(31 days)
The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents.
The Paladin System is a sterile, single use, rapid exchange (RX) PTA catheter with a nitinol-based filter between the PTA balloon and the distal tip of the catheter. The balloon has radiopaque markers to aid in accurate positioning under fluoroscopic guidance. The dilation balloon is designed to inflate to a known diameter and length at a specific inflation pressure. Paladin has balloon diameters Ø of 5.0 mm and balloon lengths of 20 mm and 30 mm. The embolic protection filter is composed of a nitinol braid chassis with an overlying polyurethane membrane with radiopaque markers on either end and radiopaque markers on the filter. The catheter has a guidewire lumen, an inflation/deflation lumen, and a filter activation wire lumen. The quidewire lumen permits the passage of a guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal end of the catheter has a handle that controls activation. The filter is identical across all sizes of balloons and can be expanded to a maximum diameter of 7 mm. The Paladin System is designed to be introduced through a 6 French vascular sheath.
This is a 510(k) premarket notification for a medical device, which seeks to establish substantial equivalence to a legally marketed predicate device. As such, it does not typically contain extensive clinical trial data or detailed performance studies in the way a PMA (Premarket Approval) application would. The document explicitly states: "The risk analysis activities for the device changes summarized in this Special 510(k) identified that no additional verification or validation activities are required to establish substantial equivalence with predicate devices." This indicates that the submission relies on the previously established performance of the predicate device (K181128) and demonstrates that the modifications made to the current device do not introduce new risks or alter its fundamental performance.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for the current device's performance study is not available in this document. The submission's conclusion is based on showing that the modified device is substantially equivalent to the predicate device, not on new clinical performance data for the modified device.
However, based on the provided text, I can infer some aspects relevant to substantial equivalence:
Indications for Use (Acceptance Criteria for Device Purpose):
The "acceptance criteria" here relate to the device's intended use and functionality being comparable to the predicate. The Indications for Use for both the modified and predicate device are nearly identical, with minor structural variations in the wording.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) aiming for substantial equivalence based on no change in performance or risk, there isn't a new performance study with specific acceptance criteria that the modified device had to meet and report on in this document. The "performance" being demonstrated is the equivalence to the predicate. The key "acceptance criteria" being highlighted are the equivalence of design and function to the cleared predicate.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Modified Paladin System relative to Predicate) |
|---|---|
| Indications for Use: Same intended use, patient population, and anatomical site. | SAME as predicate device (K181128). Indicated for PTA in carotid arteries with embolic capture, and post-dilation of self-expanding stents in carotid arteries with embolic capture. Max arterial site diameter for filter deployment of 7.0 mm. Always used with an available embolic protection device for post-dilation of self-expanding stents. |
| Contraindications: No new contraindications. | SAME as predicate device, including contraindications for coronary arteries, inability to tolerate anticoagulant/anti-platelet therapy, hypersensitivity to nitinol, and unresolved bleeding disorders. |
| Principle of Operations: Same fundamental mechanism of action. | SAME as predicate device, operating on hydraulic pressurization with an inflatable balloon, 0.014" guidewire compatible, with an adjustable nitinol filter frame and urethane filter for embolic capture. |
| Sterilization: Same method. | SAME as predicate device (EO gas). |
| Shelf Life: Same duration. | SAME as predicate device (12 months). |
| Packaging System: Same components and materials. | SAME as predicate device (balloon/filter protective sheath, HDPE spiral dispenser, PET/G snap-top tray, sterile pouch, outer cardboard carton). |
| Radiopaque Markers: Same type and placement. | SAME as predicate device (two balloon markers, two marker bands distal and proximal to filter, 6 circumferential marker bands on proximal portion of filter). |
| Angioplasty Balloon Characteristics: Same material properties and design. | SAME as predicate device (Nylon semi-compliant PTA balloon). |
| Embolic Capture Mechanism: Same design and function. | SAME as predicate device (Self-expanding nitinol filter frame with urethane membrane (40 micron pores) for capture and removal of embolic material). |
| Filter Diameter: Same adjustable range. | SAME as predicate device (Adjustable filter fits carotid artery diameters up to 7mm diameter). |
| Usable Length: Same length. | SAME as predicate device (140 cm). |
| Introducer Sheath Compatibility: Same size. | SAME as predicate device (6 F). |
| Guidewire Compatibility: Same size. | SAME as predicate device (0.014"). |
| Balloon Diameter: Same available sizes. | SAME as predicate device (5.0 mm and 5.5 mm). |
| Balloon Length: Same available sizes. | SAME as predicate device (20 mm and 30 mm). |
| Balloon RBP (Rated Burst Pressure): Same values. | SAME as predicate device (14 atm for 5.0 mm, 11 atm for 5.5 mm). |
| No New Risks Introduced: The modifications do not introduce new risks or modify existing risks. | Confirmed by risk analysis. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission.
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. No new performance study (test set) for the modified device is documented in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission.
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 a physical medical device (balloon catheter with embolic protection), not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission. The "ground truth" for this submission is demonstrating that the modified device has the same fundamental characteristics and performance as the previously cleared predicate device.
8. The sample size for the training set
Not applicable. No new training set is mentioned as this device is a physical medical device seeking substantial equivalence based on engineering and design comparisons, not a data-driven model.
9. How the ground truth for the training set was established
Not applicable. Not applicable. No new training set is mentioned as this device is a physical medical device seeking substantial equivalence based on engineering and design comparisons, not a data-driven model.
Summary of the Study (as presented in the 510(k)):
The "study" presented in this 510(k) is a documentary review and comparison of the modified Paladin System against its predicate device (K181128).
- Objective: To demonstrate that the modified Paladin System is substantially equivalent to the predicate device.
- Methodology: A detailed comparison of the device description, indications for use, fundamental technological characteristics, and performance specifications (as summarized in the table above) between the modified device and the predicate device. A risk analysis was also conducted.
- Findings: The comparison concluded that there are "no change to device design, its principles of operation or expected performance." The risk analysis determined that "no additional verification or validation activities are required" as the changes "do not create any new risks, harms nor were any existing risks altered."
- Conclusion: The information is sufficient to establish substantial equivalence.
§ 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).