The Tidal Wave Models 710/715 handheld combined pulse oximeter/capnograph are designed for continuous, non-invasive monitoring of carbon dioxide and functional oxygen saturation. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and O2 saturation sensors are already legally marketed as accessories to the Model 610 and Model 510 monitors, respectively. The TidalWave Sp monitor is a microprocessor based data acquisition system consisting of CO2 and SpO2 measurement, control circuitry and a high speed serial interface. The monitor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the TidalWave Sp monitor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tidal Wave Sp, Models 710/715 device. It's important to note that the provided document is a 510(k) summary (K032971) which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with all the specific data points requested in your prompt. Therefore, some of the information you asked for may not be explicitly stated or not applicable in this type of submission.

Acceptance Criteria and Device Performance for Tidal Wave Sp, Models 710/715

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria in a formal table like a performance specification. Instead, it states that "inter-device comparison studies were conducted to establish the TidalWave Sp accuracy and to ensure that the sensors meet their currently published accuracy specifications with the specified predicate devices."

The key performance indicators are implied to be accuracy for CO2 measurement and accuracy for SpO2 and pulse rate measurement.

Performance Metric	Acceptance Criteria (Implied/General)	Reported Device Performance
CO2 Measurement Accuracy	Accuracy comparable to predicate devices (Tidal Wave Model 610, CO2SMO Model 7100). Meet currently published accuracy specifications.	Achieved through "inter-device comparison studies" against predicate devices. The document implies that the device's accuracy meets or is equivalent to the established accuracy of the predicate devices, as it states the device operates on "infrared absorption (IR) technique for monitoring CO2" which "have endured and evolved in the clinical setting for over two decades." and is based on "its response to a known concentration of CO2 is stored in the monitor at the factory."
SpO2 and Pulse Rate Measurement Accuracy	Accuracy comparable to predicate devices (Spot Check Model 510). Meet currently published accuracy specifications for sensors.	Achieved through "inter-device comparison studies" against predicate devices. Explicitly states: "The Models 710/715 use the identical SpO2 and pulse rate software algorithms to process the information from the sensor as the predicate device, Model 510 Pulse Oximeter, cleared under K924626."
Functional Equivalence	Same intended use, patient population, and environments of use as predicate devices.	Demonstrated through comparison of product features, labeling, and promotional literature, and confirmed by testing to accepted industry standards. (This is a general statement from the summary, not a specific performance metric about accuracy).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (number of patients or measurements) used for the "inter-device comparison studies."

Data Provenance: Not explicitly stated, but the submission is from Respironics Novametrix, Inc. in Wallingford, CT, USA. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted in a controlled environment, potentially with healthy volunteers or clinical patients. The studies were retrospective in the sense that they were comparing the new device's performance against established predicate devices rather than observing real-world outcomes over a long period.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the summary. For devices like pulse oximeters and capnographs, the "ground truth" for accuracy is typically established by using highly accurate, calibrated reference measurement devices (e.g., co-oximeters for SpO2, calibrated gas analyzers for CO2) rather than expert consensus.

4. Adjudication Method for the Test Set

This is not applicable and not mentioned. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or clinical data, and their interpretations need to be reconciled to establish a ground truth. For objective physiological measurements like CO2 and SpO2, adjudication by experts is not the standard method for establishing ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or reported. MRMC studies are primarily relevant for AI-powered diagnostic tools interpreting complex medical data where human readers are involved. This device is a physiological monitor providing objective measurements, not an interpretative AI tool that assists human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation of the device's algorithms was implied and conducted as part of the "inter-device comparison studies." The device's SpO2 and pulse rate algorithms are explicitly stated to be "identical" to the predicate device (Model 510 Pulse Oximeter). The CO2 algorithm is based on established IR absorption linearity and factory calibration to known concentrations. The "accuracy" reported for these measurements is inherently the standalone performance of the device's algorithms and sensors against reference standards.

7. Type of Ground Truth Used

Based on the description of the devices (pulse oximeter/capnograph):

For CO2: Ground truth would typically be established using calibrated gas analyzers with known CO2 concentrations. The document mentions "the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory," implying calibration against such standards.
For SpO2: Ground truth would typically be established using laboratory co-oximetry (or similar invasive arterial blood gas analysis) which is considered the gold standard for measuring fractional oxygen saturation in blood.
For Pulse Rate: Ground truth would likely be established using simultaneous ECG monitoring or other highly accurate cardiac rhythm detection methods.

8. Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The Tidal Wave Sp is described as a traditional physiological monitor, not an AI/machine learning device that relies on a "training set" in the modern sense. Its algorithms are based on established biophysical principles (infrared absorption, light absorption by hemoglobin) and fixed factory calibrations, not statistical learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of modern AI/ML for this device, this question is not applicable. The device's operational parameters and calibration are set at the factory based on known physical properties and reference standards (e.g., known CO2 concentrations, specific light absorption properties of hemoglobin).

Summary

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(K032971

AUG 2 6 2004

510(K) SUMMARY

September 3, 2003

Applicant's Name and Address a.
Respironics Novametrix, Inc. 5 Technology Drive Wallingford, CT 06492
Contact Person b.
Michael J. Malis Q.A. and Regulatory Manager (203) 697-6442 (203) 284-0753 (facsimile)
Name of Device C.

Device Names (Proprietary/Trade Names):	Tidal Wave Sp, Models 710/715
Device Name (Common Name):	pulse oximeter/carbon dioxide monitor
Classification:	Class II, 21 C.F.R. 870.2700Class II, 21 C.F.R. 868.1400

Equivalent Devices

Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for the Model 512/513, and TidalWave Model 610 as well as testing to accepted industry standards. In addition, inter-device comparison studies were conducted to establish the TidalWave Sp accuracy and to ensure that the sensors meet their currently published accuracy specifications with the specified predicate devices. The predicate devices are as follows:

Tidal Wave Model 610 (510(k) No. K963327) dated 11/20/1996
CO2SMO, Model 7100 (510(k) No. K920379/A), dated 07/15/1992
Spot Check Model 510 (510(k) No. K924626), dated 12/03/1993.

Device Description e.

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f. Intended Use

The intended use of the TidalWave Sp (Models 710/715) is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care. Separate airway adapters are provided for pediatric/adult and neonatal/pediatric use. The TidalWave Sp (Models 710/715) and its airway adapters and sensors are intended to be used by trained operators when capnographic and/or pulse oximetry monitoring is required in the iudgement of a physician. The intended use, patient population and environments of use are the same or similar to the predicate devices

g. Technological Characteristics

The TidalWave Sp is a combination of the current Novametrix Tidal Wave capnography and Model 510 pulse oximeter. As with the Tidal Wave, the TidalWave Sp measures CO2 with the Capnostat CO2 sensor. In mainstream mode the Capnostat sensor 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. In sidestream mode, a sample from the patient is drawn into a sidestream cuvette attached the TidalWave Sp monitor to which the Capnostat is affixed to. The pulse oximetry parameters which are directly measured and computed by the TidalWave Sp include oxygen saturation and pulse rate.

The TidalWave Sp 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 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.

The TidalWave Sp measures oxygen saturation and pulse rate with sensors that contain red and infrared light sources. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation. The light energy from red (660 nm) and infrared (940 nm) LEDs is beamed through a sample cell- a pulsating vascular bed, the patient's finger or toe for example. The remaining light energy not absorbed by the sample cell reaches a photodiode, on the opposing side of the sensor. The signal received by the photodiode is split into its red and infrared components, sampled, software filtered, and displayed as a numerical value for functional oxygen saturation and as a waveform, the plethysogram.

Pulse rate is calculated by measuring the time interval between the peaks of the infrared light waveform. The Models 710/715 use the identical SpO2 and pulse rate software algorithms to process the information from the sensor as the predicate device, Model 510 Pulse Oximeter, cleared under K924626.

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h. Certification Statement

In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:

Respironics Novametrix, Inc. believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.

Mr. Machi

Michael J. Malis Q.A. and Regulatory Manager

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Mr. Michael J. Malis Quality Assurance and Regulatory Manager Respironics Novametrix, Incorporated 5 Technology Drive Wallingford, Connecticut 06492

Re: K032971

Trade/Device Name: Tidal Wave SP, Model 710/715 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 20, 2004 Received: August 23, 2004

Dear Mr. Malis:

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 Federal Register.

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Page 2 - Mr. Malis

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 (301) 594-4646. 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,

Chis 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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K032971 510(k) Number (if known):

Device Name:

Indications For Use:

Prescription Use_ X (Per 21 CFR 801.109)

ીરર Over-The-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number: K032471

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).