(23 days)
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
The NuCLEUS-X catheter is a coaxial catheter for use in for Percutaneous Transluminal Valvuloplasty (PTV) for mitral and aortic position and centered angioplasty applications. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. The balloon is designed with a waist formed into the middle of the balloon to allow accurate balloon placement. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter. The distal lumen terminates at the tip of the catheter and will accept the 0.035" guidewire. This lumen has 3 radiopaque platinum marker bands. One under each of the balloon shoulders and one located at the "waist" or center of the balloon for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
The provided text describes the NuMED NuCLEUS-X PTV Catheter, a medical device, and its substantial equivalence to a predicate device, the NuMED Z-MED-X PTV Catheter. The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed device rather than proving novel effectiveness through clinical trials with specific acceptance criteria in the same way a new drug or high-risk device might.
Therefore, the "acceptance criteria" discussed here are primarily focused on the device's functional and material performance relative to the predicate device, as well as adherence to regulatory standards (e.g., biocompatibility guidance, GMPs). No formal clinical study with performance acceptance criteria like sensitivity or specificity for an AI algorithm is described.
Here's an attempt to structure the information based on your request, understanding that the context is a 510(k) submission for a catheter, not an AI device with typical performance metrics:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| Intended Use | Identical to predicate device: Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve for patients with isolated pulmonary stenosis or valvular pulmonary stenosis with other minor congenital heart disease not requiring surgical intervention. |
| Device Description/Technology | Substantially equivalent to predicate device (NuMED Z-MED-X PTV Catheter) in fundamental technology. The NuCLEUS-X features a coaxial design, polymeric outer body, multi-layer polyamide inner tubing with 304 LV Stainless Steel braid. It includes a molded proximal end bifurcate with two luminal passages, one for inflation (terminating in a distally mounted polyamide balloon with a waist) and another for a 0.035" guidewire (with 3 radiopaque platinum marker bands). |
| Biocompatibility | Materials used are the same as those in the already approved Z-MED-X PTV Catheter (510(k) #K02722), which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test results indicate all materials demonstrate biocompatibility and are on file at NuMED, Inc. |
| Bench Testing (Laboratory) | All bench testing was performed in accordance with GMPs (Good Manufacturing Practices). Results supporting device performance and safety are on file at NuMED, Inc. (Copies included as an attachment to the submission). This would typically cover aspects like burst pressure, balloon inflation/deflation times, shaft flexibility, trackability, guidewire compatibility, marker visibility, etc., though specific metrics are not detailed in this summary. |
| Material Equivalence | Shaft material: Pebax (Identical to predicate). |
| Balloon material: PES2 (Identical to predicate). | |
| Image Band material: Platinum (Identical to predicate). | |
| Dimensional/Size Aspects | Shaft Size: 9Fr (Predicate has 6-9Fr). While the NuCLEUS-X explicitly states 9Fr, it falls within the range of the predicate. |
| Guidewire Size: 0.035" (Identical to predicate). | |
| Balloon Diameter: 18mm, 20mm, 22mm, 25mm, 28mm, and 30mm (Predicate has 8-10mm, 12mm, 14-16mm, 18mm, 20mm, 22mm, 25mm, 28mm, and 30mm). The proposed device offers a subset of the predicate's larger balloon sizes. | |
| Balloon Length: 4-6cm (Predicate has 2-6cm). The proposed device offers a subset of the predicate's longer balloon lengths. | |
| Risk Analysis | A FMECA (Failure Modes, Effects, and Criticality Analysis) demonstrating risk analysis for the product was attached to the submission. |
| Regulatory Compliance | Complies with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). Classified as Class II (Two) under 21 CFR 870.1250 (Percutaneous Catheter). |
Study Information
Given this is a 510(k) summary for a medical device (a catheter), the "study" referred to is not a clinical trial in the traditional sense of proving a new treatment's efficacy, but rather the collection of evidence to demonstrate substantial equivalence to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of device performance in a 510(k) summary focused on substantial equivalence through bench testing and material comparisons. The "test set" would be the device itself and its components undergoing engineering and biocompatibility evaluations. These tests would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., a batch of catheters for burst pressure testing), but not a patient-based "sample size" in the way clinical diagnostic studies use the term.
- Data Provenance: The biocompatibility testing reference (Tripartite Biocompatibility Guidance for Medical Devices) and GMP compliance for bench testing suggest controlled laboratory environments, likely in the US where NuMED, Inc. is located (Hopkinton, NY). The data is generated prospectively as part of the device development and regulatory 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)
- Not applicable. The "ground truth" for device performance in this context is established by internationally recognized standards for medical device testing, engineering specifications, and regulatory guidance (e.g., ISO standards, FDA guidance for PTV catheters), validated through bench testing, not by expert consensus on clinical data interpretation. Experts would be engineers, material scientists, and toxicologists conducting the specific tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical data interpretation (e.g., reading medical images) where there can be inter-reader variability. For device bench testing, the results are typically quantitative measurements or pass/fail criteria against established specifications.
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 catheter, not an AI or diagnostic imaging device. Therefore, no MRMC study with human readers or AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on engineering specifications, material science properties, and adherence to established regulatory and industry standards for similar medical devices. This is demonstrated through:
- Biocompatibility testing against recognized industry standards (Tripartite Biocompatibility Guidance).
- Bench testing results confirming physical characteristics and performance (e.g., balloon pressure, material strength, dimensional accuracy) against design specifications and predicate device performance.
- Material composition equivalence to a previously approved device.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 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).