Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Device Description

Nonin's® Model 7600 4-Channel Regional Oximeter System with Equanox™ Technology and Bluetooth® Wireless Technology and compatible sensors (8004CA, 8000CA) continuously monitor and record the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors. The system is comprised of three subsystems; sensor, patient oximetry device (pod) and 4-channel display unit.

The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches.

The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The pods then communicate the regional oxygen saturation readings and other data to the display unit.

The 4-channel display unit displays absolute real-time regional hemoglobin oxygen saturation (rSO2) numeric data and trend lines. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.

AI/ML Overview

The Nonin Medical, Inc. K102715 submission for the Model 7600 4-Channel Regional Oximeter System does not contain specific acceptance criteria or a detailed study description with reported device performance metrics in the provided document sections.

The document states that the device "successfully undergone extensive performance, electromagnetic, safety, clinical, environmental, and software testing to ensure that it has appropriate functional features and is substantially equivalent to the predicate devices." (Section 2) However, it does not elaborate on what constituted "successful" in terms of specific performance metrics or acceptance criteria.

The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of novel performance studies with specific statistical acceptance criteria.

Therefore, I cannot populate the table or provide answers to most of the requested points as the specific information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Not provided in the document.	The document states the device "successfully undergone extensive performance... testing," but does not provide specific performance metrics (e.g., accuracy, precision, bias) or how "successful" was defined.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective). The document only mentions "clinical" testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. 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

This information is not provided in the document. The device is a regional oximeter, not an AI-assisted diagnostic imaging device, so an MRMC study with human readers assisting AI would be out of scope for this type of device.

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

The device is an oximeter, which inherently functions as a "standalone" measurement device that provides output for human interpretation. The clinical testing mentioned would implicitly evaluate the algorithm's performance in generating these measurements. However, no specific "standalone study" with detailed methodology or results (like those seen for AI algorithms) is described. The document states it "continuously monitor[s] and record the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors," implying the device produces measurements independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated. For oximeters, the "ground truth" for oxygen saturation is typically established through co-oximetry of arterial blood samples. However, this specific method is not detailed in the provided text.

8. The sample size for the training set

This information is not provided in the document. Given that this is a 510(k) for a regional oximeter (a sensor and measurement device), rather than a machine learning algorithm that requires extensive training data, the concept of a "training set" in the context of AI/ML is likely not directly applicable here. The device's "training" would likely refer to the design and calibration process during manufacturing.

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

This information is not provided in the document. As noted above, the concept of a "training set" in the AI/ML sense is likely not applicable.

Summary

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K102715

SECTION 2. SUMMARY AND CERTIFICATION

DEC		2010
-----	--	------

A. 510(k) Summary	DEC 17 2010
Submitter:	Nonin Medical, Inc.
Contact Person:	Lori M. Mitchell RN, BSNClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443
Date Prepared:	September 17, 2010
Trade Name:	Model 7600 Regional Oximeter with Equanox™Technology and Bluetooth® Wireless Technology andcompatible Regional Sensors (Models 8004CA and8000CA)
Classification Name:and Number:	Class II, 21 CFR 870.2700
Product Code:	MUD
Predicate Device(s):	Nonin's Model 7600 4-Channel Regional Oximeter withEquanox™ Technology and Bluetooth® WirelessTechnology and compatible Regional Sensors (Models8004CA and 8000CA) are substantially equivalent to theNonin Medical, Model 7600 Regional Oximeter System(K090807), CAS Medical, Fore-Sight® Cerebral OximeterMC-2000 (K091452), Somanetics Corporation, INVOS®Model 5100B Adult/Pediatric Cerebral Oximeter(K051274).
Device Description:	Nonin's® Model 7600 4-Channel Regional OximeterSystem with Equanox™ Technology and Bluetooth®Wireless Technology and compatible sensors (8004CA,8000CA) continuously monitor and record the mixedarterial/venous blood oxygen levels through non-invasivenear-infrared spectroscopy sensors.The system is comprised of three subsystems; sensor,patient oximetry device (pod) and 4-channel display unit.

Nonin Medical Inc.

Model 7600 4-Channel Regional Oximeter System Traditional 510(K): Premarket Notification

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The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches.

Model 7600 4-Channel Regional Oximeter System:

Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (>40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Model 8004CA Regional Sensor:

Intended Use:

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room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Model 8000CA Regional Sensor:

Functional and Safety Testing:

Nonin's Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA) have successfully undergone extensive performance, electromagnetic, safety, clinical, environmental, and software testing to ensure that it has appropriate functional features and is substantially equivalent to the predicate devices.

Conclusion: Nonin's Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA) are substantially equivalent to the Nonin Medical, Model 7600 Regional Oximeter System (K090807), CAS Medical, Fore-Sight® Cerebral Oximeter MC-2000 (K091452), Somanetics Corporation, INVOS® Model 5100B Adult/Pediatric Cerebral Oximeter (K051274).

Nonin Medical Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

DEC 1 7 2010

Re: K102715

Trade/Device Name: Nonin Medical, Inc. Model 7600 4-Channel Regional Oximeter. With Equanox " Technology and Bluetooth Wireless Technology and Compatible Regional Sensors (Models 8004CA and 80000CA) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: September 17, 2010 Received: September 20, 2010

Dear Ms. Mitchell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Mitchell

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

um d. Rosas
for

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

102715

510(K) Number:

Device Name:

Nonin Medical, Inc. Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA)

Indications for Use:

Model 7600 Regional Oximeter System:

Model 8004CA Regional Sensor:

Model 8000CA Regional Oximeter Sensor:

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 Evanianos (RBB) ov. General Hospital
Nonin Medical Inc.	Infection Control, Dental DevicesModel 7600 4-Channel Regional Oximeter System Traditional 510(K): Premarket
	Notification510/k) Number: .3

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).