The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system 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 on individuals greater than 40 kg at risk for reduced-flow or no-flow ischemic states.

The INVOS™ Adult rSO2 Sensor is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing >40 kilograms. This sensor is only intended to be used with INVOS™ Near Infrared Spectroscopy (NIRS) technology including monitoring systems and devices integrated with INVOS™ NIRS technology. For additional information regarding setup and use of the INVOS™ System including indications for use, contraindications, warnings and cautions, consult the Monitoring System Operator's Manual.

Device Description

The INVOS™ PM7100 Patient Monitor is a cerebral/somatic tissue oximeter that utilizes a near infrared diffuse reflectance spectroscopy system employing near infrared light at four wavelengths. Two wavelengths are used to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. Near infrared light at two additional wavelengths are used for the sensor on/off detection algorithm.

The subject device is non-sterile and consists of a multi-channel touch screen display, preamplifier, cables, and a single use sensor.

The device utilizes up to four detachable sensors to collect signals. Up to two preamplifiers receive signals from the sensors, digitize the signals, process the data and then estimate the current rSO2 at each sensor site. The preamplifiers then transmit the measured parameter data to the monitor where the information is displayed.

AI/ML Overview

The provided document describes the K182868 submission for the INVOS™ PM7100 Patient Monitor, which is a cerebral/somatic tissue oximeter. The core of the submission focuses on demonstrating substantial equivalence to a predicate device (INVOS™ Cerebral/Somatic Oximeter System, Model 5100C, K082327), rather than establishing de novo performance criteria against a predefined clinical gold standard. Therefore, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating equivalence to the predicate, particularly in terms of rSO2 trend and backward compatibility.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met by demonstrating comparable performance to the predicate device. The document explicitly states: "Performance data demonstrates that the INVOS™ PM7100 Patient Monitor and the INVOS™ Adult rSO₂ Sensor are equivalent to the predicate."

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance
rSO2 Trend Equivalence to Predicate Device	An rSO2 trend equivalence clinical study was performed. A secondary analysis of the data for the system comparison of accuracy and precision demonstrated that rSO2 values of the subject and predicate are comparable. The INVOS™ PM7100 maintains the same fundamental rSO2 technology as its predicate (same rSO2 algorithm and optical/electrical signal chain). The study demonstrated that the INVOS™ PM7100 Patient Monitor meets the same trend performance as the predicate device.
Sensor Backward Compatibility	A sensor backwards compatibility clinical test demonstrated that the new PMSENS71-A sensor trend accuracy is equivalent to the trend accuracy of the SAFB-SM sensor when used with the INVOS™ 5100C (predicate). A secondary analysis of the system comparison of accuracy and precision demonstrated that rSO2 values of both sensors are comparable. The test supports the use of the PMSENS71-A sensor with the INVOS™ 5100C.
Sensor On/Off Detection Functionality	A sensor on/off detection clinical study was conducted. The results prove that the INVOS™ PM7100 Patient Monitor can effectively detect when the sensor is on and when the sensor is off the patient.

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

The document does not explicitly state the exact sample sizes (number of patients or measurements) for the clinical studies. It mentions "clinical study subjects" for the sensor on/off detection, but no specific numbers.
The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided. Given that the studies focus on comparing the device to a predicate and its internal consistency (e.g., sensor on/off), it's less likely to involve independent expert ground truth establishment in the way an imaging AI algorithm might. The "ground truth" for rSO2 values is generally a reference method or the predicate device itself in this context.

4. Adjudication Method for the Test Set

This information is not provided. It's unlikely that an adjudication method (like 2+1 or 3+1), typically used for subjective assessments like image interpretation, would be directly applicable to quantitative physiologic measurements like regional oxygen saturation, especially when comparing against a predicate device.

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

No. This is not an MRMC study. The INVOS™ PM7100 Patient Monitor is a physiological monitoring device that provides direct measurements, not an AI diagnostic aid for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, in essence. The studies described (rSO2 trend equivalence, sensor backwards compatibility, sensor on/off detection) are evaluating the standalone performance of the INVOS™ PM7100 device and its sensors in providing physiological measurements, compared to a predicate device or expected functionality. The device itself is an "algorithm only" system in that it processes optical signals to provide a regional oxygen saturation value.

7. The Type of Ground Truth Used

The primary "ground truth" for the rSO2 trend equivalence study appears to be the measurements from the predicate device (INVOS™ 5100C). The study aimed to demonstrate that the new device's rSO2 values are "comparable" to the predicate. For the sensor on/off detection, the ground truth would inherently be the physical state of the sensor (on or off) relative to the patient.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device development. This is not an AI/ML device that requires a distinct training set in the typical sense. The rSO2 algorithm itself is described as constant: "The INVOS™ PM7100 maintains the same fundamental rSO2 technology as its predicate i.e., the same rSO2 algorithm."

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

As no training set is described for an AI/ML algorithm, this question is not applicable based on the provided document. The rSO2 algorithm's development and validation would have been part of the original predicate device (K082327) and its preceding research activities.

Summary

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Covidien llc Samir Ibrahim Regulatory Affairs Manager 6135 Gunbarrel Avenue Boulder, Colorado 80301

January 8, 2019

Re: K182868

Trade/Device Name: INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD. OEM Dated: October 11, 2018 Received: October 12, 2018

Dear Samir Ibrahim:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Neil R Neil R Ogden -S Ogden -S 10:02:10 -05'00'

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182868

Device Name INVOS™ PM7100 Patient Monitor INVOSTM Adult rSO2 Sensor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801.109)

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

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

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510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, provided is the 510(k) summary for INVOS™ PM7100 Patient Monitor.

SUBMITTER INFORMATION:

Submitted By:	Covidien IIc6135 Gunbarrel AvenueBoulder, CO 80301
Contact:	Samir IbrahimManager Regulatory Affairs
Phone:	(720) 253-2752
Fax:	(303) 305-2212
Date of Preparation:	October 11, 2018

Device Name:

Trade Name(s):	INVOS TM PM7100 Patient Monitor
Common/Usual Name:	Cerebral Somatic Tissue Oximeter
Classification:	Class II
Classification Name:	Oximeter
CFR Reference:	21 CFR 870.2700
Product Code:	MUD and QEM
PREDICATE DEVICE:
Manufacturer:	Covidien llc

Manufacturer:	Covidien llc
Device Name:	INVOS TM Cerebral/Somatic Oximeter System, Model 5100C
510(k) Number:	K082327
Clearance Date:	April 3, 2009

Device Description:

The subject device is non-sterile and consists of a multi-channel touch screen display, preamplifier, cables, and a single use sensor.

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Accessories:

INVOSTM Adult rSO2 Sensor, PM7100 and 5100C	PMSENS71-A
INVOSTM Reusable Sensor Cable for PM7100	PMAC71RSC
INVOSTM Docking Station, PM7100	PMAC71DOC
INVOSTM Patient Monitor Stand, PM7100	PMAC71STAND
INVOSTM Reusable Sensor Cable for 5100C, Channel 1	PMAC71RSC-L-CH1
INVOSTM Reusable Sensor Cable for 5100C, Channel 2	PMAC71RSC-L-CH2
INVOSTM Reusable Sensor Cable for 5100C, Channel 3	PMAC71RSC-L-CH3
INVOSTM Reusable Sensor Cable for 5100C, Channel 4	PMAC71RSC-L-CH4

INDICATIONS FOR USE:

The INVOS™ Adult rSO2 Sensor is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing > 40 kilograms. This sensor is only intended to be used with INVOS™ Near Infrared Spectroscopy (NIRS) technology including monitoring systems and devices integrated with INVOS™ NIRS technology. For additional information regarding setup and use of the INVOS™ System including indications for use, contraindications, warnings and cautions, consult the Monitoring System Operator's Manual.

CONTRAINDICATIONS

The INVOS™ Adult rSO2 sensor is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape.

TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The INVOS™ PM7100 Patient Monitor is a four wavelength, diffuse reflectance spectroscopy system employing near infrared light. Two wavelengths of near infrared light are used to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor and two additional wavelengths are used for sensor on/off detection. An adhesive sensor containing four LED light sources and two photodiodes is applied to the skin over cerebral and somatic tissue and the returning light from two LEDs is analyzed for oxyhemoglobin and deoxyhemoglobin light absorption signals from the photodiode closer to the light source are subtracted from the farther photodiode where the returning photons penetrate more deeply in the tissue. This removes the impact of absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues.

SUBSTANTIAL EQUIVALENCE STATEMENT:

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The INVOS™ PM7100 Patient Monitor has the same intended use and indications for the adult population > 40 kg, principles of operation and technological characteristics as the predicate device. The changes in the display, preamplifier and senor do not raise any new questions of safety or effectiveness. Performance data demonstrates that the INVOS™ PM7100 Patient Monitor and the INVOS™ Adult rSO₂ Sensor are equivalent to the predicate.

Performance Data Summary:

NONCLINICAL TESTING:

The INVOS™ PM7100 Patient Monitor was designed and bench tested against the performance categories noted below. When available, the applicable standards and guidance documents were used for design and testing in support of substantial equivalence.

Bench TestCategory	Guidance/Standard
EssentialPerformance	EN 60601-1
Electrical Safety	IEC 60601-1
ElectromagneticCompatibility	IEC 60601-1-2FDA Guidance Electromagnetic Compatibility of Electrically-Powered Medical Devices
Usability	IEC 60601-1-6IEC 62366FDA Guidance Applying Human Factors and Usability Engineering to Medical DevicesDraft Guidance
Alarm	IEC 60601-1-8
Optical Safety	IEC 62471
Software	IEC 62304FDA Guidance for the Content of Premarket Submissions for Software Contained inMedical DevicesFDA Guidance General Principles of Software ValidationFDA Guidance Off-The-Shelf Software Use in Medical Devices
Biocompatibility	ISO 10993-1
Mechanical andEnvironmental	IEC 60601-1
Cybersecurity	FDA Guidance Content of Premarket Submissions for Management of Cybersecurity inMedical Devices

CLINICAL TESTING:

Three clinical studies were conducted and completed, rSO2 trend equivalence, sensor backward compatibility and sensor on/off in support the INVOS™ PM7100 Patient Monitor.

An rSOz trend equivalence clinical study was performed to demonstrate the rSO2 trend precision between the INVOS™ PM7100 and the predicate device. A secondary analysis of the data for the system comparison of accuracy and precision to support device equivalency was conducted and demonstrated that rSO2 values of subject and predicate are comparable. The INVOS™ PM7100 maintains the same fundamental rSO2 technology as its predicate i.e., the same rSO2 algorithm and the same optical and

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electrical signal chain.

A sensor backwards compatibility clinical test was performed to demonstrate that the new PMSENS71-A sensor trend accuracy is equivalent to the trend accuracy of the SAFB-SM sensor when used with the INVOS™ 5100C. A secondary analysis of the system comparison of accuracy and precision to support PMSENS71-A sensor equivalency was conducted and demonstrated that rSO2 values of both sensors are comparable. The test supports the use of the PMSENS71-A sensor with the INVOS™ 5100C.

A sensor on/off detection clinical study was conducted to demonstrate that the new sensor and the new sensor on/off algorithm are capable of detecting sensor off conditions on clinical study subjects.

The clinical studies paired with a bench study using simulated patient data demonstrate that the INVOS™ PM7100 Patient Monitor meets the same trend performance as the predicate device, the new sensor on/off feature functions as intended, and the new sensor is backwards compatible with the predicate device and is therefore deemed substantially equivalent to the predicate device.

CONCLUSION

Results from comprehensive verification and validation testing of a system design analysis, a bench-top tissue phantom test, trend performance validation clinical study, and a backward compatibility validation clinical study demonstrated that the INVOS™ PM7100 Patient Monitor is substantially equivalent to the predicate device with respect to clinical use case, characteristics, and performance. This equivalence allows for the subject device to support the same claims (adult only) and indications for use as the predicate device.

The result from the sensor on/off clinical study proves that the INVOS™ PM7100 Patient Monitor can effectively detect when the sensor is on and when the sensor is off the patient.

The results from the human factors validation have shown that the updated monitor/user interface with a touch screen display improves user-friendliness of the system but doesn't introduce unforeseen risk to the subject device.

The information provided in this 510(k) demonstrates the INVOS™ PM7100 Patient Monitor is substantially equivalent to the predicate device with respect to performance.

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).