(189 days)
The SC 35 Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, renal arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller.
The provided text describes the regulatory clearance of a medical device, the SC 35 Balloon Dilatation Catheter, and details the in vitro functional and biocompatibility tests performed to demonstrate its safety and performance. However, it does not contain information about a clinical study involving human patients or a comparative effectiveness study with AI assistance.
Here's a breakdown based on the information available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance / Outcome (Implicit) |
|---|---|---|
| In Vitro Functional Tests | Balloon Burst Testing | Met criteria for safety and performance |
| Multiple Inflation Testing | Met criteria for safety and performance | |
| Inflation/Deflation Time Testing | Met criteria for safety and performance | |
| Balloon Compliance Testing | Met criteria for safety and performance | |
| Balloon Proximal Bond Testing | Met criteria for safety and performance | |
| Sheath Withdrawal Testing | Met criteria for safety and performance | |
| Wingfolded Balloon Profile Testing | Met criteria for safety and performance | |
| Coating Coefficient of Friction Testing | Met criteria for safety and performance | |
| Particulate Analysis Testing | Met criteria for safety and performance | |
| Solvent Residual Testing | Met criteria for safety and performance | |
| Biocompatibility Tests | Cytotoxicity | Met criteria for safety and performance |
| Hemolysis | Met criteria for safety and performance | |
| Acute Intracutaneous Reactivity | Met criteria for safety and performance | |
| Acute Systemic Toxicity | Met criteria for safety and performance | |
| Sensitization | Met criteria for safety and performance | |
| Pyrogenicity | Met criteria for safety and performance |
Note: The document states "Based on...safety and performance testing, the SC 35 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use," implying all listed tests met their predefined acceptance criteria, though the specific quantitative criteria and results are not provided.
Regarding the study proving the device meets the acceptance criteria:
The "study" referenced in the document is a series of in vitro functional tests and biocompatibility tests, not a clinical study involving human subjects or AI.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document only lists the types of in vitro and biocompatibility tests performed.
- Data Provenance: The tests were performed by the manufacturer, Boston Scientific Corporation, based in Natick, MA, USA. The data would be considered prospective, as it was generated specifically for the premarket notification.
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 physical medical instrument, and the testing described consists of laboratory-based physical and chemical tests rather than interpretation of diagnostic data by experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As these are laboratory tests, there is no expert adjudication process in the sense of reviewing diagnostic outcomes. Test results would be compared against predefined engineering and biological 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. An MRMC study was not performed. The device is a physical balloon dilatation catheter, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device. The "performance" described is the physical and biological characteristics of the catheter itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Biocompatibility Standards: The "ground truth" for the in vitro tests would be the established performance specifications for balloon catheters (e.g., maximum burst pressure, inflation/deflation times, material properties) and regulatory standards for biocompatibility (e.g., ISO standards for medical devices).
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).