(56 days)
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.
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.
The provided text describes a 510(k) summary for the Capnostream20 with A2 (adaptive averaging) software for its miniMediCO2 module. This submission is for an updated software version (2.31) that introduces an adaptive averaging algorithm for calculating respiration rate, aiming to reduce false positive alarms while maintaining accuracy.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for the A2 software's performance in terms of specific sensitivity, specificity, accuracy, or alarm reduction metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The "reported device performance" related to the new software is described functionally: "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."
While the device meets the safety and performance standards of the predicate device, it doesn't quantify the improvement of the A2 software against specific targets. The performance metrics are implicitly "reduces false positive alarms" and "accurately reflects the patient's condition."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Test data are provided to validate the performance of the software and its substantial equivalence to the predicate device." However, specific details regarding the sample size used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) are NOT provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is NOT provided in the document. The text does not describe how ground truth was established for evaluating the performance of the new algorithm.
4. Adjudication Method for the Test Set
This information is NOT provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done an what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is NOT mentioned in the document. The new algorithm is for an automated respiration rate calculation, not an AI-assisted human reading task.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study described is a standalone (algorithm only) performance evaluation. The focus is on the "adaptive averaging algorithm" (A2 software) for calculating respiration rate, which operates autonomously within the miniMediCO2 module. The output (respiration rate) is then provided to the host device. The document states: "The host makes no modification to the values received from the module." This confirms it's an algorithm-only evaluation.
7. The Type of Ground Truth Used
The type of ground truth used is NOT explicitly stated. Given that the algorithm calculates respiration rate from the CO2 waveform, it is most probable that the ground truth would involve:
- Manual, expert review and calculation of respiration rate from raw CO2 waveforms or
- Comparison to another highly accurate, validated respiration rate measurement method.
8. The Sample Size for the Training Set
The document does NOT provide any information about a training set or its sample size. This is a software update described as an "adaptive averaging algorithm," but details on its development or any training data are not included in this 510(k) summary.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned, information on how its ground truth was established is NOT provided.
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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
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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 BedsideMonitor with MiniMediCO2EtCO2 module with adaptiveaveraging (A2) software(version 2.31) | Predicate Device- Capnostream20 BedsideMonitor K060065 |
|---|---|---|
| Indications foruse | The indications for use are identicalto the indications for use in thepredicate device | The Capnostream20 combined capnograph/pulseoximeter monitor is intended to provideprofessionally trained health care providers thecontinuous, non invasive measurement and |
| monitoring of carbon dioxide concentration of theexpired and inspired breath and respiration rate,and for the continuous non-invasive monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2 and pulse rate). It is intendedfor use with neonatal, pediatric and adult patientsin hospitals, hospital type facilities, intra hospitaltransport and home environments. | ||
| Targetpopulation | It is intended for use with neonatal,pediatric, and adult patients. | It is intended for use with neonatal, pediatric, andadult patients. |
| Design | Identical to MiniMediCO2 module inK060065 with the exception ofsoftware version change from 2.20to 2.31 | See K060065 |
| Where Used | It is to be used by physicians,nurses and other trained healthcare providers in critical carepatient settings, such asanesthesiology, intensive caremedicine, neonatal Intensive careand other health care areas | It is to be used by physicians, nurses and othertrained health care providers in critical carepatient settings, such as anesthesiology,intensive care medicine, neonatal Intensive careand other health care areas |
| PerformanceStandards | ISO21647ISO 9919 | ISO21647ISO 9919 |
| SafetyStandards | IEC/EN60601-1IEC/EN60601-1-2(2001)IEC60601-1-8UL60601-1ISO 14971 | IEC/EN60601-1IEC/EN60601-1-2(2001)IEC60601-1-8UL60601-1ISO 14971 |
| Biocompatibility | There are no issues ofbiocompatibility for this device andno biocompatibility testing wasdone. | There are no issues of biocompatibility for thisdevice and no biocompatibility testing was done. |
| Sterility | This device does not requiresterilization and is shipped markednon-sterile. | This device does not require sterilization and isshipped 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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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.
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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 (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
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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.
§ 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).