(537 days)
The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
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).
Here's a breakdown of the acceptance criteria and study information for the Better-Tubing™ device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Better-Tubing™ Reported Performance |
|---|---|
| Biocompatibility | Passed all ISO 10993 Part-1 Biocompatibility Tests (Intracutaneous Toxicity, Cytotoxicity, Sensitization, Systemic Toxicity, Genotoxicity, Implantation with Histopathology, Hemolysis, Whole Blood Coagulation Time, Pyrogenicity) |
| Effect of Temperature on Flow | Minimally affected by fluid temperature. Flow differed by no more than 3% at 22±2°C and 37±2°C. |
| Hemolysis (compared to Tygon® tubing) | Significantly less hemolytic than Tygon® tubing with standard occlusion (p<0.0046). No significant difference from Tygon® tubing set nonocclusively. IH (% STD-SO) of 30% ± 4% (BT-SO) and 35% ± 9% (BT-NO) vs. 100% (TY-SO). |
| Pressure Resistance | Able to withstand 2500 mmHg (50 psi) for 60 min without leaks or bursting. Pressure decreased only 2% over 60 min. |
| Tensile Strength (compared to predicate tubing) | 3 to 6 times greater than the predicate tubing. |
| Pumping Life (compared to standard tubing) | Equal to or greater than standard tubing. Decreases in flow after 6 hours were the same as Super-Tygon®. |
| Abrasion Resistance / Spallation | High abrasion resistance and thus lower spallation. |
| Material Formulation | Differs from Tygon® in its material formulation. (Implicit acceptance: new material meets performance) |
| Intended Use (Blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.) | Met, as determined by the FDA's substantial equivalence finding. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Effect of Temperature on Flow: 3 BT tubes were tested.
- Hemolysis Tests:
- Number of circuits: Four identical circuits were tested simultaneously.
- Tubing samples: Four tubings (Tygon-SO, Tygon-NO, Better-Tubing-SO, Better-Tubing-NO) were tested. This implies 'n=4' for each group as shown in Table 3.
- Blood source: Fresh heparinized bovine blood obtained from a slaughterhouse.
- Pressure Tests: A 6 ft. length of Better-Tubing™ was tested.
Data Provenance: The studies appear to be primarily prospective, in-vitro (laboratory) tests conducted by the manufacturer, Circulatory Technology Inc. The blood for hemolysis tests was bovine and obtained from a slaughterhouse. The general provenance is implied to be within the US, corresponding to the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a component (tubing) and the reported studies are performance tests (e.g., flow, pressure, hemolysis) against established benchmarks and predicate devices, not diagnostic assessments requiring expert interpretation of clinical images or data. Ground truth for these tests is based on objective measurements and established scientific protocols (e.g., ISO standards, spectrophotometric assays for hemolysis).
4. Adjudication Method for the Test Set
Not applicable. The reported studies are objective performance tests, not studies requiring expert adjudication of qualitative outcomes.
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 is a medical device (tubing), not an AI/software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (tubing), not an algorithm. The reported tests are standalone performance tests of the tubing itself.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Objective Measurements: Flow rates (ml/min), pressure (mmHg), temperature (°C), time (min), percentage changes.
- Established Test Standards: ISO 10993 Part-1 for biocompatibility.
- Reference Devices/Materials: Comparison against Tygon® tubing (predicate device) and Super-Tygon® for pumping life.
- Biochemical/Physical Assays: Spectrophotometric assay for plasma free hemoglobin to quantify hemolysis.
8. The Sample Size for the Training Set
Not applicable directly. This is a physical medical device. "Training set" typically refers to data used to train AI/machine learning models. For a physical device like this tubing, the "development" or "optimization" process would involve materials science, engineering, and manufacturing trials, which are not outlined in terms of a formal "training set" like in AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as explained in point 8. The "ground truth" for the development of such tubing would be the desired performance specifications (e.g., target tensile strength, desired flow characteristics, acceptable hemolysis levels) that the engineers aimed to achieve through material selection and design. These specifications would be derived from clinical needs, existing standards, and competitor analysis.
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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.
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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 Specificationsfor 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 IntracutaneousToxicity (Irritation) | Evaluation of local dermal irritation or toxic effects ofleachables from the test article following intracutaneousinjection in rabbits | passed |
| Cytotoxicity | Evaluation of the biocompatibility of the test articleusing an in vitro agar overlay culture test with L929mammalian fibroblast cells (Direct ContactAutian/Guess Method) | passed |
| Sensitization | Maximization (Kligman) test in guinea pigs todetermine the potential for dermal sensitization | passed |
| USP IntracutaneousToxicity (Irritation) | Evaluation of local dermal irritation or toxic effects ofleachables from the test article following intracutaneousinjection in rabbits | passed |
| USP Systemic Toxicity | Evaluation of acute systemic toxicity of leachablesextracted from the test article following a singleintravenous or intraperitoneal injection in mice | passed |
| Genotoxicity(Mutagenicity) | Determination as to whether a test article preparationwill cause mutagenic changes in histidine-dependentmutant strains of Salmonella typhimurium (Ames Test) | passed |
| USP Implantation withHistopathology (7 & 30days) | Evaluation of the test article in direct contact withliving muscle tissue in rabbits | passed |
| Hemolysis | Determination of the percent hemolysis of whole rabbitblood produced by test article (Direct Contact Method) | passed |
| Whole Blood CoagulationTime | Determination of the coagulation time of whole rabbitblood exposed to the test article | passed |
| Pyrogenicity | Determination if a test article extract injectedintravenously causes a rise in body temperature ofrabbits(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.
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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<0.0046). Statistical analysis revealed no differences in platelet counts with time, among Tygon withing and Better-Tubing™, or under conditions of standard occlusive or nonocclusive roller settings within each type of וני בייתר ל 4 ก m 1 : TM /DTV tubing.
Hemolysis with Tygon tubing was very dependent on the pump occlusion setting; a nonocclusive setting results in a significant decrease hemolysis. The Better-TubingTM was in significantly less hemolytic than Tygon tubing with the standard occlusion setting, and no different from Tygon tubing set nonocclusively. The lack of difference in hemolysis between the Better-Tubing™ with standard occlusion and nonocclusion
| Table 3. IH for Tygon tubing (TY) and Better-Tubing™ (BT) | ||||
|---|---|---|---|---|
| TUBING | TY-SO | TY-NO | BT-SO | BT-NO |
| DROP RATE* | 2.5 | 70 | 2.5 | 70 |
| IH (mg/100L) | $175 \pm 60$ | $39 \pm 10$ | $46 \pm 7$ | $50 \pm 9$ |
| IH (% STD-SO) | 100% | $24 \pm 5%$ | $30 \pm 4%$ | $35 \pm 9%$ |
| n | 4 | 4 | 4 | 4 |
| p (v. TY-SO) | -- | 0.0008 | 0.0005 | 0.0046 |
Table 3. IH for Tygon tubing (TY) and Better-TubingTM (BT)
- cm/min/100cm; SO: standard occlusion; NO: nonocclusive
is believed to be due to the relatively thin wall of the tubing tested. It is likely that Better-Tubing™ with a slightly thicker wall would show a decrease in hemolysis with decreased occlusion, similar to the decrease seen with Tygon tubing.
Pressure Tests
To determine if the Better-Tubing™ can withstand pressures up to 50 psi, a 6 ft. length of Better-Tubing™ was clamped at one end and pressurized with an air-filled syringe to 50 psi (2512 mmHg). Pressure was measured at various intervals over a 60 min period, and the tubing was inspected for leaks or other signs of failure. Pressure decreased only 2% from 2512 mmHg over a 60 min period. No leaks or other signs of failure was observed. These test demonstrate that the Better-Tubing™ is able to withstand a pressure of 2500 mmHg without leaks or bursting for 60 min. This pressure far exceeds the maximum recommended pressure of other components used in the extracorporeal circuit.
SUMMARY OF FUNCTIONAL TESTS
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.
SUBSTANTIAL EQUIVALENCE
Predicate Device
The Better-Tubing™ is substantially equivalent to the following: Product Name Company Name
| Company Name | Product Name |
|---|---|
| Norton Performance Plastics Corp. | Tygon® tubing |
Polyvinyl chloride tubing of various lengths, diameters and wall thicknesses has been routinely used in the roller pump in both dialysis and cardiopulmonary bypass circuits prior to May 28, 1976. Electromedics Inc. received a 510(k) in 1981 for Tygon tubing (K803277).
Same Intended Use
A roller pump consists of a pair of rollers that compress a tubing against a curved raceway, propelling the fluid contained within the tubing in the direction. The intended use of the Better-Tubing™ and the predicate 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.
Technological Characteristics
Predicate Device. The predicate pump tubing is made from polyvinyl chloride (PVC). Norton Performance Plastics Corp. specifies that the Tygon® tubing pump formulations are "non-pyrogenic, taste-free, odorless, and non-hemolytic". They also meet or exceed Class VI criteria which means that each formulation has passed the Class VI protocol listed in the U.S. Pharmacopeia. The tubing is available in a range of sizes and hardnesses, depending on the application and user's
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510k (K964205) Better-Tubing™, Resp3
· preference. For cardiopulmonary bypass applications, PVC tubing is available with inner diameters (ID) from 0.125" to 5/8", wall thicknesses from 1/16" to 1/8", and Shore hardnesses from 40A (e.g. Tygon® S-40-HL) to 65A (Tygon® S-65-HL). Tygon® S-65-HL tubing was developed by Norton for longer term peristaltic pumping of blood and exhibits almost 2.5 times the pumping life of Tygon S-50-HL.
The Better-Tubing™. The Better-Tubing™ differs from the predicate tubing in its material has also passed the ISO Biocompatibility Tests and has a tensile strength 3 to 6 times greater than the predicate tubing. The Better-Tubing™ is minimally affected by perfusate temperature, can withstand high pressures, and results in the same or lower hemolysis than the predicate tubing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yehuda Tamari President Circulatory Technology Inc. 21 Singworth Street Oyster Bay, NY 11771
APR - 8 1998
Re: K964205 The Better-Tubing™ Regulatory Class: II (Two) Product Code: DWF Dated: March 9, 1998 Received: March 10, 1998
Dear Mr. Tamari:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Yehuda Tamari
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K964205 |
|---|---|
| --------------------------- | --------- |
TM Device Name: BETER
Indications For Use:
The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bete Q. Zempell
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 1 964205 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
: ・ .
(Optional Format 1-2-96)
§ 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).