Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the described functionality is standard for pulse oximetry systems.

Therapeutic

No
The device is described as a non-invasive tool for physiological monitoring (measuring, displaying, and storing SpO2 and pulse rate) and is intended as an "adjunct in patient assessment," not for treatment or therapy. It explicitly states, "The device does not report any diagnosis but provides spot-checking and trending data only."

Diagnostic

No

The device description explicitly states: "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." This indicates it provides data for assessment but does not perform a diagnosis itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the CVInsight system is comprised of a cleared pulse oximeter and a software application. This indicates the system includes both hardware (the pulse oximeter) and software components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The CVInsight system measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using a pulse oximeter. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's for "measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients." This is a non-invasive physiological monitoring function.

The device is a non-invasive physiological monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

Product codes (comma separated list FDA assigned to the subject device)

DQA, JOM

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K102350, K040589, K960884, K853124

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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.

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

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