The Better-Bladder™ is a device that isolates from blood contact when measurements of blood pressure in extracorporeal circuits are made during 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 Better-Bladder™ (BB) is a length of standard perfusion tubing, a portion of which has been processed to form a sausage shaped balloon with a thin wall that is then sealed within a clear, rigid housing. This device can be used as an inline blood reservoir during extracorporeal circulation. It can also be used to monitor the blood pressure noninvasively: because the pressure of blood flowing inside the tubing is transmitted across the thin wall to the housing chamber, this pressure can be monitored via a pressure monitoring line to a pressure sensor. The BB thereby serves as a pressure transducer protector, isolating the blood from the pressure sensor and allowing noninvasive pressure measurements, which in turn can be used as input signals to control the pump speed.

AI/ML Overview

This 510(k) notification describes a medical device, the Better-Bladder™ BB14-72, and its substantial equivalence to a predicate device, focusing on its physical characteristics and performance in a mock circulatory system. The document does not describe the acceptance criteria and study design elements typically associated with AI/ML-based medical devices or diagnostics. Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's an analysis based on the provided text, addressing the points where information is available and noting when it is not:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the BB14-72 appears to be its ability to mitigate negative pressure spikes due to venous line obstruction, performing "as well or better than the predicate device," and providing "more time for a pump flow controller to respond than the predicate device."

Acceptance Criteria (Implied)	Reported Device Performance
Lower negative pressure spike than predicate device.	"The negative pressure spike for the BB14-72 was lower than that for the predicate device."
Longer time for pressure to reach steady state than predicate device.	"the time it took for the pressure to reach a steady state was longer with the BB14-72 than the predicate device."
Substantially equivalent in design, intended use, technological characteristics, and performance characteristics to the predicate device.	Concluded as "substantially equivalent" based on various comparisons and performance data.
Materials identical to predicate device.	"The materials of the BB14-72 are identical to those of the predicate device."
Method of manufacture same as predicate device.	"The method of manufacture is also the same for both the BB14-72 and the predicate device."

Study Details

The provided document describes a performance study to demonstrate the BB14-72 device's mechanical characteristics, not a clinical study involving human patients or complex AI/ML algorithms.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as a numerical sample size. The testing involved comparing the BB14-72 against the predicate device (BB14) and a 1/4" standard perfusion tubing in a "mock extracorporeal circuit." The graphs show results for three devices/configurations.
- Data Provenance: The study was conducted in a "mock extracorporeal circuit," which implies a laboratory setting. There is no mention of country of origin of data or whether it was retrospective or prospective. It's a prospective engineering performance test.
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):
- Not applicable. This was a physical device performance test using a mock circuit, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" was mechanical measurements (pressure and time).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 not an AI/ML device, and no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm; it is a physical medical device. The "standalone" performance shown is purely mechanical, not algorithmic.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" was direct physiological measurements (pressure and time) obtained from a simulated environment (mock extracorporeal circuit) under controlled conditions.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, and therefore no training set was used.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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CTI 510(k) Notification for The Better-Bladder™ BB14-72.

002 Special 510K Summary

K140321

Image /page/0/Picture/3 description: The image shows a logo with a rounded square border. Inside the border, there are two stylized letters, 'C' and 'I', arranged side by side. The 'C' is larger and open at the top, while the 'I' is smaller and fits within the open space of the 'C'. The logo appears to be a simple, minimalist design.

Circulatory Technology Inc.

worth Street, Oyster Bay, NY 11771 el. (516)-624-2424. Fax (516)-624-2414

APR 1 7 2014

Special 510(k) Summary for the Unitary Pediatric Better-Bladder™ (BB14-72) Preparation Date: 2/5/14

510(k) Owner/Contact Person Information:

Yehuda Tamari Circulatory Technology, Inc. 21 Singworth St. Oyster Bay, NY 11771 ytamari@cirtec.com

Device Information:

Trade Name: Unitary Pediatric Better-Bladder™ Common Name: in-line venous reservoir Product Class: DTN (Reservoir, blood, cardiopulmonary bypass)

Description of the Device:

Equivalent Device:

Trade Name: Better-Bladder™ 510(k) number: K981284 and K964337

Indication for Use:

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.

Intended Use:

The BB14-72 has two intended uses:

To isolate pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits. The pressure signal can be used to control pump speed for routine bypass procedures.
As an inline blood reservoir to provide compliance in the extracorporeal circuits.

These intended uses are identical to the predicate device, the Better-Bladder™ (BB14, BBB38, and BBB38-72). The predicate devices include extracorporeal membrane oxygenation (ECMO) procedures as an intended use.

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CTI 510(k) Notification for The Better-Bladder™ BB14-72.

Technological Characteristics

The BB14-72 has the same technical characteristics as the predicate device, the Better-Bladder™ (BB14, BBB38, and BBB38-72). See the following table:

Characteristic	BB14-72	Predicate Device
Design	Balloon section in a lengthof perfusion tubing	Balloon section in a lengthof perfusion tubing
Material	Balloon/tube: PVCHousing: PETG	Balloon/tube: PVCHousing: PETG
Energy source	None	None
Maximum flow	1.5 LPM	1.5 LPM

Performance Data

The BB14-72 was tested against the predicate device (BB14) and a length of ¼" standard perfusion tubing to compare the negative pressure spike due to a sudden obstruction of the venous line. This occurs when the pump is attempting to pump more than that available from the patient. The tests were conducted in a mock extracorporeal circuit, see Fig. 1. The pressure was measured at the P1 -Cannula Output Pressure point in Fig. 1. The flow in the circuit was either 500 mL/min or 1,500 mL/min. The venous line was clamped at the Clamp Point in Fig. 1, and the record pressure spikes are summarized in Fig 2.

Image /page/1/Figure/7 description: The image is a diagram of a mock extracorporeal circuit. The circuit includes a "Patient" (Bag), a venous cannula, a clamp point, and a 1/4" ID tube. The circuit also includes an oxygenator, a centrifugal pump, and pressure sensors labeled P1 and P2. There are also components labeled BB14 and BB14-72.

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CTI 510(k) Notification for The Better-Bladder™ BB14-72.

002 Special 510K Summary

From this performance data, we can conclude that the BB14-72 offers more compliance than the predicate device. The negative pressure spike for the BB14-72 was lower than that for the predicate device, and the time it took for the pressure to reach a steady state was longer with the BB14-72 than the predicate device. The lower pressure spike corresponds to a lower pressure that would be exerted a the venous cannula, and the longer time to reach steady state pressure allows more time for a pump flow controller to respond to the obstruction in the venous line. Thus, the safety of the BB14-72 is substantially equivalent to, and performs as safely and effectively or safer and more effectively as the predicate device.

Image /page/2/Figure/3 description: The image is a graph titled "Figure 2b. The negative pressure spike due to a sudden obstruction of the venous line (1,500 mL/min flow)". The graph shows pressure in mmHg on the y-axis and time in seconds on the x-axis. There are three lines on the graph, representing BB14-72, BB14, and 1/4" Tube, with a flow of 1.5 LPM. The pressure drops rapidly for all three lines, with the 1/4" Tube experiencing the most significant drop to around -240 mmHg.

Figure 2a. The negative pressure spike due to a sudden obstruction of the venous line (500 mL/min flow).

Image /page/2/Figure/5 description: The image is a graph that shows pressure in mmHg on the y-axis and time in seconds on the x-axis. There are three lines on the graph, representing BB14-72, BB14, and 1/4" ID Tube. The flow rate is 0.5 LPM. The pressure decreases over time for all three lines, eventually leveling out around -120 mmHg.

Conclusion

The BB14-72 is substantially equivalent to the predicate device in design, Intended Use, Technological Characteristics, and Performance Characteristics. The materials of the BB14-72 are identical to those of the predicate device, as well as the manufacturer and sterilizer. The method of manufacture is also the same for both the BB14-72 and the predicate device. The BB14-72 protects against large negative pressure spikes as well or better than the predicate device, and it provides more time for a pump flow controller to respond than the predicate device, indicating that the BB14-72 is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2014

Circulatory Technology, Inc. Yehuda Tamari President 21 Singworth St. Oyster Bay, New York 11771

Re: K140321

Trade/Device Name: Initary better bladder-pediatric Regulation Number: 21 CFR 870.4400 Regulation Name: Better-Bladder Regulatory Class: Class II Product Code: DTN, Dated: February 5, 2014 Received: February 18, 2014

Dear Yehuda Tamari,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act the or and statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Page 2 - Yehuda Tamari

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140321

Device Name

The Better-Bladder (BB14-72)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Bram D. Zuckerman -S 2014.04.17 13:37:36 -04'00'

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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.