The noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual.

Device Description

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for oxyhemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. This method of "spatial resolution" also allows estimation of scattering to improve measurement accuracy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SOMANETICS OxyAlert NIRSensors (models IS-C and IS-S accessories) for use with the INVOS 5100C System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit performance acceptance criteria in terms of specific numerical thresholds (e.g., accuracy, sensitivity, specificity). The core acceptance criterion is that the new sensors are as safe and effective as the predicate device.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device (INVOS® 5100C Cerebral/Somatic Oximeter System, K082327)	"Performance data demonstrates that the new photodiodes are as safe and effective as the predicate."
No New Questions of Safety or Effectiveness	"The change in photodiodes does not raise any new questions of safety or effectiveness."
Same Intended Use and Indications	Explicitly stated: "The new sensors have the same intended use and indications..."
Same Principles of Operation	Explicitly stated: "...principles of operation..."
Same Technological Characteristics	Explicitly stated: "...and technological characteristics as the predicate device."

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

Sample Size: Not explicitly stated in the provided text. The document only mentions "Bench testing." There's no information on the number of subjects or samples used in this bench testing.
Data Provenance: Not explicitly stated. The nature of "bench testing" suggests it was likely controlled laboratory testing. There's no mention of country of origin, nor whether the data was retrospective or prospective.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

Given that the study was "bench testing" for a device measuring regional hemoglobin oxygen saturation, the ground truth would likely involve a validated reference measurement instrument or method, rather than expert interpretation of images or clinical assessments by human experts in the typical sense.

4. Adjudication Method for the Test Set:

Adjudication Method: Not mentioned. The nature of "bench testing" typically involves direct comparison to a reference standard, rather than adjudication of human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This is not an AI-assisted diagnostic or interpretative device; it's a physiological monitoring sensor.
Effect Size of AI Improvement: Not applicable, as this is not an AI device designed to assist human readers in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is a sensor and monitoring system. Its primary function is to measure physiological parameters directly. The "performance data" mentioned refers to the device's ability to accurately measure these parameters. As such, the performance described is akin to a standalone performance for the sensor, comparing its output to a known reference. However, it's not an "algorithm only" device in the sense of image analysis software; it's a hardware sensor that produces data based on its measurement principles.

7. The Type of Ground Truth Used:

Ground Truth: The document states "Bench testing is submitted demonstrating the substantial equivalence of the new sensors with modified photodiodes for the stated indication." For a "two wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue," the ground truth for "performance data" would typically involve:
- Reference Oximetry or Spectroscopy: Comparison against a gold standard or a highly accurate reference oximeter/spectrometer under controlled conditions.
- Simulated Tissues or Phantoms: Use of known optical properties in phantoms to verify measurement accuracy.
- In-vitro testing: Testing under laboratory conditions with known concentrations of oxyhemoglobin and deoxyhemoglobin.
  The document does not specify which type of ground truth was used, only that performance data was submitted from "bench testing."

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable/not mentioned. This device is not described as using a machine learning or AI model that requires a "training set" in the conventional sense. The "bench testing" described is for validation and verification against a predicate device and known measurement principles, not for algorithm training.

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

Ground Truth for Training Set: Not applicable, as there is no mention of a training set or machine learning algorithm.

Summary

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SOMANETICS OxyAlert NIRSensors SPECIAL 510(K) PREMARKET NOTIFICATUON .

Date of Submission:		K091224 510(k) Summary
	Device Trade Name:and IS-S
Device Common Name:
	Device Classification Name:Product Code MUD)
Submitted by:	1653 East Maple RoadTroy, MI 48083Phone: 248-689-3050Fax: 248-689-4272
Contact Person:	Ronald A. Widman248-526-5865rwidman@somanetics.com	Vice President, Medical Affairs
	Predicate Device:Oximeter System, K082327
Accessories	SPFBIS-CIS-S	Small Adult SomaSensor (>40 kg)Pediatric SomaSensor (<40 kg)Infant/Neonatal Cerebral OxyAlertNIRSensor (<40 kg)Infant/Neonatal Somatic OxyAlert
	RSC-1RSC-2RSC-3RSC-45100C-W5100C-M5100-FTD5100C-RS5100C-SA5100C-GCX5100C-TC5100C-USB312170VLI	NIRSensor (<40 kg)Reusable Sensor Cable Channel 1Reusable Sensor Cable Channel 2Reusable Sensor Cable Channel 3Reusable Sensor Cable Channel 4One-year Extension of Warranty5100C System Operations ManualField Test DevicePortable Mobile StandSwivel ArmMounting PlateTravel CaseUSB Flash DriveComputer Connection Serial CablePhilips VueLink Adaptor Cable

: ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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SOMANETICS OxyAlert NIRSensors SPECIAL 510(K) PREMARKET NOTIFICATION

्र

Indications for Use:	The noninvasive INVOS 5100C is intended for useas an adjunct monitor of regional hemoglobinoxygen saturation of blood in the brain or in othertissue beneath the sensor. It is intended for use inindividuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intendedfor use as an adjunct trend monitor of regionalhemoglobin oxygen saturation of blood in the brainor in other tissue beneath the sensor in anyindividual.
Predicate Device	INVOS® 5100C Cerebral/Somatic OximeterSystem
Technological Characteristics:	The INVOS 5100C is a 2 wavelength, diffusereflectance spectroscopy system employing nearinfrared light to estimate the percentage ofhemoglobin saturated with oxygen in tissueunderneath the sensor. An adhesive sensorcontaining a light source and 2 photodiodes isapplied to the skin over the tissue of interest and thereturning light is analyzed for oxyhemoglobin anddeoxyhemoglobin light absorption. Absorptionsignals from the photodiode closer to the lightsource are subtracted from those from the fartherphotodiode where the returning photons penetratemore deeply in the tissue. This suppressesabsorption events originating in the outer layers oftissue that are common to both photodiodes,including the effects of skin pigmentation andsubcutaneous tissues. This method of "spatialresolution" also allows estimation of scattering toimprove measurement accuracy.
Performance Data:	Bench testing is submitted demonstrating thesubstantial equivalence of the new sensors withmodified photodiodes for the stated indication.
Substantial Equivalence:	The new sensors have the same intended use andindications, principles of operation andtechnological characteristics as the predicate device.The change in photodiodes does not raise any newquestions of safety or effectiveness. Performancedata demonstrates that the new photodiodes are assafe and effective as the predicate. Thus, the

Attachment 7

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SOMANETICS OxyAlert NIRSensors SPECIAL 510(K) PREMARKET NOTIFICATION

ﺗﺮﺗ

. '

modified sensors are substantially equivalent to the predicate sensors.

Santa Parti :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an eagle-like figure with outstretched wings. The emblem is rendered in black and white, and the overall design appears to be a government or official seal.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2009

Somanetics Corporation c/o Ronald A. Widman 1653 East Maple Rd., Troy, MI 48083-4208

Re: K091224

Trade/Device Name: OxyAlert NIRSensor Models IS-C and IS-S Accessories for Somanetics INVOS 5100C System

Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: June 12, 2009 Received: June 16, 2009

Dear Mr. Widman:

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Ronald A. Widman

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" (21 CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Joe Callaway for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K091224

Device Name: Somanetics INVOS® 5100C System and Accessories

Indications For Use:

Prescription Use × (Part 21 CFR 801 subpart D) OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beylin

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K091224

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A8-1

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).