CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE

K072295 · Oridion Capnography, Inc. · DQA · Oct 11, 2007 · Cardiovascular

Device Facts

• Record ID: K072295
• Device Name: CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
• Applicant: Oridion Capnography, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospital type facilities, intra hospital transport and home environments.

Device Story

Capnostream20 is a bedside monitor integrating miniMediCO2 capnography and pulse oximetry modules. Device inputs include CO2 waveform data and pulse oximetry signals. The miniMediCO2 module utilizes an adaptive averaging (A2) algorithm (software version 2.31) to calculate respiration rate from CO2 waveforms; algorithm filters noise and fluctuations to reduce nuisance alarms while maintaining sensitivity to clinically significant changes. Host device displays parameters and triggers alarms when thresholds are crossed; host performs no modification to module-calculated values. Used by physicians, nurses, and trained healthcare providers in critical care, anesthesiology, intensive care, and neonatal units. Benefits include improved accuracy of respiration rate and reduced false-positive alarms, aiding clinical decision-making regarding patient respiratory status.

Clinical Evidence

Bench testing only. Software validation performed to confirm performance of the adaptive averaging algorithm and substantial equivalence to the predicate. Hazard analysis conducted to evaluate risks associated with the new algorithm.

Technological Characteristics

Two-parameter bedside monitor. Components: miniMediCO2 capnography module and pulse oximetry module. Standards: ISO 21647 (capnography), ISO 9919 (pulse oximetry), IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-8, UL 60601-1, ISO 14971. Non-sterile. Software-controlled modules provide parameters to host for display and alarm generation.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring continuous, non-invasive monitoring of CO2 concentration, respiration rate, functional arterial oxygen saturation (SpO2), and pulse rate in hospital, transport, or home settings.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Capnostream20 (K060065)

Submission Summary (Full Text)

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# 4. 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

OCT 1 1 2007

### (This document is not confidential)

#### DATE THIS SUMMARY WAS PREPARED

August 15, 2007

#### SUBMITTER'S NAME AND ESTABLISHMENT ADDRESS:

Oridion Capnography Inc. 160 Gould Street Needham, MA 02494

#### ESTABLISHMENT REGISTRATION NUMBER

3003941644

#### CONTACT PERSON:

Rachel Weissbrod, Director of Regulatory Affairs

Oridion Medical 1987 Ltd.

Har Hotzvim Science Park

POB 45025

91450 Jerusalem, Israel

Telephone: [phone]

Fax: [phone]

#### DEVICE INFORMATION

Trade Name: Capnostream20 with A2 software Common Name: Two Parameter Bedside Monitor Classification Name: Capnograph/Pulse Oximeter Regulation Number: 868.1400, Carbon Dioxide Analyzer (Classification CCK) 870.2700 Pulse Oximeter (Classification DQA) Device Listing Number: B051971

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#### PREDIČATE DEVICE

Capnostream20 with the new miniMediCO2 module adaptive averaging (A3) software is substantially equivalent to the following commercially available device:

| Manufacturer | Device | 510(k)No. | Clearance Date |
|--------------------------|---------------|-----------|----------------|
| Oridion 1987 Medical Ltd | Capnostream20 | K060065 | May 4th, 2006 |

#### DEVICE DESCRIPTION

The Capnostream20 bedside monitor is a two parameter monitor consisting of a miniMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer.

This device has two modules that are classified as follows:

- 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) .
- 21 CFR870.2700 Pulse Oximeter (Classification DQA) .

Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream20 device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The miniMediCO2 capnography module software presented in this submission includes an adaptive averaging algorithm defined as the A Algorithm for calculating the respiration rate from the CO2 waveform introduced in software version 2.31 of the miniMediCO2 capnography module software. The calculated respiration rate parameter is then provided to the host (the Capnostream20 device software). The host makes no modification to the values received from the module. The host triggers an alarm when the respiration rate high or respiration rate low thresholds have been crossed. The algorithm employed in the respiration rate calculation reduces false positive alarms by filtering out noise and instantaneous fluctuations without missing true alarms that may indicate a clinically significant change to respiration rate. By

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employing the adaptive averaging algorithm, the respiration rate accurately reflects the patient's condition and significantly reduces the generation of nuisance alarms by the host.

## INTENDED USE

The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospital type facilities, intra hospital transport and home environments.

### COMPARISON TO PREDICATE DEVICE

The Capnostream20 with adaptive averaging (A?) software (miniMediCO2 software version 2.31) is identical to the predicate Capnostream20 (miniMediCO2 software version 2.20) with the exception of the algorithm changes. No changes to the host (Capnostreamon) software were made to support the new module algorithms and no significant hardware changes have been made to the device.

The new device meets the safety and performance standards met by the predicate device.

Test data are provided to validate the performance of the software and its substantial equivalence to the predicate device. The functional features and the intended use of Capnostream20 with adaptive averaging software are substantially equivalent to the predicate device.

A hazard analysis was carried out on the module with the new algorithms. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system.

| Attribute | Capnostream20 Bedside<br>Monitor with MiniMediCO2<br>EtCO2 module with adaptive<br>averaging (A2) software<br>(version 2.31) | Predicate Device- Capnostream20 Bedside<br>Monitor K060065 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The indications for use are identical<br>to the indications for use in the<br>predicate device | The Capnostream20 combined capnograph/pulse<br>oximeter monitor is intended to provide<br>professionally trained health care providers the<br>continuous, non invasive measurement and |
| | | monitoring of carbon dioxide concentration of the<br>expired and inspired breath and respiration rate,<br>and for the continuous non-invasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2 and pulse rate). It is intended<br>for use with neonatal, pediatric and adult patients<br>in hospitals, hospital type facilities, intra hospital<br>transport and home environments. |
| Target<br>population | It is intended for use with neonatal,<br>pediatric, and adult patients. | It is intended for use with neonatal, pediatric, and<br>adult patients. |
| Design | Identical to MiniMediCO2 module in<br>K060065 with the exception of<br>software version change from 2.20<br>to 2.31 | See K060065 |
| Where Used | It is to be used by physicians,<br>nurses and other trained health<br>care providers in critical care<br>patient settings, such as<br>anesthesiology, intensive care<br>medicine, neonatal Intensive care<br>and other health care areas | It is to be used by physicians, nurses and other<br>trained health care providers in critical care<br>patient settings, such as anesthesiology,<br>intensive care medicine, neonatal Intensive care<br>and other health care areas |
| Performance<br>Standards | ISO21647<br>ISO 9919 | ISO21647<br>ISO 9919 |
| Safety<br>Standards | IEC/EN60601-1<br>IEC/EN60601-1-2(2001)<br>IEC60601-1-8<br>UL60601-1<br>ISO 14971 | IEC/EN60601-1<br>IEC/EN60601-1-2(2001)<br>IEC60601-1-8<br>UL60601-1<br>ISO 14971 |
| Biocompatibility | There are no issues of<br>biocompatibility for this device and<br>no biocompatibility testing was<br>done. | There are no issues of biocompatibility for this<br>device and no biocompatibility testing was done. |
| Sterility | This device does not require<br>sterilization and is shipped marked<br>non-sterile. | This device does not require sterilization and is<br>shipped marked non-sterile. |

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## CONCLUSION

Capnostream20 with adaptive averaging software does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed device. Therefore, the device is substantially equivalent to the predicate device with respect to safety effectiveness, and intended use.

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OCT 1 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oridion Capnography, Incorporated C/O Ms. Rachel Weissbrod Director of Regulatory Affairs Oridion Medical 1987 Limited Har Hotzvim Science Park Post Office Box 45025 91450 Jerusalem ISRAEL

Re: K072295

Trade/Device Name: Capnostream20 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, CCK Dated: September 16, 2007 Received: September 20, 2007

Dear Ms. Weissbrod:

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, 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 (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 - Ms. Weissbrod

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sinite y. Michu Dnia

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 3. Statement of Indications for Use

## TWO PARAMETER CAPNOSTREAM20 MONITOR WITH ADAPTIVE AVERAGING SOFTWARE

## (This document is not confidential)

## Indications for Use

August 15, 2007

# 510(k) Number (if known)」 | し フ 22 9 S

Device Name: Capnostream20

#### Indications For Use:

The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospital type facilities, intra hospital transport and home environments.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Snyte Y. Michael Davis

(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KO72295 510(k) Number:

Oridion Medical 1987 Ltd.