(174 days)
The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The ComboCath™ OTW PTA Dilatation Catheter is an 0.014" (0.36mm) guidewire compatible balloon angioplasty catheter with an effective working length of 150cm. The angioplasty catheter includes a semi-compliant distal Balloon of known diameter and length when inflated to recommended pressures.
The device construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the quidewire and injection of fluids via the catheter's Exit Holes that are positioned proximal to the Balloon.
The proximal Hub includes an Inflation Port used for inflation of the Balloon and a standard Touhy-Borst valve with a side port terminated by a Stopcock that permits injection of fluids.
The catheter includes three radiopaque markers to aid angiographic placement of the device.
This document is a 510(k) summary for the ComboCath™ OTW PTA Dilatation Catheter, seeking to demonstrate substantial equivalence to a predicate device. This type of regulatory submission does not typically involve clinical studies with human participants or a "test set" of patients to evaluate performance against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI/ML device would. Instead, "performance" here refers to functional and material equivalence to a legally marketed predicate device.
Therefore, many of the requested categories are not applicable to this submission. I will address the applicable sections and indicate where information is not relevant to this type of device submission.
1. A table of acceptance criteria and the reported device performance
For this medical device (a balloon catheter), "acceptance criteria" and "performance" are framed in terms of substantial equivalence to a predicate device, focusing on design, materials, and functional characteristics rather than diagnostic accuracy or clinical outcomes from a study with a test set.
| Characteristic | Acceptance Criteria (based on predicate device) | Reported Device Performance (ComboCath™ OTW PTA Dilatation Catheter) |
|---|---|---|
| Intended Use | Similar to predicate (PTA in peripheral vasculature, including specific arteries and AV fistulae) | Matches predicate's intended use statement, with minor wording variations but same scope. |
| Design | Over-the-wire (OTW), two-lumen catheter shaft, thermoplastic polymer balloon, radiopaque marker. | Matches predicate's design. |
| Shaft & Balloon Material | Thermoplastic | Thermoplastic |
| Guidewire Compatibility | 0.014" (0.36 mm) | 0.014" (0.36 mm) |
| Compatible Sheath Size | 4F (predicate) | 5F (slightly different, but within acceptable functional range) |
| Balloon Diameter | 1.5 - 4.0 mm (predicate) | 2.5, 3.0, 3.5, 4.0 mm (subset, but within predicate's range) |
| Balloon Length | 20, 30, 40 mm (predicate) | 40 mm (subset, but within predicate's range) |
| Catheter Working Length | 90, 150 cm (predicate) | 150 cm (subset, but within predicate's range) |
| Biocompatibility | Pass ISO 10993-1 requirements | Passed all required testing per ISO 10993-1 |
| Functional Testing | Device functions for intended use (implied comparison to predicate's expected function) | Functional testing was conducted to support substantial equivalence and demonstrate performance for intended use. (Specific metrics not provided in summary) |
Study Proving Acceptance Criteria:
The study proving the acceptance criteria for this device is a benchtop (functional) and materials comparison study, along with biocompatibility testing. This is not a clinical study with patients or an AI performance study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This 510(k) submission does not describe a "test set" in the context of clinical data for diagnostic or therapeutic efficacy. Performance was evaluated through bench testing and material comparisons.
- Data Provenance: Not applicable.
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)
- Not applicable. Ground truth, in the sense of expert consensus on clinical cases, is not relevant to this type of device submission. Performance is validated through engineering bench testing and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set 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
- Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is related to engineering specifications, material science standards, and established functional performance requirements for similar medical devices. For example, the ground truth for guidewire compatibility is the standard diameter of a 0.014" guidewire, and the ground truth for biocompatibility is compliance with ISO 10993-1.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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).