K Number
K072295
Device Name
CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
Date Cleared
2007-10-11

(56 days)

Product Code
Regulation Number
870.2700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 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.
More Information

Not Found

No
The device description mentions an "adaptive averaging algorithm" for calculating respiration rate, which is a signal processing technique, not explicitly AI or ML. There is no mention of AI, ML, or related terms like neural networks, deep learning, or training/test sets for model development.

No.
The device is a monitor that measures and continuously monitors physiological parameters like carbon dioxide concentration, respiration rate, oxygen saturation, and pulse rate. It does not provide any treatment or therapy.

Yes

The device continuously monitors physiological parameters like carbon dioxide concentration, respiration rate, and oxygen saturation, providing data for healthcare providers to assess patient conditions and make medical decisions.

No

The device description explicitly states it is a "bedside monitor" consisting of hardware modules (capnography and pulse oximetry) implemented in a "host device." While software is an integral part of these modules and the host, the device itself is a physical piece of medical equipment, not solely software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as providing "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." These are measurements taken directly from the patient's body (breath and blood oxygen/pulse), not from a sample of bodily fluid or tissue that is tested in vitro (outside the body).
  • Device Description: The description details a bedside monitor with modules for capnography and pulse oximetry. These are technologies that measure physiological parameters directly from the patient.
  • Classification: The device is classified under 21 CFR § 868.1400 (Carbon Dioxide Analyzer) and 21 CFR 870.2700 (Pulse Oximeter). These classifications are for devices that measure physiological parameters in vivo (within the body), not in vitro.

IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on specimens.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DQA, CCK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonatal, pediatric and adult

Intended User / Care Setting

professionally trained health care providers in hospital type facilities, intra hospital transport and home environments.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060065

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/1 description: The image shows the text "K072295 CONFIDENTIAL". The text is written in a bold, sans-serif font. The word "CONFIDENTIAL" is written in all capital letters and is located below the number. The image is likely a document or record that has been marked as confidential.

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: +972-2-589-9115

Fax: +972-2-586-6680

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

1

PREDIČATE DEVICE

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

ManufacturerDevice510(k)No.Clearance Date
Oridion 1987 Medical LtdCapnostream20K060065May 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

2

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

3

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.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

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.

5

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

6

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.