Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Device Description

The 6500MA (wrap-around model) and 6500SA (interlocking model) are fingertip single-patient use disposable, transmittance sensors. They are comprised of a lamination of two foams (patient contact side and external side) with the optical components and a malleable wire within the lamination. The optical components are identical to the currently marketed Model 7000 single-patient use disposable sensor. The sensors are compatible with all Nonin-branded pulse oximeters.

AI/ML Overview

This is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a new device's absolute performance. Therefore, many of the requested details about specific study methodologies (like sample size for training sets, adjudication, or MRMC studies) are not present in this type of document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)
SpO2 Accuracy (Arms) (70-100%): $\pm$ 3 digits	SpO2 Accuracy (Arms) (70-100%): $\pm$ 2 digits
SpO2 Low Perfusion Accuracy (Arms) (70-100%): $\pm$ 3 digits	SpO2 Low Perfusion Accuracy (Arms) (70-100%): $\pm$ 2 digits
Pulse Rate Accuracy (Arms) (18-300 BPM): $\pm$ 3 digits	Pulse Rate Accuracy (Arms) (18-300 BPM): $\pm$ 3 digits
Low Perfusion Pulse Rate Accuracy (Arms) (40-240 BPM): $\pm$ 3 digits	Low Perfusion Pulse Rate Accuracy (Arms) (40-240 BPM): $\pm$ 3 digits

Study Proving Device Meets Acceptance Criteria:

The document states: "Nonin's Model 6500 sensor series have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility."

The table above demonstrates that the subject device (Model 6500 Sensor Series) meets or exceeds the performance criteria of the predicate device (Model 7000 Sensor Series) for SpO2 accuracy, and matches it for pulse rate accuracy. This forms the basis of the substantial equivalence claim.

Missing Information (Based on the Provided Text):

The following information is not detailed in the provided 510(k) summary:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "clinical testing" but does not provide details on the sample size of the test set, its provenance, or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the oximeter readings to arterial blood gas measurements (co-oximetry) in induced hypoxia studies, often without "experts" in the traditional sense for reading images, but rather with clinical staff performing procedures and measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
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: Not applicable. This is a pulse oximeter sensor, not an AI diagnostic device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is an algorithm (oximeter) and sensor, so its performance is standalone in the context of its function. However, the exact methodology for this standalone performance (e.g., how the clinical test dataset was used to derive the accuracy metrics) is not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For SpO2 accuracy, the ground truth is typically arterial blood gas analysis with co-oximetry, under controlled desaturation conditions, which is considered the gold standard for SpO2. This is implied by the standard ISO 9919:2005 for oximeters, but not explicitly stated as the method for this specific study.
The sample size for the training set: Not applicable or not specified. Pulse oximeters generally use established algorithms based on optical properties of blood, rather than machine learning training sets in the modern sense.
How the ground truth for the training set was established: Not applicable or not specified.

Summary

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K093306

510(k) Summary

Submitter:	Nonin Medical, Inc.	MAR - 4 2010
Contact Person:	Lori M. RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443
Date Prepared:	October 22, 2009
Trade Name:	Oximeter Sensor
Classification Name:and Number:	Class II, 21 CFR 870.2700
Product Code:	74 DQA
Predicate Device(s):	Nonin's 7000 sensor as cleared in the following 510(K)submissions: Model 7500 (K07128 cleared on July 12, 2007),Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model9600 (K023044 cleared on July 23, 2003), Model 2500A (K050056cleared on June 21, 2005), and Model 2500 (K002690 cleared onOctober 11, 2000).
Device Description:	The 6500MA (wrap-around model) and 6500SA (interlockingmodel) are fingertip single-patient use disposable, transmittancesensors. They are comprised of a lamination of two foams(patient contact side and external side) with the opticalcomponents and a malleable wire within the lamination. Theoptical components are identical to the currently marketed Model7000 single-patient use disposable sensor. The sensors arecompatible with all Nonin-branded pulse oximeters.
Intended Use:	Nonin's Models 6500MA and 6500SA Single-Patient UseDisposable Pulse Oximeter Sensors are indicated for non-invasivespot-checking and/or continuous monitoring of adult andpediatric patients who are well or poorly perfused, weighinggreater than 60 pounds (30 kilograms). It is intended for use inenvironments including operating room, surgical recovery, criticalcare, emergency room, long-term care, home use and mobileenvironments.

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Functional and Safety Testing:

Nonin's Model 6500 sensor series have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility.

Substantial Equivalence:

	Predicate DeviceModel 7000 Sensor Series	Subject DeviceModel 6500 Sensor Series
Patient Population:	Adult/Pediatric (weighing > 30kilograms)	Same
Sensor Application Site:	Fingers	Same
Patient Use/Reuse:	Disposable	Same
Sterility:	Non-sterile	Same
Measurement Technique:	Fingertip transmittance sensor	Same
SpO2 Accuracy (Arms) (70-100%):	$\pm$ 3 digits	$\pm$ 2 digits
SpO2 Low Perfusion Accuracy(Arms) (70-100%):	$\pm$ 3 digits	$\pm$ 2 digits
Pulse Rate Accuracy (Arms)(18-300 BPM):	$\pm$ 3 digits	Same
Low Perfusion Pulse RateAccuracy (Arms) (40-240BPM):	$\pm$ 3 digits	Same
Red:Infrared:	660 nm @ 0.8 mW maximumaverage power910 nm @ 1.2 mW maximumaverage power	Same
Operating:	0 o to +40o C (32o F to 104o F)	Same
Storage/Transportation:	-30o to +50o C (-22o F to 122o F)	-30o to +70o C (-22o F to 158o F)
Operating:Storage/Transportation:	10 to 90% non-condensing10 to 95% non-condensing	Same
Sensor Housing:	Microfoam	Polyurethane, cross-linkedpolyester foam,polyethylene/polyurethane,polyester with adhesive

Conclusion:

Nonin's Model 6500 sensor series is substantially equivalent to Nonin's Model 7000 sensors when used with Nonin-branded Pulse Oximeters monitors.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

MAR - 4 2010

Re: K093306

Trade/Device Name: Model 6500 Sensor Series Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 1, 2010 Received: February 4, 2010

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 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 – Ms. Roth

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

far

Anthony D. Watson, B.S., M.S., M.B.A. 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 (if known)	K093306
Device Name	Nonin Medical, Inc. Model 6500 Sensor Series
Indications for Use	Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

510(k) Number (if known)

K093306

Device Name

Nonin Medical, Inc. Model 6500 Sensor Series

Indications for Use

Prescription Use _ X (Part 21 CFR 801 Subpart D)

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)

L. Schultetus

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

510(k) Number:

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).