(155 days)
The Spinal-EZE™ Intraoperative Epidural Catheter Kit is intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection is accessible as a result of surgery to the spinal column through the epidural space. The only clinical setting for administration for the Spinal-EZE™ Intraoperative Epidural Catheter is intraoperative. The device is provided sterile and is intended for single-use only.
The Spinal-EZE™ Intraoperative Epidural Catheter Kit consists of a catheter assembly with a .027" ID x .060" OD that is 60 cm long with an atraumatic bullet shaped closed tip. The catheter has depth marks at 100mm increments and 6 pairs of punched holes .56mm to .61mm in diameter positioned 90° apart at 3mm increments beginning 19.99mm from the catheter tip. The catheter is manufactured from 60 durometer Barium sulfate loaded (5%) silicone elastomer. Also included in the kit is a 10cc Syringe marked "epidural", a blunt tip 65cm long Teflon coated guide wire to assist in maneuvering the catheter during insertion, a Luer lock and cap assembly to facilitate attachment of the catheter to the syringe.
The provided text is a 510(k) summary for the Spinal-EZE™ Intraoperative Epidural Catheter Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for a novel device would.
Therefore, the requested information elements related to a comparative effectiveness study, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, and detailed adjudication methods are not explicitly present in this 510(k) summary. These summaries typically highlight technical characteristics and biological safety rather than clinical performance metrics in the same way.
However, I can extract the information that is present and explain why certain information is missing based on the nature of the document.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating that the new device is as safe and effective as the predicate devices, primarily through similarity in design features, performance, and indications for use.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Summary of Testing) |
|---|---|
| Similarities in design features | Catheter assembly: 0.027" ID x 0.060" OD, 60 cm long, atraumatic bullet-shaped closed tip, depth marks (100mm increments), 6 pairs of punched holes (0.56mm-0.61mm diameter, 90° apart at 3mm increments starting 19.99mm from tip). Manufactured from 60 durometer Barium sulfate loaded (5%) silicone elastomer. |
| Similarities in performance | Closed end with lateral/radial side hole catheter, intended for intraoperative use. Fluid path materials in conformance with ISO 10993 Part 1 for Fluid path contact. |
| Similarities in indications for use | Intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection location is accessible as a result of surgery to the spinal column through the epidural space. Only for intraoperative administration, sterile, single-use. |
| Biological Safety | All materials evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 "Biological Evaluation of Medical Devices". Results indicate the device is safe and effective. |
| Other characteristics | Intended use, precautions, contraindications, sterilization method, labeling and packaging indicate substantial equivalence to predicate devices. |
Study Details
Given this is a 510(k) summary, detailed clinical study methodologies for proving specific performance metrics (like sensitivity, specificity, accuracy) are not typically included as they would be for more novel or high-risk devices. The "study" here refers to the comparison and testing done to support substantial equivalence.
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Sample size used for the test set and the data provenance:
- Not explicitly stated in the document. The testing mentioned (biological qualification safety tests, design control activities) refers to engineering and material testing, not a clinical "test set" of patient data.
- The "data provenance" is derived from internal design and testing of the device and comparison to predicate devices, rather than external clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not stated. This type of information would be relevant for studies involving human interpretation (e.g., image analysis), which is not the primary focus of this device's submission. The "ground truth" for this device's submission revolves around demonstrating material safety and functional equivalence to established devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not stated. Similar to point 2, this method is typically used for clinical consensus in diagnostic studies.
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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:
- No. This device is an intraoperative catheter kit, not an AI or diagnostic imaging device. An MRMC study is not relevant to its submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device (catheter kit), not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on established material standards (ISO 10993-1), engineering design principles, and the known performance characteristics of the legally marketed predicate devices. There is no mention of patient-level outcomes data or pathology as primary ground truth for this 510(k).
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The sample size for the training set:
- Not applicable/not stated. This is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable/not stated. This is not an AI/machine learning device.
Summary of the Study (as described in the 510(k) summary):
The "study" undertaken for the Spinal-EZE™ Intraoperative Epidural Catheter Kit was primarily a substantially equivalent comparison to predicate devices and biological and design control testing.
- Comparison Study: The device's design features, performance characteristics, and indications for use were directly compared to the I-Flow Corporation's Intra Op Catheter (K991543) and Aries Medical, Inc. (Teleflex Medical)'s Epidural Catheter (K840202). The conclusion was that the subject device exhibits "similarities in design features, performance and indications for use" to these predicates.
- Biological Safety Study: "All materials used in the fabrication... were evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 'Biological Evaluation of Medical Devices'."
- Design Control: "Design control activities have been completed and the results indicate that the subject device is safe and effective." This would encompass various engineering tests (e.g., tensile strength, flow rates, tip integrity, depth marking accuracy, hole patency) to ensure the device meets its design specifications, though specific details of these tests are not provided in the summary.
Conclusion: The 510(k) summary concludes that, based on this testing and comparison, the device is "substantially equivalent to the predicate devices" and is "safe and effective." The FDA's letter confirms this finding of substantial equivalence.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).