PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM

K972314 · Diametrics Medical, Ltd. · CCC · Dec 19, 1997 · Anesthesiology

Device Facts

• Record ID: K972314
• Device Name: PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
• Applicant: Diametrics Medical, Ltd.
• Product Code: CCC · Anesthesiology
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1150
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Neotrend Multiparameter Sensor provides continuous blood gas monitoring (pO2, pCO2, pH) and temperature; intended for critically ill patients. Input: intravascular blood samples via umbilical or femoral artery access. Principle: optical fibre/fluorescence quenching for pO2; photometric absorption for pCO2 and pH; thermocouple for temperature. Output: continuous data displayed on Paratrend 7 Senior or Satellite Monitor systems. Used in clinical settings by healthcare providers; allows simultaneous blood pressure monitoring via external transducer. Benefits: real-time blood gas data for management of critically ill patients. Device is a modification of Paratrend 7 sensor, replacing Clark electrode with optical technology.

Clinical Evidence

Bench testing only. Accuracy and precision evaluated using tonometers maintained at 37°C with precision gas mixtures. Measured values compared against calculated actual partial pressures. Bias and precision calculated over relevant gas ranges. Results demonstrated comparable performance between Senior and Satellite monitor systems.

Technological Characteristics

Materials: fibre optic sensors. Sensing: fluorescence quenching (pO2), photometric absorption (pCO2, pH), thermocouple (temp). Connectivity: integrates with Paratrend 7 Senior/Satellite monitors. Form factor: intravascular catheter. Software: analogue/digital processing.

Indications for Use

Indicated for critically ill patients of any age, particularly neonates, requiring continuous blood gas monitoring via intravascular access (umbilical or femoral artery). Limited to 72 hours of use in the US.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Paratrend 7 Intravascular Blood Gas Monitoring System
• Paratrend 7 Satellite Multiparameter Blood Gas Monitoring System
• Optex Blood Gas Monitoring System
• Neocath 1000 Umbilical Artery Oxygen Monitoring System

Submission Summary (Full Text)

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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 [phone] Tel: [phone] Fax: Date of Summary : 13 June 1997

#### Device Name (1)

| Proprietary | : Paratrend 7 Neotrend Multiparameter Sensor, with Paratrend 7<br>Multiparameter 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, Blood<br>Phase, 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

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.

#### Intended Use

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.

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# Technological Characteristics

## Measurement Technology

i

| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 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 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

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| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | ____________________ |

| Prescription Use <div style="display: inline-block; vertical-align: middle;"> <img alt="Tick" src="tick.png" style="height: 1em; margin-bottom: 0.2em;"/></div><br>(Per 21 CFR 801 109) | OR | Over-The-Counter Use ________ |
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