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510(k) Data Aggregation
(267 days)
| |
| Regulation
Number | 21 CRF 880.5140
| 21 CRF 880.5140
| 21 CRF 880.5140
The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the 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 Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml). The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the s helf life of five years.
This document is a 510(k) Summary for a Plastic LOR Syringe. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from various ISO and ASTM standards for syringes, neuraxial, and Luer connectors, as well as biocompatibility and sterilization standards. The reported device performance indicates compliance with these standards.
| Acceptance Criteria Category | Specific Standard/Clause | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | Clause 5 of ISO 7886-1:2017 (General requirements) | Conforms to requirements |
| Clause 6 of ISO 7886-1:2017 (Extraneous matter) | Conforms to requirements | |
| Clause 7 of ISO 7886-1:2017 (Lubricant) | Conforms to requirements | |
| Clause 8 of ISO 7886-1:2017 (Tolerance on graduated capacity) | Conforms to requirements | |
| Clause 9 of ISO 7886-1:2017 (Graduated scale) | Conforms to requirements | |
| Clause 10 of ISO 7886-1:2017 (Barrel) | Conforms to requirements | |
| Clause 11 of ISO 7886-1:2017 (Piston stopper/plunger assembly) | Conforms to requirements | |
| Clause 12 of ISO 7886-1:2017 (Nozzle) | Conforms to requirements | |
| Clause 13 of ISO 7886-1:2017 (Performance) | Conforms to requirements | |
| Neuraxial Small-Bore Connector | Clause 5 of ISO 80369-6:2016 (Dimensional requirements) | Conforms to requirements |
| Clause 6.1 of ISO 80369-6:2016 (Fluid leakage) | Conforms to requirements | |
| Clause 6.2 of ISO 80369-6:2016 (Sub-atmospheric pressure air leakage) | Conforms to requirements | |
| Clause 6.3 of ISO 80369-6:2016 (Stress cracking) | Conforms to requirements | |
| Clause 6.4 of ISO 80369-6:2016 (Resistance to separation from axial load) | Conforms to requirements | |
| Clause 6.5 of ISO 80369-6:2016 (Resistance to separation from unscrewing) | Conforms to requirements | |
| Clause 6.6 of ISO 80369-6:2016 (Resistance to overriding) | Conforms to requirements | |
| Luer Connector | Clause 5 of ISO 80369-7:2016 (Dimensional requirements) | Conforms to requirements |
| Clause 6.1 of ISO 80369-7:2016 (Fluid leakage) | Conforms to requirements | |
| Clause 6.2 of ISO 80369-7:2016 (Sub-atmospheric pressure air leakage) | Conforms to requirements | |
| Clause 6.3 of ISO 80369-7:2016 (Stress cracking) | Conforms to requirements | |
| Clause 6.4 of ISO 80369-7:2016 (Resistance to separation from axial load) | Conforms to requirements | |
| Clause 6.5 of ISO 80369-7:2016 (Resistance to separation from unscrewing) | Conforms to requirements | |
| Clause 6.6 of ISO 80369-7:2016 (Resistance to overriding) | Conforms to requirements | |
| Sterile Barrier Packaging | ASTM F1886/F1886M-16 (Visual inspection) | Maintained integrity |
| ASTM F88/F88-15 (Seal strength) | Maintained integrity | |
| ASTM F1929-15 (Dye penetration test) | Maintained integrity | |
| Sterilization & Shelf Life | ISO 10993-7:2008 (EO residue) | EO ECH residue did not exceed the limit |
| USP 39-NF 34 (Bacteria Endotoxin Limit) | Endotoxin limit did not exceed 2.15 EU/device | |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Tests on aging samples) | Maintained performance during claimed shelf life (5 years) | |
| Biocompatibility | (Implicitly based on ISO 10993 for indirect contact, |
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(296 days)
55442 sunny.teekasingh@smiths-medical.com Phone: (763) 383-3336 May 31, 2018 Date Regulation No. 21 CFR 880.5140
PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics.
The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ connector is designed to be used with regional anesthesia systems only.
The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector.
PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only.
The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.
The PORTEX® Regional Anesthesia Portfolio with NRFit™, consisting of five (5) categories of product including PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector and the PORTEX® Filter Straw with NRFit™ Connector.
PORTEX® products and components with NRFit™ connector are intended for the injection or infusion of regional anesthetics or narcotics.
The NRFit ™ connector conform to ISO 80369-6. Small bore connector for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which are 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® Regional Anesthesia Portfolio with NRFit™ connector are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.
This looks like a 510(k) summary for a medical device modification, specifically for the PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector, PORTEX® Filter Needle with NRFit™ Connector, and PORTEX® Filter Straw with NRFit™ Connector.
This document does not describe a study involving AI/ML performance, human readers, or expert adjudication for image analysis. Instead, it focuses on the non-clinical performance testing of a new medical device connector (NRFit™) to demonstrate its substantial equivalence to a predicate device. The acceptance criteria and the "study" that proves the device meets them are based on these non-clinical, bench-top tests, primarily conforming to existing ISO standards.
Therefore, for aspects related to AI/ML, human readers, expert ground truth, and training data, the response will state that this information is not applicable to this type of device submission.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a set of medical connectors, and the "performance" here relates to physical and biological safety and efficacy as defined by recognized standards.
| Category | Evaluation | Test Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Functional Performance (NRFit™ Connector) | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended |
| 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 | Met pre-established specifications and performed as intended | |
| Resistance to separation from unscrewing | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Leakage by Pressure Decay | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Subatmospheric Pressure | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| 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 | Met pre-established specifications and performed as intended | |
| Packaging | Package integrity, sterile barrier | ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | Met pre-established specifications and performed as intended |
| 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. | Met pre-established specifications and performed as intended |
| Biocompatibility | Residuals (Ethylene Oxide) | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Met pre-established specifications and performed as intended |
| Intracutaneous Reactivity | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Met pre-established specifications and performed as intended | |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met pre-established specifications and performed as intended | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Met pre-established specifications and performed as intended | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Met pre-established specifications and performed as intended | |
| Genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Met pre-established specifications and performed as intended | |
| Leachable substances | ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | Met pre-established specifications and performed as intended | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | Met pre-established specifications and performed as intended | |
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | Met pre-established specifications and performed as intended | |
| Particulate matter | USP 788, Particulate Matter in Injections | Met pre-established specifications and performed as intended |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a "test set" in the context of AI/ML or image data. The testing described is non-clinical (bench testing) for device components. The sample size for each specific non-clinical test (e.g., number of connectors tested for axial load) is not explicitly provided in this summary but would be detailed in the full test reports. Data provenance is not applicable here as it refers to physical and biological testing of manufactured products, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for physical medical devices and their connectors, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of data for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to physical product testing against international standards, not a diagnostic or classification task requiring expert adjudication.
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 not an AI-assisted diagnostic or imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements and assessments against recognized international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788) for functional performance, sterility, packaging, and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm.
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