(88 days)
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.
Not Found
This FDA 510(k) clearance letter for the Novametrix Medical Systems, Inc. CO2SMO Plus! With NICO device does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The document is a regulatory clearance letter, which confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It briefly mentions the "Indications For Use" but does not describe specific performance metrics, acceptance criteria, or the methodology of a study to demonstrate these.
To fully answer your request, here's a breakdown of what's missing and why it cannot be extracted from the provided text:
-
A table of acceptance criteria and the reported device performance: This information is typically found in the summary of the 510(k) submission itself, often in sections detailing device performance data or clinical validation. The clearance letter only states that the device is "substantially equivalent" to a predicate, implying that its performance is deemed acceptable based on comparison to existing devices. It does not provide the specific performance values or the criteria against which they were measured.
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Sample size used for the test set and the data provenance: This level of detail would be in the study design section of the 510(k) submission, not the clearance letter.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As with sample size, this is part of the study design information, absent from this document.
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Adjudication method: Not present in this regulatory letter format.
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Multi Reader Multi Case (MRMC) comparative effectiveness study information: This type of study detail would be in the clinical or performance data section of the 510(k) submission. Given the device (CO2SMO Plus! with NICO for physiological monitoring), it's less likely to involve a comprehensive MRMC study in the way an imaging AI algorithm would.
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Standalone performance: While the device functions as a "standalone" monitor, the performance study demonstrating its accuracy in a standalone mode, with specific metrics, is not detailed here. The letter only approves the device for marketing.
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The type of ground truth used: This would be specific to each parameter being measured (e.g., CO2 values correlated with blood gas analysis, cardiac output against a gold standard method). This information is not in the clearance letter.
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Sample size for the training set: This device is a physiological monitoring system, not an AI/ML algorithm that undergoes a "training" phase in the typical sense (unless it incorporates some adaptive algorithm, which is not mentioned). Therefore, a "training set" as understood for AI is unlikely to be relevant here, or if it were, the details would be in the detailed submission.
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How the ground truth for the training set was established: See point 8.
In summary: The provided document is an FDA 510(k) clearance letter. Its purpose is to inform the manufacturer that their device has been found substantially equivalent to a predicate and can be legally marketed. It meticulously avoids detailing the specific study results, acceptance criteria, or ground truth establishment methods, as those are contained within the full 510(k) submission document, which is a much more extensive technical dossier.
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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.
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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
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| 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 |
|---|---|
| --------------- | --------- |
§ 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).