(90 days)
The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopague marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter. The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port (guidewire port) enables insertion of the guide wire. The balloon catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating to improve the trackability and pushability characteristics.
This 510(k) K130161 is for a Special 510(k) notification, indicating that the device (Passeo-35 PTA Catheter) is a modification of a previously cleared device (Passeo-35 PTA Catheter, K082933).
Crucially, the document states:
- "The determination of substantial equivalency on this subject device does not rely upon the nonclinical test data. There is no nonclinical test data submitted in this application."
- "The determination of substantial equivalency on this subject device does not rely upon the clinical data. There is no clinical data submitted in this application."
This means that no new studies (clinical or non-clinical) were conducted or submitted to demonstrate that the modified device meets any acceptance criteria. The substantial equivalence is based solely on the fact that the changes are minor (only labeling changes) and the device's technological characteristics, materials, and manufacturing remain unchanged from the previously cleared predicate device.
Therefore, the requested information about acceptance criteria and studies cannot be provided from this document, as none were performed for this specific 510(k) submission. Any original studies or acceptance criteria would have been part of the original K082933 submission.
For completeness, if this were a submission requiring new clinical or non-clinical data, the table and details would be structured as follows:
1. Table of Acceptance Criteria and Reported Device Performance
(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)
| Acceptance Criteria (e.g., specific endpoints for safety/effectiveness) | Reported Device Performance |
|---|---|
| No new criteria or performance data for this submission. | N/A |
2. Sample size used for the test set and the data provenance
(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)
- Sample Size (Test Set): N/A
- Data Provenance: N/A (e.g., country of origin, retrospective/prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)
- Number of Experts: N/A
- Qualifications: N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)
- Adjudication Method: N/A
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 available in the provided document as no new studies were conducted for this Special 510(k). This is also not an AI device.)
- MRMC Study Conducted: No
- Effect Size: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)
- Standalone Study Conducted: No
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)
- Type of Ground Truth: N/A
8. The sample size for the training set
(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)
- Training Set Sample Size: N/A
9. How the ground truth for the training set was established
(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)
- Ground Truth Establishment (Training Set): N/A
§ 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).