(87 days)
Not Found
No
The description details a microprocessor-based system using electrochemical technology and a conversion algorithm to process sensor data into pH units for display. There is no mention of AI, ML, or related concepts.
No.
The device is intended for monitoring physiological parameters (pH and temperature) to detect ischemia, not for treating any condition.
Yes
The device is intended for "monitoring local tissue pH and temperature... during cardiac operations," which are parameters used to assess ischemia. Monitoring these physiological parameters to gain insights into a patient's condition falls under the definition of a diagnostic device.
No
The device description explicitly details hardware components including a monitor, sensor (electrodes and thermistor), and interface module, in addition to the software.
Based on the provided text, the Terumo Khuri™ Myocardial pH Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The system is intended for "monitoring local tissue pH and temperature... such as the myocardium, during cardiac operations." This involves direct measurement within living tissue (in vivo).
- Device Description: The description details a sensor with electrodes designed for "insertion into tissue" and a reference electrode for "insertion into the tissue." This confirms the in vivo nature of the measurement.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens, including blood, tissue, and urine, taken from the human body to provide information for diagnosis, monitoring, or screening. The key here is that the testing is done outside the living body (in vitro).
Since the Khuri MpH system directly measures parameters within the living myocardium, it falls under the category of an in vivo diagnostic or monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Terumo Khuri™ Myocardial pH Monitoring System is intended for use in monitoring local tissue pH and temperature, typically during procedures in which specific tissues may be subjected to conditions which may result in ischemia, such as the myocardium, during cardiac operations. These parameters are displayed at 37°C corrected value. For documentation purposes, the integral printer provides a hard copy of displayed parameter.
Product codes
CBZ
Device Description
The Terumo Khuri™ Myocardial pH Monitoring System (Khuri MpH system) is an AC-powered (battery support for memory retention), microprocessor-based device consisting of a monitor, sensor and interface module'. The myocardial pH sensor will consist of two pH measurement probe electrodes and a reference electrode for the purpose of monitoring continuous myocardial tissue pH and temperature during cardiac surgery. The system uses electrochemical technology to measure the hydrogen ion content of the myocardial tissue, and report that information via electrical cable back to the monitor, where a processing unit coverts the electrical signal into pH units for display on the monitor. The Khuri MpH system Monitor consists of a single board computer and a dedicated circuit that contains digital circuitry to interface with the interface module that connects to the sensor (pH electrodes and reference probe). The system will have an LCD flat touch screen display that will control the mode and operation of the monitor. The monitor will have a printer that will enable the user to print out case results. The monitor will be able to be mounted on a vertical pole or rest on a flat surface. Each Khuri MpH system Sensor consists of two pH electrodes and one reference electrode. The pH electrodes are designed with a pointed tip for insertion into tissue with minimal resistance. The pH electrode consists of a closed end glass tube made from pH sensitive glass. The tube is filled with a phosphate based internal buffering solution in which a silver wire coated with silver chloride is inserted. The wire is attached to a cable, which is encased in an electrically shielded sheath and attaches to the monitor. The analog voltage signal from the sensor is fed into an interface module that amplifies and conditions the analog signal to remove any interfering noise. The analog signal is then converted into digital information in the A to D converter. This digital signal is then fed from the interface module to the monitor where a conversion algorithm, in the monitor, is used to convert digital information into pH units. The values are then displayed on the monitor screen.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
myocardium
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
The performance characteristics of the Khuri MpH system were exhaustively tested and compared with the performance characteristics of the predicate device. All new and existing performance characteristics of the Khuri MpH system have been validated. The Khuri MpH system performs as intended according to its performance specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
(a)
Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
0
K020967
PG 1 OF 3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is
Terumo Cardiovascular Systems Corporation Submitter's Name: Submitter's Address: 1311 Valencia Avenue, Tustin CA 92780 Contact Person: Steve Arick Phone Number: (734) 741-6238 FAX Number: (734) 663-5062 March 15, 2002 Summary Date:
Device Trade Name: Terumo Khuri™ Myocardial pH Monitoring System
Device Classification Name: Device Classification Name:
Predicate Devices: K862114 Khuri Regional Tissue pH Monitor
Device Description:
Image /page/0/Picture/9 description: The image shows two electronic devices on a wooden surface. The device on the left has a screen and a white rectangular component connected by a cable. The device on the right has a more complex structure with visible internal components and a coiled cable. Both devices appear to be related, possibly part of the same system, and are positioned against a neutral background.
Terumo Khuri™ Myocardial pH Monitoring System
The Terumo Khuri™ Myocardial pH Monitoring System (Khuri MpH system) is an AC-powered (battery support for memory retention), microprocessor-based device consisting of a monitor, sensor and interface module'. The myocardial pH sensor will consist of two pH measurement probe electrodes and a reference electrode for the purpose of monitoring continuous myocardial tissue pH and temperature during cardiac surgery. The system uses electrochemical technology to measure the hydrogen ion content of the myocardial tissue, and report that information via electrical cable back to the monitor, where a processing unit coverts the electrical signal into pH units for display on the monitor.
1
The glass pH electrode is the most common method used to obtain accurate pH measurements. Due to the nature of the glass used in the electrode, an electric potential is developed across the glass. This potential is proportional to the difference in pH between an analyte solution in contact with the exterior surface of the glass and the phosphate based internal buffering solution.
The Khuri MpH system Monitor consists of a single board computer and a dedicated circuit that contains digital circuitry to interface with the interface module that connects to the sensor (pH electrodes and reference probe). The system will have an LCD flat touch screen display that will control the mode and operation of the monitor. The monitor will have a printer that will enable the user to print out case results. The monitor will be able to be mounted on a vertical pole or rest on a flat surface.
Each Khuri MpH system Sensor consists of two pH electrodes and one reference electrode. The pH electrodes are designed with a pointed tip for insertion into tissue with minimal resistance. The pH electrode consists of a closed end glass tube made from pH sensitive glass. The tube is filled with a phosphate based internal buffering solution in which a silver wire coated with silver chloride is inserted. The wire is attached to a cable, which is encased in an electrically shielded sheath and attaches to the monitor. The tip of the glass is pointed to allow easy insertion in to the myocardial tissue during use. The thermistor is a metal oxide ceramic tip. which is imbedded in the plastic surrounding the rear of the glass tube.
A reference electrode is used to complete the circuit. The reference electrode consists of an Ag/AgCl wire inserted into a plastic tube of KCI electrolyte solution. The front end of the tube is tapered to a small diameter to facilitate insertion into the tissue (usually near the sternum) during use. It is plugged with a semi-permeable material that prevents bulk leakage of fluid but maintains electrical contact with the patient during pH measurement. The wire protrudes from the sealed back end of the tube and is attached to a cable, which connects to the monitor.
The analog voltage signal from the sensor is fed into an interface module that amplifies and conditions the analog signal to remove any interfering noise. The analog signal is then converted into digital information in the A to D converter. This digital signal is then fed from the interface module to the monitor where a conversion algorithm, in the monitor, is used to convert digital information into pH units. The values are then displayed on the monitor screen.
Indications for Use:
The Khuri MpH system is intended for use in monitoring local tissue pH and temperature, typically during procedures in which specific tissues may be subjected to conditions which may result in ischemia, such as the myocardium, during cardiac operations. These parameters are displayed at 37°C corrected value. For documentation purposes, the integral printer provides a hard copy of displayed parameter.
2
Technological Characteristics:
The Khuri MpH system is identical to the technology found in the Khuri Regional Tissue pH Monitor. The Khuri MpH system is identical to its predicate device except in the following ways:
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Placement of the thermistor for temperature measurement is now integrated in the pH measuring electrode. With the Khuri Regional Tissue pH monitor the temperature measurement was located in three separate 22-guage needle precision thermister temperature probes.
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The Khuri MpH system Probe is intended for single-use only. The Khuri Regional Tissue pH monitor electrodes were designated to be reusable.
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Line power: The Khuri MpH system runs off of AC line power. The Khuri Regional Tissue pH monitor was battery powered. The Khuri MoH system conforms to IEC 601-1 series.
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The Khuri MpH system Sensor will be Gamma Radiation sterilized, where as the Khuri Regional Tissue pH Probes were Ethylene Oxide sterilized. However, both were sterilized according to the sterility assurance level of 10° therefore, there is no impact on safety and effectiveness.
Nonclinical Performance:
The performance characteristics of the Khuri MpH system were exhaustively tested and compared with the performance characteristics of the predicate device. All new and existing performance characteristics of the Khuri MpH system have been validated.
Conclusions from Nonclinical Tests:
The Khuri MpH system performs as intended according to its performance specifications. The Khuri MpH system is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA," arranged in a circular pattern around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2002
Terumo Cardiovascular Systems Corporation c/o Mr. Steve Arick Regulatory Affairs Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K020967
Trade Name: Terumo Khuri™ Myocardial pH Monitoring System Regulation Number: 21 CFR 868.1170 Regulation Name: Analyzer, Ion Hydrogen-Ion, (pH) Blood, Phase Indwelling Regulatory Class: Class II (two) Product Code: CBZ Dated: March 15, 2002 Received: March 25, 2002
Dear Mr. Arick:
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. Iisting 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 such 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.
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Page 2 - Mr. Steve Arick
Please be advised that FDA's issuance of a substantial equivalence determination does not niean that FDA has made a determination that your device complies with other requirements of the Act 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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Dala Tell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2.4 ODE Form, Indications for Use Statement
Page 1 _of 1
510(k) Number (if known): KOXO967
Device Name: Terumo Khuri™ Myocardial pH Monitoring System
Indications for Use:
The Terumo Khuri™ Myocardial pH Monitoring System is intended for use in monitoring local tissue pH and temperature, typically during procedures in which specific tissues may be subjected to conditions which may result in ischemia, such as the myocardium, during cardiac operations. These parameters are displayed at 37°C corrected value. For documentation purposes, the integral printer provides a hard copy of displayed parameter.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020967