(537 days)
Not Found
No
The summary describes a physical tubing device and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No
A therapeutic device is one that treats or alleviates a disease or condition. This device is a component of a pump used for cardiopulmonary bypass and does not directly provide therapy to the patient; it is a conduit for blood.
No
Explanation: The device, Better-Tubing™, is described as a blood compatible conduit for pumping blood during cardiopulmonary bypass, which is a therapeutic rather than a diagnostic function. There is no mention of it being used for diagnosis, disease detection, or monitoring of any medical condition.
No
The device description clearly states it is a 6 ft. length of tubing, which is a physical hardware component. The performance studies also focus on the physical properties and performance of the tubing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications." This describes a device used outside the body to manage blood flow, not a device used to examine specimens in vitro (in a lab setting) to diagnose a condition.
- Device Description: The description reinforces its use as tubing within an extracorporeal circuit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The performance studies focus on the physical properties of the tubing and its interaction with blood flow, not on diagnostic accuracy.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This tubing does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the Better-Tubing™ is to provide a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
Product codes
DWE
Device Description
The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC):
- It has a pumping life equal to or greater than standard tubing. .
- It has superior resilience. Decreases in flow after 6 hours with the BT were . the same as those with Super-Tygon®.
- It is minimally affected by changes in the perfusate temperature, whereas ● with standard tubing, hypothermia can result in a 35% decrease in flow [Pfaender LM, Riley JB. An In Vitro Comparison of the Effects of Temperature on the Stroke Volume and Occlusion Setting of Various Tubing Types in a Roller Pump. J. Extracorp. Tech. 11(2):78-88, 1979].
- It has high abrasion resistance and thus lower spallation, and therefore . should allow greater safety.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies
The Better-Tubing™ was found to be unaffected by perfusate temperature, able to withstand a pressure of 2500 mmHg for 60 min, and have the same or less hemolysis than Tygon tubing.
Biocompatibility: In accordance with the "ISO 10993 Part-1 Biological Evaluation of Medical Devices", the Better-Tubing™ is in the device category of an externally communicating device with a circulating blood path, with a prolonged contact duration of 24 hr to 30 days. The Better-Tubing™ has passed the ISO Biocompatibility Tests summarized in Table 2. Tests included: USP Intracutaneous Toxicity (Irritation), Cytotoxicity, Sensitization, USP Systemic Toxicity, Genotoxicity (Mutagenicity), USP Implantation with Histopathology (7 & 30 days), Hemolysis, Whole Blood Coagulation Time, and Pyrogenicity. All tests passed.
Effect of Temperature on Flow: A heat exchanger was used to achieve water temperatures of 22±2° and 37±2°C. At pump speeds of 25, 50, 100, and 150 RPM, inlet pressure was adjusted from 50 to -400 mmHg and flow was recorded for three BT tubes. The Better-Tubing™ was minimally affected by fluid temperature, with flow differing by no more than 3% at the two fluid temperatures tested at pump inlet pressures up to -400 mmHg.
Hemolysis Tests: Four identical circuits were tested simultaneously using fresh heparinized bovine blood. Two degrees of roller occlusiveness were examined: standard occlusion (SO, drop rate of 2.5 cm/min), and nonocclusive setting (NO, 70 cm/min/100cm). Tubings tested were Tygon S-50-HL 3/8" ID x 1/16" wall and the Better-Tubing™ 3/8" ID x 1/32" wall. Flows varied from 1.4 to 3.0 L/min (average 2.0 L/min), and pressure differences across the pump (△P) from 140 to 275 mmHg (average 220 mmHg). Plasma free hemolysis (IH, mg free hemoglobin in plasma per 100 L) was assayed at 0, 30 min, and every hour thereafter for six hours of pumping. The IH values were normalized as a percentage of the IH for the standard occlusion setting (control).
Compared to IH for Tygon tubing with standard occlusion (TY-SO), IH for Tygon set nonocclusively (TY-NO) and Better-Tubing™ at either occlusion (BT-SO, BT-NO) were significantly less (p
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
Attachment 5 Better-Tubing™ 510(k) Summary
Att. 5 Page 1
F DA / GODIN / ODE / DMG
APR 15 09
21 Singworth Street, Oyster Bay, NY 11771
(516)-624-2424, Fax (516)-624-2414
510(k) Summary for Better-Tubing™
DEVICE NAME Classification Name:
Cardiopulmonary bypass pump tubing. Classification #74DWE, Class II with regulation #870.4390.
"Better-Tubing™" Trade Name:
BT14. Catalog Number:
EXECUTIVE SUMMARY
The Better-Tubing™ is a biocompatible, biostable, non-toxic, and non-pyrogenic tubing with superior pumping characteristics. It is intended for use in extracorporeal applications of short term duration such as in the roller pumps used during cardiopulmonary bypass procedures. The Better-Tubing™ is equivalent in intended use to Tygon® tubing, the uting curtiopanionaly of pare proplications. The Better-Tubing™ differs from Tygon® in its material formulation, and possesses exceptional resilience and high abrasion resistance, among other characteristics.
DESCRIPTION OF THE DEVICE
The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC):
- It has a pumping life equal to or greater than standard tubing. .
- It has superior resilience. Decreases in flow after 6 hours with the BT were . the same as those with Super-Tygon®.
- It is minimally affected by changes in the perfusate temperature, whereas ● with standard tubing, hypothermia can result in a 35% decrease in flow [Pfaender LM, Riley JB. An In Vitro Comparison of the Effects of Temperature on the Stroke Volume and Occlusion Setting of Various Tubing Types in a Roller Pump. J. Extracorp. Tech. 11(2):78-88, 1979].
- It has high abrasion resistance and thus lower spallation, and therefore . should allow greater safety.
Functional Characteristics of the Better-Tubing™
Figure I shows typical flow-pressure characteristics of the Better-Tubing TM model BT14 at a range of clinical pump speeds.
Technical Specifications of the Better-TubingTM
Nominal specifications for the Better-Tubing™ (BT) are given in Table 1.
INTENDED USE OF THE DEVICE
The intended use of the Better-Tubing™ is to provide a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
Image /page/0/Figure/26 description: The image is a graph titled "Figure 1. Functional Characteristics". The graph shows the relationship between flow in ml/min on the y-axis and Pin in mmHg on the x-axis. There are four lines on the graph, representing different speeds: 150 rpm, 100 rpm, 50 rpm, and 30 rpm. The flow increases slightly as Pin increases for all speeds.
1
OPERATION OF THE DEVICE
The Better-Tubing™ is placed in the roller pump used a the arterial, cardioplegia, venting, or suction pump, appropriate connections to the extracorporeal circuit are made, and the desired pump occlusion is set.
SAFETY AND EFFECTIVENESS
Biocompatibility
In accordance with the "ISO 10993 Part-1 Biological Evaluation of Medical Devices", the Better-Tubing™ is in the device category of an externally communicating device with a circulating blood path, with a prolonged contact duration of 24 hr to 30 days. The Better-Tubing™ has passed the ISO Biocompatibility Tests summarized in Table 2.
Effect of Temperature on Flow
the effect fluid of To determine temperature on the flow characteristics of the Better-Tubing™ and Tygon® tubing a heat exchanger was used in the test circuit to achieve water temperatures of 22±2° and 37±2°C to conditions represent the pumping of mild hypothermia and normothermia, respectively. At pump speeds of 25, 50, 100, and 150 RPM, inlet pressure was adjusted from 50 to -400 mmHg and flow was recorded at each pressure for three BT tubes.
Figure 2a summarizes the average results obtained and Figure 2b expresses flow as a percentage of initial flow. As the graphs show, the Better-Tubing™ is minimally affected by fluid temperature at a wide range of pump speeds. Flow differed by no more than 3% at the two fluid temperatures tested at pump inlet pressures up to -400 mmHg.
Hemolysis Tests
To compare the Better-Tubing™ and Tygon tubing in terms of hemolysis, four identical circuits were tested simultaneously using fresh heparinized bovine blood obtained from a slaughterhouse, as described previously [Tamari, Lee-Sensiba, Leonard, and Tortolani: A Dynamic Method for Setting Roller Pumps Nonocclusively Reduces Hemolysis and Predicts Retrograde Flow, ASAIO Journal, 1997; 43:39-52]. Two degrees of roller occlusiveness were examined: the standard occlusion setting (abbreviated SO, drop rate of 2.5 cm/min), and a nonocclusive setting (NO, 70 cm/min/100cm). The tubings tested were Tygon S-50-HL 3/8" ID x 1/16" wall and the Better-Tubing™ 3/8" ID x 1/32" wall. Flows varied from 1.4 to 3.0 L/min (average 2.0 L/min), and pressure differences across the pump (△P) from 140 to 275 mmHg (average 220 mmHg) were established with an
| Table 1: Nominal Specifications
| for the Better-Tubing™ | |
|---|---|
| BT14 | |
| ID (in) | 1/4 |
| Wall thickness (in) | 0.050 |
| Length (ft) | 6 |
| Flow (ml/min) per revolution* | 12 |
| Priming volume (ml/10 in) | 8.0 |
| * For a roller pump with a 6" raceway. |
Table 2. Test Article: Better-Tubing™ pump tubing. Biocompatibility tests were Fable 2. Test Antierer Bized samples in accordance with the ISO 10993 Part-I 'Biological Evaluation of Medical Devices".
| Test Method | Test Description | Results |
|---|---|---|
| USP Intracutaneous | ||
| Toxicity (Irritation) | Evaluation of local dermal irritation or toxic effects of | |
| leachables from the test article following intracutaneous | ||
| injection in rabbits | passed | |
| Cytotoxicity | Evaluation of the biocompatibility of the test article | |
| using an in vitro agar overlay culture test with L929 | ||
| mammalian fibroblast cells (Direct Contact | ||
| Autian/Guess Method) | passed | |
| Sensitization | Maximization (Kligman) test in guinea pigs to | |
| determine the potential for dermal sensitization | passed | |
| USP Intracutaneous | ||
| Toxicity (Irritation) | Evaluation of local dermal irritation or toxic effects of | |
| leachables from the test article following intracutaneous | ||
| injection in rabbits | passed | |
| USP Systemic Toxicity | Evaluation of acute systemic toxicity of leachables | |
| extracted from the test article following a single | ||
| intravenous or intraperitoneal injection in mice | passed | |
| Genotoxicity | ||
| (Mutagenicity) | Determination as to whether a test article preparation | |
| will cause mutagenic changes in histidine-dependent | ||
| mutant strains of Salmonella typhimurium (Ames Test) | passed | |
| USP Implantation with | ||
| Histopathology (7 & 30 | ||
| days) | Evaluation of the test article in direct contact with | |
| living muscle tissue in rabbits | passed | |
| Hemolysis | Determination of the percent hemolysis of whole rabbit | |
| blood produced by test article (Direct Contact Method) | passed | |
| Whole Blood Coagulation | ||
| Time | Determination of the coagulation time of whole rabbit | |
| blood exposed to the test article | passed | |
| Pyrogenicity | Determination if a test article extract injected | |
| intravenously causes a rise in body temperature of | ||
| rabbits(USP Rabbit Pyrogen Test) | passed |
Image /page/1/Figure/15 description: This image contains two line graphs that show the effect of temperature on Better-Tubing flow. The left graph shows flow in ml/min, while the right graph shows flow in percentage. Both graphs show data for 22C and 37C at different RPMs, including 150rpm, 100rpm, 50rpm, and 25rpm. The x-axis for both graphs represents Pin in mmHg, ranging from -400 to 100.
Figure 2a, 2b. Effect of temperature on Better-Tubing™ flow.
2
510k (K964205) Better-Tubing™, Resp3
adjustable screw-type clamp. Four tubings at the standard and nonocclusive settings were tested.
stance seron sype campe roun, 30 min, and every hour thereafter for six hours of pumping, were assayed Spectrophotometrically for plasma free hemolysis (IH, mg free hemoglobin in plasma per 100 L spectioning the my to pasma free asheriment, the IH values were normalized by expressing them as of blood pullifical was carcuation of the standard occulusion setting (considered the control condition). Paired a percentage of the fir for the standard wolfized IH among the various tubings and pumps, and the two occlusion settings. A p value less than 0.05 was considered to establish a statistically significant difference.
Table 3 provides the index of hemolysis values obtained for Tygon and the Better-Tubing™ . Compared to the IH for Tygon tubing with the standard occlusion, the Hs for Tygon set nonocclusively and the Better-Tubing™ at either occlusion were significantly less (p