(265 days)
The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00mm are also indicated for post-delivery expansion of balloon expandable stents.
The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal shaft (25 cm) consists of two (2) lumina. One lumen enables inflation and deflation of the balloon, the other permits the insertion of a guidewire. Two (2) radiopaque markers indicate the length of the cylindrical portion of the balloon. The 1.5 mm diameter balloon catheter has one (1) x-ray marker only. The balloon is protected with a removable sheath which protects the initial profile. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The two markers on the shaft of the catheter appear when the tip of the balloon-tipped catheter leaves the guiding catheter (brachial: 100 cm/femoral: 110 cm). The proximal section of the catheter is a single-lumen, stainless steel hypotube with a luer adapter connected to the balloon lumen. A needle with a luer port is included for flushing the distal guide wire lumen. SeQuent Neo has a hydrophilic coated surface at the distal catheter portion. Due to this, SeQuent Neo provides optimal gliding properties during intervention.
This document describes the premarket notification (510(k)) for the SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters, outlining the device's characteristics, intended use, and substantial equivalence to predicate devices. It focuses on non-clinical performance and biocompatibility evaluations.
Here is an analysis of the provided text, addressing your specific questions, noting that this document pertains to a medical device (catheter) rather than a software algorithm or AI, so some questions are not directly applicable.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table with corresponding reported performance values for each criterion. Instead, it states that "design verification and validation (DV&V) testing in accordance with the requirements of September 8, 2010 FDA guidance Class II Special Controls Guidance Document for Certain PTCA Catheters, including ISO 10993 compliant biocompatibility evaluations" were performed. The results "demonstrate the SeQuent Neo catheter is suitable for its intended use."
The evaluations performed are listed as follows:
| Acceptance Criterion (Type of Evaluation) | Reported Device Performance (Implicitly Met) |
|---|---|
| Biocompatibility Evaluations | Suitable for intended use |
| Cytotoxicity | Met |
| Sensitization | Met |
| Intradermal reactivity | Met |
| Acute Systemic Toxicity | Met |
| Haemocompatibility (Thrombogenicity, Complement Activation, Hemolysis) | Met |
| Pyrogenicity | Met |
| Non-clinical Evaluations (Bench) | Suitable for intended use |
| Dimensional verification | Met |
| Balloon Preparation, Deployment, and Retraction | Met |
| Balloon Rated Burst Pressure | Met |
| Balloon Fatigue (Repeat Balloon Inflations) | Met |
| Balloon Compliance (Diameter vs. Pressure) | Met |
| Balloon Inflation and Deflation Time | Met |
| Catheter Bond Strength | Met |
| Flexibility and Kink Test | Met |
| Torque Strength | Met |
| Radiopacity | Met |
| Coating Integrity | Met |
| Particulate Evaluation | Met |
| Balloon Rated Burst Pressure (in Stent) | Met |
| Balloon Fatigue (Repeat Balloon Inflations, in Stent) | Met |
| Catheter Withdrawal Force | Met |
| Shelf Life / Packaging | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing for a physical medical device. Therefore, a "test set" in the context of data used for an algorithm is not applicable here. The evaluations involved physical samples of the catheters. Specific sample sizes for each bench test are not provided in this summary. The data provenance is B. Braun Interventional Systems Inc., located in Bethlehem, PA, USA. The testing is considered prospective as it's part of the premarket submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the document describes physical bench testing and biocompatibility assessments of a device, not an algorithm requiring expert-established ground truth from medical images or clinical data. Device performance is determined through standardized engineering and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or for establishing ground truth from expert opinions on data, which is not the nature of the tests described for this physical medical device.
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 question is not applicable. The device is a PTCA balloon catheter, not an AI or imaging-related product. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a PTCA balloon catheter, not an algorithm. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific evaluations listed in the document:
- Biocompatibility: Ground truth is established through standardized laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/toxicity) as per ISO 10993 standards.
- Non-clinical (Bench) Evaluations: Ground truth is established by engineering specifications, physical measurements, and adherence to industry standards (e.g., ISO 14971, FDA guidance for PTCA catheters). For instance, "Balloon Rated Burst Pressure" has a defined pass/fail criterion based on pressure applied.
The document also mentions a "clinical literature evaluation ... to evaluate the benefits and risks of PTCA catheter clinical use." This literature review would draw upon existing outcomes data from previously marketed PTCA catheters.
8. The sample size for the training set
This question is not applicable as the document describes a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above (no training set for a physical device).
§ 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.