(30 days)
The intended use of the Mercury module with Capnostat 5 is to provide:
- spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5. The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.
This document describes a Special 510(k) for a device modification, specifically an increase in the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM on the Mercury Module with Capnostat 5 CO2 sensor. The submission asserts that the device is "identical" to the predicate device except for this specification change, which was made to align with maximum inspiratory flow for ventilators cleared for use with neonates.
Because this is a Special 510(k) for a minor modification, the typical structure of a comprehensive de novo submission with detailed performance studies and acceptance criteria as outlined in your prompt is not present. Special 510(k)s often rely on demonstrating that the change does not significantly affect safety or effectiveness, often by showing that the modified device still meets existing performance standards or by providing limited testing related only to the change.
Therefore, many of the specific details you requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for a full-scale AI/ML device validation are not available in this type of submission.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:
Acceptance Criteria and Device Performance Study (K092217)
This submission is a Special 510(k) for a minor modification to an existing device (Mercury Module with Capnostat 5 CO2 sensor). The modification involves increasing the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM. This type of submission relies on demonstrating substantial equivalence to a predicate device and that the change does not significantly affect safety or effectiveness.
Due to the nature of this submission (a device modification rather than a new device), the provided text does not contain explicit performance acceptance criteria or detailed study results in the manner one would expect for a novel AI/ML device. Instead, the focus is on the equivalence to the predicate device and the justification for the specification change.
The primary "acceptance criterion" for this Special 510(k) appears to be that the modified device remains substantially equivalent to the cleared predicate device (K080652) and that the change aligns with existing standards for neonatal ventilators.
Based on the provided text, a formal "study" with specific performance metrics and statistical analyses (as would be typical for an AI/ML product) is not described. The manufacturer states that the device is "identical" except for the changed specification.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this Special 510(k), explicit performance acceptance criteria are not detailed in the provided text. The "acceptance" is implied by the FDA's decision of substantial equivalence.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K080652) | The submitted device is considered "identical" to the predicate except for the modified specification. |
| Neonatal Flow/CO2 Sensor Upper Limit: 30 LPM (New Specification) | The device's nominal upper limit for neonatal flow and CO2/flow sensors is 30 LPM, aligned with ventilators for neonates. |
| Maintenance of Intended Use: Spirometric and CO2 monitoring in neonatal, pediatric, and adult patients during general anesthesia, ICU, and ED. | The device maintains the same intended use as the predicate device. |
| Safety and Effectiveness Not Adversely Affected by Change | Implied by the Special 510(k) pathway and FDA clearance. |
The following points cannot be answered definitively from the provided text as it pertains to a hardware device modification, not an AI/ML algorithm requiring such specific validation details.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable/Not Provided: For a hardware modification like this, a "test set" in the context of AI/ML validation (e.g., a dataset of images or patient records) is not relevant. The testing would involve verifying the hardware's performance characteristics. Details on such testing (e.g., number of units tested, conditions) are not in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable/Not Provided: Ground truth in the AI/ML sense (e.g., expert labels for clinical conditions) is not relevant for this hardware modification. The "ground truth" for the modified specification would likely be established through engineering design, material specifications, and performance verification against known physical standards, rather than expert clinical consensus.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not Applicable/Not Provided: This method is used in AI/ML studies to resolve discrepancies in expert annotations. It is not relevant to the validation of a hardware device's technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- Not Applicable/Not Provided: MRMC studies are specific to evaluating clinical performance of AI/ML tools used by human readers. This submission concerns a physical sensor's performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable/Not Provided: This pertains to AI/ML algorithm performance independent of human interpretation. It is not relevant for a hardware sensor.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Not Applicable/Not Provided: The "ground truth" for this device's performance would likely be based on physical measurements against calibrated standards, engineering specifications, and established physiological ranges for neonatal respiration, rather than clinical consensus, pathology, or outcomes data in the AI/ML context.
8. The Sample Size for the Training Set
- Not Applicable/Not Provided: "Training set" refers to data used to train an AI/ML model. This device is a hardware sensor, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable/Not Provided: As above, this concept refers to AI/ML model development and is not applicable to this hardware device modification.
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AUG 2 1 2009
Section iv - 510 (k) Summary
[ Refer to 21 C.F.R § 807.92 ]
| Submitted by: | Respironics Novametrix, LLC5 Technology DriveWallingford, CT 06484 |
|---|---|
| Contact Person: | Kevin MaderQ.A. and Regulatory ManagerPhone: 203-697-6466 |
| Date Prepared: | 7/20/2009 |
| Proprietary Name: | Mercury Module with Capnostat 5 CO2 sensor |
| Common Name: | spirometer with CO2 sensor |
| Classification Name: | Class II, 21 CFR 868.1850 and 868.1400 |
| Predicate Device: | Mercury Module with Capnostat 5 CO2 sensor (K080652) |
Description of Device: The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5.
Intended Use of the Device: Mercury Module with Capnostat 5 CO2 sensor has the same intended use as the predicate device. For reference, the intended use of the Mercury Module with Capnostat 5 CO2 sensor is to provide spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).
Technological Characteristics The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO ¿ during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 21 2009
Mr. Kevin Mader Manager of Quality Assurance and Regulatory Affairs Respironics Novametrix, Incorporated 5 Technology Drive Wallingford, Connecticut 06492-1950
Re: K092217
Trade/Device Name: Mercury Module with Capnostat 5 Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: II Product Code: BZK, CCK Dated: July 20, 2009 Received: July 22, 2009
Dear Mr. Mader:
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 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.
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Page 2 - Mr. Mader
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony C. Austin
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Respironics Novametrix LLC Modification to the Mercury Module with Capnostat 5 CO2 Sensor Special 510(k) - Device Modification
Section ii Indications for Use
1092217 510(k) Number (if known):
Device Name: Mercury Module with Capnostat 5
Indications for Use:
The intended use of the Mercury module with Capnostat 5 is to provide:
- spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-The -Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schuttm
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: k 092217
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).