(56 days)
The intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
The Capnostat 5 CO2 sensor is designed for continuous, non-invasive monitoring of carbon dioxide .. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters are already legally marketed as accessories to the predicate device. The Capnostat 5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The Capnostat 5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the Capnostat 5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for NoO. O2 and barometric pressure.
This 510(k) submission describes a device modification to an existing CO2 sensor, the Capnostat 5 CO2 sensor. The core of the submission is about demonstrating that the modified device is substantially equivalent to its predicate device (Capnostat III sensor in Tidal Wave Sp. Model 710/715 [510(k) K032971]). For devices like this, the "acceptance criteria" are typically related to performance specifications that show the device functions as intended and is safe and effective, similar to the predicate. The study would then demonstrate that these specifications are met.
However, the provided text does not contain a detailed study section with explicit acceptance criteria, results, and specific study parameters like sample sizes, expert qualifications, or ground truth methods. The document is primarily a 510(k) summary, which focuses on describing the device, its intended use, and its technological characteristics in comparison to a predicate device. It confirms substantial equivalence based on these characteristics and mentions that the device is a modification.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will explain why each field cannot be filled, or what can be inferred if any information is available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. | Not provided in the document. |
| (Typically, this would include accuracy, precision, response time, stability, etc. for CO2 measurement in various clinical scenarios, often compared to a gold standard or the predicate device's performance.) | (The document states the device measures CO2 using IR absorption and calibrates to accurately reflect CO2 concentration, but gives no specific performance numbers.) |
Explanation: The document describes the technical function of the CO2 sensor (infrared absorption, beam splitter, pulsed IR source, calibration to a known CO2 concentration) but does not provide specific numerical acceptance criteria or performance results from any studies. For a device modification of this nature, performance data (e.g., accuracy against a known gas mixture, stability over time, performance in different temperature/humidity conditions) would typically be part of the supporting documentation but is not included in this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not provided.
- Data Provenance: Not provided.
Explanation: No specific performance study data, including sample sizes or data provenance (e.g., whether a clinical study was performed, and if so, where and when), is mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not provided.
- Qualifications of Experts: Not applicable/Not provided.
Explanation: This type of device (CO2 sensor) typically doesn't use human expert ground truth in the way an imaging AI algorithm would. Its ground truth would be established by reference gas mixtures or another highly accurate, independently verified CO2 measurement device. No details on such a "ground truth" establishment are provided, nor are human experts relevant for this specific device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not provided.
Explanation: As explained above, human expert adjudication methods are not typically used for establishing ground truth for a CO2 sensor's performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No.
Explanation: This is a hardware CO2 sensor, not an AI diagnostic tool that assists human readers with interpretation. Therefore, a MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Partially yes, but specific study details are not provided.
Explanation: The device itself is designed for standalone measurement of CO2. The description focuses on its technical mechanism (IR absorption, calibration) which implies standalone performance is its primary function. However, no specific "standalone study" with quantifiable results is documented in this summary. The device's performance is inherently "standalone" in how it acquires and processes CO2 data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated, but for this type of device, it would typically be a reference gas analyzer or known, certified CO2 gas mixtures.
Explanation: The text mentions "To calibrate, the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory." This implies that the ground truth for calibration (and by extension, for evaluating accuracy) comes from controlled, known CO2 concentrations.
8. The sample size for the training set
- Sample Size: Not applicable/Not provided.
Explanation: This device is a hardware sensor with embedded firmware, not a machine learning model that undergoes a "training set" in the conventional AI sense. Its calibration is done at the factory with known CO2 concentrations, but this is a calibration process, not a machine learning training process.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable/Not provided in terms of a "training set" for AI.
Explanation: As mentioned above, the concept of a "training set" and associated ground truth establishment for AI models does not directly apply to this device. Its accuracy is established through calibration against known CO2 concentrations, which serves a similar function to ground truth validation in a traditional engineering context.
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Respironics Novametrix LLC Capnostat 5 CO2 Sensor Special 510(k) - Device Modification
NOV 1 9 2004
Section iv - 510 (k) Summar
[ Refer to 21 C.F.R § 807.92 ]
- Submitted by: Respironics Novametrix, LLC 5 Technology Drive Wallingford, CT 06492
- Kevin Mader Contact Person: Q.A. and Requiatory Manager Phone: 203-697-6466
- Date Prepared: 9/22/2004
- Capnostat 5 CO2 sensor Proprietary Name:
- Common Name: CO2 sensor
- Classification Name: Class II, 21 C.F.R 868.1400
- Capnostat III sensor in Tidal Wave Sp. Model 710/715 [510(k) K032971] Predicate Device:
Description of Device: The Capnostat 5 CO2 sensor is designed for continuous, non-invasive monitoring of carbon dioxide .. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters are already legally marketed as accessories to the predicate device. The Capnostat 5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The Capnostat 5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the Capnostat 5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for NoO. O2 and barometric pressure.
- Intended Use of the Device: This sensor has the same intended use as the predicate device. For reference, the intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
Technological Characteristics. Capnostat 5 CO2 sensor is a mainstream CO2 sensor that attaches to an airway adapter (also referred to as a cuvette) and in which the patient's inspired and expired breath passes. The airway adapter is attached to a mouthpiece or mask, or to the breathing circuit between the endotracheal tube and ventilator circuit wye, if the patient is intubated. It is designed to use neonatal and adult CO2 airway adapters. The Capnostat CO2 sensor uses an infrared absorption (IR) technique for monitoring CO2. IR based methods have endured and evolved in the clinical setting for over two decades, and remain the most popular and versatile technique today. The principle is based on the fact that CO2 molecules
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absorb infrared light energy at specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When the IR light beam is passed through a gas sample containing CO2, the electronic signal from the photodetector can be obtained. This signal is then compared to the energy of the IR source, and calibrated to accurately reflect CO2 concentration in the sample. To calibrate, the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory. Solid state CO2 sensors (such as the Capnostat) use a beam splitter to simultaneously measure the IR light at two wavelengths: one which is absorbed by CO2 and one which is not. The wavelength which is not absorbed by CO2 is related to the intensity of the IR light source. Also, the IR light source is electronically pulsed (rather than interrupting the IR beam with a chopper wheel) in order to eliminate effects of changes in electronic components.
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with its wings spread, facing to the right. The image is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Mr. Kevin Mader Manager of Quality Assurance and Regulatory Affairs Respironics Novametrix, Incorporated 5 Technology Drive Wallingford, Connecticut 06492-1950
Re: K042601
Trade/Device Name: Capnostat 5 CO2 Sensor Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 1, 2004 Received: November 2, 2004
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 such 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 Eederal 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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clair Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section ii Indications for Use
KO42601 ______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):
Device Name: Capnostat 5 CO2 Sensor
Indications for Use:
The intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
X 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)
Aure Sylvion
(Division Sign(Off) (Division SignQlil)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number. K
Page 1 of
§ 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).