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510(k) Data Aggregation
(29 days)
The ON-Q* QuikBloc* Over-the-Needle Catheter Set is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The ON-Q* QuikBloc* Over-the-Needle Catheter Set is contraindicated for the epidural space.
ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Sets are available in four product codes (20 GA x 4" Needle, 16 GA x 3" Catheter (with and without Stimulating needle); 20 GA x 6" Needle, 16 GA x 5" Catheter (with and without stimulating needle)). The kits include: 1) ON-Q* QuikBloc* Over-the-Needle Catheter Set (some models include an integrated stimulating cable) 2) Removable Needle Wing 3) Non-DEHP 24 inch Needle Extension Set, 4) Non-DEHP 6 inch Catheter Extension Set 5) Connector Securement Device 6) Occlusive Dressing 7) Adhesive Strips 8) Catheter ID label These devices are sold as disposable, sterile, single use, devices.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
Based on the provided text, the document describes a 510(k) premarket notification for a medical device, the ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set. It asserts substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving quantitative performance against those criteria as would be expected for a novel device or a device demonstrating new clinical claims.
Therefore, much of the requested information for acceptance criteria and a detailed study is not present in this document.
However, I can extract the information that is implicitly or explicitly stated:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria or detailed performance metrics are provided in this document. The submission is based on substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility (ISO 10993 guidelines) | No adverse reaction to test articles, no adverse effects. Components have existing 510(k) clearance and deemed safe for intended use. |
| Functionality (Operates as intended) | Functions as designed and can be operated by the user as intended through the user interface and instructions provided. |
| Safety & Effectiveness comparable to predicate devices | "The ON-Q* Pain Relief System QuikBloc* Over-the-Needle Catheter Set is as safe and effective and performs as well as the predicate devices." (Conclusion) |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "evaluated for biocompatibility by their corresponding vendors" and "Gamma or EO sterilized samples of the components...were tested". This suggests component-level testing rather than a specific clinical test set for the integrated device.
- Data Provenance: The document states "tested in vitro or in laboratory animals". It doesn't specify country of origin or whether it was retrospective or prospective, but animal and in vitro testing are typically prospective lab studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/specified. This document describes a 510(k) submission based on substantial equivalence and non-clinical testing (biocompatibility, functionality). There is no mention of a human-reader study or ground truth established by experts for performance evaluation.
4. Adjudication method for the test set
Not applicable/specified. There is no mention of human-reader studies or a need for adjudication.
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 catheter set, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
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 or software.
7. The type of ground truth used
For biocompatibility, the "ground truth" would be established by the standardized methods and endpoints defined in ISO 10993 guidelines (e.g., absence of cytotoxicity, irritation, sensitization). For functionality, the "ground truth" would be the successful operation of the device according to its design specifications and user instructions. There is no mention of pathology, expert consensus, or outcomes data in a clinical sense for performance claims in this document.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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