(88 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or related concepts in the intended use, device description, or any other section. The device appears to rely on standard physiological monitoring techniques and calculations.
No
The device is described as a monitoring system that provides data such as cardiac output, spirometric, carbon dioxide, and pulse oximetry information. It calculates parameters like cardiac output and systemic vascular resistance. Its intended use is for monitoring and providing diagnostic information, not for treating a disease or condition.
Yes
The device is described as providing "cardiac output monitoring," "spirometric, carbon dioxide and pulse oximetry monitoring," and calculating "additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance," all of which are diagnostic functions.
No
The device description explicitly mentions "Separate flow sensors and CO2 airway adapters are provided" and that these are "single patient use devices." This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is used for monitoring physiological parameters directly from the patient during mechanical ventilation. It measures things like cardiac output, spirometry, carbon dioxide levels in the breath, and pulse oximetry. These are all in vivo measurements, meaning they are taken from within the living body, not from a sample outside the body.
The device is a patient monitoring system, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The intended use of the CO2,SMO Plus! with NICO is to provide:
- cardiac output monitoring via the method of partial rebreathing in adult patients receiving . mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
- . spirometric, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate flow sensors and CO2 airway adapters are provided for pediatric/adult and neonatal use.
It is intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician.
It is intended that:
- the neonatal flow and combined CO /flow sensors be used with ET tube sizes less . than or equal to 4 mm and
- the pediatric/adult flow and combined CO2/flow sensors be used with ET tube sizes # greater than 4 mm or with 22 mm ID breathing circuit devices such as a mouthpiece.
The fittings of the flow sensors and CO2 airway adapters comply with ISO [5356-1: 1987 (E)].
The flow sensors and CO2 airway adapters may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the same fitting specification.
The flow sensors, combination CQ2fflow sensors, single patient use CO, airway adapters and valve assembly are single patient use devices.
The CO2SMO Plus! with NICO can calculate additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance.
The use of the CO2SMO Plus! with NICO is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO, level cannot be tolerated.
Product codes
73 BZC
Device Description
Not Found
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
neonatal, pediatric and adult patients
Intended User / Care Setting
trained operators; intensive care unit (ICU) and the emergency department (ED)
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and appear to be connected by a flowing ribbon-like element. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 1998
Mr. Robert H. Schiffman Novametrix Medical Systems, Inc. 56 Carpenter Lane Wallingford, CT 06492
Re : K982499 CO2SMO Plus! With NICO Requlatory Class: II (two) Product Code: 73 BZC Dated: July 17, 1998 Received: July 20, 1998
Dear Mr. Schiffman:
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 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 In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. 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.
1
Page 2 - Mr. Robert H. Schiffman
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 diaqnostic 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 qeneral 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,
sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | K982499 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications For Use:
The intended use of the CO2,SMO Plus! with NICO is to provide:
- cardiac output monitoring via the method of partial rebreathing in adult patients receiving . mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
- . spirometric, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate flow sensors and CO2 airway adapters are provided for pediatric/adult and neonatal use.
It is intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician.
It is intended that:
- the neonatal flow and combined CO /flow sensors be used with ET tube sizes less . than or equal to 4 mm and
- the pediatric/adult flow and combined CO2/flow sensors be used with ET tube sizes # greater than 4 mm or with 22 mm ID breathing circuit devices such as a mouthpiece.
The fittings of the flow sensors and CO2 airway adapters comply with ISO [5356-1: 1987 (E)].
The flow sensors and CO2 airway adapters may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the same fitting specification.
The flow sensors, combination CQ2fflow sensors, single patient use CO, airway adapters and valve assembly are single patient use devices.
The CO2SMO Plus! with NICO can calculate additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance.
The use of the CO2SMO Plus! with NICO is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO, level cannot be tolerated.
(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 __________ |
| (Division Sign-Off) | Lam Modoo |
|---|---|
| 10-15-98 | |
| (Optional Format 1-2-96) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number | K982499 |
|---|---|
| --------------- | --------- |