(290 days)
Not Found
No
The summary describes a standard capnograph with added wireless capability and does not mention any AI or ML components or functions.
No.
The device measures and monitors physiological parameters (carbon dioxide partial pressure and respiratory rate) rather than directly treating a condition or performing a therapeutic action.
No
The device measures, displays, and monitors physiological parameters (carbon dioxide partial pressure and respiratory rate) but does not provide a diagnosis.
No
The device description explicitly states it is a "portable medical device capable of measuring, displaying, and monitoring carbon dioxide and respiratory rates from exhaled air," indicating it includes hardware components for measurement and display, not just software.
Based on the provided text, the EMMA® Capnograph is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the EMMA® Capnograph clearly states it "measures, displays and monitors carbon dioxide partial pressure and respiratory rate from exhaled air." Exhaled air is a bodily product, but the measurement is happening in vivo (on the living patient) by analyzing the air they breathe out, not by examining a collected specimen in a laboratory setting.
- The intended use and device description focus on monitoring physiological parameters directly from the patient. The device is used during anesthesia, recovery, and respiratory care, and in various clinical settings, all of which involve direct patient interaction and monitoring.
Therefore, the EMMA® Capnograph is a medical device used for patient monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
Product codes
CCK
Device Description
The subject device, EMMA® Capnograph (EMMA), the same as the predicate, is a portable medical device capable of measuring, displaying, and monitoring carbon dioxide and respiratory rates from exhaled air. The difference between the subject device and the predicate device is the addition of the wireless capability to allow for the wireless transmission of data. The intended use and measurement functions have not changed from the previous clearance.
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
adult, pediatric and infant patients.
Intended User / Care Setting
operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings
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)
The subject device was evaluated for electromagnetic compatibility testing to the latest IEC 60601-1-2 standard, radio co-existence testing, and cybersecurity risk mitigations.
Key Results:
- EMC Testing in accordance with IEC 60601-1-2:2014, including radiated immunity to 10 V/m. Testing supports the addition of the wireless radio capabilities does not impact the essential performance.
- Radio co-existence testing in accordance with the FDA Guidance for Radio Frequency Wireless Technology in Medical Devices. Testing supports the quality of the service of the wireless connection is maintained under normal and anticipated abnormal conditions.
- Cybersecurity testing in accordance with the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Testing supports the acceptability of the cybersecurity risks.
- Conducted operational verification after storage of the device at -40°C. Test supports the acceptability of the lower temperature specification.
- Conducted operational verification of the device at 60 kPa atmospheric pressure. Test supports the acceptability of the lower temperature specification.
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.
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
§ 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).
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March 29, 2021
Masimo Corporation Katelynn Kirby Regulatory Affairs Specialist III 52 Discovery Irvine, California 92618
Re: K201590
Trade/Device Name: EMMA Capnograph Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: February 26, 2021 Received: March 2, 2021
Dear Katelynn Kirby:
We have reviewed vour 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 af fecting 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 equi valence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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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): 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 (QS) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201590
Device Name EMMA Capnograph
Indications for Use (Describe)
EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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ION
510(k) Summary K201590
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | June 11 2020 |
| Contact: | Katelynn Kirby
Regulatory Affairs Specialist III
Masimo Corporation
Phone: (949) 297-7408 |
| Trade Name: | EMMA Capnograph |
| Common Name: | Carbon Dioxide Gas Analyzer |
| Classification Regulation: | 21 CFR 868.1400, Class II |
| Product Code: | CCK |
| Establishment Registration
Number: | 3011353843 |
| Reason for Premarket
Notification: | Addition of Wireless Capabilities |
| Predicate Device: | K072813 - EMMA Emergency Capnometer |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
5.1. Device Description
The subject device, EMMA® Capnograph (EMMA), the same as the predicate, is a portable medical device capable of measuring, displaying, and monitoring carbon dioxide and respiratory rates from exhaled air. The difference between the subject device and the predicate device is the addition of the wireless capability to allow for the wireless transmission of data. The intended use and measurement functions have not changed from the previous clearance.
| Feature | EMMA Specification |
|---|---|
| General | |
| Display type | Integrated Visual Display |
| Airway Adapter Adult/Pediatric | Single patient use proprietary airway adapter, 6 cc dead space. |
| Airway Adapter Infant | Single patient use proprietary airway adapter, 1 cc dead space. |
| Performance Specifications | |
| CO2 | 0-40 mmHg: +/- 2 mmHg. |
The specifications for EMMA are as follows:
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ATION
510(k) Summary K201590
| Feature | EMMA Specification |
|---|---|
| Respiration Rate (3-150 breaths/min) | 41-99 mmHg: 6% of reading |
| $\pm$ 1 breaths/min | |
| Total System Response Time |