The Neotrend Multiparameter Sensor is inserted via an intravascular access device into the vascular system, e.g. umbilical artery (neonates), femoral artery (paediatrics, adults). It is intended to be used in the management of critically ill patients of any age, but especially neonates, by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer.

The Neotrend sensor is designed for use in conjunction only with the custom umbilical artery catheter supplied when the umbilical artery is to be the access site.

The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.

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

Device Description

The Neotrend Sensor (N7004S) 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 Neotrend device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The application has been expanded to include umbilical artery access.

AI/ML Overview

The provided text describes the Neotrend Multiparameter Sensor, a modified version of the Paratrend 7 sensor. It details the device's technical characteristics, intended use, and claims substantial equivalence to previously cleared devices. However, the document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, it presents a comparison of the Neotrend sensor's accuracy to its predicate device, the Paratrend 7. This comparison focuses on bias and precision for pO₂, pCO₂, and pH measurements. The study methodology is outlined, but specific acceptance criteria (e.g., maximum allowable bias or standard deviation) are not provided. Therefore, it's impossible to report whether the device "meets" acceptance criteria based on this document.

Here's a breakdown of the information that is available and the parts that are missing based on your request:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: NOT PROVIDED. The document states "The data presented above satisfies product accuracy claims and shows comparable results for both Senior and Satellite," but it does not specify what those "product accuracy claims" are in terms of concrete numerical acceptance criteria (e.g., ΔpO₂ < X mmHg, pH bias < Y, etc.).
Reported Device Performance: The study measures bias (mean of the differences between measured and actual values) and precision (sample standard deviation of the differences) for pO₂, pCO₂, and pH. However, the actual numerical values for bias and precision are NOT PROVIDED in the summary. It only states that "The differences obtained on both Senior and Satellite systems are comparable."

2. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: NOT SPECIFIED. The document mentions "The data were collected over the relevant range of gases" and "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." This implies a series of measurements, but the exact number of samples or sensors tested is not given.
Data Provenance: Not explicitly stated as "country of origin," but the submitter is "Diametrics Medical Limited Short Street High Wycombe Bucks HP11 2QH UK." The study setup using tonometers suggests controlled laboratory conditions rather than patient data. It is a prospective study in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable/Not provided. The ground truth in this study was established using precision gas mixtures and the Henderson-Hasselbalch equation for pH, not by human experts.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. Ground truth was established by physicochemical methods (precision gas mixtures, Henderson-Hasselbalch equation), not through human adjudication of differing readings.

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:

MRMC Study: No, this was not an MRMC study. This device is a sensor, not an AI-assisted diagnostic tool interpreted by human readers. The study focuses on sensor accuracy compared to a predicate device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Study: The described accuracy comparison is effectively a standalone performance evaluation of the sensor system. It assesses the device's ability to measure blood gas parameters against known "actual" values (derived from precision gas mixtures and calculation). No human intervention (other than operating the equipment) in the measurement process itself is described.

7. The type of ground truth used:

Ground Truth: For pO₂ and pCO₂, the ground truth was "actual" partial pressures calculated from precision gas mixtures used to equilibrate tonometers. For pH, the ground truth was "actual" pH values determined using the Henderson-Hasselbalch equation from the different tonometers. This is a physicochemical reference standard.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/Not provided. This document describes a performance evaluation of a sensor and monitor system, not a machine learning or AI algorithm that would require a separate training set.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable as there is no mention of a training set for an AI algorithm.

Summary

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Section 12 : 510(k) Summary

This section satisfies the 510(k) summary as required by 21 CFR 807-92 (C).

DEC 1 9 1997

17-172314

Submitter

Miss Karima Hebri Diametrics Medical Limited Short Street High Wycombe Bucks HP11 2QH UK +44 1494 471671 Tel: +44 1494 474890 Fax: Date of Summary : 13 June 1997

Device Name (1)

Proprietary	: Paratrend 7 Neotrend Multiparameter Sensor, with Paratrend 7Multiparameter Senior & Satellite Monitor System
Common	: Multiparameter Catheter

Device Classification (1)

Panel	: Anaesthesiology Devices Panel
Classification	: Class III
FDA CFR	: 868-1150
Description	: Analyser Gas, Carbon Dioxide, Partial Pressure, BloodPhase, Indwelling
Classification No.	: 73CCC

Device Name (2)

ﺮ ﺍﻟﻤﺴﺮ

Proprietary	: Umbilical Artery Catheter
Common	: Catheter, Umbilical Artery

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Device Classification (2)

Panel	: General Hospital and Personal Use Devices Panel
Classification	: Class II
FDA CFR	: 880-5200
Description	: Catheter, Umbilical Artery
Classification No.	: 80FOS

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 Neotrend Multiparameter Sensor is a modification of the Paratrend 7 Intravascular Blood Gas Monitoring System and Paratrend 7 Satellite Multiparameter Blood Gas Monitoring System. Furthermore, it is also judged to be substantially equivalent to the Optex Blood Gas Monitoring System and the Neocath 1000 Umbilical Artery Oxygen Monitoring System.

Device Description

Intended Use

The Neotrend sensor is designed for use in conjunction only with the custom umbilical artery catheter supplied when the umbilical artery is to be the access site.

The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.

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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℃ 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 15 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.

The differences obtained on both Senior and Satellite systems are comparable.

Conclusion

The data presented above satisfies product accuracy claims and shows comparable results for both Senior and Satellite.

The device under review is considered substantially equivalent.

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is an emblem that resembles an eagle or a bird with outstretched wings, stylized in a flowing, abstract manner.

Rockville MD 20857

DEC 19 1997

Ms. Jan Walters Diametrics Medical Limited Short Street High Wvcombe Bucks. HP11 2QH ENGLAND

Re: K972314 Paratrend 7 Multiparameter Senior and Satellite Monitor System ---with Neotrend Multiparameter Sensor Regulatory Class: III (three) 73 CCC Product Code: Dated: September 22, 1997 September 23, 1997 Received:

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, Druq, 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 Walters

This letter will allow you to begin 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 requlation (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 regulation 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. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 __

510(k) Number (if known): K972314

Device Name: Neotrend Mulitiparameter Sensor

Indications For Use:

The Neotrend sensor is designed for use in conjunction only with the custom umbilicat ======================================================================================== artery catheter supplied when the umbilical artery is to be the access site.

The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.

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)

jo AWeterstone

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	____________________

Prescription Use (Per 21 CFR 801 109)	OR	Over-The-Counter Use ________
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(Optional Format 1-2-96)

Regulation Number and Section

§ 868.1150 Indwelling blood carbon dioxide partial pressure (P

2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(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.”