(18 days)
K 051263, K 042601
Not Found
No
The summary describes a sensor using infrared absorption technology for CO2 measurement and calculation of respiratory rate, with no mention of AI or ML.
No
The device is a CO2 sensor for monitoring purposes, it does not provide any therapy or treatment to the patient.
Yes
Explanation: The device measures physiological parameters (CO2 concentrations and respiratory rate) to provide information about a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "sensor" that uses "infrared absorption technology" and is a "measurement module integrated inside the sensor," indicating it is a hardware device.
Based on the provided information, the Dräger Infinity MCable Mainstream CO2 sensor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Dräger sensor measures CO2 directly in the patient's exhaled breath, which is a physiological measurement happening in vivo (within the living body), not in vitro (in glass or outside the body).
- The intended use describes monitoring a physiological process (respiration) in real-time. This is characteristic of a patient monitoring device, not an IVD.
Therefore, this device falls under the category of a patient monitoring device rather than an IVD.
N/A
Intended Use / Indications for Use
The Dräger Dräger Infinty MCable Mainstream CO2 sensor is meant to be used for continuous, real time measurement of CO2 concentrations of ventilated patients from neonates to adults.
This sensor is only intended for use with devices made by Dräger Medical, or with devices which are approved for use with Dräger CO2 components (Dräger-compatible devices).
Product codes
CCK
Device Description
The Infinity MCable - Mainstream CO2 uses infrared absorption technology to accomplish mainstream CO2 measurements. The sensor is able to measure end-tidal CO2 and inspired CO2 and calculates the respiratory rate. This measurement module is integrated inside the sensor and no longer part of the host device (e.g. ventilator). CO2 compensation has been advanced for the foreign gases helium and nitrous oxide.
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
neonates to adults
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 051263, K 042601
Reference Device(s)
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).
0
510(k) Summary acc. to 21 CFR 807.92
Applicants Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
APR 2 3 2010
Manufacturer Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
Establishment Registration Number :
9611500
Contact Person:
Ulrich Schroeder Director Regulatory & Clinical Affairs
Tel. No.: + 49 (451) 882-3648 Fax No.: + 49 (451) 882-3018
Applicants US Contact Person
Joyce Kilroy Vice President, Processes, Quality & Regulatory
Tel. No.: (215) 660-2626 Fax No .: (215) 721-5424
Date submission was prepared:
2010-03-30
Device Name:
Common Name: Classification Name: Regulation Number: Class:
Infinity MCable - Mainstream CO2 Carbon dioxide gas analyzer, CCK 21 CFR 868.1400 11
1
Image /page/1/Picture/0 description: The image shows the logo for Dräger Medical. The word "Dräger" is in bold, and the word "medical" is in a thinner font. Below the logo, it says "A Dräger and Siemens Company."
A Dräger and Siemens Company
| 510(k) number | Trade name | Company |
|---|---|---|
| K 051263 | Evita XL, Option | |
| SmartCare with | ||
| Option Capno | ||
| Package CO2 | ||
| Mainstream | ||
| sensor #6871500 | Dräger Medical AG & Co. KG | |
| K 042601 | CAPNOSTAT 5 | RESPIRONICS NOVAMETRIX, INC. |
Legally Marketed Predicate Device to which Substantial Equivalence is claimed:
Device Description:
The Infinity MCable - Mainstream CO2 uses infrared absorption technology to accomplish mainstream CO2 measurements. The sensor is able to measure end-tidal CO2 and inspired CO2 and calculates the respiratory rate. This measurement module is integrated inside the sensor and no longer part of the host device (e.g. ventilator). CO2 compensation has been advanced for the foreign gases helium and nitrous oxide.
Technological Characteristics
The Infinity MCable - Mainstream CO- is based on the same technological principles as the Dräger predicate (specific dual wavelength infrared absorption by CO2 molecules) using the same wavelengths. Same parameters are measured as CO2 waveform; end tidal CO2j inspired CO2 and respiration rate from capnogram as well as the measurement range is identical to the predicate (0 to 100 mmHg). The new Infinity MCable - Mainstream CO2 Sensor uses the existing legally marketed accessories of the Dräger predicate.
Indication for Use:
The Dräger Infinity MCable Mainstream CO2 sensor is meant to be used for continuous, real time measurement of CO2 concentrations of ventilated patients from neonates to adults. This sensor is only intended for use with devices made by Dräger Medical, or with devices which are approved for use with Dräger CO2 components (Dräger-compatible devices)
Conclusion:
All modifications have been evaluated for safety and effectiveness. The summary of the design control activities and the risk analysis show that these types of modifications do not change the device operating principle or mechanism of action. The modifications do not alter the fundamental scientific technology and therefore the safety and effectiveness is substantially equivalent to the legally marketed predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and tail feathers. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Ulrich Schroeder Director Regulatory & Clinical Affairs Draeger Medical AG & Company KG 53/55 Moislinger Allee Luebeck Germany D-23542
APR 2 3 2010
Re: K100941
Trade/Device Name: Infinity MCable Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: March 31, 2010 Received: April 5, 2010
Dear Mr. Ulrich Schroeder:
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 ffor 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. 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.
3
Page 2-Mr. Ulrich Schroeder
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson Director Division of Anesthesiology, General Hospital, Infection Control and General Hospital, Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Infinity MCable
Indications for Use:
The Dräger Dräger Infinty MCable Mainstream CO2 sensor is meant to be used for continuous, real time measurement of CO2 concentrations of ventilated patients from neonates to adults.
This sensor is only intended for use with devices made by Dräger Medical, or with devices which are approved for use with Dräger CO2 components (Dräger-compatible devices).
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100941
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