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The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices 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, ViewMate Z and Philips CX50 ultrasound consoles.

The provided document is a 510(k) summary for the ViewFlex Xtra ICE Catheter, seeking to expand its indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results with numerical performance metrics for the device itself.

Based on the provided text, a comprehensive answer to your request cannot be fully generated as the document does not include the detailed information you're looking for regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.

However, I can extract the relevant information and state what is not present:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the document. The submission is for an expanded indication for use, relying on substantial equivalence to a previously cleared device.
• Reported Device Performance: Not explicitly stated with numerical metrics. The document mentions "image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381)" were referenced to demonstrate the ability to image devices, but no performance metrics (e.g., sensitivity, specificity, resolution) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

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 mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not mentioned.

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

• MRMC Study: Not mentioned. The device is a diagnostic ultrasound catheter, not an AI or image analysis algorithm that assists human readers.
• Effect Size of AI Improvement: Not applicable, as this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable, as this is a medical device for direct visualization, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not mentioned directly. The document states that "images collected during the use of the predicates for visualizing other devices within the heart" were used, implying the ground truth was visual confirmation by users of the predicate devices.

8. The sample size for the training set

• Not applicable, as this is a medical device for direct visualization, not a machine learning model.

9. How the ground truth for the training set was established

• Not applicable.

Overall Summary:

The 510(k) submission for the ViewFlex Xtra ICE Catheter primarily focuses on demonstrating substantial equivalence to predicate devices for an expanded indication of use (visualizing other devices within the heart). It states that the design, technological characteristics, and materials are identical to the previously cleared ViewFlex Xtra ICE Catheter (K121381). To support the expanded indication, it refers to "image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381) and images collected during the use of the predicates for visualizing other devices within the heart."

The document explicitly states: "There have been no device changes and no changes to the visualization location. This submission is to expand the current indications for use to include visualizing other devices within the heart." This implies that the previous clearance (K121381) would have contained the detailed performance data, which is not included in this summary. The current submission's "proof" is the established equivalence and the prior clearance, not new, detailed performance studies.

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The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical -mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Intracardiac echo, Intraoperative, Laparoscopic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculoskeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esophogeal. (Cardiac), Peripheral Vessel, Other (Carotid).

The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, cardiac ultrasound imaging system. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The subject of this submission is the addition of new indications to Philips CX50 ultrasound system and the transducers that employ the new indications. The new indications include: ICE (intracardiac echo), Intraoperative, and Laparoscopic.

The provided 510(k) summary for the Philips CX50 Diagnostic Ultrasound System with additional indications (K123784) states that no new clinical tests were conducted for this submission. The device's safety and effectiveness are supported by non-clinical performance data and its substantial equivalence to predicate devices (Philips Healthcare HD11 Diagnostic Ultrasound System, K062247, and Philips iU22, K030455).

Therefore, there is no information in the provided text regarding acceptance criteria for a study proving the device meets those criteria, as no such study was performed or submitted as part of this 510(k) notification.

The document explicitly states:

"This release of CX50 introduces no new indications for use, modes, features, or technologies relative to the predicate devices (HD11, K062247, and iU22, K030455) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Since no new clinical tests were performed, the remaining sections of your request (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for training set) are not applicable to the information provided in this 510(k) summary.

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