(204 days)
The text does not directly provide K/DEN numbers for Reference Devices. It states "Reference Device(s) Not Found".
No
The document describes a device for measuring physiological parameters (CO2 and respiration rate) and does not mention any AI or ML capabilities.
No
The device measures physiological parameters (carbon dioxide and respiration rate) and provides alarms, but it does not directly treat or alleviate a medical condition. It's a diagnostic/monitoring device.
No
The device is described as measuring end tidal carbon dioxide, inspired carbon dioxide, and respiration rate, and providing alarms if these parameters vary beyond preset limits. This indicates a monitoring function rather than a diagnostic one.
No
The device description explicitly states it is a "Pod" which is a hardware component that connects to existing monitors. It measures physical parameters (carbon dioxide and respiration rate) using hardware.
Based on the provided information, the Siemens INFINITY etCO2 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of transfused blood, or to monitor therapeutic measures.
- Device Function: The Siemens INFINITY etCO2 device measures end tidal carbon dioxide, inspired carbon dioxide, and respiration rate directly from the patient's breath (either mainstream or side-stream). This is a direct physiological measurement taken from the patient, not an examination of a specimen in vitro (outside the body).
- Intended Use: The intended use describes measuring these parameters in patients to provide information about their respiratory status. This is a form of patient monitoring, not laboratory testing of a specimen.
Therefore, the Siemens INFINITY etCO2 device falls under the category of patient monitoring equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of Siemens INFINITY etCO2 pod is to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in both mainstream and side-stream measurement modes (side-stream is not intended for use in the neonatal population). In conjunction with an INFINITY modular bedside monitor, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.
Siemens INFINITY etCO2 is indicated for use in the adult, pediatric and neonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode is not intended for use in the neonatal patient population). In conjunction with the SC 7000 / SC 9000XL monitors, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.
Product codes
73CCK
Device Description
The INFINITY etCO2 Pod is an addition to Siemens SC8000/SC7000/SC9000XL INFINITY modular bedside monitoring series. When connected to an INFINITY modular bedside monitor the etCO2 pod will measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate.
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/Neonatal
Intended User / Care Setting
A healthcare environment by healthcare professionals
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)
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
510(k) SUMMARY
as required per 807.92(c)
1. Submitters Name, Address:
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: June 11, 1999
Trade Name, Common Name and Classification Name: 2.
- A. Trade Name: Siemens INFINITY etCO2 Pod
Common Name, Classification Name, Class and Regulation Number: B.
| Common Name | Classification
Number | Class | Regulation Number |
|----------------------------------------------|--------------------------|-------|-------------------|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 73CCK | II | 868.1400 |
Predicate Device Identification: 3.
Siemens SC9000 etCO2 Module 510(k) K954632
Novametrix CO2SMO Plus 510(k) K963380
4. Device Description:
The INFINITY etCO2 Pod is an addition to Siemens SC8000/SC7000/SC9000XL INFINITY modular bedside monitoring series. When connected to an INFINITY modular bedside monitor the etCO2 pod will measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate.
ડ. Intended Use:
The intended use of Siemens INFINITY etCO2 pod is to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in both mainstream and side-stream measurement modes (side-stream is not intended for use in the neonatal population). In conjunction with an INFINITY modular bedside monitor, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.
-
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
1
6. Table of Device Similarities and differences to predicate device
| Predicate Device | Predicate Device | Applicant | Explanation of
Differences | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Manufacturer | Siemens Medical Systems
SC9000 etCO2 Module | Novametrix Medical Systems
CO2SMO Plus | Siemens Medical Systems
INFINITY etCO2 Pod | |
| 510(k) Number | K954632 | K963380 | To be assigned | |
| Intended Use | To measure end tidal carbon dioxide,
inspired carbon dioxide, and
respiration rate in both mainstream
and side-stream measurement modes
(side-stream is not intended for use in
the neonatal population). In
conjunction with the SC9000, visual
and audible alarms will be produced
if any of these parameters vary
beyond preset limits, and timed or
alarm recordings will be produced. | To provide spirometric, carbon
dioxide and pulse oximetry
monitoring | To measure end tidal carbon dioxide,
inspired carbon dioxide, and respiration rate
in both mainstream and side-stream
measurement modes (side-stream is not
intended for use in the neonatal
population). In conjunction with the SC
7000 / SC 8000 / SC 9000XL monitors,
visual and audible alarms will be produced
if any of these parameters vary beyond
preset limits, and timed or alarm recordings
will be produced. | Siemens etCO2 pod does
not measure or display
spirometry or pulse
oximetry |
| Intended Population | Adult/Pediatric | Adult/Pediatric/Neonatal | Adult/Pediatric/Neonatal | |
| Intended
Environment | A healthcare environment by
healthcare professionals | Same | Same | |
| Measuring Capabilities | | | | |
| Displayed parameters | EtCO2, iCO2, Respiration rate (RRc) | Spirometry, Pulse oximetry,
EtCO2, iCO2, Respiration rate
(RRc) | EtCO2, iCO2, Respiration rate (RRc) | Siemens etCO2 pod does
not measure or display
spirometry or pulse
oximetry |
| Display Scales | 0-40, 0-80 mmHg | 0-50, 0-75, 0-100 mmHg | 0-40, 0-60, 0-80, 0-100 mmHg | More display flexibility |
| Measuring method | Dual-wavelength, non-dispersive
infrared | Same | Same | |
| Measuring
capabilities | Mainstream and Sidestream | Same | Same | |
| Measuring range | 0 to 99 mmHg CO2 partial pressure | 0 to 100 mmHg partial pressure | 0 to 100 mmHg CO2 partial pressure | *A CO2 ≥ 100 is
considered out of range |
| Averaging | Breath, 10s, 20s | Breath, 10s, 20s, Instantaneous | Breath, 10s, 20s, Instantaneous | Improvement |
2
COMPANY CONFIDENTIAL
2
- Assessment of non-clinical performance data for equivalence: Section T
-
- Assessment of clinical performance data for equivalence: Section V
-
- Biocompatability: Not applicable
-
- Sterilization: Not applicable
-
- Standards and Guidances: EN 864: 1996 IEC 60601-1
3
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
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 that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
Re: K992116 Siemens INFINITY etCO2 Pod Regulatory Class: II (two) Product Code: 73 CCK October 15, 1999 Dated: Received: October 15, 1999
Dear Mr. Simard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. David Simard
This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
feamothw. Wutoduca fro,
elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): _
Device Name: Siemens INFINITY etCO2 Pod
Indications for Use:
Siemens INFINITY etCO2 is indicated for use in the adult, pediatric and neonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode is not intended for use in the neonatal patient population). In conjunction with the SC 7000 / SC 9000XL monitors, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.
MRI Compatibility Statement: The Siemens INFINITY etCO2 Pod is not intended for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
to AW. Watscher
Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K9921116