(58 days)
Not Found
No
The description focuses on the mechanical and hydraulic properties of the device and its function as a pressure transducer protector and reservoir. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device isolates blood contact to measure pressure and acts as an inline reservoir, which are functional aspects of a blood circuit, not direct therapeutic interventions on a patient.
No
The device isolates blood from a pressure sensor and protects the transducer; it measures blood pressure, but does not provide a diagnosis.
No
The device description clearly details physical components (tubing, balloon, housing) and its function as a physical reservoir and pressure transducer protector, indicating it is a hardware device.
Based on the provided information, the Better-Bladder™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use is to isolate blood contact for blood pressure measurements in extracorporeal circuits and to act as an inline reservoir. These are functions related to managing blood flow and pressure within a medical circuit, not analyzing biological samples in vitro (outside the body).
- Device Description: The description details a physical device used within a blood circuit to facilitate pressure monitoring and provide compliance. It does not describe a test or assay performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing blood components, detecting biomarkers, diagnosing diseases, or any other activity typically associated with IVD devices.
The device is clearly intended for use in vivo (within the body's circulation system, albeit in an extracorporeal circuit) to manage physical parameters (pressure and volume) of the blood flow.
N/A
Intended Use / Indications 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DTN
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.
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
Pediatric
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The tests were conducted in a mock extracorporeal circuit. The pressure was measured at the P1 -Cannula Output Pressure point. The flow in the circuit was either 500 mL/min or 1,500 mL/min. The venous line was clamped, and the record pressure spikes are summarized in Fig 2.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
CTI 510(k) Notification for The Better-Bladder™ BB14-72.
002 Special 510K Summary
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:
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.
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.
1
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 length | |
| of perfusion tubing | Balloon section in a length | |
| of perfusion tubing | ||
| Material | Balloon/tube: PVC | |
| Housing: PETG | Balloon/tube: PVC | |
| Housing: 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.
2
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.
3
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
4
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
5
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)
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.
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.