(41 days)
Continuous nerve block kit and set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
The Arrow Continuous Peripheral Nerve Block Catheter set and kit is comprised of components and accessories which have already been cleared for the same indications for use under earlier 510(k)s. This submission is intended to clarify that the catheter and the associated components and accessories, which we refer to as kits and sets, may be used for non-stimulating procedures. Many of the components and accessories of these kits and sets are already cleared for use in PNB stimulating procedures as well. It is the option of the clinician as to whether they would or would not use stimulation. A typical basic Peripheral Nerve Block ("PNB") set / kit includes the following components. The primary components of any PNB set or kit are: Catheter with stylet, Anesthesia Conduction ("AC") Needle, SnapLock™.
The provided 510(k) summary for the "Continuous Peripheral Nerve Block Catheter Kit and Set" (K121403) states that this medical device submission is intended to clarify that the device, which includes components already cleared for stimulating procedures, may also be used for non-stimulating procedures. The submission explicitly states that no additional bench testing is required because the clarification for non-stimulating use does not change the cleared indications for use and does not introduce any new safety or efficacy concerns compared to the predicate devices. Therefore, the device does not rely on a new study to prove it meets acceptance criteria, but rather on demonstrating substantial equivalence to existing predicate devices.
Based on the provided document, here's the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present specific acceptance criteria or performance data for the proposed device from a standalone study because it is claiming substantial equivalence based on the device's components being identical to already cleared predicate devices. The "performance" assessment is comparative to the predicate.
| Acceptance Criteria (based on predicate device characteristics) | Reported Device Performance (Proposed Device) |
|---|---|
| Indications for Use: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Identical: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. |
| Technology: Components of predicate devices (K030937, K021567, K001587) | Identical: Components are identical to the predicates. Including catheter with stylet, Anesthesia Conduction (AC) Needle, SnapLock™. |
| Materials: Materials used in predicate devices (K001587, K021567, K030937) | Identical: All materials in all components are identical to the predicates. |
| Environment of Use: Hospital, sub-acute facilities, pain clinics, physician offices. | Identical: Hospital, sub-acute facilities, pain clinics, physician offices. |
| Patient Population: Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations. | Identical: Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations. |
| Contraindications: Pre-existing nerve injury, neuritis or plexitis; skin/systemic sepsis; bleeding tendencies/anticoagulants. | Identical: Pre-existing nerve injury, neuritis or plexitis; skin/systemic sepsis; bleeding tendencies/anticoagulants. |
| Catheter Specifications (K030937): Effective length (30-90 cm), Gauge (19 Ga, 20 Ga), Material (SS spring core in polyurethane), Echogenic, Color (White/19Ga, Blue/20Ga), Length markings, Exposed length at tip (5mm/19Ga, 6mm/20Ga). | Identical: Meets all specified catheter specifications of the predicate (K030937). |
| AC Needle Specifications (K030937): Length (38-152mm), Gauge (17 Ga, 18 Ga), Geometry (5mm/17Ga, 6mm/18Ga), Exposed Length at Distal needle (5mm/17Ga, 6mm/18Ga). | Identical: Meets all specified AC needle specifications of the predicate (K030937). |
| SnapLock™ Connector (K001587 for non-stimulating, K030937/K021567 for stimulating): Designed for non-stimulating and stimulating procedures. | Identical: Connector for non-stimulating procedures (K001587). Integral wire (K030937), Connection Tab (K021567) for stimulation. |
2. Sample size used for the test set and the data provenance
Not applicable. No new test set or data was generated for this 510(k) submission. The submission relies on demonstrating substantial equivalence to already cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set requiring expert ground truth establishment was conducted. The device's safety and effectiveness relies on its similarity to previously cleared devices.
4. Adjudication method for the test set
Not applicable. No new test set requiring an adjudication method was conducted.
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 medical device (catheter kit), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances. The current submission argues that the proposed device is identical in design, materials, and intended use (with clarification for non-stimulating procedures) to these predicates.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/algorithmic device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device and does not involve a training set as would be used for an AI/algorithmic device.
§ 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).