(729 days)
K 951094, K963935, K 962638
Not Found
No
The description focuses on fiber optic sensing, software-modified instruments for measurement and display, and calibration with saline. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is indicated for monitoring, which is a diagnostic function, not a therapeutic intervention.
Yes
The device is indicated for "monitoring sublingual PCO2," which involves measuring a physiological parameter (PCO2) to provide information about a patient's condition, making it a diagnostic device.
No
The device description explicitly lists hardware components including a Disposable Sensor, Instrument, Fiber Optic Interconnect Cable, and Calibration Fluid. While software is mentioned as modifying the instrument, the device is not solely software.
Based on the provided information, the CapnoProbe Sublingual Tonometer System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The CapnoProbe system directly measures pCO2 in vivo (under the tongue) in a hospital patient. It does not analyze a sample taken from the patient.
- The device description clearly states it measures SL CO2 and temperature directly from the sublingual area.
- The intended use is for monitoring sublingual PCO2 in hospital patients. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the CapnoProbe Sublingual Tonometer System is a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.
Product codes (comma separated list FDA assigned to the subject device)
73 CCK, 73 CBR, 78 KNT
Device Description
The CapnoProbe A System provides a measurement of Sublingual pCO2 (SL CO2). The CapnoProbe A consists of a Disposable Sensor, Instrument, Fiber Optic Interconnect Cable and Calibration Fluid. The Disposable Sensor contains a fiber optic pCO- sensor and temperature sensor. The Disposable Sensor is placed under the tongue for a measurement of pCO2 and temperature.
The Disposable Sensor connects to the fiber optic interconnect cable. The fiber optic interconnect cable connects to a software modified ABG Module.
The instrument is a software modified Optical CAM and ABO Module. The softwaremodified instruments measures SL CO2 and temperature, displaying SL CO2. The instrument is dedicated to the function as programmed by the software. The instruments are referred to as a CapnoProbe A Monitor and a CapnoProbe A Module. Prior to use the CapnoProbe A System with disposable pCO2 sensor is calibrated with provided tonometered saline. The saline calibration fluid is the same as the predicate SensiCath System initialization fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sublingual (under the tongue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel, hospital patients
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)
Laboratory and animal data are presented to establish and compare performance of the CapnoProbe A System to a predicate pCO2 measurement system, the Tonocap TC-200. The bench data establishes performance of the CapnoProbe A System and Tonocap to controlled levels of tonometered saline. Both systems perform equally well under laboratory conditions.
The animal study demonstrates equivalence of pCO2 measurement under the tongue, versus stomach mucosal tissue of test animals. Both systems tracked pCO2 changes. The Pearson r Correlation Coefficient of the two CapnoProbe A Systems is higher than the Pearson r Correlation Coefficient of the two predicate Tonocap Systems.
A comparison of clinical data for the CapnoProbe A System and published Tonocap clinical data on volunteer and stable subjects indicates the CapnoProbe A System is as repeatable as the predicate TonoCap System. A volunteer clinical study demonstrates repeatability of the CapnoProbe A System.
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.
SensiCath Blood Gas Sensor – 510(k) K 951094, OpticalCAM Blood Gas Measurement System - 510(k) K963935, Datex-Engstrom Tonocap - 510(k) K 962638
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).
0
DEC 21 2000
Optical Sensors Incorporated
510(k) Summary
| Company Name: | Optical Sensors Incorporated |
|---|---|
| Device Name: | CapnoProbe A System |
| Contact: | Paulita LaPlante |
| President and CEO | |
| Optical Sensors Incorporated | |
| 7615 Golden Triangle Drive | |
| Eden Prairie, MN 55344 | |
| Phone: | 612-947-9595 |
| Fax: | 612-944-6022 |
| Summary Date: | December 13, 2000 |
| Trade Name: | CapnoProbe A System |
| Common Name: | Carbon Dioxide Gas Analyzer |
| Classification Name: | CFR 868-1400 73CCK |
| Carbon Dioxide Gas Analyzer | |
| Predicate Devices: | SensiCath Blood Gas Sensor – 510(k) K 951094 |
| OpticalCAM Blood Gas Measurement System - 510(k) K963935 | |
| Datex-Engstrom Tonocap - 510(k) K 962638 |
Description of Device 1.0
The CapnoProbe A System provides a measurement of Sublingual pCO2 (SL CO2). The CapnoProbe A consists of a Disposable Sensor, Instrument, Fiber Optic Interconnect Cable and Calibration Fluid. The Disposable Sensor contains a fiber optic pCO- sensor and temperature sensor. The Disposable Sensor is placed under the tongue for a measurement of pCO2 and temperature.
The Disposable Sensor connects to the fiber optic interconnect cable. The fiber optic interconnect cable connects to a software modified ABG Module.
1
The instrument is a software modified Optical CAM and ABO Module. The softwaremodified instruments measures SL CO2 and temperature, displaying SL CO2. The instrument is dedicated to the function as programmed by the software. The instruments are referred to as a CapnoProbe A Monitor and a CapnoProbe A Module. Prior to use the CapnoProbe A System with disposable pCO2 sensor is calibrated with provided tonometered saline. The saline calibration fluid is the same as the predicate SensiCath System initialization fluid.
2.0 Intended use of Device
The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.
3,0 Technological Characteristics
The technical characteristics of the CapnoProbe A System are measurement of pCO2 by a fiber optic sensor. The fiber optic pCO2 technical features of the CapnoProbe A System are equivalent to the predicate SensiCath Blood Gas Sensor and OpticalCAM Blood Gas Measurement System.
4.0 Data Summary
Laboratory and animal data are presented to establish and compare performance of the CapnoProbe A System to a predicate pCO2 measurement system, the Tonocap TC-200. The bench data establishes performance of the CapnoProbe A System and Tonocap to controlled levels of tonometered saline. Both systems perform equally well under laboratory conditions.
The animal study demonstrates equivalence of pCO2 measurement under the tongue, versus stomach mucosal tissue of test animals. Both systems tracked pCO2 changes. The Pearson r Correlation Coefficient of the two CapnoProbe A Systems is higher than the Pearson r Correlation Coefficient of the two predicate Tonocap Systems.
A comparison of clinical data for the CapnoProbe A System and published Tonocap clinical data on volunteer and stable subjects indicates the CapnoProbe A System is as
2
repeatable as the predicate TonoCap System. A volunteer clinical study demonstrates repeatability of the CapnoProbe A System.
Conclusions 5.0
The data and information presented supports the conclusion the technology of the CapnoProbe A System is substantially equivalent to the noted prodicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling three abstract shapes, possibly representing human figures or wings, stacked on top of each other.
DEC 21 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Paulita LaPlante President & CEO Optical Sensors Incorporated 7615 Golden Triangle Drive Technology Park Five Minneapolis, MN 55344
Re: K984579 Trade Name: CapnoProbe-A SL Regulatory Class: II (two) Product Code: 73 CCK, 73 CBR, 78 KNT Dated: July 18, 2000 Received: July 20, 2000
Dear Ms. LaPlante:
We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is ent dovelally 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 Incorpours of and of 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 ene golors 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
4
Page 2 - Ms. Paulita LaPlante
obligation you might have under sections 531 through 542 of the Act obrigation you might welectronic Product Radiation Control provisions, or other Federal laws or regulations.
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 Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obtainou more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page ___of
510(k) Number (if known): -
Sublingual Tonometer CO2 Measurement System Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use:
The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
pöölle
K984579