(39 days)
For the spinal administration of anesthetic agents to provide regional anesthesia.
The Spinal Needle consists of a stainless steel cannula with a ground beveled 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 Spinal Needle will be provided as a sterile, single use, disposable device. The Spinal Needle will be available in a variety of lengths and gauges.
Here's an analysis of the provided text regarding the "Spinal Needle" device and its regulatory submission:
Summary: The provided document demonstrates a substantial equivalence determination for a Spinal Needle. However, it explicitly states that no bench testing or clinical studies were conducted by Epimed International, Inc. for this submission. The basis for acceptance is solely the device being identical to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Implied) | The device is deemed "safe and effective" based on its identical nature to the predicate device (Manan Medical Products Spinal Needle K852427). |
| Substantial Equivalence (Explicit) | The device "is substantially equivalent to the predicate device." |
| Physical and Technical Characteristics (Explicit) | "The Spinal Needle has identical physical and technical characteristics to the Manan Medical Products Spinal Needle." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set was used for this submission.
- Data Provenance: Not applicable. No data was generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. No ground truth was established by experts for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication was used.
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
- MRMC Study: No. This device is a physical medical instrument (spinal needle), not an AI diagnostic tool. Therefore, an MRMC study is not relevant, nor was one performed.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical medical instrument, not an algorithm. Therefore, a standalone performance study is not applicable, nor was one performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. No specific ground truth establishment was conducted for this submission. The "ground truth" for regulatory purposes here is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. No training set was used. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. No training set was used.
§ 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).