(100 days)
The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.
The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.
The provided document is a 510(k) summary for a medical device (Imager II Angiographic Catheter) seeking substantial equivalence to a predicate device. It primarily discusses regulatory compliance and biocompatibility. It does not present a study proving the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would.
Instead, the document states that the device has been tested and compared to a predicate device, and all data gathered demonstrate substantial equivalence. The "acceptance criteria" here are geared towards regulatory approval rather than clinical performance metrics.
Therefore, many of the requested details about statistical studies, sample sizes, ground truth establishment, and expert involvement are not available in this type of regulatory submission.
Here's an analysis based on the information provided, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Biocompatibility: Device materials are biocompatible for intended use. | "The IMAGER™II Angiographic Catheters have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use." |
| Substantial Equivalence: Device is substantially equivalent to the NightHawk Angiographic Catheter (predicate device), with no new safety or efficacy issues. | "The IMAGER™II Angiographic Catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." |
| Intended Use: Provides a pathway for delivering contrast media to selected sites in the vascular system. | This is the stated intended use; functionality is implied to meet this by substantial equivalence to the predicate. |
| Device Characteristics: (e.g., shapes, lengths, radiopacity consistent with predicate) | "Available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy." (Implied to be consistent with or improved over predicate characteristics). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any specific performance or equivalence testing. The 510(k) process relies on demonstrating equivalence through various engineering, performance, and biocompatibility tests, not typically a large-scale clinical "test set" as understood in AI/ML studies.
- Data Provenance: Not specified. Testing would have been conducted by the manufacturer, Boston Scientific/Medi-Tech, likely under controlled laboratory conditions, possibly involving internal tests and external contract labs for biocompatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable in the context of this 510(k) submission. The ground truth for biocompatibility is established by ISO 10993 standards and testing protocols. For substantial equivalence, it's a comparison to the known performance and characteristics of the predicate device. There is no mention of human expert-labeled "ground truth" data sets.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of a formal adjudication process for interpreting test results in the way one would for clinical image reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This document describes a 510(k) submission for an angiographic catheter, which is a physical medical device. MRMC studies are typically performed for diagnostic imaging devices or AI-powered algorithms to assess human reader performance with and without assistance. This device does not fall into that category.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: Established by international standards (ISO 10993) and the results of specific biological evaluations (e.g., cytotoxicity, sensitization, irritation tests).
- For Substantial Equivalence: Comparison to the known specifications, materials, and intended use of the legally marketed predicate device (NightHawk Angiographic Catheter).
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this type of device and regulatory submission. This is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no AI/ML training set. Any internal developmental testing or engineering validation would have relied on established engineering principles, material science, and test methods.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).