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K Number
K960070
Device Name
NUMED ATRIOSEPTOSTOMY CATHETER
Manufacturer
NUMED, INC.
Date Cleared
1996-04-02

(88 days)

Product Code
DQO
Regulation Number
870.1200
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This catheter is intended for balloon atrioseptostomy. Used for the palliation of several congenital heart defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Device Description

The NuMED Septostomy Catheter is a new balloon catheter designed for the neonate with congenital heart disease requiring septostomy. It is a dual lumen catheter, 50cm in length with a 13.5mm ± 0.5mm non-compliant balloon on the distal end. The catheter also features an end hole that will accommodate an 0.018" guidewire. The inflated geometry of the balloon at the rated inflation volume of 2cc is a 13.5mm sphere. There is an imaging band under the balloon for balloon positioning in the left atrium. The catheter tip is angled at 35° to facilitate passage through the interarterial opening in the left atrium. To inflate the balloon to it's maximum diameter, 2cc of diluted contrast media is pushed into the balloon extension after purging. Catheters marked every 5cm (up to 50cm) and are supplied with a one way stopcock for balloon sealing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies that demonstrate the NuMED Atrioseptostomy Catheter meets them, based on the provided text:

Acceptance Criteria and Device Performance

TestAcceptance CriteriaReported Device Performance
1. Balloon Volume vs. DiameterBalloon diameter must be within ± 10% of the rated diameter (13.5mm) at 2cc (i.e., 12.15mm to 14.85mm).Mean diameter at 2.0cc inflation volume was 13.49mm (range 13.0 - 13.9mm), which falls within the 12.15mm to 14.85mm acceptance range.
2. Bond IntegrityMinimum of 3 lb. at all test points.Distal hub to 'Y', Balloon hub to extension, Balloon extension to 'Y' connector, Catheter body to 'Y' connector, Tip to balloon: All > 10.0 lbs.
Proximal balloon bond: 8.0 lbs (range 7.0 - 9.0 lbs, std dev. = 1 lb.).
Tip to catheter: 8.0 lbs (range 7.0-9.0 lbs, std dev. = 1 lb.). All exceed minimum 3 lbs.
3. Guidewire CompatibilityMinimal resistance while pushing catheter over guidewire. Force may not be great enough to bend guidewire.In no case was the guidewire kinked or was the force in excess of that necessary to insert a guidewire into a similar catheter. All samples were acceptable.
4. Maximum Luminal Injection PressureMust withstand 500 psi.All samples passed 750 psi injection. Average burst pressure was 905.5 psi (range 875 - 950 psi). A limit of 600 psi will be added to the injection criteria.
5. Multiple Inflation TestingBalloon diameter must still be within ± 10% after 40 inflation/deflation cycles.All samples were tested 50 times with no failures or leaks. One sample was inflated 500 times without failure. The diameter, at maximum volume of 2cc, was "virtually unchanged" from the first to the fiftieth inflation. (Statistical analysis provided showed a mean change of 0.15, range 0.1-0.3, std dev 0.085).
6. Injection RateDemonstrate that this device can be used for fluid injection.Mean injection rate of 4cc/sec (range 3.6 to 4.4 cc/sec).
8. Balloon DeflatabilityDeflation achieved in less than 20 seconds.Deflation was achieved by applying negative pressure to the balloon using a 3 cc syringe. Deflation times were 5 - 10 seconds to achieve 50% deflation and all balloons were fully deflated within 15 seconds.
9. Balloon Non-Compliance During UseMinimal deformation, as observed visually.When pulled through a deer heart septum, no deformation was visually observed. This was also demonstrated in a submitted videotape of animal testing.
10. Balloon Protector TestingAbility to form balloon to accept a 6F introducer.All catheters (10 samples) fitted with balloon protectors were admitted through the recommended 6F introducer without incident. No resistance, kinking, or detrimental effects were noted.
11. Introducer CompatibilityCatheter must be admitted through a 6F Introducer.All catheters (10 samples) were admitted through the recommended 6F introducer without incident. No resistance, kinking, or detrimental effects were noted. Catheters showed no signs of damage after inflation and microscopic examination.

Study Details:

Bench Testing (Laboratory Testing)

  1. Sample sizes used for the test set and the data provenance:

    • Balloon Volume vs. Diameter: 10 full-length, sterile catheters. Data provenance is laboratory bench testing, presumably conducted in the USA (where NuMED is located).
    • Bond Integrity: 10 full-length, sterile catheters. Data provenance is laboratory bench testing.
    • Guidewire Compatibility: 20 full-length, sterile catheters. Data provenance is laboratory bench testing.
    • Maximum Luminal Injection Pressure: 10 sterilized, full-length test catheters. Data provenance is laboratory bench testing.
    • Multiple Inflation Testing: 10 full-length catheters. Data provenance is laboratory bench testing.
    • Injection Rate: 10 full-length sterilized catheters. Data provenance is laboratory bench testing.
    • Balloon Deflatability: 5 full-length, sterile catheters. Data provenance is laboratory bench testing.
    • Balloon Non-Compliance During Use: Not explicitly stated, but at least two catheters (NuMED and Baxter Miller). Data provenance is R&D lab testing using a deer heart.
    • Balloon Protector Testing: 10 Atrioseptostomy catheters. Data provenance is laboratory bench testing.
    • Introducer Compatibility: 10 catheters. Data provenance is laboratory bench testing.

    All bench testing appears to be retrospective as the results are being reported after the tests were conducted.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Bench Testing: No external experts were used to establish ground truth for the measurements in bench testing. The results are objective measurements from equipment (micrometers, pull testers, pressure gauges).
    • Balloon Deflatability: Dr. Ziyad Hijazi, a medical professional, provided input on the maximum allowable deflation time (20 seconds) and also evaluated deflation during animal testing. His qualifications are stated as "New England Medical Center Pediatric Cardiology."
    • Balloon Non-Compliance During Use: Visual observation by the R&D lab staff, and confirmed by Dr. Hijazi via a videotape of animal testing (G940143).

  3. Adjudication method for the test set:

    • Not applicable for the objective measurements performed in bench testing. The results are direct measurements.

  4. 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 a medical device (catheter), not an AI diagnostic tool.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a medical device, not an algorithm.

  6. The type of ground truth used:

    • Bench Testing: Objective physical measurements using calibrated equipment (e.g., micrometer, Chatillon pull tester, pressure gauge).
    • Balloon Deflatability & Non-Compliance: A combination of objective timing (stopwatch) and expert clinical observation/assessment by Dr. Ziyad Hijazi.

  7. The sample size for the training set:

    • Not applicable. This is a medical device, not a machine learning model. The concept of a "training set" doesn't directly apply here. The device was designed and iterated based on engineering principles and prior device experience (referenced as approved materials from IDE G940143, K931009, and G890030) rather than iterative training on a dataset.

  8. How the ground truth for the training set was established:

    • Not applicable (as above). The closest analogy might be the established safety and performance profiles of the predicate devices and the materials approved under previous IDEs, which serve as foundational knowledge for the design.

Animal Testing

  1. Sample sizes used for the test set and the data provenance:

    • Animal Testing: 5 piglets. Data provenance is prospective animal testing performed at the cath lab, as reported by Dr. Ziyad Hijazi.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Animal Testing: Dr. Ziyad Hijazi (New England Medical Center Pediatric Cardiology) performed the testing and provided the summary. He is the expert establishing the direct observations and conclusions from the animal procedures and autopsies.

  3. Adjudication method for the test set:

    • Not applicable. The observations were direct clinical procedures and subsequent autopsy findings, reported by the performing expert.

  4. 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.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable.

  6. The type of ground truth used:

    • Animal Testing: Direct observation of the procedure by the performing cardiologist (Dr. Hijazi), and post-mortem autopsy findings to assess septal defect size and any complications. Videotapes and slides were also used as evidence.

  7. The sample size for the training set:

    • Not applicable. The animal testing represents validation of the finished device design.

  8. How the ground truth for the training set was established:

    • Not applicable.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).