(212 days)
The Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter has the following characteristics:
- · 19 Ga. & 20 Ga., 14" to 24" in length.
- · Offered in open and closed end distal tip configurations.
- · Offered in styletted and non-styletted versions.
- · Internal radiopaque, echogenic coiled reinforced wire to allow visibility under fluoroscopy and/or ultrasound.
- · Catheters to be provided in sterile kit/set style configurations or as a standalone replacement catheter.
The catheter is a single-use, disposable device consisting of a polymer coated stainless steel spring. The catheter is available in various lengths, as well as open-ended or closed-ended configurations; the closed-ended models having three eyes (injection ports) at the distal end. The Spirol® Block is also available in styletted or non-styletted versions, as well as 19 Ga. or 20 Ga. models.
The provided document is a 510(k) summary for a medical device called the "Spirol® Block Continuous Peripheral Nerve Block Catheter." This type of document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance.
As such, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this document because it describes a different type of device approval process.
Here's why and what information can be extracted:
- No Acceptance Criteria or Performance Metrics: The 510(k) process for this type of device does not typically involve defining specific numerical "acceptance criteria" and then demonstrating the device "meets" them in the way clinical trials for new drugs or AI algorithms might. Instead, the focus is on showing the new device functions similarly and is as safe and effective as a legally marketed predicate device.
- No "Study" as such for comparative efficacy: There isn't a "study that proves the device meets acceptance criteria" in the sense of a clinical trial or a performance study with human readers improvement. The "study" here refers to non-clinical testing to confirm technological characteristics and biocompatibility.
- No AI Component: This device is a physical catheter, not an AI or algorithm-based device. Therefore, questions related to AI-specific metrics (standalone performance, MRMC studies, human reader improvement with AI) are not relevant.
However, I can extract information about the non-clinical testing performed and the basis for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Technological Characteristics: | |
| - Single-use, disposable | - Polymer coated stainless steel spring (identical to P1) |
| - Polymer coated stainless steel spring | - Available in various lengths (identical to P1) |
| - Available in various lengths | - Open-ended or closed-ended configurations (identical to P1) |
| - Open-ended or closed-ended configurations | - Three eyes (injection ports) at distal end for closed-ended (identical to P1) |
| - Three eyes (injection ports) at distal end | - Styletted or non-styletted versions (identical to P1) |
| - Styletted or non-styletted versions | - 19 Ga. or 20 Ga. models (identical to P1) |
| - 19 Ga. or 20 Ga. models | - Insertion by trained physician with introducer needle (identical to P1) |
| - Catheter placement remains after needle withdrawal | - Connects to standard Luer-lock accessories (identical to P1) |
| - Conveys anesthetic agents | |
| Functional/Material Performance: | |
| - Resists kinking, collapsing, shearing | - Polymer coated stainless steel spring proven to resist (bench testing) |
| - Withstands minimum acceptable tensile force | - Proven to withstand (bench testing) |
| - Materials compatible with PNB drugs | - Tested for compatibility (bench testing) |
| - Injection ports remain patent | - Designed to remain patent (bench testing) |
| - Deliver injectants at sufficient flow rate | - Designed to deliver (bench testing) |
| - Catheter and connector compatibility | - Tested and proven compatible (bench testing) |
| Biocompatibility (per ISO 10993): | |
| - Cytotoxicity | - Meets necessary biocompatibility requirements |
| - Sensitization | - Meets necessary biocompatibility requirements |
| - Irritation or Intracutaneous Reactivity | - Meets necessary biocompatibility requirements |
| - Acute Systemic Toxicity (catheter only) | - Meets necessary biocompatibility requirements |
| - Sub-acute / Sub-chronic Toxicity (catheter only) | - Meets necessary biocompatibility requirements |
| - Genotoxicity (catheter only) | - Meets necessary biocompatibility requirements |
| - Implantation (catheter only) | - Meets necessary biocompatibility requirements |
| Non-Clinical Testing: | |
| - Dimensional | - Performed, results demonstrate comparability |
| - Substance compatibility | - Performed, results demonstrate comparability |
| - Kink testing | - Performed, results demonstrate comparability |
| - Stiffness | - Performed, results demonstrate comparability |
| - Tensile strength | - Performed, results demonstrate comparability |
| - Connector attachment | - Performed, results demonstrate comparability |
| - Flow test | - Performed, results demonstrate comparability |
| - Resistance to leakage during aspiration or vacuum | - Performed, results demonstrate comparability |
| - Resistance to leakage under pressure | - Performed, results demonstrate comparability |
| - Corrosion resistance | - Performed, results demonstrate comparability |
| - Skive testing | - Performed, results demonstrate comparability |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests. Medical device bench testing often uses small, representative samples, but specific numbers are not provided in this summary.
- Data Provenance: The tests were performed internally by Epimed International, Inc. or by external labs for specific ISO 10993 testing. No country of origin for data is specified beyond the company's location in the USA. All testing described is pre-clinical/bench testing, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. "Ground truth" in the context of expert consensus is typically for diagnostic interpretation tasks (e.g., radiology). For a physical medical device, "ground truth" refers to established engineering specifications, material standards (e.g., ISO 10993), and regulatory requirements. These were assessed through the non-clinical testing listed. While engineers and quality assurance personnel ("experts") would design and oversee these tests, their number and specific qualifications for "establishing ground truth" are not detailed.
4. Adjudication method for the test set:
- Not applicable. This concept applies to expert review of clinical cases. The tests described are objective, physical, and chemical tests against defined standards.
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 device is a physical catheter, not an AI or imaging interpretation device, and no human reader studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used:
- For technological characteristics and functional performance: Engineering specifications, design inputs, and established performance of the predicate devices.
- For biocompatibility: ISO 10993 series of standards.
- For non-clinical testing (dimensional, strength, flow, etc.): Industry standards, internal specifications, and performance data from predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The design validation and non-clinical testing confirm the device meets its intended specifications.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary, the document demonstrates substantial equivalence through:
- Comparing the Intended Use and Indications For Use to Predicate Device #2 (K122027).
- Comparing the design, manufacture, and material composition to Predicate Device #1 (K981329).
- Presenting results from a series of non-clinical bench and laboratory performance tests (dimensional, substance compatibility, kink testing, stiffness, tensile strength, connector attachment, flow test, resistance to leakage, corrosion resistance, and skive testing) to show comparable performance to the predicate devices.
- Confirming biocompatibility according to ISO 10993 standards.
§ 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).