Search Results

The Artimes Balloon Dilatation Catheter is indicated for:

1. Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients coronary ischemia for the purpose of improving myocardial perfusion

2. Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

The Artimes1 (Rx type) device is a coronary dilatation catheter designed for easy guidewire exchange. The catheter working length is 140cm. Lubricious coatings are applied to the distal section. Balloon diameters range from Ø1.5mm to Ø4.0mm. The balloon material is made of a semi-compliant Pebax material for diameter 1.5mm to 4.0mm with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube with a wire. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of pebax/nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of balloon diameters less than 2.0mm which incorporate a centrally positioned single marker band. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

Note 1: the Artimes balloon dilatation catheter family contains Ø1.0-1.25mm x 5-30mm configurations which are NOT intend for sales in the United States (US) but rest of world (ROW) based upon availability of regulatory approvals. Separate Catalog numbers have been assigned to the Artimes US product (801-DDLLU, reference section 11.0) for the Ø1.5-4.0mm x 5-30mm configurations with its IFU and label, compared with Artimes ROW product (801-DDLL) for the Ø1.0-4.0mm x 5-30mm configurations. Additional 510k or relevant (e.g. IDE or PMA) submission will be executed if BrosMed Medical is going to registry those configurations (Ø1.0-4.0mm x 5-30mm) in the United States.

The provided document is a 510(k) summary for the Artimes Balloon Dilatation Catheter. It describes the device, its intended use, and claims substantial equivalence to predicate devices, supported by performance testing. However, it does not contain the level of detail requested for a typical AI/software device study, particularly regarding acceptance criteria, sample sizes, and ground truth for a clinical study. The device is a physical medical device (catheter), not primarily an AI or software device.

Therefore, many of the requested fields cannot be filled. I will provide what information is available and indicate when information is "Not Applicable" or "Not Provided" given the nature of the document.

Here's the breakdown based on the provided text:

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

Specific numerical acceptance criteria for each test (e.g., specific burst pressure values, fatigue cycles) are not provided in this summary document. It only states that the tests were performed and "met all acceptance criteria."

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 Provided (for clinical studies). The performance tests mentioned are in vitro and biocompatibility tests. The sample sizes for these engineering and lab tests are not specified.
• Data Provenance: Not Applicable/Not Provided (for a clinical study). The data described are from in vitro and biocompatibility testing, not patient data.

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)

• Number of Experts: Not Applicable. This device is a physical medical device, not an AI/Software device requiring expert interpretation for ground truth.
• Qualifications of Experts: Not Applicable.

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

• Adjudication Method: Not Applicable. This is not a study requiring expert adjudication of results.

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 done. This is a physical medical device, not an AI/Software device.
• Effect Size: Not Applicable.

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

• Standalone Performance: Not Applicable. This is a physical medical device.

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

• Type of Ground Truth: For the performance tests, the "ground truth" would be established by validated engineering specifications and international standards for medical device testing, as referenced by the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)." This typically involves objective measurements against predefined thresholds, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable. This is a physical medical device, not an AI/Software device that requires a training set.

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

• Ground Truth for Training Set: Not Applicable.

Ask a specific question about this device