The Capnostream™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up . The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

Device Description

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 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 microMediCO2 module provides the following inputs to the host monitor: EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2, Pulse Rate, Respiratory Rate, and saturation pattern detection (SPD) parameters to the host for display. The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

AI/ML Overview

This document is a 510(k) summary for the Capnostream™ 35 Portable Respiratory Monitor. It details the device's indications for use, technological characteristics, and performance data from non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, precision, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through validation of software functions, usability testing, and wireless connectivity.

Software Validation: "to ensure that all modified software functions as intended."
- Reported Performance: Passed. Implicitly, the software performed as expected and intended.
Cybersecurity Documentation: "identified cybersecurity risks and summarized how they were mitigated."
- Reported Performance: Cybersecurity risks were identified and mitigated.
Usability Testing (per IEC 60601-1-6): "assessed the ability of 15 intended users with varying levels of experience to perform key tasks as well as understand Capnostream™35′s display."
- Reported Performance: Passed.
Wireless Connectivity Testing: "The wireless communication testing passed for all wireless key types compatible with the device."
- Reported Performance: Passed.

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

Usability Testing:
- Sample Size: 15 intended users.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. It's implied to be prospective testing specific to this device.
Other tests (Software, Cybersecurity, Wireless Connectivity): Sample sizes for data points are not specified, as these are typically functional or engineering tests rather than studies on a "test set" of patients or data records.

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

This information is not provided in the document. The listed tests (software validation, usability, wireless connectivity) do not typically involve establishing a clinical "ground truth" derived from expert consensus in the same way a diagnostic algorithm might. Usability testing relies on user feedback, and software/connectivity validation relies on engineering specifications.

4. Adjudication method for the test set

This information is not provided as it's not applicable to the types of tests described. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving expert interpretation, which is not what was performed for these non-clinical tests.

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

There is no indication that an MRMC comparative effectiveness study was done. The device description and performance data focus on device functionality and its equivalence to predicates, not on AI assistance to human readers or effect sizes of such assistance. The device is a monitor, not an AI diagnostic tool.

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

The performance data listed (software validation, usability, wireless connectivity) are for the device as a standalone product in terms of its functions. There is no mention of an "algorithm only" performance study separate from the device's integrated operation. The device itself performs continuous non-invasive monitoring and provides specific parameters and alerts.

7. The type of ground truth used

Software Validation: The "ground truth" is adherence to predefined software requirements and specifications.
Usability Testing: The "ground truth" is the successful and easy completion of key tasks by users and their understanding of the display, measured against usability objectives.
Wireless Connectivity Testing: The "ground truth" is successful connection and data transmission/reception according to wireless communication standards and protocols.

These are functional and engineering "ground truths," not clinical ones like pathology or expert consensus on patient conditions.

8. The sample size for the training set

This information is not provided. The document describes non-clinical performance tests of a medical monitor, not the development or training of a machine learning algorithm.

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

This information is not provided, as there is no mention of a training set or ground truth establishment for algorithm training in the context of this device's K200594 submission.

Summary

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Oridion Medical 1987 Ltd. % Jonathan Kahan Partner Hogan Lovells US LLP 555 13th St. NW Washington, DC, District of Columbia 20004

Re: K200594

Trade/Device Name: Capnostream 35 Portable Respiratory Monitor Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, DQA, MNR Dated: March 6, 2020 Received: March 6, 2020

Dear Jonathan Kahan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K200594

Device Name

Capnostream™35 Portable Respiratory Monitor

Indications for Use (Describe)

The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K200594

510(k) SUMMARY

Oridion Medical 1987 Ltd.'s Capnostream™ 35 Portable Respiratory Monitor

Submitter

Oridion Medical 1987 Ltd. 7 Hamarpe St. P.O. Box 45025 Jerusalem, Israel 9777407

Phone: +972-54-5449290Facsimile: +972-2-586-6680

Contact Person: Lital David

Date Prepared: April 17, 2020

Name of Device: Capnostream™ 35 Portable Respiratory Monitor

Common or Usual Name: Analyzer, gas, carbon-dioxide, gaseous-phase

Classification Name: 21 CFR 868.1400 Carbon dioxide gas analyzer 21 CFR 870.2700 Oximeter 21 CFR 868.2375 Breathing frequency monitor

Regulatory Class: II

Product Code: CCK, DQA, MNR

Predicate Devices

CapnoStream 35 Portable Respiratory Monitor (K150272) NellCor Bedside Respiratory Patient Monitoring System (K141518)

Device Description

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The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

Indications for Use

The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up. The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Summary of Technological Characteristics

The primary difference between the subject and predicate devices is (1) addition of two pulse oximetry derived algorithms: Nellcor Respiratory Rate (RR) and Nellcor Saturation Pattern detection (SPD), (2) expansion of compatible WiFi authentication protocols, and (3) User Interface (GUI) language expansion. The sensor and algorithms used to sense RR and SPD are identical to K141518. There have been no changes to the hardware since clearance in K150272. Thus, these changes do not raise different questions of safety or efficacy.

Performance Data

Non-clinical tests were performed to support the determination of substantial equivalence:

. Software validation to ensure that all modified software functions as intended. This included cybersecurity documentation that identified cybersecurity risks and summarized how they were mitigated.
Usability testing per IEC 60601-1-6. Testing assessed the ability of 15 intended users with varying levels of experience to perform key tasks as well as understand Capnostream™35′s display.

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Wireless connectivity testing. The wireless communication testing passed for all wireless key . types compatible with the device.

Conclusions

The modified Capnostream™35 is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).