(21 days)
No
The device description focuses on integrating data from external devices and does not mention any AI/ML capabilities or related terms.
No.
The device is an interface module for integrating external measurement devices to a monitor, not a therapeutic device itself.
No
The device is an interface module that integrates data from external measurement devices for display on a monitor and alarm integration; it does not perform diagnostic functions itself.
No
The device description explicitly states it is a "single-width plug-in parameter module," indicating it is a physical hardware component that plugs into a monitoring system.
Based on the provided information, the Datex-Ohmeda S/5™ E-INT module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to integrate external measurement devices to patient monitors for viewing real-time and trended data. This involves connecting to devices that measure physiological parameters in vivo (within the body), not analyzing samples in vitro (outside the body).
- Device Description: The description focuses on its function as a plug-in module for a monitoring system, facilitating data display and alarm integration from external devices. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Detection or measurement of specific analytes
- Diagnosis or screening based on laboratory results
The device's function is to act as an interface for data from other medical devices, which are likely measuring physiological parameters directly from the patient. This falls under the category of patient monitoring equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Intended Use:
The Datex-Ohmeda S/5™ E-INT module is used to enable integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.
Indications for use:
The Datex-Ohmeda S/5™ E-INT module is indicated for integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.
The device is indicated for use by qualified medical personnel only.
Product codes
MSX, CCK
Device Description
The Datex-Ohmeda Interface module, E-INT is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda S/5™ Interface module, E-INT can be used with the following Datex-Ohmeda S/5™ modular monitors:
- . S/5 Anesthesia Monitor(AM) with main software S-STD93 or newer version
- S/5 Compact Anesthesia Monitor (CAM), with main S-STD93 or newer version ●
- S/5 Critical Care Monitor (CCM) with main software S-ICU97 or newer version .
- S/5 Compact Critical Care Monitor (CCCM), with main S-ICU97 or newer version .
The E-INT integrates real time and trended parameter data from external devices for viewing on the monitor display. The E-INT can integrate alarms from the Capnomac Ultima ™ and Critikon Dinamap TM 1846SX to the Datex-Ohmeda S/5 Monitor Alarm System.
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
Not Found
Intended User / Care Setting
"qualified medical personnel only."
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 Datex-Ohmeda S/5™ E-INT module has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.
- COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices .
- . FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993
- IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety) .
- EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. . 1:1991 + Amdt. 2:1995)
- CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 + Amdt. . 1:1991) + S2:1998 (=IEC Amdt 2:1995)
- UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. . 2:1995)
- IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests) .
- FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical . Devices. (May 11, 2005)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Page 1 of 3
NOV - 2 2005
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Interface Module, E-INT
GENERAL COMPANY INFORMATION as required by 807.92(a){1)
COMPANY NAME/ADDRESS/PHONE/FAX:
GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344
NAME OF CONTACT:
Mr. Joel Kent
DATE:
September 28, 2005
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda S/5TM Interface Module, E-INT
COMMON NAME:
Interface Module
CLASSIFICATION NAME:
The following Class II classification appears applicable:
| Product Code | Classification Name | CFR Section |
|---|---|---|
| MSX | System, network and communication, physiological monitors | 870.2300 |
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
The Datex-Ohmeda S/5™ Interface Module, E-INT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda Interface Board B-INT (K935477).
1
DEVICE DESCRIPTION as required by 807.92(a)(4)
The Datex-Ohmeda Interface module, E-INT is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda S/5™ Interface module, E-INT can be used with the following Datex-Ohmeda S/5™ modular monitors:
- . S/5 Anesthesia Monitor(AM) with main software S-STD93 or newer version
- S/5 Compact Anesthesia Monitor (CAM), with main S-STD93 or newer version ●
- S/5 Critical Care Monitor (CCM) with main software S-ICU97 or newer version .
- S/5 Compact Critical Care Monitor (CCCM), with main S-ICU97 or newer version .
The E-INT integrates real time and trended parameter data from external devices for viewing on the monitor display. The E-INT can integrate alarms from the Capnomac Ultima ™ and Critikon Dinamap TM 1846SX to the Datex-Ohmeda S/5 Monitor Alarm System.
INTENDED USE as required by 807.92(a)(5)
Intended Use:
The Datex-Ohmeda S/5™ E-INT module is used to enable integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.
Indications for use:
The Datex-Ohmeda S/5™ E-INT module is indicated for integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.
The device is indicated for use by qualified medical personnel only.
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The Datex-Ohmeda S/5™ Interface Module, E-INT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda Interface Board B-INT (K935477).
The E-INT module has the following similarities compared to the predicate B-INT board (K935477):
- identical intended use and indications for use .
- identical fundamental scientific technology .
- the same (improved) electronic measurement board .
- same (improved) module software .
- use the same operating principle .
- . similar accessories (modified to fit both B-INT and E-INT)
- have the same user interface at the monitor (can be used with the same monitor software) .
- the Customer and parameter specifications are the same, except for the storage � temperature, which has been modified to be the same for the whole S/5 Monitor system.
- . have the same safety and effectiveness
- . are manufactured using the same processes
The main differences between the new E-INT module and the predicate B-INT board (K935477) is primarily due to fact that the new E-INT module has the following changes:
- Transformed the Interface board inserted into the rear of the Monitor frame to a plug-in . module
- Minor improvements to the electronic measurement board .
- . Minor improvements to the module software
- The accessories have been modified for use both with the B-INT and E-INT module �
2
- The separate connector for interfacing G-series gas modules and two additional channels . for serial communiction have been removed as obsolete due to the evolution of the Datex-Ohmeda monitoring system since the B-INT design in 1993.
- . Added interface for Dräger Julian, Cato and Cicero, for North American Dräger (NAD) ventilator models 2B & 2C, for Baxter Vigilance CCO/SvO2, Baxter Explorer CO/SvO2 and for Oximetrix 3 and Spirometry data from the Ultima monitor
- The specification for storage temperature has been modified to be the same for the whole . S/5 Monitor system.
Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the Datex-Ohmeda S/STM Interface Module, E-INT are substantially equivalent to the predicate Datex-Ohmeda -Interface board B-INT (K935477).
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
The Datex-Ohmeda S/5™ E-INT module has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.
- COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices .
- . FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993
- IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety) .
- EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. . 1:1991 + Amdt. 2:1995)
- CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 + Amdt. . 1:1991) + S2:1998 (=IEC Amdt 2:1995)
- UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. . 2:1995)
- IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests) .
- FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical . Devices. (May 11, 2005)
CONCLUSION:
The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda $/5™ Interface Module, E-INT compared to the legally marketed (predicate) Datex-Ohmeda Interface Board B-INT (K935477).
3
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2005
Mr. Joel Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492
Re: K052880
Trade/Device Name: Datex-Ohmeda S/5TM Interface Module E-INT and accessories Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: October 11, 2005 Received: October 12, 2005
Dear Mr. Kent:
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.
4
Page 2 - Mr. Kent
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 vour 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Clurs
Chiu-Lin, Ph.D.
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
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Datex-Ohmeda S/5™ Interface Module, E-INT and accessories.
Indications for use:
The Datex-Ohmeda S/5™ E-INT module is indicated for integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.
The device is indicated for use by qualified medical personnel only.
Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am Sulion
Christon Sign-Off Olvision of Anesthesiology, General Hospital,
Infection of Anesthesiology, General Hospital, and and of Aniestricsiology. Gene Infection Control. Dental Devices
510(k) Number K052886
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