(105 days)
Not Found
No
The description focuses on the mechanical function and material composition of a pressure isolator, with no mention of AI or ML.
No
The device acts as an interface to prevent fluid contact with gauges during pressure transduction, not directly treating or curing a medical condition.
No
This device acts as an interface to prevent fluid contact with pressure gauges during cardiopulmonary bypass. It transduces pressure but does not itself analyze or interpret that data for diagnostic purposes; it merely facilitates the measurement.
No
The device description clearly states it is a physical, disposable device made of polyvinylchloride with a housing and diaphragm, intended to act as an interface between hardware components (extracorporeal circuit and pressure gauge). It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as an interface between an extracorporeal circuit and a pressure gauge during cardiopulmonary bypass procedures to prevent fluid contact with the gauge. This is a mechanical function related to monitoring pressure within a blood circuit, not analyzing a biological sample to diagnose a condition.
- Device Description: The description focuses on the physical components (housing, diaphragm) and their function in isolating pressure, not on reagents, assays, or methods for analyzing biological specimens.
- Performance Studies: The performance studies described focus on mechanical integrity, connection strength, and pressure transduction accuracy. These are tests of the device's physical function in the extracorporeal circuit, not its ability to accurately measure or detect substances in a biological sample.
IVD devices are specifically designed to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The pressure isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device may be used in procedures lasting up to 6 hours in duration.
Product codes (comma separated list FDA assigned to the subject device)
DRS
Device Description
The Terumo Pressure Isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device is geometrically similar to the IBC Isolator device, which is the predicate device for purposes of this application. Furthermore, the operating principles and product technology of the two devices are identical.
The primary differences between the Terumo Pressure Isolator and the predicate IBC Isolator are herein identified as material differences, specific dimensions of the components and the type of diaphragm material that is encapsulated within the device housing.
The Terumo Pressure Isolator has a housing that is made of rigid polyvinylchloride and the predicate IBC Isolator is comprised of polycarbonate. Both of these materials permit a clear view of the fluids that enter the isolator, although the polycarbonate housing is clearer than the polyvinylchloride housing.
From the perspective of product geometry, the Terumo Pressure Isolator is designed with a more rounded housing as compared to the IBC Isolator, which is characterized by more distinct edges at the opposing ends of the housing chamber. It is expected that the rounded design featured by the Terumo Pressure Isolator will facilitate enhanced fluid flow and would be less susceptible to fluid becoming stagnated within the chamber.
Finally, the Terumo Pressure Isolator includes a flexible polyvinylchloride diaphragm inside the housing chamber, whereas the predicate IBC Isolator includes a polyurethane diaphragm.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Terumo conducted head-to-head studies to assess the relative functional capabilities of the Terumo Pressure Isolator to the predicate IBC device. The studies included a tubing connection test (pre-connection with solvent as well as testing without a solvent bond) whereby the strength of the connection between circuit tubing and the device was measured - and the resulting conclusion is that there is no difference.
Testing also included a pressure transduction assessment if the Terumo Pressure Isolator was capable of accurately and consistently transferring circuit pressures to gauges at a distal point in the pressure monitoring circuit. Again, the Terumo device was noted to be functionally equivalent to the predicate device.
Terumo Cardiovascular also conducted a mechanical integrity assessment in the form of Jeak test where both negative and positive pressures were applied to the isolator and the devices were examined for evidence of breach. The Terumo device and the predicate device were found to be equivalent.
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
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).
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: Dr DEC-1 0 2009
Section 5 -510(k) Summary (for FDA Website Presentation)
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| Page | |
|---|---|
| Submitter Information | 18 |
| Device Names / Classification | 18 |
| Identification of Predicate Device | 18 |
| Summary | 18 |
| Conclusion for 510(k) Summary | 19 |
1
TERUMO
Submitter Information:
This submission was prepared in August 2009 by:
Garry A. Courtney, MBA, RAC Regulatory Affairs & Compliance Manager Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420 Fax: 410-398-6079
This submission was prepared for:
Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Registration #1124841
Device Names/Classifications: Proprietary Name
Classification Name
Common Name
Terumo Pressure Isolator
Transducer, Blood Pressure, Extravascular (Code: DRS )
Transducer Isolator
Predicate Device(s):
Terumo Cardiovascular Systems has identified the IBC Isolator (Model 2000N) as an appropriate predicate device for which comparisons of the new Terumo device shall be demonstrated. The IBC Isolator is manufactured by International Biophysics Corporation and is legally marketed under 510(k) application K841959. The 510(k) application was originally sponsored by Sterile Design, Incorporated in Oldsmar, Florida with an FDA decision date of October 19, 1984.
Summary:
The Terumo Pressure Isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device is geometrically similar to the IBC Isolator device, which is the predicate device for purposes of this application. Furthermore, the operating principles and product technology of the two devices are identical.
The primary differences between the Terumo Pressure Isolator and the predicate IBC Isolator are herein identified as material differences, specific dimensions of the components and the type of diaphragm material that is encapsulated within the device housing.
The Terumo Pressure Isolator has a housing that is made of rigid polyvinylchloride and the predicate IBC Isolator is comprised of polycarbonate. Both of these materials permit a clear view of the fluids that enter the isolator, although the polycarbonate housing is clearer than the polyvinylchloride housing. This difference would not be problematic in an operating arena and neither device offers a therapeutic and/or functional advantage as a result of materials used and or housing clarity.
18
2
From the perspective of product geometry, the Terumo Pressure Isolator is designed with a more rounded housing as compared to the IBC Isolator, which is characterized by more distinct edges at the opposing ends of the housing chamber. It is expected that the rounded design featured by the Terumo Pressure Isolator will facilitate enhanced fluid flow and would be less susceptible to fluid becoming stagnated within the chamber.
Finally, the Terumo Pressure Isolator includes a flexible polyvinylchloride diaphragm inside the housing chamber, whereas the predicate IBC Isolator includes a polyurethane diaphragm. This difference in materials does not create any functional advantages for either device as both materials are capable of transducing circuit pressures to gauges that would be at the distal end of the pressure circuit.
With respect to product performance, Terumo conducted head-to-head studies to assess the relative functional capabilities of the Terumo Pressure Isolator to the predicate IBC device. The studies included a tubing connection test (pre-connection with solvent as well as testing without a solvent bond) whereby the strength of the connection between circuit tubing and the device was measured - and the resulting conclusion is that there is no difference.
Testing also included a pressure transduction assessment if the Terumo Pressure Isolator was capable of accurately and consistently transferring circuit pressures to gauges at a distal point in the pressure monitoring circuit. Again, the Terumo device was noted to be functionally equivalent to the predicate device.
Terumo Cardiovascular also conducted a mechanical integrity assessment in the form of Jeak test where both negative and positive pressures were applied to the isolator and the devices were examined for evidence of breach. The Terumo device and the predicate device were found to be equivalent.
Additional Safety Information:
- · Sterilization conditions for the Terumo Pressure Isolator are validated to provide a Sterility Assurance Level (SAL) of 104. Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution.
- Terumo maintains biocompatibility studies as recommended in the FDA General Program . Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993. "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.
Conclusion:
Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the Terumo Pressure Isolator is substantially equivalent to the predicate IBC Isolator device. It is further concluded that any recognized differences noted during the assessments do not raise any new issues of patient/user safety or product effectiveness.
3
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
EC 1 0 2009
Terumo Cardiovascular Systems Corp. c/o Mr. Garry A. Courtney Regulatory Affairs 125 Blue Ball Rd. Elkton, MD 21921
Re: K092644
Trade Name: Terumo Pressure Isolator Regulation Number: 21 CFR 870.2850 Regulation Class: Class II (two) Product Code: DRS Dated: October 15, 2009 Received: October 16, 2009
Dear Mr. Courtney:
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 reguirements 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 (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
4
Page 2 - Mr. Garry A. Courtney
or any Federal 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
pura R. h. hmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
T TERUMO
Section 4
Indications for Use
510(k) Number (if known): Unknown at time of submission ko92644
Device Name: Terumo Pressure Isolator
Indications for Use:
The pressure isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device may be used in procedures lasting up to 6 hours in duration.
Prescription Use XX (Part 21 CFR 801 Subpart D) OROver-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vihinen
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K092644