The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.

Device Description

The BB consists of a unitary length of tubing, a section of which has been processed to form an enlarged diameter with a thinner wall. The enlarged section is very responsive to pressure differences across its thin wall. Because the entire device is made from a single length of smooth perfusion tubing, there are no connections between the thinker wall tubing portions. This unique design eliminates both physical and material (chemical) discontinuities. The thin walled section in its housing can withstand over 1500 mmHg (three times the maximum pressure expected under worst-case clinical conditions). The BB does not incorporate vent tubes for air aspiration or drug infusion. These can be added by placing a perfusion connector with a dual Luer fitting (e.g. Avecor Model # DL1414) at the inlet to the BB, see Fig. 7b.

AI/ML Overview

Here's an analysis of the provided text regarding the "Better-Bladder™" device's acceptance criteria and studies:

Summary of Device Acceptance Criteria and Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance	Study Type/Evidence
Functional Equivalence	Pressure measurement noninvasively with BB vs. invasively.	Equivalent to invasively measured pressure.	Bench tests
Performance Comparison	Comparable or superior performance to predicate devices.	Comparable or superior to predicate devices (Quest PMS-2, SciMed R30 Assist Reservoir).	Bench tests
Pressure Withstand (Thin-Walled Section)	Withstand over 1500 mmHg (3x max clinical pressure).	Withstood over 1500 mmHg.	Bench tests
Internal Pressure Test (Individual Unit)	Withstand an internal pressure of 900 mmHg (1.8x max clinical pressure).	Each BB individually tested to 900 mmHg.	Individual unit testing during manufacturing
Housing Pressure Test (Individual Unit)	Withstand a housing pressure of 900 mmHg.	Each BB individually tested to 900 mmHg.	Individual unit testing during manufacturing
Sterilization, Sterilant Residuals, Pyrogenicity	Compliance with established standards.	See K964337 (implies previous FDA clearance or established protocol).	Cross-reference to previous submission
Biocompatibility	Compliance with ISO 10993 Part-1.	Blood path material (polyvinyl chloride) passed biocompatibility tests in accordance with ISO 10993 Part-1.	Material testing (implied by passing standard)
General Safety	Compliance with established standards.	See K964337.	Cross-reference to previous submission
Quality Assurance	Compliance with established standards.	See K964337.	Cross-reference to previous submission
Design Integrity (Bond)	Bond between tubing and housing external to blood path.	Bond is external to blood path, no blood compatibility concerns.	Design characteristic (verified by inspection/design review)

Detailed Study Information:

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document primarily refers to "bench tests" and "individual unit testing" for functional evaluations. Specific sample sizes for these tests are not provided.
- The data provenance is not explicitly stated (e.g., country of origin). The testing appears to be prospective as it describes evaluations performed on the Better-Bladder™ to demonstrate its performance against predefined criteria and predicate devices.
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):
- This device is a physical medical device (pressure monitoring/blood reservoir) and the "ground truth" for its functional performance (e.g., pressure measurement accuracy, pressure withstand, biocompatibility) is established through objective physical measurements and adherence to engineering/biological standards, not through expert review of data like imaging. Therefore, the concept of "experts establishing ground truth for a test set" in the context of human interpretation is not applicable here. The "experts" involved would be engineers, materials scientists, and quality control personnel following established protocols.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Again, this device is a physical, non-AI medical device. The "adjudication method" in the context of human interpretation of results (like in clinical trials or image analysis) is not applicable. Objective measurements and adherence to predetermined specifications are used.
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:
- No, an MRMC comparative effectiveness study was not done. This is a physical device, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, a standalone performance was done, as the device's functional integrity and performance were evaluated on its own (bench tests, individual unit tests) against established engineering and biological standards, without human interpretation in the loop as part of its primary function. The device's function is to objectively measure pressure and act as a reservoir, not to process data for human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is based on objective engineering measurements (e.g., pressure equivalence to invasive methods, maximum pressure withstand, material properties conforming to ISO 10993 Part-1). For comparison, the predicate devices themselves serve as a benchmark for performance.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. This device does not use machine learning or AI, so there is no "training set" or ground truth for one.

Summary

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K981/284

SAFETY AND EFFECTIVENESS

510(k) Summary

Once a substantial equivalence determination is made, a 510(k) summary providing information on the safety and effectiveness of the Better-Bladder™ will be provided upon the request of any person. The 510(k) summary is included in Attachment 5.

Functional Testing

With respect to this notification, the Better-Bladder™ was functionally evaluated in a series of bench tests. The test protocols, experimental data, and analyses are provided as Attachment 6. These tests and the data obtained demonstrate that the pressure measured noninvasively with the BB is equivalent to that measured invasively, and that the BB shows comparable or superior performance to the predicate devices.

General Safety See K964337.

See K964337.

Sterilization, Sterilant Residuals, Pyrogenicity See K964337.

Biocompatibility See K964337.

Quality Assurance See K964337.

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SUBSTANTIAL EQUIVALENCE

Predicate Devices

The Better-Bladder™ is substantially equivalent to the following devices:

Company Name

Quest Medical (formerly Delta Medical Industries) SciMed Surgical (now AVECOR Cardiovascular)

Product Name (Model) Pressure Monitoring Separator Chamber (PMS-2) R30 Assist Reservoir

These devices are currently available cardiovascular and/or dialysis devices that have been determined to be substantially equivalent to devices in commercial distribution prior to May 28, 1976.

Same Intended Use

The Better-Bladder™

The Better-Bladder™ (BB) has two intended uses:

To isolate pressure transducers from blood contact when measurements of blood pressure in extracorporeal 1. circuits are made during short or long term procedures.
As an inline blood reservoir. such as the bladders used to sense decreasing pump inlet pressure. The pressure 2. signal can be used to control pump speed during short or long term procedures.

Predicate Devices

The Quest Pressure Monitoring Separator Chamber is intended to help in the monitoring of arterial pressure by providing an air-liquid phase separator (same as BB use 1).

The R30 Assist Reservoir is intended to hold a reserve supply of blood in the perfusion circuit and is designed to sense venous return pressure during ECMO procedures (same as BB use 2). It incorporates two vent tubes at the top for air aspiration or drug infusion.

Technological Characteristics

The technological characteristics of the BB do not affectiveness. The equivalency of the blood contacting portion of the BB with respect to a) material, b) design, c) general manufacturing methods, and d) use in an extracorporeal circuit is discussed below.

Material. The blood of the patient is only exposed to the inner surface of the tubing forming the BB. The a) blood path of the BB consists of a medical grade tubing extruded from a polyvinyl chloride formulation that has passed biocompatibility tests in accordance with ISO 10993 Part-1 Biological Evaluation of Medical Devices.

b) Design. The BB consists of a unitary length of tubing, a section of which has been processed to form an enlarged diameter with a thinner wall. The enlarged section is very responsive to pressure differences across its thin wall. Because the entire device is made from a single length of smooth perfusion tubing, there are no connections between the thinker wall tubing portions. This unique design eliminates both physical and material (chemical) discontinuities. The thin walled section in its housing can withstand over 1500 mmHg (three times the maximum pressure expected under worst-case clinical conditions). The BB does not incorporate vent tubes for air aspiration or drug infusion. These can be added by placing a perfusion connector with a dual Luer fitting (e.g. Avecor Model # DL1414) at the inlet to the BB, see Fig. 7b.

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c) General Manufacturing. The blood path of the BB is an extruded tube, part of which is formed in a

secondary operation. The Housing of the BB, made of PETG, does not contact the patient and therefore its physical characteristics, rather then its blood compatibility, are important. Each BB is individually tested to an internal pressure as well as a Housing pressure of 900 mmHg, which is 1.8 times the maximum clinically expected pressure and also significantly higher than the maximum operating pressures recommended for many devices in the extracorporeal circuit. Tests have also been conducted where a pressure of 1500 mmHg was applied internally to the BB without any failure.

The thin walled section of the unitary tubing forming the BB is sealed within the Housing by forming a bond between the outside of the unitary tubing and the inside of the Housing. The bonding is external to the blood path and therefore does not pose any blood compatibility concerns.

d) Use in an extracorporeal circuit. Most extracorporeal circuits monitor pump inlet and/or pump outlet pressures, but typically with "dead-ended" pressure lines. Since the BB is a flow-through device, stagnation is eliminated and the likelihood of thrombosis is decreased. The predicate bladders must be positioned horizontally, and are thereby susceptible to stasis and blood cell accumulation at the bottom of the device (see Fig. 7A), which can contribute to thrombus formation.

HOW THE BETTER-BLADDER™ ENHANCES SAFETY AND EFFECTIVENESS

1. The bubble in the tube is formed such that its internal surface is continuous and fissureless, thereby eliminating chemical or physical discontinuities, factors that can increase thrombus formation.
In terms of bladders, the predicate bladders must be positioned horizontally, and are thereby susceptible to 2. stasis and blood cell accumulation at the bottom of the device, both of which can contribute to thrombus formation. The BB can be placed vertically, thus providing gravitational washout that significantly reduces stasis or accumulation of red cells (see Fig. 7).
1. The BB can provide adjustable compliance that reduces pressure oscillations due to pumping action of the roller pump.
1. The predicate bladder must be placed on the floor to achieve appropriate gravitational flow. The BB, however, can be placed much closer to the patient with the loss of "gravity" drainage compensated by applying slight negative pressure to the housing. This allows for shorter venous tubing which reduces the prime volume, the foreign surface exposed to blood as well as the of the blood to the surface. The shorter circuit and smaller surface area also reduces heat loss of the blood in the extracorporeal circuit.
1. In terms of pressure isolators, the BB is a flow-through device, reducing the chance of clotting. The predicate devices can pose greater risk of clotting because there is NO flow in the pressure line connecting the blood path to the isolator.
1. If the BB is used to obtain a pressure signal to control the pressure at which the purnp would turn off is easily adjustable via the pressure monitor. The predicate bladder relies on a mechanical switch and is not adjustable.

Image /page/2/Figure/13 description: The image shows two diagrams, labeled A and B, illustrating flow conditions with predicate devices. Diagram A shows a silicone bladder with blood inside, and the text indicates that blood cells settle in this configuration. Diagram B depicts a perfusion connector with two stopcocks, and the text indicates that blood cells wash through in this setup. The diagrams are part of Figure 7 and reference 'The Better-Bladder™'.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with three stylized lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 1998

Mr. Yehuda Tamari President Circulatory Technology, Inc. 21 Singworth Street Oyster Bay, NY 11771

K981284 Re: "Better-Bladder™" Requlatory Class: II Product Code: DTN Dated: May 13, 1998 Received: May 14, 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 legally marketed predicate 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, Druq, 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, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 Register. Please note: this response to your premarket notification submission does not affect any obliqation 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 requlations.

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Paqe 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 Ehus, 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" (21CFR 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/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 10 Better-Bladder™ Indications for Use

510(k) Number Device Name:

K98 1284-

Better-Bladder тм

The Better-Bladder™ is a device that isolates pressure transducers from blood contact Indications for Use: when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.

981284

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_

age 1

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Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.