(147 days)
The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in a balloon dilation catheter.
The device consists of three major components; a) 30ml barrel, b) inflation mechanism and c) 6% standard conical fitting and stopcocks system for connecting to the PTCA catheter. The barrel has graduation markings at 0.5ml interval to the full 30ml capacity A dual scale pressure gauge mounted at distal end of the barrel is capable of indicating pressure up to 30atm at 1atm or 10psi intervals. Reinforced polyurethane tubing extending from the svringe exit port connects to a 6% male/female conical fitting for attaching to the 3-way stopcock and to the angiographic catheter.
Acceptance Criteria and Device Performance Study for OXTI Inflation Devices
This document summarizes the acceptance criteria and the study performed to demonstrate the OXTI Inflation Device meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Biocompatibility | Cytotoxicity | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) |
| Sensitization | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Intracutaneous reactivity | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Acute systematic toxicity | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Hemocompatibility | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Functional & Performance | 6% conical fitting efficacy | Per ISO 594.1 & 2 | Meets ISO 594.1 & 2 (results not quantified but stated as satisfactory) |
| Whole device resistance to water leakage | (Implicit: No leakage) | Meets (results not quantified but stated as satisfactory) | |
| Tubing joints resistance to tensile pull | (Implicit: Withstand specified tensile forces) | Meets (results not quantified but stated as satisfactory) | |
| Barrel and plunger resistance to water leakage | (Implicit: No leakage) | Meets (results not quantified but stated as satisfactory) | |
| Forces to initiate and continue pushing of plunger | (Implicit: Within acceptable ergonomic/functional range) | Meets (results not quantified but stated as satisfactory) | |
| Pressure Gauge Accuracy | Accuracy against a standard, calibrated gauge | Tested at 2atm pressure intervals up to 30atms (Implicit: Meets specified accuracy tolerances) | Meets (results not quantified but stated as satisfactory) |
Note: The provided 510(k) summary states that "Results of various tests support the claim that the OXTI Inflation Device meets requirements specified by various international voluntary standards and is substantially equivalent to legally marketed predicate devices." However, specific quantitative acceptance criteria or detailed numerical results for each test are not explicitly provided in this summary. The reported device performance is described as meeting the requirements.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench tests and material biocompatibility tests. These do not typically involve human subject data or a "test set" in the context of clinical studies.
- Sample Size for Test Set: Not applicable in the context of a clinical test set. For bench testing, the sample size would refer to the number of devices or components tested. This information is not specified in the provided summary.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for bench tests. The tests were performed as part of the device's pre-market evaluation by OXTI Corporation, located in New Taipei City, TAIWAN.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are bench tests and biocompatibility tests, which rely on established scientific methods and standards (e.g., ISO for conical fittings, established toxicity protocols). Ground truth in this context is determined by adherence to these standards, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are technical/engineering and biocompatibility evaluations, not clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The OXTI Inflation Device is a mechanical medical device for pressure creation and monitoring, not an imaging or diagnostic device that would utilize human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The OXTI Inflation Device is a mechanical device, not an algorithm. Its performance is inherent to its design and functional capabilities, not dependent on an algorithm operating alone.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation consists of established international voluntary standards (e.g., ISO 594.1 & 2 for conical fittings) and established scientific protocols for material biocompatibility testing. The "truth" is whether the device's physical and biological properties meet the requirements of these standards and protocols.
8. The Sample Size for the Training Set
Not applicable. The OXTI Inflation Device is a mechanical device, and its development and testing do not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The device's design and engineering are based on principles of mechanical design, material science, and established medical device requirements, rather than trained on data.
§ 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.