The Model 509M Pulse Oximeter Module is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. 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. The O2 saturation sensors are already legally marketed as accessories to the Model 2001 monitor. The Model 509M displays digital values of SpO₂ and pulse rate and transmits these values as well as the plethysmogram to a Philips Monitoring System via the VueLink Interface. The Model 509M module consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor is responsible for handling the user interface and communications with external devices via VueLink interface. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the algorithms which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

AI/ML Overview

The provided 510(k) summary for the K032755 (Model 509M Pulse Oximeter) does not contain a specific table of acceptance criteria or detailed results from a study proving device performance against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device (Model 2001 Pulse Oximeter, K993979, K000794) and mentions "inter-device comparison studies" to establish accuracy and sensor compatibility.

However, based on the information provided, we can infer some aspects related to acceptance criteria and the nature of the "study."

Here's an attempt to structure the information, acknowledging the limitations of the provided document:

Acceptance Criteria and Study for K032755 (Model 509M Pulse Oximeter)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., specific SpO2 accuracy ranges with mean absolute difference (MAD) or root mean square (RMS) error). However, it implies that the device is expected to meet the accuracy specifications of its legally marketed sensors, which were previously cleared with the predicate device (Model 2001).

Acceptance Criteria (Inferred)	Reported Device Performance
SpO2 Accuracy: Meet published accuracy specifications of the existing SpO2 sensors when used with the Model 509M. Equivalent to the predicate device (Model 2001 Pulse Oximeter).	Accuracy Not Quantified Directly: "Inter-device comparison studies were conducted to establish the Model 509Ms accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." The Model 509M uses the "identical SpO2 and pulse rate software algorithm" as the predicate device, Model 2001.
Pulse Rate Accuracy: Equivalent to the predicate device (Model 2001 Pulse Oximeter).	The Model 509M uses the "identical SpO2 and pulse rate software algorithm" as the predicate device, Model 2001.
Performance during no motion and motion conditions: Maintain accuracy during these conditions.	Intended for use "during both no motion and motion conditions." (Verification of this performance is implied by the equivalence claim).
Performance for well or poorly perfused patients: Maintain accuracy for these patient types.	Intended for use with "patients who are well or poorly perfused." (Verification of this performance is implied by the equivalence claim).
Patient Population: Operate equivalently across neonatal, pediatric, and adult patients.	Intended for use in "neonatal, pediatric and adult patients." (Verification of this performance is implied by the equivalence claim).

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

Sample Size: The document does not specify the sample size for the "inter-device comparison studies."
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It just states "inter-device comparison studies were conducted."

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

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the "inter-device comparison studies." For pulse oximeters, ground truth for SpO2 typically involves co-oximetry of arterial blood samples, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe any human interpretation or adjudication process for establishing ground truth or evaluating device performance. For pulse oximetry, the ground truth is typically a direct physiological measurement, not an adjudicated expert opinion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. The Model 509M is a physiological monitoring device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone evaluation of the device's accuracy was implicitly done through the "inter-device comparison studies." The summary states these studies were conducted "to establish the Model 509Ms accuracy" and "to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This refers to the device's ability to accurately measure SpO2 and pulse rate, independent of a human operator's interpretation of its output.

7. The type of ground truth used

The type of ground truth used for pulse oximeter accuracy studies is typically co-oximetry of arterial blood samples. While not explicitly stated in this summary, this is the standard for SpO2 accuracy validation, and it is implied that the "inter-device comparison studies" would have referred to such objective physiological measurements for establishing accuracy reference.

8. The sample size for the training set

The document states: "The Model 509M uses the identical SpO2 and pulse rate software algorithm to process the information from the sensor as the predicate device, Model 2001 Pulse Oximeter, cleared under K993979 and K000794." This implies that the algorithm itself has been previously developed and validated with the predicate device. The summary does not provide any information regarding a training set specifically for the Model 509M, as it utilizes an existing, cleared algorithm.

9. How the ground truth for the training set was established

Since the Model 509M uses an "identical" algorithm to the predicate device (Model 2001), the ground truth for any original algorithm development (what might be considered a "training set" for the algorithm itself) would have been established during the development and clearance of the Model 2001 Pulse Oximeter (K993979, K000794). This would typically involve co-oximetry of arterial blood samples across a range of oxygen saturations in human subjects, as per ISO or FDA guidance for pulse oximeters. The current submission does not describe this historical training data or its ground truth establishment, as it primarily relies on demonstrating equivalence and sensor compatibility for the new device variant.

Summary

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K032755

MAY 2 1 2004

510(K) SUMMARY

December 15, 2003

Applicant's Name and Address a.

Respironics Novametrix, Inc. 5 Technology Drive Wallingford, CT 06492

b. Contact Person

Michael J. Malis Q.A. and Regulatory Manager (203) 697-6442 (203) 284-0753 (facsimile)

Name of Device ပ

Device Names (Proprietary/Trade Names):	Model 509M Pulse Oximeter
Device Name (Common Name):	Pulse Oximeter
Classification:	Class II, 21 C.F.R. 870.270074DQA/74 DPZ

Equivalent Devices d.

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 509M, as well as testing to accepted industry standards. In addition, inter-device comparison studies were conducted to establish the Model 509Ms accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001. The predicate device is as follows:

Model 2001 Pulse Oximeter, Novametrix Medical Systems, Inc., K993979,K000794) 1.

Device Description e.

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The Model 509M is powered by an external DC power supply. Audible and visual alarms for high/low saturation and pulse rate are available. Visual alerts are provided as a status for highlow outdren and Philips monitor's display (providing the alarms on the Philips dipslay are not disabled) The Model 509M also includes a temporary (2 minute) and diseay are not alsublour, he other configurable settings. The Model 2001 Pulse Oximeter has visual indicators for pulse error conditions, and alarm silence.

Intended Use f.

The Model 509M Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 509M Pulse Oximeter and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician. The intended use, patient population and environments of use are the same or similar to the predicate device, the Novametrix Model 2001.

g. Technological Characteristics

The Model 509M Pulse Oximeter measures functional 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 and infrared 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, processed using proprietary algorithms and displayed as a numerical value for functional oxygen saturation and as a waveform, the plethysmogram.

The Model 509M uses the identical SpO2 and pulse rate software algorithm to process the information from the sensor as the predicate device, Model 2001 Pulse Oximeter, cleared under K993979 and K000794.

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 notice are truthful and accurate and no material fact has been omitted.

Michael Means

Michael J. Malis Q.A. and Regulatory Manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2004

Mr. Kevin Mader Manager of Quality Assurance and Regulatory Affairs Respironics Novametrix, Inc. 5 Technology Drive Wallingford, Connecticut 06492

Re: K032755

Trade/Device Name: Modcl 509M Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Codc: DQA, DPZ Dated: April 15, 2004 Received: April 19, 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 Amerouse over and 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 approvisions 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 (1 NET), to may of each 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.

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

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Page 2 -- Mr. Kevin Mader

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and hoting (21 CF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirements us bet form in all ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFX 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wifi are n you ve organ 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), If you desire specific at not to research (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 Inter State State 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,

Ches Chiu Lin, 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K032755

Model 509M Pulse Oximeter Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Usc:

The Model 509M Pulse Oximeter is intended to provide continuous, non-invasive monitoring The Model 505M F alse Oxinced is intended to protein neonatal, pediatric and adult patients of functional artenal oxygen saturation and for patients who are well or poorly perfused dultrig both no motion and motion ochalities and intra-hospital transport environments such as the in nospital, noopkar type for department and intensive care units.

Prescription Use_X (Part 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)

Söng Hams 5/20/2004

esthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number: K032755

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).