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).

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.

AI/ML Overview

The provided text is a 510(k) summary for the Dräger Infinity MCable - Mainstream CO2, a device designed for continuous, real-time measurement of CO2 concentrations. The summary primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the detailed aspects of a clinical study typically associated with AI/ML device evaluations. Therefore, a table of acceptance criteria and reported device performance cannot be generated, nor can details about sample size, expert ground truth, adjudication methods, or MRMC studies be provided from this document.

The document states that "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." This indicates that the evaluation of the device relied on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance metrics described in this summary.

Information that can be extracted from the provided text:

While the detailed study information is not available, here's what can be inferred or directly stated from the document:

Device: Dräger Infinity MCable - Mainstream CO2
Purpose: Continuous, real-time measurement of CO2 concentrations in ventilated patients (neonates to adults).
Technological Principle: Uses infrared absorption technology (specific dual wavelength infrared absorption by CO2 molecules).
Measured Parameters: CO2 waveform, end-tidal CO2, inspired CO2, and respiration rate from capnogram.
Measurement Range: 0 to 100 mmHg.
Predicate Device:
- K051263 - Evita XL, Option SmartCare with Option Capno Package CO2 Mainstream sensor #6871500 (Dräger Medical AG & Co. KG)
- K042601 - CAPNOSTAT 5 (RESPIRONICS NOVAMETRIX, INC.)

The following details are not present in the provided 510(k) summary:

Table of acceptance criteria and reported device performance: Not included. The document focuses on substantial equivalence rather than explicit performance metrics against pre-defined acceptance criteria.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not relevant or mentioned. This is a CO2 measurement sensor, not an AI/ML-driven diagnostic imaging device requiring human reader improvement studies.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not explicitly detailed, but as a sensor, its performance is inherently standalone in generating the measurements. There is no "human-in-the-loop" performance as described for AI/ML diagnostic tools.
The type of ground truth used: Not explicitly stated, as the evaluation was based on substantial equivalence to predicate devices and design control activities. For CO2 sensors, ground truth would typically come from calibrated gas mixtures or established reference methods.
The sample size for the training set: Not applicable and not mentioned, as this device primarily relies on a physical principle (infrared absorption) rather than a machine learning model trained on data.
How the ground truth for the training set was established: Not applicable and not mentioned.

Summary

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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

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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, OptionSmartCare withOption CapnoPackage CO2Mainstreamsensor #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:

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.

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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.

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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

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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

Page 1 of 1

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).