(91 days)
Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration.
The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) 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. It consists of a Barrel and Plunger. It has ISO 80369-6 NRFit™ and ISO 80369-7 LUER connectivity. The markings area is 0ml - 10ml and the priming volume is 10ml.
The provided text is a 510(k) summary for the Pajunk VPC (Visual Pressure Control) NRFit and LUER Loss of Resistance Syringe. It details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.
Key takeaway: This document describes the physical and functional performance testing of a medical device (a syringe), not the performance of an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML model evaluation (e.g., ground truth establishment, reader studies, training set size) are not applicable to this document. The "device" in this context refers to the physical syringe, not a software algorithm.
Here's the breakdown based on the provided document, addressing the relevant points and noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists various performance characteristics, standards, and their results. The acceptance criterion is implied by the "Pass" result for each test, indicating compliance with the specified standard or internal protocol.
| Test Detail | Standard / Level | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Sterilization | ISO 11135 | Pass | Pass |
| Residuals | ISO 10993-7 | Pass | Pass |
| Biocompatibility | ISO 10993-1 | Pass | Pass |
| Liquid Leakage | ISO 80369-7, 6.1 (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Air Leakage | ISO 80369-7, 6.2 (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Stress Cracking | ISO 80369-7, 6.3 (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Axial Load | ISO 80369-7, 6.4 (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Unscrewing torque | ISO 80369-7, 6.5 (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Overriding | ISO 80369-7, 6.6 (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Liquid Leakage | ISO 80369-6, 6.1 | Pass | Pass |
| Air Leakage | ISO 80369-6, 6.2 | Pass | Pass |
| Stress Cracking | ISO 80369-6, 6.3 | Pass | Pass |
| Axial Load | ISO 80369-6, 6.4 | Pass | Pass |
| Unscrewing torque | ISO 80369-6, 6.5 | Pass | Pass |
| Overriding | ISO 80369-6, 6.6 | Pass | Pass |
| Stability of markings | Internal protocol (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Identification of LOR | Internal Protocol (General, 3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
| Tightness | Internal Protocol (3-year accelerated, 5-year accelerated, 1-year real-time aging) | Pass | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes (number of syringes) used for each individual test. It mentions that "tests have been performed" on devices for shelf-life validation.
- Data Provenance: The tests are physical and chemical performance tests of a manufactured device, not data collection from patients or retrospective/prospective studies in the clinical sense. The manufacturer is Pajunk GmbH Medizintechnologie, located in Geisingen, Germany. The tests would have been performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The ground truth for this device is the physical and chemical properties and functioning according to established international standards (ISO) and the manufacturer's internal protocols. "Experts" in this context would be test engineers and scientists adhering to the specified test methods, not clinical experts establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for establishing ground truth from multiple readers for image interpretation (e.g., in AI/ML studies). For mechanical and chemical device testing, results are typically objective measurements against predefined acceptance limits.
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 is not applicable. This document describes the performance of a physical medical device (syringe), not an AI/ML algorithm or a system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This document is about a physical medical device, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance relies on objective measurements and adherence to specified international standards (ISO) and validated internal protocols for physical, chemical, and functional characteristics. Examples include measurable parameters for leakage, axial load, unscrewing torque, and adherence to sterilization parameters and residual limits.
8. The sample size for the training set
- This is not applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- This is not applicable. There is no "training set."
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).