The Nonin® Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

Device Description

The Model 7500FO display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Model 7500FO can be powered externally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack.

The Model 7500FO includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor alarm, user defined defaults, real-time data outputs, and patient security mode. Nonin's fiber optic sensors and cables contain no conductive components, they can safely be placed on the patient's finger while inside an MR (magnetic resonance) environment.

AI/ML Overview

Here's an analysis of the provided text regarding the Nonin® Model 7500FO Digital Pulse Oximeter, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K071415) does not explicitly state specific numerical acceptance criteria for the device's performance in terms of accuracy (e.g., A_rms values, bias, precision for SpO2 or pulse rate). It broadly states that the device "successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device."

Without explicit acceptance criteria in the document, it's impossible to create a table directly comparing them to reported performance. The document focuses on establishing substantial equivalence to a predicate device (Nonin Model 8604FO Pulse Oximeter and Fiber Optic Sensor, K910001). This implies that the performance of the Model 7500FO is expected to be comparable to that of the predicate device, which would have had its own established performance characteristics.

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

Sample Size: The document does not specify the numerical sample size (number of patients or data points) used for the clinical testing. It only states "clinical testing."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that Nonin Medical, Inc. is based in Minnesota, USA, it is likely that the clinical study was conducted in the USA and was prospective, as is typical for device approval studies. However, this is an inference, not explicitly stated.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any clinical testing. For pulse oximeters, the ground truth for SpO2 is typically established through arterial blood gas analysis (co-oximetry), which does not inherently involve expert consensus in the same way as image interpretation.

4. Adjudication Method for the Test Set

The concept of "adjudication method" (e.g., 2+1, 3+1) is primarily relevant for studies involving subjective human interpretation of data, particularly in medical imaging where multiple readers may review cases. For a device like a pulse oximeter, which provides a direct physiological measurement, adjudication methods are not applicable in the traditional sense. The comparison would be between the device's output and the objective ground truth (e.g., co-oximetry).

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are used to compare the diagnostic accuracy of different methods (e.g., imaging modalities or AI algorithms) when interpreted by multiple human readers, often involving a human-in-the-loop component. This device is a standalone physiological monitor, not an interpretive diagnostic tool that involves human readers in its primary function.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the testing described is inherently a standalone performance study. The Model 7500FO Digital Pulse Oximeter is a device that provides measurements (SpO2 and pulse rate) directly. Its performance is evaluated by comparing its output against a reference standard (ground truth), not by how it aids a human interpreter. The "clinical testing" mentioned would assess the algorithm's ability to accurately measure SpO2 and pulse rate on patients without human intervention in the measurement process itself, beyond proper sensor placement.

7. Type of Ground Truth Used

For pulse oximeters, the universally accepted "ground truth" for oxygen saturation (SpO2) is arterial blood gas analysis (co-oximetry). This involves drawing arterial blood and analyzing it with a co-oximeter to determine the actual arterial oxygen saturation (SaO2). The pulse oximeter's readings (SpO2) are then compared to these SaO2 values. The document doesn't explicitly state "co-oximetry" but this is the standard method for establishing ground truth for oximeters. For pulse rate, the ground truth could be established via ECG or a manual pulse count.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This suggests one of two possibilities:

The device's underlying algorithms were developed and validated internally by Nonin using proprietary data, and this information is not typically part of a 510(k) submission unless specifically requested or deemed critical to substantial equivalence beyond the predicate.
The device's core technology and algorithms are sufficiently similar to the predicate device, or are based on established biophysical principles, such that a separate, explicitly defined "training set" for the purpose of this 510(k) submission was not deemed necessary to describe.

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

Since no training set is mentioned, no information is provided on how its ground truth was established.

Summary

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SECTION 2. SUMMARY AND CERTIFICATION fight 1 of 2

A.

Submitter:	Nonin Medical, Inc.
Contact Person:	Lori M. RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443	AUG - 8 2007
Date Prepared:	May 18, 2007
Trade Name:	Model 7500FO Digital Pulse Oximeter
Classification Name:and Number:	Class II, 21 CFR 870.2700
Product Code:	DQA
Predicate Device(s):	Nonin's Model 7500FO is substantially equivalent to theModel 8604FO Pulse Oximeter and Fiber Optic Sensormanufactured by Nonin Medical, Inc. that was cleared bythe FDA under K910001 on 7/1/91.
Device Description:	The Nonin® Model 7500FO Digital Pulse Oximeter is aportable, tabletop device indicated for use in measuring,displaying, and recording functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate of adult,pediatric, and infant patients in an MR environment.Testing was performed in MR conditional environments at1.5T and 3T. It is indicated for spot-checking and / orcontinuous monitoring of patients who are well or poorlyperfused.The Model 7500FO display uses light-emitting diodes(LED) components to present patient's SpO2 and pulse ratevalues, as well as alarm limit and volume settings. TheModel 7500FO can be powered externally with a 12 VDC1.5A AC adapter or with an integral sealed 7.2-voltrechargeable NiMH battery pack.The Model 7500FO includes adjustable audible and visualpulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low

K071415

page 1 of 2

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	battery alarms, sensor alarm, user defined defaults, real-time data outputs, and patient security mode.Nonin's fiber optic sensors and cables contain noconductive components, they can safely be placed on thepatient's finger while inside an MR (magnetic resonance)environment.
Intended Use:	The Nonin® Model 7500FO Digital Pulse Oximeter is aportable, tabletop device indicated for use in measuring,displaying, and recording functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate of adult,pediatric, and infant patients in an MR environment.Testing was performed in MR conditional environments at1.5T and 3T. It is indicated for spot-checking and / orcontinuous monitoring of patients who are well or poorlyperfused.
Functional andSafety Testing:	Nonin's Model 7500FO Pulse Oximeter and fiber opticsensor have successfully undergone both bench and clinicaltesting in order to demonstrate that it has appropriatefunctional features and is substantially equivalent to thepredicate device.
Conclusion:	Nonin's Model 7500FO is substantially equivalent to theModel 8604FO Pulse Oximeter manufactured by NoninMedical, Inc. and cleared by the FDA under K910001 on7/01/91.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circle around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG = 8 2007

Ms. Lori M. Roth Clinical Regulatory Specialist Nonin Medical, Incorporated 13700 15t Avenue North Plymouth, Minnesota 55441-5443

Re: K071415

Trade/Device Name: Model 7500FO Digital Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 18, 2007 Received: May 21, 2007

Dear Ms. Roth:

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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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) 276-0115. 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/industry/support/index.html.

Sincerely vours.

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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Indications for Use Statement

510(K) Number:	K071415
----------------	---------

Device Name:

Model 7500FO Digital Pulse Oximeter

Indications for Use:

ision Sign-Off) (uchnar B.C.) Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices (10(k) Number:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nonin Medical Inc.

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).