(139 days)
The catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The AcuNav catheters are, disposable, and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization.
The provided document is a 510(k) summary for the Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F. It states that the device is substantially equivalent to a previously cleared predicate device (AcuNav Diagnostic Ultrasound Catheter 8F, 10F, K071234) and therefore does not provide information on acceptance criteria or a study proving that the device meets those criteria through clinical data.
The summary explicitly states: "Because the AcuNav catheters in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence."
Instead, the submission relies on the substantial equivalence to a predicate device and non-clinical tests to demonstrate safety and effectiveness.
Here is a breakdown of the information that can be extracted or deduced from the document, along with an explanation of why other requested information is not available:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study demonstrating performance against specific acceptance criteria was required or provided, this table cannot be populated from the given document. The document focuses on demonstrating that the new device shares the same "Features/Characteristic" of the predicate, implying that if the predicate performed acceptably, so will the new device.
| Feature/Characteristic | Acceptance Criteria (Not explicitly stated for new device performance) | Reported Device Performance (Implied by Substantial Equivalence to Predicate) |
|---|---|---|
| Indications for use: | Equivalent to predicate | Cardiac, Pediatric, Intra-luminal, Intra-cardiac visualization |
| - Cardiac | Equivalent to predicate | √ |
| - Pediatric | Equivalent to predicate | √ |
| - Intra-luminal | Equivalent to predicate | √ |
| - Intra-cardiac | Equivalent to predicate | √ |
| Mode of operation: | Equivalent to predicate | 2D, C, D, CW |
| - 2D | Equivalent to predicate | √ |
| - C | Equivalent to predicate | √ |
| - D | Equivalent to predicate | √ |
| - CW | Equivalent to predicate | √ |
| Patient contact materials | ISO 10993-1 compliance | ISO 10993-1 compliant |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. As no clinical study demonstrating performance of the new device was conducted, there are no test sets, data provenance, or sample sizes associated with such a study in this document. The submission relies on the established safety and effectiveness of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical test set data was provided for the new device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set data was provided for the new device.
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 diagnostic ultrasound catheter, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm, but rather a medical hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No clinical test set data was provided for the new device.
8. The sample size for the training set:
Not applicable. No training set for an algorithm for the new device was mentioned. The device is a hardware component.
9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm for the new device was mentioned.
Summary of Non-Clinical Tests:
The document mentions that the device has been evaluated for:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
And has been found to conform with applicable medical device safety standards, including:
- UL 60601-1
- IEC 60601-2-37
- AIUM/NEMA UD-3
- AIUM/NEMA UD-2
- EN/IEC 60601-1, 60601-1-1, 60601-1-2
- ISO 10993-1 (Biocompatibility)
These non-clinical tests serve as the basis for demonstrating the safety of the device, implying that meeting these standards is an "acceptance criteria" for the non-clinical aspects, but they do not relate to clinical performance criteria for diagnosis or imaging quality against a ground truth.
§ 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).