(30 days)
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile (EO), single-use, intravascular medical device for use in coronary angioplasty procedures. The catheter consists of a dual-lumen polymeric shaft with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of a guidewire to facilitate advancement of the catheter to the appropriate location. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The- Wire (OTW) platforms. Marks on the proximal portion of the catheter shaft (at 90 cm and 100 cm) indicate the exit of the balloon catheter tip out of the guide catheter. Radiopaque marker bands located under the balloon aid in positioning the system during the procedure. Hydrophilic and hydrophobic coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheters (1.20 mm and 1.50 mm balloon models) are available in balloon lengths from 8 mm to 20 mm. The Emerge™ PTCA Dilatation Catheters (2.00 - 4.00 mm balloon models) are available in balloon lengths from 8 mm to 30 mm.
Here's a breakdown of the acceptance criteria and study information for the Emerge PTCA Dilatation Catheter based on the provided document:
This document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for a new AI-powered diagnostic. Therefore, the information provided primarily relates to device performance testing (bench testing and biocompatibility) and does not include details about acceptance criteria or studies involving human readers, AI assistance, or complex ground truth establishment in the way typically seen for AI/ML-based diagnostic devices.
The "device" in this context is a physical medical device (a PTCA Dilatation Catheter), not an AI algorithm. As such, many of the requested points related to AI studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests and biocompatibility tests conducted to demonstrate substantial equivalence. It does not provide specific numerical acceptance criteria or detailed quantitative results in this summary. Instead, it states that the tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Conformance for intended use | Bench testing completed, providing reasonable assurance of design and testing conformance. No new safety or performance issues raised. |
| Biocompatibility requirements | Biocompatibility and chemical characterization tests completed. |
| Substantial equivalence to predicate devices | Tests support substantial equivalence to predicate devices (K113220, K121196, K130391) based on indications, characteristics, safety, and performance. |
Specific Performance Tests (Bench Testing):
- Corrosion Resistance
- Proximal Mark Abrasion Resistance
- Proximal Shaft Marks
- Repeat Inflation
- Midshaft Bond Tensile
- Shaft and Bond Burst Pressure
Specific Biocompatibility and Chemical Characterization Tests:
- Cytotoxicity
- Partial Thromboplastin Time
- Sensitization
- In Vitro Hemocompatibility
- Intracutaneous Reactivity
- Complement Activation
- Acute Systemic Injection
- USP Physicochemical
- Materials Mediated Pyrogenicity
- Latex Assay
- Mutagenicity
- Nonvolatile Residue
- Hemolysis
- SEM
Regarding AI-Specific Criteria (Not Applicable to this Device):
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI model evaluated on a data test set.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI-based diagnostic model is not relevant here. The "ground truth" for this catheter is its ability to perform its mechanical and biological functions safely.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI for human reader assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical medical device like this, "ground truth" relates to engineering specifications, material properties, and biological safety standards (e.g., ISO standards, FDA guidance documents). There isn't a "ground truth" in the diagnostic sense.
- 8. The sample size for the training set: Not applicable. This is a physical device; there is no "training set" in the AI sense.
- 9. How the ground truth for the training set was established: Not applicable.
Clarification:
The provided document is an FDA 510(k) clearance letter and summary for a PTCA Dilatation Catheter, which is a physical medical device used in coronary angioplasty. It is not an AI/ML-based diagnostic system. Therefore, the questions related to AI studies, test sets, training sets, ground truth establishment by experts, and reader studies are not relevant to the information presented in this document. The "study" described is a series of non-clinical bench tests and biocompatibility evaluations confirming the physical and biological properties of the catheter.
§ 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.