(170 days)
The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.
The Reprocessed Balloon Inflation Device consists of a threaded plunger, locking mechanism, pressure gauge, Device and connecting tube. A finger latch controls the locking mechanism on the device. When the device is unlocked the threaded plunger may be advanced or withdrawn. Locking of the device allows for generation and monitoring of pressure in atmospheres (atm) and pounds per square inch (psi).
This document describes the 510(k) summary for the SterilMed Reprocessed Balloon Inflation Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and performance against those criteria in the way envisioned by the prompt.
Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in the given text because the 510(k) submission for a reprocessed device typically relies on demonstrating that the reprocessed device performs comparably to the original and its predicate, rather than conducting new clinical trials or extensive performance studies with ground truth.
Here's the information that can be extracted and synthesized from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance (General) | Representative samples underwent bench testing to demonstrate appropriate functional performance. |
| Cleaning Validation | Process validation testing was performed to validate the cleaning procedures. |
| Sterilization Validation | Process validation testing was performed to validate the sterilization procedures. |
| Packaging Validation | Process validation testing was performed to validate the device's packaging. |
| Visual Inspection | The manufacturing process includes visual testing of all products produced. |
| Functional Testing (Manufacturing) | The manufacturing process includes functional testing of all products produced. |
| Substantial Equivalence (Overall) | The Reprocessed Balloon Inflation Device is substantially equivalent to the Encore 26 Inflation Device (K955869) based on similarities in functional design, materials, indications for use, and methods of construction. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not explicitly stated. The document mentions "representative samples" for bench testing and "all products produced" for manufacturing testing, but specific numbers are not provided.
- Data Provenance: Not specified, but generally, bench testing data for 510(k) submissions are generated domestically by the submitter (SterilMed, Inc. is in Minneapolis, MN). The study is prospective in the sense that testing was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. This type of information is typically required for diagnostic devices where subjective interpretation or a definitive "ground truth" (e.g., disease presence/absence) needs independent verification. For a reprocessed mechanical device, ground truth is established through objective engineering tests and comparisons to specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / None (as per medical imaging/clinical trial context). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies. For a mechanical device, performance is typically objectively measured against pre-defined specifications, and any deviation would be assessed by engineering personnel.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant to diagnostic AI-powered devices, not a reprocessed mechanical surgical tool like a balloon inflation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is purely mechanical and does not involve any algorithms or AI for standalone performance evaluation. Its function is to create and monitor pressure and deflate a balloon, which is a direct physical action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Predicate Device Performance: The "ground truth" for this device is effectively its ability to meet the original design specifications of a new device and to perform equivalently to the predicate device (Encore 26 Inflation Device, K955869). This is assessed through objective criteria in bench testing (e.g., pressure generation, pressure monitoring accuracy, locking mechanism function, durability) and validation of reprocessing effectiveness (cleaning, sterility, packaging integrity).
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is a mechanical device, not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this type of device.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.