(28 days)
The POT PTCA balloon dilatation catheter is indicated for:
- balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
- balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
- balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only)
Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.
The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible Nylon balloon at its distal tip. It is typically a rapid exchange (Rx) type with a single-lumen catheter. It is a single-use device and available in various sizes.
Based on the provided text, the document is a 510(k) summary for the "POT PTCA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report with specific acceptance criteria, sample sizes, and expert adjudication for a novel AI/software device. As such, most of the requested information regarding an AI/ML device's acceptance criteria and study proving its performance is not present in this document.
However, I can extract the information related to performance testing for this physical medical device (a balloon catheter) and note the absence of data pertinent to AI/ML device evaluations.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance (for the physical device, not AI/ML):
The document mentions that bench testing was performed and met all acceptance criteria. However, it does not explicitly list the specific numerical acceptance criteria for each test. It only states that the tests demonstrated the device performed as intended and did not impact functionality.
| Acceptance Criteria (Description) | Reported Device Performance |
|---|---|
| Dimensional verification | Met all acceptance criteria (specific values not provided in document) |
| Simulated Use | Met all acceptance criteria (specific outcomes not provided in document) |
| Balloon Rated Burst Pressure | 20-22 atm (Identical to predicate) |
| Balloon Fatigue | Met all acceptance criteria (specific outcomes not provided in document) |
| Balloon Compliance | Met all acceptance criteria (specific outcomes not provided in document) |
| Balloon Inflation and Deflation Time | Met all acceptance criteria (specific outcomes not provided in document) |
| Balloon Burst (in stent) | Met all acceptance criteria (specific outcomes not provided in document) |
| Balloon Fatigue (in stent) | Met all acceptance criteria (specific outcomes not provided in document) |
Information NOT available in the document, as it pertains to AI/ML device studies, not physical medical devices like this one:
- Sample sizes used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here refers to physical bench tests, not a dataset for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering specifications and standardized testing, not expert consensus as in image interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its physical properties and mechanical performance, established by engineering standards and measurements.
- The sample size for the training set: Not applicable (no AI/ML training involved).
- How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Document (for a physical medical device):
- Device Name: POT PTCA Balloon Dilatation Catheter
- Purpose: To demonstrate substantial equivalence to a predicate device (Apollo Balloon Dilatation Catheter K133852 & K153742). This is a 510(k) submission for a physical medical device, not an AI/ML software.
- Study Type: Bench testing (in vitro) to assess physical characteristics and performance.
- Tests Performed:
- Dimensional verification
- Simulated Use
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance
- Balloon Inflation and Deflation Time
- Balloon Burst (in stent)
- Balloon Fatigue (in stent)
- Result of Tests: "In vitro bench testing met all acceptance criteria and demonstrated that the subject device performed as intended and did not impact the functionality of the device."
- Ground Truth (for this device): The ground truth for performance of this physical device is based on engineering specifications, recognized standards, and comparison to the predicate device's established performance.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.