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510(k) Data Aggregation
(169 days)
Arrow Epidural Catheter Kit
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.
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(190 days)
Arrow Epidural Catheter Kit
The Arrow Epidural Catheter kit permits access to 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 describes the Teleflex Medical, Inc. Arrow Epidural Catheter Kit (K143581) and its substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and studies for an AI device.
However, I can extract the information provided about the device's performance testing, which serves a similar purpose of demonstrating that the device meets certain criteria for its intended use.
Here's the closest possible interpretation of your request based on the provided document:
Description of Device: The Arrow Epidural Catheter Kit is intended to permit access to the epidural space for the administration of epidural anesthetic for up to 72 hours. It contains an epidural catheter and various accessory components, including a 0.2 Micron In-Line Flat Anesthesia Conduction Filter.
No AI/ML Powered Device: Please note that this document is a 510(k) summary for a medical device (an epidural catheter kit) and does not describe an AI/ML powered device. Therefore, sections related to AI/ML specific criteria (like human reader improvement with AI, standalone performance, training data, etc.) are not applicable and are not present in the document.
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests and met internal requirements or relevant industry standards. The specific quantitative acceptance criteria are generally "Internal Requirement" or compliance with the specified standard.
| Test | Acceptance Criteria (Principle of Test) | Reported Device Performance |
|---|---|---|
| Luer Strength Test | Force is applied to the male and female luer tapers until failure. | Meets internal requirement (implies satisfactory strength) |
| Housing Burst Pressure Test | Hydrostatic pressure is applied until part bursts. | Meets internal requirement (implies satisfactory burst integrity) |
| Flow Rate Test | 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. | Meets internal requirement (implies satisfactory flow rate) |
| Filter Luer Slip | To test unscrewing gauging, liquid leakage, air leakage, separation force (ISO 594-1). | Complies with ISO 594-1 (implies satisfactory luer slip performance) |
| Filter Luer-Lock | To test unscrewing torque, ease of assembly, resistance to overriding, stress cracking (ISO 594-2). | Complies with ISO 594-2 (implies satisfactory luer-lock performance) |
| Bacterial Retention and Bubble Point Test | To test bacterial retention of membrane filter (ASTM F838). | Complies with ASTM F838 (implies 100% bacterial retention and appropriate bubble point) |
| Biocompatibility | Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic systemic toxicity, genotoxicity, implantation, and extractables & leachables (ISO 10993). | Complies with ISO 10993 (implies biocompatibility) |
| EO Residuals | EO residual testing for prolonged contact devices (ISO 10993-7). | Complies with ISO 10993-7 (implies acceptable EO residual levels) |
| LAL Bacterial Endotoxin | LAL bacterial endotoxin testing for medical devices that have contact with CSF (AAMI ST72). | Complies with AAMI ST72 (implies acceptable endotoxin levels) |
| Packaging | Packaging stability, Distribution simulation testing (ISO 11607-1, ASTM D4169). | Complies with ISO 11607-1 and ASTM D4169 (implies satisfactory packaging integrity and stability) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the specific sample sizes used for each of the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in the full test reports, not in the 510(k) summary. The tests appear to be laboratory-based rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring adjudication of interpretations.
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. The device is an epidural catheter kit, not an AI/ML system, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance tests described, the "ground truth" would be the established scientific principles, engineering specifications, and validated measurement techniques as outlined in the referenced ISO, ASTM, and AAMI standards, or the internal requirements. These are not types of ground truth typically associated with AI/ML systems.
8. The sample size for the training set
This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.
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