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The CryoCor Model 1255 Surgical Probe is intended to be used for the treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue. The Probe is part of a Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques.

The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.

The CryoCor Model 1255 Surgical Probe is a single-use, disposable device that interfaces with the Cryoablation console and delivers Cryoablation therapy to the target tissue, using N2O as a cryogen and employing the Joule-Thomson effect to cause a block of electrical conduction through tissue through cryonecrosis. Placement of the Probe tip is accomplished under direct visualization by manipulation of the Probe handle (applying torque to the shaft and/or deflecting the articulation segment). The Breva Model Series may include multiple articulation lengths and multiple tip lengths. The first model of the Breva Model Series to be commercialized will be the Breva 1255-15-12 (i.e. 5cm articulation length, 15 mm tip length, and 12cm shaft length).

Here's a breakdown of the acceptance criteria and study information for the CryoCor Model 1255 Surgical Probe, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document only mentions "Bench testing" and does not specify a numerical sample size for the test set.
   • Data Provenance: Not explicitly stated, but "Bench testing" implies laboratory-controlled conditions, not human clinical trial data. The device is intended for use in cardiac surgery, but no clinical data is presented for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The testing described is bench testing, which typically does not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for bench testing would be predefined engineering specifications.

3. Adjudication method for the test set:

   • This information is not provided as the disclosed testing is bench testing, not a clinical study requiring adjudication of expert interpretations.

4. 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?

   • No, an MRMC comparative effectiveness study was not done. This device is a surgical probe, not an AI-powered diagnostic tool that would typically involve human readers or AI assistance in interpretation.

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

   • No, this is not applicable. The device is a physical surgical probe, not an algorithm.

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

   • For the bench testing, the "ground truth" would be the engineering design specifications and performance requirements for the device. For biocompatibility, it would be the standards set by ISO 10993-1. For sterilization, it would be the validated E-beam radiation cycle parameters.

7. The sample size for the training set:

   • This information is not applicable/not provided as the device is a physical surgical probe, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • This information is not applicable as the device is a physical surgical probe, not a machine learning algorithm.

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The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.

The Model 3100 Series Sheath Introducer Kit consists of various sheath introducers, each packaged in a kit together with a dilator, introducer catheter and guide wire.

The sheath introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. A radioopaque marker at the tip of the sheath will aid during placement while utilizing fluoroscopic guidance. There are side holes at the distal end to allow for injection of contrast media.

The dilator is tapered at the distal tip to allow for use of standard needles for trans-septal procedures, and will accommodate a guide wire or needle no larger than 0.038".

The introducer catheter is gradually tapered distally to allow for gradual dilation of entry into vasculature without producing damage.

The guide wire is 0.038" in diameter, 150 cm in length with a "I"-tip configuration. It is supplied in a hoop dispenser with a "J" straightener attached to the distal end. The proximal end of the hoop dispenser has a luer hub to facilitate flushing of the wire.

The provided 510(k) summary for K040552 describes a medical device, the CryoCor Model 3100 Series Sheath Kits, which are Catheter Introducers. The summary focuses on showing substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics traditionally associated with validating new clinical claims or complex algorithms.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set details) are not applicable or not provided in this type of submission.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified. The studies appear to be bench and pre-clinical comparisons, rather than human clinical trials.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. The "test set" likely refers to engineering or bench test samples, not clinical patient data requiring expert ground truth.

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

   • Not applicable/Not provided.

4. 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:

   • No. This device is a physical catheter introducer, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For performance testing, the "ground truth" would be the engineering specifications and established performance metrics for catheter introducers. For biocompatibility, it's compliance with ISO standards. For sterilization, it's a validated cycle.

7. The sample size for the training set:

   • Not applicable/Not provided. As above, this is a physical device, not an AI model.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided.

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