(47 days)
The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
The Blunt Nerve Block Needle consists of a stainless steel cannula with an atraumatic distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub. The Blunt Nerve Block Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study.
Crucially, this document is a 510(k) summary for a "Blunt Nerve Block Needle." Medical devices of this type typically do not have performance acceptance criteria in the same way as AI/software devices. Therefore, many of the requested elements for an AI product's study will not be present. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Characteristics: Similar to predicate Pajunk Sprotte Needles. | The Blunt Nerve Block Needle has similar physical and technical characteristics to the Pajunk Sprotte Needles. |
| Intended Use: For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter. | The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia. (Matches intended use of predicate according to the submission.) |
| Safety and Effectiveness: Demonstrated through substantial equivalence to predicate. | Conclusion: The comparison to the predicate device demonstrates that the Blunt Nerve Block Needle is safe and effective and is substantially equivalent to the predicate device(s). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission is for a physical medical device (a needle), not a diagnostic AI or imaging device that would typically have a "test set" of data. The submission relies on a comparison to a predicate device.
- Data Provenance: Not applicable. The "study" isn't a data-driven performance study in the AI sense, but rather a regulatory comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is not an AI/software device, so an MRMC study is not relevant or included.
- Effect Size of Human Reader Improvement with AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: No. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For this submission, the "ground truth" equivalent is the established safety and effectiveness of the predicate devices (Pajunk Sprotte Needles). The Epimed needle is deemed safe and effective because it is substantially equivalent to these already-approved devices, which are presumed to have established their "truth" through prior regulatory pathways and clinical use.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no concept of a "training set" for this type of medical device submission.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth was Established: Not applicable.
Summary of the "Study" (or lack thereof, for AI purposes):
The submission for the Epimed International, Inc. Blunt Nerve Block Needle is a 510(k) Premarket Notification based on substantial equivalence to predicate devices. It does not involve a study with acceptance criteria, test sets, or ground truth in the way an AI/software medical device would.
Instead, the "study" is a non-clinical comparison that asserts:
- The device has similar physical and technical characteristics to the Pajunk Sprotte Needles (K911260, K911221, K911202).
- The device has the same intended use as the predicate devices: "For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter."
- No bench testing of performance characteristics was conducted as the submission relies solely on this similarity and intended use to the predicates.
The conclusion is that because it is sufficiently similar to an already legally marketed device with a known safety and effectiveness profile, the new device is also considered safe and effective, and therefore, substantially equivalent.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).