(88 days)
Baxter Miller Balloon Atrioseptostomy catheter
Not Found
No
The description focuses on the mechanical and functional aspects of a balloon catheter. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies are bench and animal tests evaluating physical properties and procedural success, not algorithmic performance.
Yes
The device is intended for the palliation of several congenital heart defects, which are medical conditions, and it actively modifies the patient's anatomy (performing a septostomy) to achieve a therapeutic effect.
No
The device is a septostomy catheter used for a therapeutic procedure (atrioseptostomy) to palliate congenital heart defects. Its function is to create or enlarge an opening in the atrial septum, not to diagnose a condition. The performance studies focus on mechanical and functional aspects of the catheter, not diagnostic accuracy.
No
The device is a physical catheter with a balloon, designed for a surgical procedure. The description focuses on its physical characteristics, materials, and mechanical performance testing. There is no mention of software as a component or primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (balloon atrioseptostomy) to palliate congenital heart defects. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a catheter with a balloon designed for mechanical manipulation within the heart. It does not involve the analysis of biological samples (blood, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Function: The device's function is to create an opening in the atrial septum, which is a physical modification of the patient's anatomy. It does not provide information about the patient's health status based on in vitro analysis.
- Performance Studies: The performance studies focus on the mechanical properties and functional performance of the catheter (balloon size, bond strength, guidewire compatibility, inflation/deflation, etc.) and its ability to perform the intended procedure in animal models. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
In summary, the NuMED Septostomy Catheter is a therapeutic medical device used for a surgical procedure, not an in vitro diagnostic device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
The non-compliant balloon and dual lumen design of the NuMED Septostomy cathers from other marketed catheters:
- · The balloon will not deform during the procedure like a latex balloon. The result is a similar diameter opening produced using a smaller diameter balloon.
- · The non-compliant balloon is heat bonded to the catheter shaft, thus reducing the risk of balloon detachment.
- · The balloon design facilitates the use of a 5F introducer sheath. This will minimize blood loss in the neonates.
- · The catheter end hole can be utilized for guidewire, contrast injection, or blood analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left atrium, IVC (inferior vena cava), heart, RFV (right femoral vein)
Indicated Patient Age Range
neonate
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Laboratory (Bench) Testing:
- Balloon Volume vs. Diameter:
- Sample Size: 10 full length, sterile catheters.
- Methodology: Catheters submerged in body temperature water bath, inflated with fluid, and diameter measured with a micrometer at various volume increments.
- Results: At 2.0cc inflation, mean diameter was 13.49 mm (range 13.0 - 13.9 mm).
- Bond Integrity:
- Sample Size: 10 full length, sterile catheters.
- Methodology: Tested proximal balloon bond and tip bond using a Chatillon pull tester. Balloon lifted circular weights until failure; tip bond tested by pulling until inner tubing failure and then balloon pulled until bond failure.
- Results: Proximal balloon bond: 8.0 lbs (range 7.0 - 9.0 lbs). Tip to catheter: 8.0 lbs (range 7.0 - 9.0 lbs). Tip to balloon: > 10.0 lbs.
- Guidewire Compatibility:
- Sample Size: 20 full length sterile catheters.
- Methodology: 0.021" guidewires (measured for compliance) were pushed through catheters, evaluating resistance.
- Results: No guidewire kinking or excessive force noted. All acceptable.
- Maximum Luminal Injection Pressure:
- Sample Size: 10 sterilized, full length test catheters.
- Methodology: Catheter tip plugged, pressurized to 750 PSI, then pressurized to failure.
- Results: All samples passed 750 PSI. Average burst pressure was 905.5 PSI (range 875 - 950 PSI).
- Multiple Inflation Testing:
- Sample Size: 10 full length catheters; one sample tested 500 times.
- Methodology: Catheters sterilized and inflated with recommended volume at body temperature. Inflated/deflated 50 times (one sample 500 times). Diameter measured after inflation.
- Results: All samples tested 50 times with no failures or leaks. One sample inflated 500 times without failure. Diameter virtually unchanged.
- Injection Rate:
- Sample Size: 10 full length sterilized catheters.
- Methodology: Catheters attached to hydraulic pressure injector (300 psi), subjected to 5-second pressure injection, and fluid quantity measured to calculate cc/sec.
- Results: Mean injection rate of 4 cc/sec (range 3.6 to 4.4 cc/sec).
- Luminal Frequency Response:
- Results: Catheters not recommended for use in measuring luminal frequency.
- Balloon Deflatability:
- Sample Size: 5 full length, sterile catheters (laboratory); animal testing also performed by Dr. Hijazi.
- Methodology: Simulated use in lab: catheters introduced into silicone sheet, inflated with contrast solution, pulled through sheet, then deflated using 3.0cc syringe. Animal testing: negative pressure applied with 3 cc syringe.
- Results: Lab results not explicitly detailed for time. Animal testing showed deflation times of 5-10 seconds for 50% deflation, and full deflation within 15 seconds.
- Balloon Non-Compliance During Use:
- Methodology: Catheter used on a deer heart in R&D lab; balloon pulled through septum to observe deformation. Compared to Baxter Miller. Also demonstrated on videotape of animal testing (G940143).
- Results: No deformation visually observed with NuMED non-compliant balloon. Baxter Miller showed diameter reduction. NuMED 13.5mm balloon created 12mm hole; Baxter 18mm balloon created 11.5mm hole.
- Balloon Protector Testing:
- Sample Size: 10 Atrioseptostomy catheters.
- Methodology: Catheters fitted with PTFE balloon protectors, sterilized, then tested with a 6F B. Braun introducer.
- Results: All catheters admitted through introducer without incident, resistance, kinking, or detrimental effects.
- Introducer Compatibility:
- Sample Size: 10 catheters.
- Methodology: Tested for admittance through 6F B. Braun Introducers after sterilization. Inflated and checked for damage.
- Results: All catheters admitted without incident. No resistance, kinking, or detrimental effects. No damage observed after inflation.
Animal Testing:
- Study Type: In vivo animal study.
- Sample Size: 5 piglets.
- Data Source: Testing performed by Dr. Ziyad Hijazi (New England Medical Center Pediatric Cardiology).
- Methodology: NuMED Atrioseptostomy Catheter (13.5 mm balloon, 2 cc capacity, 0.018" to 0.021" GW) used for septostomy procedures on piglets. Different inflation volumes (e.g., 1.0cc to 2.0cc) were used. Procedures primarily involved advancing the catheter, inflating the balloon, and pulling it across the septum. Post-procedure autopsy was performed to assess heart size and defect size.
- Key Results:
- Piglet #237: Perforation of IVC when fully inflated balloon (2 cc) pulled all the way to IVC. Septal defect 10-12 mm with smooth edges, circular shape.
- Piglet #238: Successful septostomy without guidewire; balloon inflated to 1.2 cc, 1.5 cc, 1.8 cc, and 2.0 cc. Defect 10-11 mm.
- Piglet #235: Successful septostomy using 1.2, 1.5, 1.8, and 2.0 cc. Guidewire used when balloon could not be advanced. Defect 11 mm.
- Piglet #239: Successful septostomy using 1.0, 1.5, and 1.7 cc. 2.0 cc not tried due to small animal size. Defect 10 mm.
- Piglet #236: Uneventful septostomy with 1.0, 1.5, 1.7, and 2.0 cc. Defect 11 mm.
- All procedures recorded on videotape and slides taken.
Key Metrics
- Balloon Diameter at Rated Volume (2.0cc): Mean Diameter 13.49 mm (Range 13.0 - 13.9 mm)
- Proximal balloon bond strength: 8.0 lbs (Range 7.0 - 9.0 lbs, Std dev. = 1 lb.)
- Tip to catheter bond strength: 8.0 lbs (Range 7.0 - 9.0 lbs, Std dev. = 1 lb.)
- Tip to balloon bond strength: > 10.0 lbs.
- Maximum Luminal Injection Pressure (Burst Pressure): 905.5 psi Average Burst (Range 875 - 950 psi)
- Injection Rate: 4 cc/sec (Range 3.6 to 4.4 cc/sec)
- Balloon Deflation Time: 5 - 10 seconds to achieve 50% deflation; all balloons fully deflated within 15 sec (animal testing).
Predicate Device(s)
Baxter Miller Balloon Atrioseptostomy catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
January 2, 1996
APR - 2 1996
Submitted By: NuMED, Inc., Main St., Hopkinton, NY 12940 (Ph) 315-328-4491
Contact Person: Susan D. Jones
Device Name: NuMED Atrioseptostomy Catheter; Class II
Predicate Devices: Baxter Miller Balloon Atrioseptostomy catheter
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.
The non-compliant balloon and dual lumen design of the NuMED Septostomy cathers from other marketed catheters:
- · The balloon will not deform during the procedure like a latex balloon. The result is a similar diameter opening produced using a smaller diameter balloon.
- · The non-compliant balloon is heat bonded to the catheter shaft, thus reducing the risk of balloon detachment.
- · The balloon design facilitates the use of a 5F introducer sheath. This will minimize blood loss in the neonates.
- · The catheter end hole can be utilized for guidewire, contrast injection, or blood analysis.
Materials and colorants used in this device were approved under IDE G940143 and are the same as those used in previously approved NuMED products: PTA K931009 and PTV G890030.
Biocompatibility Testing
The materials used in the NuMED Atrioseptostomy Balloon Catheter are the same as those used in our PTA (K931009) and PTV Catheters (IDE #G890030) which have been tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices.
Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc.
1
Laboratory (Bench) Testing All bench testing was performed in accordance with GMP's and the results are as follows.
Balloon Volume vs. Diameter 1 .
Acceptance Criteria: Balloon diameter must be within ± 10% of the rated diameter at the rated volume of 2cc. (i.e., 12.15mm to 14.85mm)
Justification: ±10% demonstrates the noncompliance of the balloon, and is still well below the maximum inflated diameter of 19.0mm of the predicate device .
Equipment: 3cc syringe, micrometer (CC-0078), water bath @ 98°F ± 5°F, water @ 68°F ± 10°F
Methodology:
Ten full length, sterile catheters with a distally mounted balloon were tested at body temperature - room temperature fluid was injected into the balloon, which was submerged in a body temperature bath. The balloons were inflated to each volume increment and measured with a micrometer (CC-0078).
Results:
| Inflation
Volume | Sample
1 Dia. | Sample
2 Dia. | Sample
3 Dia. | Sample
4 Dia. | Sample
5 Dia. | Sample
6 Dia. | Sample
7 Dia. | Sample
8 Dia. | Sample
9 Dia. | Sample
10 Dia. |
|---------------------|------------------|------------------|------------------|------------------|------------------|------------------|------------------|------------------|------------------|-------------------|
| 0.5cc | 7.8 | 7.9 | 7.8 | 8.1 | 8.0 | 8.2 | 8.1 | 8.0 | 8.1 | 7.9 |
| 1.0cc | 10.0 | 10.2 | 10.1 | 10.7 | 10.5 | 10.8 | 10.6 | 10.7 | 10.6 | 10.5 |
| 1.5cc | 11.8 | 11.9 | 11.8 | 12.2 | 12.0 | 12.1 | 12.1 | 12.1 | 12.0 | 12.0 |
| 2.0cc | 13.0 | 13.2 | 13.1 | 13.7 | 13.5 | 13.6 | 13.9 | 13.8 | 13.6 | 13.5 |
| 2.5cc | 13.5 | 13.6 | 13.6 | 13.9 | 13.7 | 13.9 | 13.9 | 13.9 | 13.7 | 13.6 |
| 3.0cc | *** | *** | *** | *** | *** | *** | *** | *** | *** | *** |
*** Burst
| Volume (cc) | Mean Diameter (mm) | Range | Standard Deviation |
|---|---|---|---|
| 0.5 | 7.99 | 7.8 - 8.2 | 0.137 |
| 1.0 | 10.47 | 10.0 - 10.8 | 0.275 |
| 1.5 | 12.00 | 11.8 - 12.2 | 0.133 |
| 2.0 | 13.49 | 13.0 - 13.9 | 0.300 |
| 2.5 | 13.73 | 13.5 - 13.9 | 0.157 |
2. Bond Integrity
Acceptance Criteria: Minimum of 3 lb. at all test points
Justification: The predicate device latex balloon bond failed at a value of 2.7 Ibs. in laboratory testing, using the same test methodology.
Equipment: Chatillon pull tester (CC-0013, 0-10 lbs.), circular weight, test fixture Methodology:
Ten full length, sterile catheters with a distally mounted balloon were tested. The specified bonds were pulled at room temperature with a Chatillon pull tester.
The balloon bond testing performed simulates an actual use condition. To test the proximal balloon bond and balloon operation, the balloon was used to lift a circular weight until failure. To test the tip bond, catheters were gripped at the balloon and pulled until inner tubing failure. This tip was then gripped and the balloon was pulled until bond failure occurred.
2
The methodology for balloon bond testing was as follows:
BALLOON BOND
- [a] Inflate catheter with 2.0cc of fluid.
- [b] Insert extensions through the weight and slide weight into place over vertically held balloon.
- [c] Holding the catheter by the shaft, lift the weight off the counter (see Fig. below)
Image /page/2/Figure/6 description: The image shows a diagram of a catheter shaft with a septostomy balloon. A 2lb "doughnut" weight with a 6mm opening is attached to the catheter shaft above the balloon. The diagram also indicates the direction of lift with an arrow labeled "LIFT". The catheter shaft is positioned vertically, with the balloon at the bottom and the weight in the middle.
- [d] Repeat this testing by adding weight rings until the balloon fails when lifting.
The additional testing was conducted on these same samples after balloon failure. The balloon was cut to reveal the balloon to catheter tip bond. The balloon was then pulled to 10 lbs. to insure that it would not come off. Since the grip points for this test were the catheter shaft and the broken balloon this test also formulated the tip to catheter bond test. In all cases these bonds exceeded 10 lbs. (see Fig below).
Image /page/2/Figure/9 description: This image shows a diagram of a balloon with labels pointing to different parts of the balloon. The labels include 'GRIP POINT', 'PULL', 'TIP AREA', 'TIP TO BALLOON BOND', and 'BALLOON WITH PROXIMAL BOND REMOVED'. The diagram shows the balloon being pulled from the grip point.
Results:
| Test Site | Average | Range |
|---|---|---|
| Distal hub to 'Y' | > 10.0 lbs. | > 10.0 lbs. |
| Balloon hub to extension | > 10.0 lbs. | > 10.0 lbs. |
| Balloon extension to 'Y' | ||
| connector | > 10.0 lbs. | > 10.0 lbs. |
| Catheter body to 'Y' connector | > 10.0 lbs. | > 10.0 lbs. |
| Proximal balloon bond | 8.0 lbs | 7.0 - 9.0 lbs (std dev. = 1 lb.) |
| Tip to catheter | 8.0 lbs | 7.0-9.0 lbs. (std dev. = 1 lb.) |
| Tip to balloon | > 10.0 lbs. | > 10.0 lbs. |
3
3. Guidewire Compatibility
Acceptance Criteria: minimal resistance while pushing catheter over guidewire. Force may not be great enough to bend guidewire.
Justification: This resistance is equal to or less than the resistance of 0.021" guidewires in balloon dilatation catheters of comparable size (i.e., same recommended guidewire size).
Equipment: Micrometer CC-0078; 0.021" guidewires
Methodology: Guidewires of a 0.021" labeled diameter were measured to ensure compliance of ± 0.001". These guidewires were then inserted through 20 full length sterile catheters. The guidewires were gripped at 2" from the guidewire hub and pushed through the catheter tip.
Results:
In no case was the guidewire kinked or was the force in excess of that necessary to insert a guidewire into a similar catheter. NuMED catheters are 100% inspected with the appropriate pin gauge for QC acceptance prior to release for packaging.
| Model | n | Average | Std. Deviation | 99.9%
Confidence | Range |
|---------|----|---------|----------------|---------------------|----------------|
| 2100-01 | 20 | NA | NA | NA | All acceptable |
Maximum Luminal Injection Pressure 4.
Acceptance Criteria: Must withstand 500 psi
Tustification: Predicate device does not allow for pressure iniection, this value is equivalent to the currently marketed Berman Angiographic catheter, of the same French size.
Equipment: pressure gauge CC-0115, 0-4000 psi, pressure generating apparatus
Methodology:
Ten sterilized, full length test catheters with balloon attached were used. The catheter tip was plugged (using a stainless steel pin) on each catheter to give a static pressure measurement. Catheters were pressurized to 750 PS1, a value in excess of that normally used in the cath lab, and then pressurized to failure. The following values are the data acquired from this testing. A limit of 600 psi will be added to the injection criteria.
Results:
| Sample # | 750 psi Injection | Burst Pressure | |
|---|---|---|---|
| 1 | Pass | 875 psi | |
| 2 | Pass | 950 psi | |
| 3 | Pass | 950 psi | |
| 4 | Pass | 900 psi | |
| 5 | Pass | 950 psi | |
| 6 | Pass | 880 psi | |
| 7 | Pass | 890 psi | |
| 8 | Pass | 890 psi | |
| 9 | Pass | 890 psi | |
| 10 | Pass | 880 psi | |
| SUMMARY | All Samples Passed 750 psi | 905.5 psi Average Burst | |
| Mean | Range | Standard Deviation | 99% Confidence |
| 905.5 psi | 875 - 950 psi | 31.486 | 741.7 lb. |
9
4
- Multiple Inflation Testing 5.
Acceptance Criteria: The balloon diameter must still be within ± 10% after 40 inflation/deflation cycles.
Justification: Industry standard for multiple inflations is 40 cycles.
Equipment: micrometer CC-0078, 3cc syringe, water bath @ 98°F ± 5°F, water @ 68°F ± 10°F
Methodology:
Ten full length catheters were sterilized and inflated with the recommended volume. The test was conducted at body temperature. The test sample was inflated, the O.D. measured, then deflated. All samples were inflated 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, since the non-compliant balloon was not stressed during inflation. This explains why the one sample inflated 500 times did not fail.
Results:
The raw data for the multiple inflation testing is as follows: All samples were tested 50 times with #10 tested 500 times. Individual diameter measurements were not taken on all 500 inflations of the sample. The following is the statistical analysis of balloon diameter change after 50 inflations. The raw data is enclosed within this section.
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| -------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
-
- Injection Rate
Acceptance Criteria: Demonstrate that this device can be used for fluid injection.
- Injection Rate
Justification: The predicate device does not have a through-lumen and cannot be used for this purpose.
Equipment: NuMED hydraulic pressure injector: Pressure Gauge CC-0115, 0-4000 psi: water @ 68°F ± 10°F
Methodology:
The iniection rate test was conducted on 10 full length sterilized catheters. The purged catheters were attached to the NuMED hydraulic pressure injector and the injection pressure was set at 300 psi. The injection machine consists of a hydraulic cylinder with a pressure gauge mounted at the fluid outlet. The hydraulic arm exerts a pressure on a metal syringe to expel fluid. This machine was attached directly to the distal port of the catheter and the iniection pressure read 300 psi. The catheters were then subjected to a 5 second pressure injection. The injection fluid was then measured and a cc/sec value was calculated. The injection media used was room temperature water.
5
Results:
| Sample # | Qty Fluid Injected | Calculated Rate (cc/sec) | |
|---|---|---|---|
| 1 | 21cc | 4.2 | |
| 2 | 19cc | 3.8 | |
| 3 | 21cc | 4.2 | |
| 4 | 20cc | 4.0 | |
| 5 | 19cc | 3.8 | |
| 6 | 18cc | 3.6 | |
| 7 | 20cc | 4.0 | |
| 8 | 18cc | 3.6 | |
| 9 | 22cc | 4.4 | |
| 10 | 22cc | 4.4 | |
| Mean | Range | Standard Deviation | 99% Confidence |
| 4cc/sec | 3.6 to 4.4 | 0.298 | 2.45 cc/sec |
-
- Luminal Frequency Response
These catheters are not recommended for use in measuring luminal frequency.
- Luminal Frequency Response
-
- Balloon Deflatability
Acceptance Criteria: Deflatation achieved in less than 20 seconds.
- Balloon Deflatability
Justification: As per Dr. Ziyad Hijazi, the maximum allowable deflation time was set at 20 seconds.
Equipment: 3.0cc syringe, stopwatch, silicone sheeting
Methodology:
Deflation testing was performed at NuMED in a simulated use condition in the laboratory. A total of (5) full length, sterile catheters were introduced into a section of silicone sheet, then inflated with a 30% solution of Renographin and water. They were then pulled through the sheet to simulate the septostomy procedure. These catheters were then deflated using the same 3.0cc syringe used for inflation.
Results:
Balloon deflatability was also evaluated by Dr. Hijazi during animal testing performed on 2-6-95. Deflation was achieved by applying negative pressure to the balloon using a 3 cc syringe (the contrast mixture was 30%). Deflation times were 5 - 10 seconds to achieve 50% deflation and all balloons were fully deflated within 15 sec. For a faster deflation time, the physician may use a larger (10 cc) syringe. These steps have been added to the Instructions for Use.
6
- Balloon Non-Compliance During Use 9.
Acceptance Criteria: minimal deformation, as observed visually
Justification: The predicate device exhibits great deformation.
Equipment: N/A
Methodology & Results::
The catheter was used on a deer heart in the R&D lab. The balloon was slowly pulled through the septum and since this is a non-compliant material no deformation was visually observed. The Baxter Miller was then also pulled slowly through the septum of the deer heart and it was visually observed that the balloon diameter reduced in diameter. The size of the hole that was accomplished was similar in each case: 12mm hole using the 13.5mm NuMED balloon, and 1 1.5mm hole using the 18mm Baxter balloon.
Noncompliance of the balloon was also demonstrated and confirmed by Dr. Hijazi on the previously submitted videotape of the animal testing performed (G940143).
-
- Balloon Protector Testing
Acceptance Criteria: Ability to form balloon to accept a 6F introducer
- Balloon Protector Testing
Justification: This is the label recommended introducer size for this device.
Equipment: Septostomy catheters, balloon protectors
Methodology:
The balloon protectors are made of PTFE (Teflon). It has an I.D. of 0.068" and will form and protect the balloon. Ten Atrioseptostomy catheters were fitted with balloon protectors, sent to sterilization, then opened and tested with a 6F B. Braun introducer upon return.
Results:
All catheters were admitted through the recommended 6F introducer without incident. No resistance, kinking or detrimental effects to the catheter were noted.
-
- Introducer Compatibility
Acceptance Criteria: Catheter must be admitted through a 6F Introducer
- Introducer Compatibility
Justification: This is the size of introducer recommended in the device labeling.
Equipment: 6F B. Braun Introducers, Sterile Atrioseptostomy Catheters Methodology:
Ten catheters will be opened and tested for admittance through the recommended introducer upon return from sterilization.
Results:
All catheters were admitted through the recommended 6F introducer without incident. No resistance, kinking or detrimental effects to the catheter were noted. The catheters were then inflated and checked for any signs of damage. None were observed.
Under microscopic examination, the actual profile of the individual components is as follows: Catheter Shaft = 0.052"; Proximal Bond Area = 0.064"; Balloon Area = 0.065". All NuMED catheters are equipped with a 0.068" max. balloon protector/profiling sleeve prior to sterilization. The attachment of this sleeve ensures that the balloon will be admitted through the introducer.
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Animal Testing B.
Animal testing was performed on five piglets on February 6, 1995 using finished samples of the NuMED Atrioseptostomy Catheter manufactured as per the design submitted (13.5 mm balloon, 2 cc capacity, 0.018" to 0.021" GW). The following summary was provided by Dr. Ziyad Hijazi (New England Medical Center Pediatric Cardiology) who performed the testing.
"On 2/6/95, piglet #237 weight 3.5 kg was taken to the cath lab. 5F sheath in the RFV percutaneously. A 4F wedge catheter was advanced to the LA (left atrium). An 0.018" guidewire was advanced and the septostomy catheter was exchanged for the other cather over the wire. The balloon was inflated with 1.2 cc 30% mixture of contrast and saline, then the wire was removed and a syringe with mixture of contrast and saline was attached to this end (the distal lumen end). The balloon was pulled across the septum without difficulty. Initially 1.5 cc, then 1.8 cc, without any problem. To assess the result of pulling a fully inflated balloon (2 cc) all the way down to the IVC (inferior vena cava) resulted in perforation of the IVC. Autopsy revealed the heart size to be 35 g, the IVC revealed a laceration at the junction with the right atrium. Inspection of the septal defect size that was created revealed smooth edges, circular shape and it measures 10-12 mm in diameter.
"On 2/6/95, piglet #238 weight 3.5 kg was taken to the cath lab. 5F sheath in the RFV percutaneously. The septostomy catheter was advanced to the LA via the PFO without difficulty and without the need for a guidewire. Position was confirmed with hand injection of contrast/saline mixture in the LA. The balloon was inflated to 1.2 cc, pulling through was easy, then the catheter was re advanced to the LA without difficulty, again position was confirmed by contrast injection, balloon was inflated to 1.5 cc, this pulled through also easily. repeat procedure with a balloon capacity of 1.8 cc and 2.0 cc without any problem. Autopsy revealed heart size is 36 g. Nice size defect measuring 10-11 mm. No other findings.
"On 2-6-95, piglet #235 weight 3.2 kg was taken to the cath lab. 5F sheath in the RFV percutaneously. Septostomy using 1.2, 1.5, 1.8 and 2.0 cc successfully as described above. No problems. On occasions, the balloon could not be advanced through the defect, therefore, a guidewire was used to advance into the LA. Once in LA contrast injection demonstrated the location of the catheter tip in the LA. Autopsy revealed that the heart size is 36 g. The defect size is 11 mm. No other findings.
"On 2/6/95, piglet #239 weight 2.9 kg was taken to the cath lab. 5F sheath in the RFV percutaneously. Septostomy using 1.0, 1.5 and 1.7 cc was successful. 2.0 cc was not tried secondary to the small size of the animal. Autopsy revealed that the heart is 25 g. Good defect size 10 mm.
"On 2/6/95, piglet #236 weight 2.8 kg was taken to the cath lab. 5F sheath in the RFV percutaneously. Septostomy with 1.0, 1.5, 1.7 and 2.0 cc was uneventful. Autopsy revealed heart to be 24.5 g. defect size 11 mm.
" All procedures were recorded on videotape and slides were taken for all animals."
Dr. Hijazi provided us with copies of the slides and videotape which were included with IDE G940143 for this device.
8
Intended Use: This catheter is intended for balloon atrioseptostomy.
Comparison Information:
| MODEL: | NUMED | BAXTER MILLER |
|---|---|---|
| Indications | 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. | 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. | ||
| Introducer: | 6FR | 8FR |
| Shaft Size: | 5FR | 5FR |
| Guidewire Size: | 0.018" to 0.021" | N/A |
| Usable Length: | 50cm | 50cm |
| Balloon Capacity | 2.0cc | 4.0cc |
| Inflated Diameter: | 13.5mm | 19.0mm |
| Balloon Length: | 1.35cm | NA |
| Max. Injection Pressure | 600psi | NA |
| Flow Rate: | 4cc per second | NA |
| Tip Angulation | 35° | 35° |
| Materials: | Shaft: polyamide | |
| Balloon: polyamide | ||
| Image Band: Platinum | PVC Shaft | |
| Latex Balloon | ||
| Construction: | Dual lumen construction with distally | |
| mounted non-compliant balloon. Distal | ||
| lumen open to tip. | PVC catheter with distally mounted | |
| latex balloon. Single Lumen with stylet | ||
| for stiffness. |
catheters are marketed for balloon atrioseptostomy. The parameters of the NuMED These catheters are comparable to those of the currently marketed catheters.