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.

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 The telescopic introduction mechanism in the predicate Paratrend 7 sensor has been replaced by a rotary advancing mechanism.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.

AI/ML Overview

This document describes the Paratrend 7 Plus Multiparameter Sensor, a modified version of the Paratrend 7 sensor, intended for continuous blood gas monitoring in critically ill patients.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance thresholds for bias, precision, or correlation coefficients. Instead, it presents the approach taken to demonstrate "product accuracy claims" and "comparable results" to a predicate device.

The study aimed to show substantial equivalence to the predicate device, Paratrend 7, and its own previously cleared versions, as well as to Optex and Baxter Swan-Ganz systems.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Bias	Demonstrate comparable bias to predicate device and "actual" values.	Calculated (mean of differences between measured Paratrend 7 value and actual value). No specific values provided. Implied to be acceptable as "product accuracy claims" are satisfied.
Precision	Demonstrate comparable precision to predicate device.	Calculated (sample standard deviation of differences). No specific values provided. Implied to be acceptable as "product accuracy claims" are satisfied.
Correlation (Senior vs. Satellite systems)	Strong linear correlation between Senior and Satellite monitor readings.	"Good correlation" evident from linear regression analysis (correlation coefficients, line-intercept, line-gradient were recorded but not provided).
Statistical Difference (Senior vs. Satellite systems)	No significant difference at the 5% level.	"No significant difference at the 5% level" using a paired sample t-test.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size (number of measurements) used in the tonometer study. It mentions data collected "over the relevant range of gases."
Data Provenance: The study was conducted by Diametrics Medical Limited, a UK-based company. The data appears to be prospective as it involves setting up tonometers and taking measurements with the device under review.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth in this study was established using precision gas mixtures and the Henderson-Hasselbalch equation to determine "actual" partial pressures and pH values in tonometers. This approach does not involve human experts establishing ground truth; it relies on established chemical and physical principles.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by physical and chemical methods (tonometers with precision gas mixtures and calculation). There was no human interpretation or adjudication involved in determining the "actual" values.

5. 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 device is an intravascular blood gas monitoring system, not an imaging or diagnostic device that involves human reader interpretation or AI assistance in that context. The study focuses on device performance against a controlled "actual" value.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary study described is a standalone performance evaluation of the device. The device's measurements (algorithm/sensor output) were compared to a known ground truth (tonometer values). Human "in-the-loop" performance in terms of interpretation or decision-making was not evaluated in this accuracy study, though the device's output is intended for use by clinicians.

7. The Type of Ground Truth Used

The ground truth used was physico-chemical ground truth, established by:

Pre-equilibrated precision gas mixtures for "actual" partial pressures.
Calculation using the Henderson-Hasselbalch equation for "actual" pH values.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance evaluation of a medical device (sensor and monitor systems), not a machine learning or AI algorithm that typically requires a large training set. The device's measurement technology (fibre optic, fluorescence quenching, photometric absorption, thermocouple) is based on established physical and chemical principles, not on learned patterns from a training dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a "training set" in the context of this device's development or evaluation.

Summary

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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 MonitorSystem 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, BloodPhase, Indwelling
Classifiction No	:	73CCC

Short Street Wycombe High Bucks. HP11 2QH Ellin age local and d
Tel: 44 (0) 1494 471671

391

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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

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

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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.

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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.

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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

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Page 1 of 1

510(k) Number (if known): K970906

Device Name: Paratrend 7+ Intravascular Blood Gas Monitoring System

Indications For Use:

Completion of Monitoring and Sensor Withdrawal

Within the United States market, the use of this device should be limited to 72 hours.

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Prescription Use - J ----

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 .

Regulation Number and Section

§ 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.”