(121 days)
The VANTAGE™ Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Popliteal arteries. The VANTAGE™ Peripheral Dilatation Catheter is not intended for use in the coronary arteries or in neurovasculature.
The 10 cm VANTAGE™ Peripheral Dilatation Catheter is a double-lumen catheter with a poly(ethylene)terephthalate (PET) balloon bonded to the shaft. The 10 cm VANTAGE™ Peripheral Dilatation Catheter has a range of balloon sizes from 3 mm to 7 mm in inflated diameter. The catheter is available in 75 cm to 125 cm shaft lengths.
The provided text describes a medical device, the VANTAGE™ Peripheral Dilatation Catheter, and its performance relative to established safety and effectiveness criteria. However, it does not include information on acceptance criteria for an AI/algorithm-based device, human expert involvement in ground truth establishment, or multi-reader multi-case studies. The study described focuses on physical performance and biocompatibility tests of a catheter, not on an AI algorithm's diagnostic or predictive capabilities.
Here's an attempt to structure the available information per your request, while highlighting the absence of AI-specific details:
Device: VANTAGE™ Peripheral Dilatation Catheter - Additional Sizes
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a physical medical device (catheter) and not an AI algorithm, the "acceptance criteria" are implied by the successful completion of various engineering and biocompatibility tests designed to ensure the device is safe and performs as intended. There aren't specific numerical "criteria" listed in the format you might expect for an AI algorithm's sensitivity/specificity, but rather that the device "passed" or "was found to be clinically acceptable."
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical Performance | Catheter Preparation Test | Clinically Acceptable | Passed |
| Balloon Minimum Burst Strength Test (Rupture) | Clinically Acceptable | Passed | |
| Balloon Compliance Test (Distensibility) | Clinically Acceptable | Passed | |
| Balloon Inflation/Deflation Tests | Clinically Acceptable | Passed | |
| Balloon Fatigue Test (Repeated Inflation) | Clinically Acceptable | Passed | |
| Tip Pulling Test | Clinically Acceptable | Passed | |
| Bonding Strength Test | Clinically Acceptable | Passed | |
| Catheter Body Burst Pressure Test | Clinically Acceptable | Passed | |
| Contrast Medium Flow Rate Test | Clinically Acceptable | Passed | |
| Dimensional Measurements (Tip Diameter, Profile) | Clinically Acceptable | Passed | |
| Biocompatibility | Cytotoxicity Elution | USP Class IV / Passed | Passed |
| Sensitization | USP Class IV / Passed | Passed | |
| USP XXII Plastics Test (Class IV) - Intracutaneous Test | USP Class IV / Passed | Passed |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The studies listed are laboratory or bench tests on the physical catheter, not analyses of data in the context of an AI algorithm. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes physical device testing, not an AI algorithm requiring expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable. The document describes testing of a physical medical device, not an AI system that would assist human readers in interpretation. Therefore, there is no discussion of human readers improving with or without AI assistance, or any effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
For the physical performance tests, the "ground truth" would be established engineering standards, material specifications, and regulatory requirements (e.g., burst pressure limits) for catheter performance. For biocompatibility, it's defined by the Tripartite Biocompatibility Guidelines and USP Class IV standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI algorithm validation.
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
Summary of AI-Related Information in the Text:
The provided text describes a 510(k) submission for a conventional medical device (a catheter). It focuses on the physical and biological characteristics of the device. None of the information typically associated with the evaluation of an AI or algorithm-driven device is present in this document. The request's template is designed for AI/ML medical devices, which operate under a different set of evaluation criteria than traditional hardware devices.
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K9665183
APR 2 4 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510 (k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990.
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Submitted by 1.
Advanced Cardiovascular Systems 3200 Lakeside Drive Santa Clara, CA 95052 -
- General Information
Device Name: VANTAGE™ Peripheral Dilatation Catheter- Additional Sizes
- General Information
| Predicate Device: | VANTAGE™ Dilatation Catheter (ACS)Ultra-thin™ Dilatation Catheter (Medi-Tech) |
|---|---|
| ------------------- | ----------------------------------------------------------------------------------- |
PTA Balloon Dilatation Catheter Common Name:
Device Classification: Class II
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- Indications for Use
The VANTAGE™ Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Popliteal arteries. The VANTAGE™ Peripheral Dilatation Catheter is not intended for use in the coronary arteries or in neurovasculature.
- Indications for Use
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- Product Description
The 10 cm VANTAGE™ Peripheral Dilatation Catheter is a double-lumen catheter with a poly(ethylene)terephthalate (PET) balloon bonded to the shaft. The 10 cm VANTAGE™ Peripheral Dilatation Catheter has a range of balloon sizes from 3 mm to 7 mm in inflated diameter. The catheter is available in 75 cm to 125 cm shaft lengths.
- Product Description
న. Rationale for Substantial Equivalence
The 10 cm VANTAGE" Peripheral Dilatation Catheter is substantially equivalent to the ACS VANTAGE™ Dilatation Catheter (510 (k) Notification K934433) and Medi-Tech's Ultra-thin" Balloon Dilatation Catheter (510 (k) Notification K920547). The 10 cm VANTAGE" Peripheral Dilatation Catheter is equivalent
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to the VANTAGE™ and Ultra-thin" Balloon Dilatation Catheters in term of its indications for use, functionality, performance and safety. The VANTAGE™ Dilatation Catheter and Ultra-thin" Balloon Dilatation Catheter were found to be substantially equivalent to devices which were in commercial distribution prior to May 28, 1976.
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6. Safety and Performance Studies
The following tests were performed on the 10 cm VANTAGE™ Peripheral Dilatation Catheter:
- Catheter Preparation Test 1)
- Balloon Minimum Burst Strength Test (Balloon Rupture) 2)
- Balloon Compliance Test (Distensibility) 3)
- Balloon Inflation/Deflation Tests 4)
- Balloon Fatigue Test (Repeated Balloon Inflation) ર)
- Tip Pulling Test ()
- Bonding Strength Test 7)
- Catheter Body Burst Pressure Test 8)
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- Contrast Medium Flow Rate Test
- Dimensional Measurements (Tip Diameter and Profile Test) 10)
The results of each of the tests were found to be clinically acceptable.
The 10 cm VANTAGE™ Peripheral Dilatation Catheter has been tested per the Tripartite Biocompatibility Guidelines and has passed the USP Class IV for plastics. The following biocompatibility tests were conducted:
- Cytotoxicity Elution 1)
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- Sensitization
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- USP XXII Plastics Test (Class IV) - Intracutaneous Test
The 10 cm VANTAGE™ Peripheral Dilatation Catheter passed each of the biocompatibility tests conducted.
- Conclusions 7)
Based upon the indications for use, technological characteristics, and safety and performance studies, the 10 cm VANTAGE™ Peripheral Dilatation Catheter has been shown to be safe and effective for its intended use.
§ 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).