(48 days)
The ARROW FlexBlock Continuous Peripheral Nerve Block kit/set permits placement of catheters next to nerves and 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.
The catheter is designed to deliver anesthesia to manage perioperative pain and /or alleviate postoperative analgesia.
The ARROW FlexBlock Continuous Peripheral Nerve Block Catheter has the following characteristics:
- 19 Ga., 30 to 90 cm with at minimum one flashback window to visualize fluids inside . catheter
- . Offered in open and closed tip configurations
- Internal radiopaque, echogenic coiled reinforced wire to visualize under Ultrasound .
- Catheters are provided in sterile kit/set configurations or as a standalone replacement . catheter .
In this 510(k) summary for the ARROW FlexBlock Continuous Peripheral Nerve Block Catheter (K122027), the document describes a medical device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, the provided text does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or a comparative effectiveness study involving human readers or AI.
The submission focuses on bench testing and biocompatibility. Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in document | Demonstrates comparable tensile strength, column strength, and flow rate to predicate devices. (Nonclinical Testing section) |
| Not explicit in document | No adverse effects observed in in vivo studies conducted with catheter extracts. (Nonclinical Testing section) |
| Not explicit in document | Meets requirements of applicable ISO 10993 Guidelines for patient contacting components. (Nonclinical Testing section) |
| Not explicit in document | No significant risk of acute toxicity from relevant leachable chemicals under proposed conditions and duration of clinical use. (Nonclinical Testing section) |
| Not explicit in document | Comparable extractable and leachable (E&L) profiles for one-cycle vs. two-cycle EO sterilized devices. (Nonclinical Testing section) |
Comment: The document states that the "results of the performance testing, i.e. tensile strength, column strength and flow rate, demonstrate that the FlexBlock Continuous Peripheral Nerve Block Catheter is as safe, as effective and performs comparably to the primary predicate (K 103658) and referenced predicate (K121403)." However, specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and their corresponding measured values are not provided. The general acceptance criterion appears to be "comparable to predicate devices" for physical characteristics and "safe and effective" for biocompatibility and material properties.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not available in the provided 510(k) summary. The document describes "nonclinical testing" and "pre-clinical evaluations" but does not detail a "test set" in the context of clinical or diagnostic performance evaluation with human subjects or a dataset for an AI algorithm. The testing described focuses on bench and in vitro (extractables and leachables) studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not available in the provided 510(k) summary. The submission focuses on device characteristics and substantial equivalence based on engineering and biocompatibility testing, not on a diagnostic or interpretive task that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not available in the provided 510(k) summary for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary. Such studies are typically relevant for diagnostic imaging devices or AI-powered tools where human interpretation is involved. This device is a catheter for anesthesia delivery.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is not applicable as the device is a medical catheter, not an AI algorithm or a device that performs diagnostic interpretation independently.
7. The Type of Ground Truth Used
This information is not applicable in the context of a diagnostic or interpretive device. For the nonclinical testing described (tensile strength, flow rate, biocompatibility), the "ground truth" would be established by standardized measurement techniques and established safety limits for materials.
8. The Sample Size for the Training Set
This information is not applicable and not available as this device does not involve a training set for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not available as this device does not involve a training set for an AI algorithm.
Summary of Findings from the Document:
The K122027 submission for the ARROW FlexBlock Continuous Peripheral Nerve Block Catheter is a declaration of substantial equivalence based primarily on:
- Same Intended Use: To deliver anesthesia for continuous nerve blocks, comparable to predicate devices.
- Technological Characteristics: Similar materials (internal radiopaque, echogenic coiled reinforced wire), configurations (open/closed tip), and dimensions to predicate devices.
- Nonclinical Testing: Bench testing for physical properties (tensile strength, column strength, flow rate) demonstrating performance comparable to predicates.
- Biocompatibility: In vivo studies and extractable/leachable (E&L) studies demonstrating the safety of materials and compatibility with common anesthetic drugs, meeting ISO 10993 guidelines.
The document does not describe any clinical trials on human patience to demonstrate safety and effectiveness for a medical device that received 510(k) clearance. Instead, these are assessed through substantial equivalence to existing legally marketed predicate devices, supported by non-clinical (bench and in vitro) testing.
§ 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).