(195 days)
Not Found
No
The summary describes a sensor technology change and mechanical modification, with no mention of AI/ML in the device description, performance studies, or training/test set descriptions.
No.
The device is for monitoring blood gas data and blood pressure, which are diagnostic/monitoring functions rather than direct therapeutic interventions.
Yes
Explanation: The device provides "continuous blood gas data" and measures parameters like pO2, pH, and pCO2. These measurements are used to assess the patient's physiological state, which is a key function of a diagnostic device in managing critically ill patients.
No
The device description clearly states it is a "Sensor" that is "inserted via an intravascular access device into the vascular system". This indicates a physical hardware component that is placed within the body, not a software-only device.
Based on the provided text, the Paratrend 7+ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to be used in the management of critically ill patients by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure. The sensor is inserted intravascularly into the vascular system.
- Device Description: The sensor is inserted via an intravascular access device into the vascular system.
- Anatomical Site: The device is used within the vascular system (e.g., radial, femoral arteries).
IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or treatment. The Paratrend 7+ System, however, is used within the patient's vascular system for continuous, real-time monitoring of blood gases and blood pressure. This is an in vivo application, not an in vitro one.
N/A
Intended Use / Indications for Use
The Paratrend 7 Plus Multiparameter Sensor is intended to be inserted via an intravascular access device into the vascular system (e.g. radial, femoral arteries). It is intended to be used in the management of the critically ill patient by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer.
The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.
The Paratrend 7+ System is intended to be used in the management of the critically ill patient by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Paratrend 7+ Multiparameter Sensor is inserted via an intravascular access device into the vascular system (e.g. radial, femoral arteries).
Within the United States market, the use of this device should be limited to 72 hours.
Product codes
73CCC, 73CCE
Device Description
The Paratrend 7 Plus Sensor (MPS7004P) is a modified version of the currently legally marketed device, the Paratrend 7 sensor (MPS7004). The measurement of pO2 using an electrochemical sensor (Clark electrode) in the predicate Paratrend 7 sensor has been replaced in the Paratrend 7 Plus device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The telescopic introduction mechanism in the predicate Paratrend 7 sensor has been replaced by a rotary advancing mechanism. The application has been expanded to include venous access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system (e.g. radial, femoral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
critically ill patient
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 device under review was manufactured under standard process conditions and calibrated on the Senior Monitor.
The tonometers were maintained at 37°C and were pre-equilibrated with precision gas mixtures thereby allowing the calculation of "actual" partial pressures. The Henderson-Hasselbalch equation is used to determine the "actual" pH values in the different tonometers.
The measured (displayed) values were recorded after a 20 minute equilibration time. The PDMs were then transferred to Satellite monitors and the measured readings recorded. The PDMs were then returned to the Senior monitor prior to transferring the sensor to the next equilibrated tonometer.
The data were analysed by calculating the bias (the mean of the differences between the measured Paratrend 7 value and that the actual value of the equilibrated solution) and the precision (sample standard deviation of the differences). The data were collected over the relevant range of gases, as shown in the following table.
The differences obtained on both Senior and Satellite systems were compared.
A linear regression was then performed of the measured Senior readings vs. the measured Satellite readings. The correlation coefficient, line-intercept and line-gradient were recorded.
Conclusion: The data presented above satisfies product accuracy claims and shows comparable results for both Senior and Satellite. The similarity of the two data sets can be assessed from an analysis of the difference of the Senior and Satellite differences. A paired sample t-test has been applied to the Senior and Satellite readings. The two data sets showed no significant difference at the 5% level. A linear regression analysis of the Senior data vs the Satellite data for pO3, pH and pCO2 readings provides further evidence of good correlation between Senior and Satellite readings.
Key Metrics
bias, precision (sample standard deviation of the differences), correlation coefficient, line-intercept, line-gradient, paired sample t-test, significant difference at the 5% level
Predicate Device(s)
Paratrend 7 Intravascular Blood Gas Monitoring System, Paratrend 7 Satellite Multi Parameter Blood Gas Monitoring System, Optex Blood Gas Monitoring System, Baxter Swan-Ganz Continuous Cardiac Output Oximetry
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
Image /page/0/Picture/0 description: The image shows a logo for "DIAMETRICS MEDICAL LIMITED". The logo consists of a graphic element above the text. The graphic element is composed of four vertical bars of varying heights, with a curved shape to the right of the bars. The text is arranged in three lines, with "DIAMETRICS" on the first line, "MEDICAL" on the second line, and "LIMITED" on the third line.
970906
Section 12 : 510(k) Summary
SEP 2 3 1997
This section satisfies the 510(k) summary as required by 21 CFR 807-92 (C).
Submitter
Miss Jan L Walters Diametrics Medical Limited Short Street High Wycombe Bucks HP11 2QH UK +44 1494 471671 Tel: +44 1494 474890 Fax: Date of Summary : 10 March 1997
Device Name
| Proprietary | : Paratrend 7 Multiparameter Senior and Satellite Monitor
System with Paratrend 7 Plus Multiparameter Sensor |
|-------------|-----------------------------------------------------------------------------------------------------------------|
| Common | : Multiparameter Catheter |
Device Classification
| Panel | : | Anaesthesiology Devices Panel |
|---|---|---|
| Classification | : | Class III |
| FDA CFR | : | 868-1150 |
| Description | : | Analyser Gas, Carbon Dioxide, Partial Pressure, Blood |
| Phase, Indwelling | ||
| Classifiction No | : | 73CCC |
Short Street Wycombe High Bucks. HP11 2QH Ellin age local and d
Tel: 44 (0) 1494 471671
391
1
Statement of Substantial Equivalence
Diametrics Medical Ltd claims substantial equivalence to products which have received FDA clearance by the Premarket Notification process.
The Paratrend 7 Multiparameter Senior and Satellite Monitor Systems with Paratrend 7 Plus Multiparameter Sensor is a modification of the Paratrend 7 Intravascular Blood Gas Monitoring System and Paratrend 7 Satellite Multi Parameter Blood Gas Monitoring System. Furthermore, it is also judged to be substantially equivalent to the Optex Blood Gas Monitoring System and the Baxter Swan-Ganz Continuous Cardiac Output Oximetry.
Device Description
The Paratrend 7 Plus Sensor (MPS7004P) is a modified version of the currently legally marketed device, the Paratrend 7 sensor (MPS7004). The measurement of pO2 using an electrochemical sensor (Clark electrode) in the predicate Paratrend 7 sensor has been replaced in the Paratrend 7 Plus device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The telescopic introduction mechanism in the predicate Paratrend 7 sensor has been replaced by a rotary advancing mechanism. The application has been expanded to include venous access.
Intended Use
The Paratrend 7 Plus Multiparameter Sensor is intended to be inserted via an intravascular access device into the vascular system (e.g. radial, femoral arteries). It is intended to be used in the management of the critically ill patient by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer.
The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.
Technological Characteristics
Measurement Technology
| pO2 : | fibre optic, fluorescence quenching |
|---|---|
| Temp : | thermocouple |
| pCO2 : | fibre optic, photometric absorption |
| pH : | fibre optic photometric absorption |
Monitor Technology
Analogue/digital
2
Comparison of Accuracy to the Predicate Paratrend 7 Device
The device under review was manufactured under standard process conditions and calibrated on the Senior Monitor.
The tonometers were maintained at 37°C and were pre-equilibrated with precision gas mixtures thereby allowing the calculation of "actual" partial pressures. The Henderson-Hasselbalch equation is used to determine the "actual" pH values in the different tonometers.
The measured (displayed) values were recorded after a 20 minute equilibration time. The PDMs were then transferred to Satellite monitors and the measured readings recorded. The PDMs were then returned to the Senior monitor prior to transferring the sensor to the next equilibrated tonometer.
The data were analysed by calculating the bias (the mean of the differences between the measured Paratrend 7 value and that the actual value of the equilibrated solution) and the precision (sample standard deviation of the differences). The data were collected over the relevant range of gases, as shown in the following table.
The differences obtained on both Senior and Satellite systems were compared.
A linear regression was then performed of the measured Senior readings vs. the measured Satellite readings. The correlation coefficient, line-intercept and line-gradient were recorded.
Conclusion
The data presented above satisfies product accuracy claims and shows comparable results for both Senior and Satellite.
The similarity of the two data sets can be assessed from an analysis of the difference of the Senior and Satellite differences.
A paired sample t-test has been applied to the Senior and Satellite readings. The two data sets showed no significant difference at the 5% level.
A linear regression analysis of the Senior data vs the Satellite data for pO3, pH and pCO2 readings provides further evidence of good correlation between Senior and Satellite readings.
The device under review is considered substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1997
Ms.. Jan L. Walters Diametrics Medical Limited Short Street High Wycombe Bucks. HP11 2QH ENGLAND
K970906 Re: Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor Requlatory Class: III (three) Product Code: 73 CCE Dated: June 24, 1997 Received: June 26, 1997
Dear Ms. Walters:
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 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). 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.
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 regulations affecting your device can be found in the Code of Federal Regulations, 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 requlation (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 regulatory 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 obligation 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 regulations.
4
Page 2 - Ms. Jan L. Walters
This letter will allow you to beqin 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 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Collehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): K970906
Device Name: Paratrend 7+ Intravascular Blood Gas Monitoring System
Indications For Use:
The Paratrend 7+ System is intended to be used in the management of the critically ill patient by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Paratrend 7+ Multiparameter Sensor is inserted via an intravascular access device into the vascular system (e.g. radial, femoral arteries).
Completion of Monitoring and Sensor Withdrawal
Within the United States market, the use of this device should be limited to 72 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
·············································································································································································· Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use - J ----
OR
Over-The-Counter Use ..........
(Optional Format 1-2-96)
Atl. A. Carlouski.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number .