(30 days)
The ViewFlex™ Xtra ICE Catheter, part of the ViewMate™ System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II and ViewMate Z ultrasound consoles.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific, quantifiable acceptance criteria in the traditional sense of a performance study (e.g., a specific sensitivity or specificity threshold). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through various non-clinical tests.
The criteria can be inferred from the "Comparison to Predicate Devices" and "Summary on Non-Clinical Testing" sections.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Same intended use and fundamental scientific technology as the predicate device. | "The ViewFlex™ Xtra ICE Catheter has the same intended use and fundamental scientific technology as the predicate device." |
| Technological Equivalence: Technological characteristics (packaging, biocompatibility, sterilization, labeling) are substantially equivalent to the predicate device. | "The technological characteristics of the ViewFlex™ Xtra ICE Catheter are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling." |
| Safety and Effectiveness (Design Modifications): Design modifications do not adversely affect safety and effectiveness. | "Through biocompatibility and bench performance testing it was demonstrated that the design modifications do not adversely affect the safety and effectiveness." |
| Performance Specifications (Bench Testing): Device meets established performance specifications. | "The results of bench testing demonstrated that the device meets the established performance specifications." |
| Biocompatibility Specifications: Modified design meets specifications in accordance with ISO 10993-1. | "The results of biocompatibility testing demonstrated that the modified design meets specifications in accordance with ISO 10993-1." |
| Overall Substantial Equivalence: Based on the above, the device is substantially equivalent to the predicate. | "Based on this and the data provided in this pre-market notification, the subject device and predicate device has been shown to be substantially equivalent." (FDA's letter further confirms this determination). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing (bench testing and biocompatibility testing). There is no mention of a clinical test set involving human patient data being used to establish the device's performance regarding its primary indication (visualizing cardiac structures and blood flow). Therefore, there is:
- No sample size for a clinical test set.
- No data provenance (country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
As there was no clinical test set described for the primary indication of visualizing cardiac structures and blood flow, this information is not applicable or provided. The "ground truth" for the non-clinical tests would be established by the physical and chemical properties measured during bench and biocompatibility testing, compared against predetermined engineering specifications and ISO standards, respectively.
4. Adjudication Method for the Test Set
Again, since no clinical test set for diagnostic performance is described, an adjudication method is not applicable or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe an MRMC comparative effectiveness study, nor does it address human reader improvement with or without AI assistance. This device is an imaging catheter, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is an intracardiac ultrasound catheter, a direct imaging device, not an algorithm or AI system for which standalone performance would be applicable. Its "performance" is its ability to acquire images, which is assessed through bench testing and its similarity to the predicate device.
7. The Type of Ground Truth Used
For the non-clinical testing described:
- Bench Testing: Engineering specifications and performance metrics derived from the device's design and intended function (e.g., deflection capabilities, ultrasound signal quality, physical dimensions).
- Biocompatibility Testing: Compliance with ISO 10993-1 standards for biological evaluation of medical devices.
- Substantial Equivalence: Comparison to the established characteristics and performance of the predicate device (ViewFlex Plus Catheter (K101239)).
8. The Sample Size for the Training Set
Not Applicable. This is a hardware device (an intracardiac ultrasound catheter), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As no training set is relevant for this type of device.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.