data Provenance: The tests are described as being conducted on the physical devices themselves (both subject and predicate devices). The origin of this data would be in-laboratory testing by the manufacturer (PAJUNK® GmbH Medizintechnologie) or their contracted laboratories (e.g., Sterigenics Germany GmbH for sterilization). The document does not specify geographical origin beyond "Germany" for the manufacturer and sterilizer. The testing appears to be prospective as it's part of the submission for a new device.
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 device submission. This document describes the substantial equivalence of physical medical devices (needles), not an AI/ML system that requires expert annotation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable to this type of device submission. MRMC studies are typically for evaluating diagnostic imaging systems or AI tools.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this type of device submission. These are physical needles, not an AI algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/ML is not directly applicable here. Instead, the "truth" is established by:
- Compliance with recognized international standards: e.g., ISO 9626 for bending rigidity, ISO 7864 for bonding, ISO 80369-6 for small bore connectors, ISO 11135-1 for sterilization, ISO 10993 for biocompatibility.
- Direct comparative testing against legally marketed predicate devices: The subject devices are compared directly to the PAJUNK® ATRAUMATIC STANDARD SPROTTE NEEDLE (K911260) and PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (K040965). The predicate devices serve as the benchmark for "substantially equivalent" performance.
- Physical measurements and laboratory analyses: e.g., pull-off force measurements, penetration force measurements, chemical residual analysis, sterility testing.
8. The Sample Size for the Training Set
This information is not applicable to this type of device submission, as it's not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable to this type of device submission.
§ 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).