The CVInsight system is comprised of a pulse oximeter and a software application installed and operating on a personal computer. The pulse oximeter device is indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients who are well or poorly perfused. The intended use environments are Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies. CVInsight measures, displays, and stores functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provides alarm functionality for these parameters. Additionally, CVInsight provides a utility for recording trends of pulse rate, SpO2, and the percentage of change from a user-defined baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

Device Description

The CVInsight system is comprised of a cleared pulse oximeter and software application operating on a personal computer and is intended to be a non-invasive tool in the physiological monitoring of adult and pediatric patients. CVInsight wirelessly acquires and displays measures of pulse rate, functional oxygen saturation of arterial hemoglobin (SpO2), and provides alarm functionality for these parameters. CVInsight provides factory default values or optional clinician determined threshold values in which triggers alarm conditions during CVInsight operation. The device calculates percentage of change from a baseline value for the pulse strength values derived from the photoelectric plethysmograph waveform and graphically displays these values over time. The device also provides event indications based upon threshold values input by the clinician. This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. The device does not report any diagnosis but provides spot-checking and trending data only. It is the clinician's responsibility to make proper decisions based upon their experience and training.

AI/ML Overview

The provided submission for the CVInsight device is a Traditional 510(k) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone clinical study with detailed performance metrics and acceptance criteria in the format typically found for novel AI/ML devices.

Therefore, much of the requested information cannot be extracted directly from the provided text because it describes design verification and validation through general performance testing, not a specific clinical study with granular detail on acceptance criteria for device performance, ground truth establishment, or human reader effectiveness.

However, based on the available text, here's what can be deduced:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions "All tests that were created for the CVInsight system had passing results with acceptance criteria successfully met," but it does not provide a specific table detailing the acceptance criteria or the numerical reported device performance for functional oxygen saturation (SpO2) or pulse rate accuracy.

The core of the submission emphasizes that the device does not raise new questions of safety and efficacy and is at least as safe and effective as the predicate devices. The performance testing is described in general terms, covering software, bench verification, biocompatibility, environmental testing, and a clinical simulation (usability testing).

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

The document mentions "a clinical simulation (usability testing)" but does not specify the sample size for a test set or the data provenance (country of origin, retrospective/prospective). Given the nature of a pulse oximeter device, the "test set" would likely refer to a cohort of human subjects on whom the oximeter was tested. This information is absent.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the number of experts used to establish ground truth or their qualifications. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using a co-oximeter and ECG, respectively, rather than human experts.

4. Adjudication Method

Since the document does not describe the establishment of a "ground truth" by experts, there is no adjudication method mentioned.

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

No MRMC comparative effectiveness study is mentioned. The CVInsight system is described as a medical device for measuring and displaying physiological parameters, not a diagnostic aid requiring human interpretation of images or complex data that would necessitate an MRMC study.

6. Standalone Performance Study

The submission describes "Design verification tests" and "bench verification testing" as part of "Performance Testing" which implies standalone testing of the algorithm/device. However, the document does not provide detailed results or specific metrics for these standalone tests beyond stating that "All tests...had passing results with acceptance criteria successfully met."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used in the performance testing. For pulse oximeters, the ground truth for functional oxygen saturation (SpO2) is typically established by arterial blood gas analysis with a co-oximeter, and for pulse rate by ECG. However, this level of detail is not provided.

8. Sample Size for the Training Set

The document does not mention a "training set" or its sample size. The CVInsight device is based on established pulse oximetry principles and likely uses algorithms that are well-understood in the field, rather than a machine learning model that requires a distinct training phase with a large dataset.

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

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

Summary

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Traditional 510(k) Tab 5 – 510(k) Summary

CVInsight SEP 4 2012

TAB 5


510(K) SUMMARY

Official Contact	Jan BerkowChief Technology OfficerIntelomed, Inc.4284 Lampl LaneAllison Park, PA 15101berkowjk@intelomed.com412-213-3251 phone866-614-6295 fax
Date of Submission	January 10, 2012
Classification Reference	21 CFR 870.2700
	21 CFR 870.2780
Product Code	DQAJOM

Common/Usual Name	Oximeter
Proprietary Name	CVInsight
Predicate Device(s)	K102350, Nonin Medical 3150 Pulse OximeterK040589, Nonin Medical 9700 Pulse Oximeter with Pulse Wave formK960884, LSI TeleTrens Model Number TM10K853124, Novametrix Pulse Oximeter, Model 500
Reason for submission	New Device

Indications For Use

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Traditional 510(k) Tab 5 - 510(k) Summary CVInsight

poorly perfused. The intended use environments are Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies. CVInsight measures, displays, and stores functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provides alarm functionality for these parameters.

Additionally, CVInsight provides a utility for recording trends of pulse rate, SpO2, and the percentage of change from a user-defined baseline values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

Device Description

CVInsight wirelessly acquires and displays measures of pulse rate, functional oxygen saturation of arterial hemoglobin (SpO2), and provides alarm functionality for these parameters. CVInsight provides factory default values or optional clinician determined threshold values in which triggers alarm conditions during CVInsight operation.

The device calculates percentage of change from a baseline value for the pulse strength values derived from the photoelectric plethysmograph waveform and graphically displays these values over time. The device also provides event indications based upon threshold values input by the clinician.

This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. The device does not report any diagnosis but provides spot- checking and trending data only. It is the clinician's responsibility to make proper decisions based upon their experience and training.

Substantial Equivalence

CVInsight has the following similarities to the predicate devices:

. Same intended use.
t Same operating principle of
- 0 collecting data from a pulse oximeter/sensor
- calculating data 0
- displaying data O

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CVInsight

Traditional 510(k) Tab 5 – 510(k) Summary

graphically displaying data trends o
Same vehicle of transmission of data via a wireless connection. .
Similar that CVInsight provides factory default values or optional clinician determined threshold . values which triggers alarm conditions during operation.

Intelomed, Inc. has determined that the CVInsight system does not raise new questions of safety and efficacy and has demonstrated that it is at least as safe and effective as the predicate devices as per the device comparison table below.

Features	Proposed Device(CVInsight)	K102350Nonin Medical3150 PulseOximeter	K040589Nonin MedicalAvant 9700 PulseOximeter	K960884TeleTrens Model# TM10	K853124NovametrixPulse Oximeter,Model 500
Product Code	DQA (JOM)	DQA	DQA	DSI	JOM
IndicationsFor Use	The CVInsightsystem is comprisedof a pulse oximeterand a softwareapplication installedand operating on apersonal computer.The pulse oximeterdevice is indicatedfor use inmeasuring,displaying, andstoring functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulserate of adult andpediatric patients. Itis intended for spot-checking and / ordata collection andrecording ofpatients who arewell or poorlyperfused. Theintended useenvironments areHospitals, MedicalFacilities,Ambulatory, Sub-Acute, and SleepStudies. CVInsightmeasures, displays,and storesfunctional oxygen	Nonin's Model3150 WristOx2Pulse Oximeter is asmallwrist-worn deviceindicated for use inmeasuring,displaying, andstoring functionaloxygen saturationof arterialhemoglobin (SpO2)and pulse rate ofadult andpediatric patients.It is intended forspot-checking and/or data collectionand recording ofpatients who arewell or poorlyperfused. Theintended useenvironments aresleep andpulmonary rehablabs,surgical recovery,critical care,emergency room,long-term care,home use andmobile units.	The Nonin AvantTM9700 Digital PulseOximeter is aportable, tabletopdevice indicated foruse insimultaneouslymeasuring,displaying, andrecordingfunctional oxygensaturation ofarterial hemoglobin(SpO2)and pulse rate ofadult, pediatric,infant, and neonatalpatients inhospitals, medicalfacilities, homecare, andsub-acuteenvironments. Itmay also be used inpatient transport,sleep laboratories,and EMSenvironments. TheAvantTM 9700 isintended forcontinuousmonitoring and/or spot-checking ofpatients during bothno motion and	The Teletrens isintended for use inthe non-invasivemonitoring of ECG,blood pressure,pulse rate, pulseoximetry,temperature andrespiration in thehospital/clinicenvironment.The TeleTrens isintended to be usedin accordance withaccepted hospitaland clinicalprotocols andinstructionscontained in thisoperators manual.Use of the TeleTrensfor applications notspecified in thismanual may resultin inaccuratepatient information.Use of the TeleTrenswith other thanrecommended orsupplied accessoriesor parts may resultin inaccuratepatient informationor damage to themonitor	Pulse oximetry is anon-invasivemeans ofobtaininginformationregarding oxygensaturation ofarterial blood.Oxygen saturationmonitoring isintended to beused in a varietyof clinicalsituationsincludingrespiratorytherapy,anesthesia, andthe NICU.
Features	Proposed Device(CVInsight)	K102350Nonin Medical3150 PulseOximeter	K040589Nonin MedicalAvant 9700 PulseOximeter	K960884TeleTrens Model# TM10	K853124NovametrixPulse Oximeter,Model 500
Product Code	DQA (JOM)	DQA	DQA	DSIFederal law restrictsthis device to saleby or on the orderof a physician.	JOM
	saturation ofarterial hemoglobin(SpO2) and pulserate, and providesalarm functionalityfor theseparameters.Additionally,CVInsight provides autility for recordingtrends of pulse rate,SpO2, and thepercentage ofchange from a user-defined baselinevalue for values ofpulse rate and pulsestrength derivedfrom thephotoelectricplethysmographwaveform.		motion conditions,for patients who arewell or poorlyperfused.
Prescriptive	Yes	Yes	Yes	Yes	Yes
Environmentof Use	Hospitals, MedicalFacilities,Ambulatory, Sub-Acute, Sleep Studies	Hospitals, MedicalFacilities,Ambulatory, Sub-Acute, Sleep Study,Mobile Units	Hospitals, medicalfacilities, homecare, sub-acuteenvironments,patient transport,sleep laboratories,and EMSenvironments.	Hospital/ClinicEnvironment	Variety of clinicalsettings includingrespiratorytherapy,anesthesia, andthe NICU.
PatientPopulation	Adult and Pediatric	Adult and Pediatric	Adult, pediatric,infant, and neonatal	Unknown	Unknown
SoftwareDriven	Yes	Yes	Yes	Yes	Yes
Measures	Functional oxygensaturation ofarterial hemoglobin(SpO2), pulse rate,photoelectricplethysmographwaveform, changesin pulse rate,changes inphotoelectricplethysmograph	Functional oxygensaturation ofarterial hemoglobin(SpO2), and pulserate	Functional oxygensaturation ofarterial hemoglobin(SpO2), and pulserate	ECG, bloodpressure, pulse rate,functional oxygensaturation ofarterial hemoglobin(SpO2),temperature, andrespiration.	Photoelectricplethysmographwaveform, oxygensaturation ofarterial blood(SaO), and pulserate, changes inphotoelectricplethysmographwaveformamplitude
Features	Proposed Device(CVInsight)	K102350Nonin Medical3150 PulseOximeter	K040589Nonin MedicalAvant 9700 PulseOximeter	K960884TeleTrens Model# TM10	K853124NovametrixPulse Oximeter,Model 500
Product Code	DQA (JOM)waveformamplitude	DQA	DQA	DSI	JOM
Components	Pulse oximeter,pulse oximetersensor,CVInsight software,PC	Pulse oximetersensor control unit,Pulse oximetersensor	Desktop unitcontains OEM IIImodule used inNonin Model 3150sensor control unit,Pulse oximetersensor, Avant 9700display software	Pulse oximeter(Nonin Model 3150)sensor control unit,Pulse OximeterSensor, other non-pulse oximetersensors, TeleTrensdisplay software, PC	Desktop display
Communication Interface	Physiological datafrom sensor andpulse oximeter	Physiological datafrom sensor andpulse oximeter	Physiological datafrom sensor andpulse oximeter	Physiological datafrom sensor andpulse oximeter	Physiological datafrom sensor andpulse oximeter
Sensor SiteLocation	Forehead	Forehead, ear, orfinger	Forehead, ear, orfinger	Finger	Finger
Power	Battery for SensorControl Unit,AC Power for PC	Battery	AC power	Battery for PulseOximeter, AC Powerfor PC	AC power withback-up battery
Alarms/Alerts	No alarms or alerts.Notifications areprovided only	None	Yes	Yes	Notifications areprovided only
Transmissionof SensorData to PC	Data transmitted toPC via Bluetooth	Bluetoothtransmissioncapability	Hardwired desktopsystem	Data transmitted toPC via Bluetooth	Hardwireddesktop system

Intelomed, Inc.

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Traditional 510(k)

Tab 5 - 510(k) Summary

CVInsight

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Traditional 510(k) Tab 5 - 510(k) Summary

CVInsight

Performance Testing

Design verification tests were performed on the Intelomed CVInsight system as a result of the risk analysis and product requirements. Formal test protocols were written and executed to verify and validate the CVInsight system. All tests that were created for the CVInsight system had passing results with acceptance criteria successfully met, which demonstrates the safety & effectiveness of the device. Testing included software code reviews, software unit testing, software integration testing, bench verification testing, biocompatibility testing, environmental testing by analysis, user manual/labeling inspection, drawing inspections, and a clinical simulation (usability testing).

The following FDA Guidance Documents were used as part of this submission package.

Pulse Oximeters Premarket Notification Submissions 510(k)s; Draft Guidance July 19, 2007 ●
Wireless Medical Telemetry Risks and Recommendations; September 27, 2000-.

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. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; May 2005
In summary, the CVInsight System is substantially equivalent to the Nonin 3150 Pulse Oximeter cleared in K102350, Nonin 9700 Pulse Oximeter with Pulse Wave form cleared in K040589, LSI TeleTrens Model Number TM10 cleared in K960884, and Novametrix Pulse Oximeter, Model 500 cleared in K853124.

ﺎ

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

4 2012 SEP

Intelomed. Inc. c/o Mr. Jan Berkow 4284 Lampl Lane Allison Park, PA 15101

Re: K120052

Trade/Device Name: CVInsight Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, JOM Dated: July 20, 2012 Received: July 23, 2012

Dear Mr. Berkow

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.

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

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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.

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,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120052

Traditional 510(k) Tab 4 - Indications for Use Statement CVInsight

Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

The CVInsight system is comprised of a pulse oximeter and a software application installed and operating on a personal computer. The pulse oximeter device is indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spotchecking and / or data collection and recording of patients who are well or poorly perfused. The intended use environments are Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies. CVInsight measures, displays, and stores functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provides alarm functionality for these parameters.

Additionally, CVInsight provides a utility for recording trends of pulse rate, SpO2, and the percentage of change from a user-defined baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

Prescription Use × (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 Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices

Intelomed, Inc.	Page 4-2
510(k) Number	K120052
	6/21/2012

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).