Who is the manufacturer of CVINSIGHT?

Intelomed, Inc. filed the 510(k) submission for CVINSIGHT (K120052).

What is the FDA product code for CVINSIGHT?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CVINSIGHT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CVINSIGHT?

Nonin Medical 3150 Pulse Oximeter (K102350); Nonin Medical 9700 Pulse Oximeter with Pulse Wave form (K040589); LSI TeleTrens Model Number TM10 (K960884); Novametrix Pulse Oximeter, Model 500 (K853124).

Who can help prepare an FDA 510(k) submission like CVINSIGHT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CVINSIGHT

K120052 · Intelomed, Inc. · DQA · Sep 4, 2012 · Cardiovascular

Device Facts

Record ID	K120052
Device Name	CVINSIGHT
Applicant	Intelomed, Inc.
Product Code	DQA · Cardiovascular
Decision Date	Sep 4, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2
Attributes	Pediatric

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 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 values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

Device Story

CVInsight is a non-invasive physiological monitoring system consisting of a pulse oximeter sensor and PC-based software. The system wirelessly acquires SpO2, pulse rate, and photoelectric plethysmograph (PPG) waveform data. The software processes these inputs to display real-time values, store data, and generate trends. It calculates the percentage change in pulse rate and pulse strength from user-defined baselines derived from the PPG waveform. Clinicians set threshold values for alarm conditions. The device is used in hospitals, clinics, and sleep labs as an adjunct to clinical assessment; it does not provide diagnostic conclusions. Clinicians use the displayed trends and event indications to inform patient assessment and decision-making. The system benefits patients by providing continuous or spot-check monitoring of oxygenation and perfusion status.

Clinical Evidence

Bench testing only. Evidence includes software code reviews, unit and integration testing, bench verification, biocompatibility, environmental testing, and clinical simulation (usability testing). No clinical patient trials were conducted.

Technological Characteristics

System includes pulse oximeter sensor, control unit, and PC software. Wireless data transmission via Bluetooth. Measures SpO2, pulse rate, and PPG waveform. Provides alarm functionality based on factory or clinician-defined thresholds. Software-driven analysis of trends and baseline deviations.

Indications for Use

Indicated for adult and pediatric patients, including those well or poorly perfused, for measurement, display, and storage of SpO2 and pulse rate. Used in hospitals, medical facilities, ambulatory, sub-acute, and sleep study environments.

Regulatory Classification

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.

Predicate Devices

Nonin Medical 3150 Pulse Oximeter (K102350)
Nonin Medical 9700 Pulse Oximeter with Pulse Wave form (K040589)
LSI TeleTrens Model Number TM10 (K960884)
Novametrix Pulse Oximeter, Model 500 (K853124)

Submission Summary (Full Text)

{0}------------------------------------------------ K120052 Pg 1 of 6 ## Traditional 510(k) Tab 5 – 510(k) Summary CVInsight SEP 4 2012 | TAB 5 | | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | 510(K) SUMMARY | | | | | | Official Contact | Jan Berkow Chief Technology Officer Intelomed, Inc. 4284 Lampl Lane Allison Park, PA 15101 berkowjk@intelomed.com 412-213-3251 phone 866-614-6295 fax | | Date of Submission | January 10, 2012 | | Classification Reference | 21 CFR 870.2700 | | | 21 CFR 870.2780 | | Product Code | DQA JOM | | | | | Common/Usual Name | Oximeter | | Proprietary Name | CVInsight | | Predicate Device(s) | K102350, Nonin Medical 3150 Pulse Oximeter K040589, Nonin Medical 9700 Pulse Oximeter with Pulse Wave form K960884, LSI TeleTrens Model Number TM10 K853124, Novametrix Pulse Oximeter, Model 500 | | Reason for submission | New Device | # 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 spot-checking and / or data collection and recording of patients who are well or {1}------------------------------------------------ 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 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. #### 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 {2}------------------------------------------------ K120052 pg 3 of 6 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) | K102350 Nonin Medical 3150 Pulse Oximeter | K040589 Nonin Medical Avant 9700 Pulse Oximeter | K960884 TeleTrens Model # TM10 | K853124 Novametrix Pulse Oximeter, Model 500 | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DQA (JOM) | DQA | DQA | DSI | JOM | | 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 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 | Nonin's Model 3150 WristOx2 Pulse Oximeter is a small wrist-worn device 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 sleep and pulmonary rehab labs, surgical recovery, critical care, emergency room, long-term care, home use and mobile units. | The Nonin AvantTM 9700 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and sub-acute environments. It may also be used in patient transport, sleep laboratories, and EMS environments. The AvantTM 9700 is intended for continuous monitoring and/ or spot-checking of patients during both no motion and | The Teletrens is intended for use in the non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature and respiration in the hospital/clinic environment. The TeleTrens is intended to be used in accordance with accepted hospital and clinical protocols and instructions contained in this operators manual. Use of the TeleTrens for applications not specified in this manual may result in inaccurate patient information. Use of the TeleTrens with other than recommended or supplied accessories or parts may result in inaccurate patient information or damage to the monitor | Pulse oximetry is a non-invasive means of obtaining information regarding oxygen saturation of arterial blood. Oxygen saturation monitoring is intended to be used in a variety of clinical situations including respiratory therapy, anesthesia, and the NICU. | | Features | Proposed Device (CVInsight) | K102350 Nonin Medical 3150 Pulse Oximeter | K040589 Nonin Medical Avant 9700 Pulse Oximeter | K960884 TeleTrens Model # TM10 | K853124 Novametrix Pulse Oximeter, Model 500 | | Product Code | DQA (JOM) | DQA | DQA | DSI Federal law restricts this device to sale by or on the order of a physician. | JOM | | | 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. | | motion conditions, for patients who are well or poorly perfused. | | | | Prescriptive | Yes | Yes | Yes | Yes | Yes | | Environment of Use | Hospitals, Medical Facilities, Ambulatory, Sub- Acute, Sleep Studies | Hospitals, Medical Facilities, Ambulatory, Sub- Acute, Sleep Study, Mobile Units | Hospitals, medical facilities, home care, sub-acute environments, patient transport, sleep laboratories, and EMS environments. | Hospital/Clinic Environment | Variety of clinical settings including respiratory therapy, anesthesia, and the NICU. | | Patient Population | Adult and Pediatric | Adult and Pediatric | Adult, pediatric, infant, and neonatal | Unknown | Unknown | | Software Driven | Yes | Yes | Yes | Yes | Yes | | Measures | Functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, photoelectric plethysmograph waveform, changes in pulse rate, changes in photoelectric plethysmograph | Functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate | Functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate | ECG, blood pressure, pulse rate, functional oxygen saturation of arterial hemoglobin (SpO2), temperature, and respiration. | Photoelectric plethysmograph waveform, oxygen saturation of arterial blood (SaO), and pulse rate, changes in photoelectric plethysmograph waveform amplitude | | Features | Proposed Device (CVInsight) | K102350 Nonin Medical 3150 Pulse Oximeter | K040589 Nonin Medical Avant 9700 Pulse Oximeter | K960884 TeleTrens Model # TM10 | K853124 Novametrix Pulse Oximeter, Model 500 | | Product Code | DQA (JOM) waveform amplitude | DQA | DQA | DSI | JOM | | Components | Pulse oximeter, pulse oximeter sensor, CVInsight software, PC | Pulse oximeter sensor control unit, Pulse oximeter sensor | Desktop unit contains OEM III module used in Nonin Model 3150 sensor control unit, Pulse oximeter sensor, Avant 9700 display software | Pulse oximeter (Nonin Model 3150) sensor control unit, Pulse Oximeter Sensor, other non- pulse oximeter sensors, TeleTrens display software, PC | Desktop display | | Communication Interface | Physiological data from sensor and pulse oximeter | Physiological data from sensor and pulse oximeter | Physiological data from sensor and pulse oximeter | Physiological data from sensor and pulse oximeter | Physiological data from sensor and pulse oximeter | | Sensor Site Location | Forehead | Forehead, ear, or finger | Forehead, ear, or finger | Finger | Finger | | Power | Battery for Sensor Control Unit, AC Power for PC | Battery | AC power | Battery for Pulse Oximeter, AC Power for PC | AC power with back-up battery | | Alarms/Alerts | No alarms or alerts. Notifications are provided only | None | Yes | Yes | Notifications are provided only | | Transmission of Sensor Data to PC | Data transmitted to PC via Bluetooth | Bluetooth transmission capability | Hardwired desktop system | Data transmitted to PC via Bluetooth | Hardwired desktop system | Intelomed, Inc. {3}------------------------------------------------ K120052 Pg. 4 of 6 # Traditional 510(k) Tab 5 - 510(k) Summary # CVInsight : ' {4}------------------------------------------------ K120052 pg. 5 of 6 ## 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-. {5}------------------------------------------------ - . 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 {End of tab} {6}------------------------------------------------ ## 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 {7}------------------------------------------------ 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 {8}------------------------------------------------ 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 |

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