(29 days)
The Vector 4 " PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.
The Vector" PTA Balloon Catheter is a high pressure, non-compliant balloon catheter with a radio-opaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radio-opaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of · the physician.
It is a coaxial dual lumen over the wire balloon dilatation catheter. The central lumen, accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation'lument or the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter, to and through the stenosis. The distal tip is visible under fluoroscopy.
The balloon is a high pressure composite balloon with a radio-opaque coating on the working length to help visualize placement within the lesion during both placement and inflation; without the use of contrast. The balloon's rated burst pressure is 30 atm.
The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.
The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.
The modifications to the Vector TM PTA Balloon Dilatation Catherer are as follows.
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- The balloon will be coated with Parylene C coating, referred to throughout as Parylene, providing a natural lubricity for insertion and withdrawal through the introducer.
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- Each balloon catheter hub will be laser marked to include the balloon and introducer size, rated burst pressure and the product name, Vector" PTA. Balloon Catheter for customer convenience.
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- The balloon protector ID for the 5x40mm balloon was increased slightly.
There are no changes in the balloon catheter dimensions or significant changes in weight with these modifications ..
The provided text describes a 510(k) summary for the Vector4™ PTA Balloon Dilatation Catheter. The document outlines device modifications and performance testing but does not contain the detailed information requested regarding specific acceptance criteria values, sample sizes for test sets (beyond stating "all devices met"), ground truth establishment methods, expert involvement, or multi-reader multi-case studies.
Therefore, I cannot fully complete the requested table and answer all questions with the provided input. However, I can extract the available information and indicate where details are missing.
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Stated Acceptance (Pass/Fail) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Balloon rated burst pressure | Met performance specifications | "All devices met the performance specifications." |
| Balloon compliance | Met performance specifications | "All devices met the performance specifications." | |
| Balloon Diameter Sizing | Met performance specifications | "All devices met the performance specifications." | |
| Inflation/deflation times | Met performance specifications | "All devices met the performance specifications." | |
| Repeat inflation | Met performance specifications | "All devices met the performance specifications." | |
| Removal, Refold and Reuse | Met performance specifications | "All devices met the performance specifications." | |
| Crossing Profile | Met performance specifications | "All devices met the performance specifications." | |
| Balloon Burst | Met performance specifications | "All devices met the performance specifications." | |
| Material/Integrity | Coating integrity/Particulates | Met performance specifications | "All devices met the performance specifications." |
| Design/Compatibility | Balloon Protector | Met performance specifications | "All devices met the performance specifications." |
| Guide Wire and Introducer Compatibility | Met performance specifications | "All devices met the performance specifications." | |
| Aging Performance | Aged Balloon Testing (Rated Burst Pressure, Compliance, Diameter Sizing, Inflation/deflation times, Repeat Inflation, Removal/Refold & Reuse, Flexibility/Kink, Crossing Profile, Particulate/Coating Integrity, Balloon Protector, Guide Wire/Introducer Compatibility, Balloon Burst) | Met performance specifications after accelerated aging | "The bench testing demonstrated that the device meets specifications before and after aging..." |
| Biocompatibility | Biocompatibility (ISO 10993-1) | Met requirements | "the device is biocompatible meeting the requirements of ISO 10993-1." |
| Sterilization | Sterilization (SAL 10⁻⁶) | Met requirements | "The device is sterilized by ethylene oxide to an SAL 10⁻⁶ level..." |
Missing Information: The specific numerical or qualitative thresholds for "performance specifications" for each test are not provided in the document.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states "All devices met the performance specifications" for the various tests. However, the exact sample size (number of devices) used for each test set is not specified.
- Data Provenance: The tests are described as "bench testing" and conducted on "the modified Vector™ PTA Balloon Dilatation Catheter." This implies the data is prospective (generated specifically for this submission) and likely from an in-house or contracted lab, representing a controlled testing environment, not clinical data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This device is a medical catheter undergoing bench testing for physical and material performance, not an AI or diagnostic device that requires expert-established ground truth for image interpretation or diagnosis. Therefore, no experts for establishing ground truth are mentioned or applicable in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As this is bench testing of a physical device, not a diagnostic interpretation or clinical outcome, adjudication methods for ground truth establishment are not relevant. Test results would be objectively measured against predefined engineering specifications.
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
- No: This is a physical medical device (catheter), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not applicable and was not performed.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the traditional sense: For a physical medical device's bench testing, "ground truth" refers to predefined engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and design requirements. The device's performance is measured against these objective criteria.
8. The sample size for the training set
- Not Applicable: This submission describes the testing of a physical medical device, not the development or validation of an AI algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set for a physical medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).