(169 days)
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.
This document is a 510(k) summary for the Arrow Epidural Catheter Kit, which is a medical device. It does not describe an AI/ML device, therefore, the requested information points (1-9) about acceptance criteria and study proving device meets acceptance criteria are not applicable in the context of an AI/ML device.
However, I can provide the available information related to the device and its testing as presented in the document:
Device Type: Medical Device (non-AI/ML). Specifically, an Anesthesia Conduction Kit.
G. Indications for Use:
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Patient Population: Adult
H. Technological Characteristics Comparison to the predicate:
The proposed Arrow Epidural Catheter Kit with 0.2 Micron In-Line Flat Anesthesia Conduction Filter is substantially equivalent to the predicate device (Arrow Epidural Catheter Kit - K143581) with respect to indications for use, technology, and construction. The differences mentioned are minor and related to the filter component:
- Filtration Area: Predicate: 3.8 cm², Proposed: 5.25 cm²
- Housing Material: Predicate: Modified acrylic, Proposed: Modified Acrylic (This appears to be a re-statement, not a difference in material, possibly a clarification from the manufacturer)
- Filter Material: Predicate: Polyethersulfone, Proposed: Supor Polyethersulfone
- Kit Components: Same, except for the 0.2 Micron Anesthesia Conduction Filter.
I. Performance Data:
A summary of tests relied upon to demonstrate substantial equivalence to the predicate is provided. These tests are physical and biological performance tests for the medical device components.
| Test | Reference to Standard (if applicable) | Principle of Test |
|---|---|---|
| Luer Strength Test | Internal Requirement | Force is applied to the male and female luer tapers until failure. |
| Housing Burst Pressure Test | Internal Requirement | Hydrostatic pressure is applied until part bursts. |
| Flow Rate Test | Internal Requirement | Water is passed through the filter at a pressure of 10 psi and collected in a graduated cylinder for 60 seconds. The volume of water is recorded. |
| Filter Luer Slip | ISO 594-1 | To test unscrewing gauging, liquid leakage, air leakage, separation force. |
| Filter Luer-Lock | ISO 594-2 | To test unscrewing torque, ease of assembly, resistance to overriding, stress cracking. |
| Bacterial Retention and Bubble Point Test | ASTM F838 | To test bacterial retention of membrane filter. |
| Biocompatibility | ISO 10993 | Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic systemic toxicity, genotoxicity, implantation, and extractables & leachables. |
| EO Residuals | ISO 10993-7 | The EO residual testing for prolonged contact devices. |
| LAL Bacterial Endotoxin | AAMI ST72 | LAL bacterial endotoxin testing for medical devices that have contact with CSF. |
| Rabbit Pyrogen | ISO 10993-11 | Material Mediated Rabbit Pyrogen |
| Packaging | ISO 11607-1, ASTM D4169 | Packaging stability, Distribution simulation testing |
J. Conclusion:
"The Arrow Epidural Catheter kit has the same indications for use and technology of construction as the predicate devices. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent."
Since this document pertains to a traditional physical medical device and not an AI/ML powered device, the requested information points (1-9) regarding acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test/training sets, expert qualifications, ground truth methods, MRMC studies, standalone performance) are not applicable to the content provided. The "performance data" provided refers to the physical and biological tests conducted on the device's components to ensure its safety and effectiveness.
§ 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).