The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.

The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner.

Device Description

The Model 512/53 Pulse Oximeters are designed for non-invasive measurement 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 successories to the Model 510 monitor. The Model 510 displays digital values of SpO2 and pulse rate. The Model 512/513 consists of a microprocessor based data acquisition system that measures oxygen saturation data. The Model 513 also contains additional circuitry to support battery backed trend data storage and retrieval. Data is stored in a 16Kbyte serial Flash RAM, with time and date retrieved from a separate serial real time clock. The trend data may be transferred serially to a printer or PC via an IRDA compatible chipset.

AI/ML Overview

Acceptance Criteria and Device Performance for Model 512/513 Pulse Oximeter

The provided document describes the predicate device equivalence of the Model 512/513 Pulse Oximeter, rather than a standalone study with defined acceptance criteria and performance metrics for the new device. The core of the submission relies on demonstrating that the Model 512/513 is substantially equivalent to the legally marketed Model 510 Pulse Oximeter and that its sensors meet the currently published accuracy specifications of the Model 510.

Therefore, the "acceptance criteria" for the Model 512/513 can be inferred as meeting or performing comparably to the Model 510's established accuracy specifications. The document does not explicitly state these numerical specifications for the Model 510, nor does it provide specific novel performance data for the Model 512/513 beyond stating that "inter-device comparison studies were conducted to establish the Model 512/513s accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 510."

However, based on the information provided, we can structure the response by inferring the likely acceptance criteria based on standard pulse oximetry requirements and what is typically tested for equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of explicit numerical acceptance criteria for the Model 512/513 in the provided text, and the reliance on demonstrating equivalence to the Model 510, the table below reflects this approach. The "Reported Device Performance" is derived from the statement that the device meets the predicate's specifications.

Acceptance Criterion (Inferred from Predicate Equivalence)	Reported Device Performance (Model 512/513)
Functional arterial oxygen saturation (SpO2) accuracy comparable to Model 510's published specifications	Sensors meet currently published accuracy specifications of the Model 510.
Pulse rate accuracy comparable to Model 510's published specifications	Sensors meet currently published accuracy specifications of the Model 510.
Non-invasive measurement capability	Designed for non-invasive measurement.
Ability to operate in specified patient populations (neonatal, pediatric, adult)	Intended for neonatal, pediatric, and adult patients.
Ability to operate in specified environments (hospital, hospital-type facilities, intra-hospital transport)	Intended for hospital, hospital-type facilities, and intra-hospital transport.
Use of identical SpO2 and pulse rate software algorithm as predicate device (Model 510)	Uses identical SpO2 and pulse rate software algorithm as the predicate device, Model 510.

Note: The FDA's Oximeter regulation (21 CFR 870.2700) typically requires accuracy testing against arterial blood gas (SaO2) measurements over a range of saturations (e.g., 70-100% SpO2), often using hypoxic challenge studies. The absence of these specific details indicates that the submission focuses on predicate equivalence through comparison studies, implying the Model 510 already met these regulatory standards.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "inter-device comparison studies were conducted," but details on the number of subjects, measurements, or data points are absent.
Data Provenance: Not explicitly stated. The document does not mention the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, it is highly probable these were prospective clinical studies, but this is not confirmed in the text.

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

Number of Experts: Not applicable/not stated in the context of expert review for ground truth in this submission. The ground truth for pulse oximetry accuracy studies is typically established through direct arterial blood gas (SaO2) measurements performed by trained medical personnel, not by a panel of experts reviewing images or other subjective data.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Pulse oximetry accuracy studies generally rely on direct physiological measurements (arterial blood gas analysis) as the gold standard, rather than expert adjudication of subjective assessments.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is assessed. This device is a measurement device, not an interpretive one.

6. Standalone Performance Study (Algorithm only without human-in-the-loop)

Standalone Study: Yes, in essence, the "inter-device comparison studies" to establish the Model 512/513's accuracy and ensure sensors meet published specifications of the Model 510 represent a standalone performance assessment of the device's measurement capabilities. While not using the explicit term "standalone study," the objective of these comparisons was to verify the device's inherent accuracy in measuring SpO2 and pulse rate, independent of a human interpreting its output.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for pulse oximetry accuracy is typically established by arterial blood gas (SaO2) measurements, which are considered the gold standard for arterial oxygen saturation. While not explicitly stated in the provided text, this is the standard methodology for validating pulse oximeter accuracy.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not stated. The document indicates that the Model 512/513 uses the "identical SpO2 and pulse rate software algorithm" as the predicate device, Model 510. This implies the algorithm was already developed and validated with the Model 510. There is no mention of a new algorithm requiring a separate training set for the Model 512/513, suggesting it leverages the existing, validated algorithm from the predicate device.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. As the Model 512/513 uses the identical algorithm from the predicate device (Model 510), any "training" would have occurred during the development of the Model 510. The document does not provide details on the training set or ground truth establishment for the Model 510's algorithm development. It focuses solely on the equivalence of the 512/513 to the already-cleared 510.

Summary

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AUG 2 3 2004

K032949

510(K) SUMMARY

July 27, 2004

Applicant's Name and Address a.
Respironics Novametrix, Inc. 5 Technology Drive Wallingford, CT 06492
b. Contact Person
Kevin Mader Q.A. and Regulatory Manager (203) 697-6466 (203) 284-0753 (facsimile)
c. Name of Device

Device Names (Proprietary/Trade Names):	Models 512/513 Pulse Oximeter
Device Name (Common Name):	Pulse Oximeter
Classification:	Class II, 21 C.F.R. 870.2700 / 74DQA

Equivalent Devices ರ
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, as well as testing to accepted industry standards. In addition, inter-device comparison studies were conducted to establish the Model 512/513s accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 510. The predicate device is as follows:
1. Model 510 Pulse Oximeter, Novametrix Medical Systems, Inc., K924626
Device Description e.

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f. Intended Use

The Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital-type facilities and intra-hospital transport. The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport. The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner. The intended use, patient population and environments of use are the same or similar to the predicate device, the Novametrix Model 510

g. Technological Characteristics

The Model 512/513 Pulse Oximeters measure 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 Models 512/513 use the identical SpO2 and pulse rate software algorithm to process the information from the sensor as the predicate device, Model 510 Pulse Oximeter, cleared under K924626.

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.

Kevin Mader Q.A. and Regulatory Manager

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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of three lines that resemble an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2004

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

Re: K032949

Trade/Device Name: Model 512/513 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 4, 2004 Received: August 5, 2004

Dear Mr. Malis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nate revealed 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 mendments, 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 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 NTV). It may of our 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. 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 incall that 117A has mace a detess and regulations administered by other Federal agencies. of the Act of ally i ederal states and equirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu fisting (21 CF ren 807), while systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality sign 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) This teller will and A you vegal finding of substantial equivalence of your device to a premaired predicated. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), II you desire specific at 120 to: Journee 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 may obtain 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,

Clus

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):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of The Model 012 Handreld Patiention and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.

The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive The Model 315 Transhild France to the line and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.

The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner

Prescription Use ど (Per 21 CFR 801.109) ાર

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sigg-Division of Anesthesiology, General Hospital, Infection Control, Dental De 510(k) Number

(Optional Format 1-2-96)

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).