(30 days)
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.
All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.
The Chocolate Balloon Catheters are supplied sterile and intended for single use only.
The provided document describes the Chocolate PTA Balloon Catheter, a medical device. The 510(k) summary focuses on establishing substantial equivalence to predicate devices, primarily through bench testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Tests Performed) | Reported Device Performance |
|---|---|
| Balloon Rated Burst Pressure | Performed. Results support substantial equivalence. |
| Balloon Inflation and Deflation | Performed. Results support substantial equivalence. |
| Balloon Fatigue / CS Fatigue | Performed. Results support substantial equivalence. |
| Catheter Diameter, Balloon Profile and Tip Configuration | Performed. Results support substantial equivalence. |
| Balloon Compliance | Performed. Results support substantial equivalence. |
| Trackability, Pushability | Performed. Results support substantial equivalence. |
| Kink Resistance | Performed. Results support substantial equivalence. |
| Device Interface Compatibility | Performed. Results support substantial equivalence. |
Study that proves the device meets the acceptance criteria:
The study conducted was a series of bench tests (in vitro tests) designed to evaluate the physical and mechanical properties of the Chocolate PTA Balloon Catheter. The purpose of these tests was to demonstrate that the device performs reliably and safely for its intended use, and that its performance is substantially equivalent to predicate devices.
Specific Information not available in the text:
The document broadly states that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and "Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use." However, it does not provide specific quantitative acceptance criteria or detailed results for each individual test. For example, it doesn't state what the accepted range for balloon rated burst pressure was, or the actual burst pressures observed.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample size (number of devices) used for each individual bench test.
- Data Provenance: The data is from bench testing (in vitro), meaning it was conducted in a laboratory setting, not on human subjects or patient data. The country of origin for the testing is not explicitly stated, but the submitter (TriReme Medical, Inc.) is located in Pleasanton, CA, USA, suggesting the testing likely occurred in the US or under US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the evaluation was based on bench testing of physical device properties, not on interpretation of medical images or clinical outcomes that would require expert consensus for ground truth.
4. Adjudication method for the test set
- This information is not applicable as the evaluation was based on bench testing, not on human interpretation or categorization of data requiring adjudication.
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
- This information is not applicable. The device is a PTA Balloon Catheter, a physical medical device used for dilatation. It is not an AI-powered diagnostic or assistive technology that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used
- The "ground truth" for this device's evaluation was based on engineering specifications and established performance standards for PTA balloon catheters, as determined by the design and intended use of the device. The bench tests measured objective physical properties against these predefined parameters.
8. The sample size for the training set
- This information is not applicable. This is a traditional medical device (PTA balloon catheter), not a machine learning or AI-based device, so there is no concept of a "training set" in the context of its development or evaluation mentioned here.
9. How the ground truth for the training set was established
- This information is not applicable for the reasons stated above (no training set for this type of 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).