(120 days)
Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
The Tuohy Epidural Needle is a device used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.
Tuohy Epidural Needles consist of a plastic cannula hub, containing a stainless steel bushing, affixed to a stainless steel cannula with medical grade adhesive and a stainless steel stylet affixed to a plastic stylet hub with medical grade adhesive. The cannula hub has the option of a permanent, fixed wing or a removable wing depending on user preference. The needle assembly is protected with a polypropylene sheath.
Tuohy Epidural Needles are provided as a sterile, single use, disposable devices. The Tuohy Epidural Needles will be available in a variety of lengths and gauges. They may be packaged individually or included in regional anesthesia trays (kits).
This FDA 510(k) premarket notification for the Remington Medical Inc. Tuohy Epidural Needle does not describe a study involving an AI/CADe device or its performance criteria, as it is for a physical medical device (an epidural needle).
Therefore, I cannot provide information on acceptance criteria and study details related to AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, or ground truth types in the context of an AI device.
The provided document details the substantial equivalence of a physical medical device (Tuohy Epidural Needle) to predicate devices. It focuses on the physical and functional characteristics of the needle.
However, I can extract the acceptance criteria and reported device performance for the physical device as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):
| Acceptance Criteria (Standard) | Reported Device Performance (Remington Medical Inc. Tuohy Epidural Needles) |
|---|---|
| Hub to Needle Bond Strength | Complies with ISO 7864. Tests demonstrated substantial equivalence to predicate device; verification/validation testing to internal functional specifications (e.g., bond strength between cannula, hub, and stylet) was performed. |
| Color Coding | Complies with ISO 6009. |
| Catheter Placement (Functional) | Test confirmed no negative impact to the catheter post-placement through visual inspection under magnification. Testing was done to internal functional specifications. |
| Needle Flow | Comparison data to predicate device (K990519) performed; demonstrated substantial equivalence. |
| Biocompatibility | Complies with ISO 10993-1. Biocompatibility testing performed included: cytotoxicity, sensitization, irritation or intracutaneous reactivity, and acute systemic toxicity. |
| Pyrogenicity | Tested and confirmed. |
| Sterilization | Valuations performed to demonstrate compliance to applicable standards. (Method: ETO for both subject and predicate devices). |
| General Functional Specifications | Verification/validation testing to internal functional specifications (e.g. catheter placement, and bond strength between cannula, hub, and stylet) was performed. These tests demonstrated that the Remington Medical Inc. Tuohy Epidural Needles are substantially equivalent to the predicate device. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each performance test. It broadly states "Tests were performed on the Remington Medical Inc. Tuohy Epidural Needles."
- Data Provenance: The tests are described as "non-clinical testing" conducted to internal functional specifications and relevant ISO standards. No information on country of origin of data (likely internal company testing) or whether it was retrospective or prospective is given, as it refers to engineering and laboratory testing, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical epidural needle, not an AI/CADe system requiring expert-established ground truth from images or other medical data. The "ground truth" for this device's performance is objective measurement against engineering specifications and relevant ISO standards.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is mentioned as it is not a clinical study involving subjective interpretation. Performance is measured against objective 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 is not an AI device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- For the physical properties and performance (e.g., bond strength, flow, biocompatibility): The "ground truth" is established by international standards (ISO 7864, ISO 6009, ISO 10993-1) and internal functional specifications. These are objective, measurable criteria. For catheter placement, visual inspection under magnification was used to confirm no negative impact.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI device, there is no training set or ground truth in that context.
§ 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).