(107 days)
Not Found
No
The description mentions a "signal processing algorithm" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML development (training sets, test sets, specific performance metrics like AUC or MRMC in the context of AI model evaluation).
No.
The device is indicated for detection and monitoring, not for providing therapy or treatment.
Yes
The device is indicated for the detection of subcutaneous infiltrations and extravasations, and it assesses patients for these conditions, which are diagnostic activities.
No
The device description explicitly states that the ivWatch Model 400 consists of hardware components: the ivWatch Patient Monitor (IPM), a reusable optical sensor cable, and a single-use sensor receptacle. It also describes the physical process of emitting and measuring light.
Based on the provided information, the ivWatch Model 400 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- ivWatch Model 400 Function: The ivWatch Model 400 performs continuous, non-invasive monitoring of human tissue adjacent to a PIV insertion site. It uses light to measure changes in the tissue in vivo (within the living body). It does not analyze samples taken from the body.
Therefore, the ivWatch Model 400 falls under the category of a non-invasive monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The iv Watch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for the subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.
Product codes
PMS
Device Description
The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use sensor receptacle.
The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical sensor cable from the patient's skin. Measured changes between the emitted and reflected signals are processed by the ivWatch signal processing algorithm to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the PIV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the PIV site for a possible infiltration event.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue adjacent to peripheral intravenous (PIV) insertion sites
Indicated Patient Age Range
adults and pediatrics
Intended User / Care Setting
healthcare practitioners; healthcare setting
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
The pediatric IRB approved clinical study demonstrates that the Model 400 is just as safe and effective in the pediatric population under the age of 18 years old as the use of the predicate device in the adult population. Safety and efficacy of the Model 400 has been demonstrated in accepted case studies representing an age distribution from 2 weeks to 17 years, patient weight measurements from 3.3 to 196.7 kg (mean, 34.5 kg), distributed skin pigmentations and similar proportions between male and female subjects.
The clinical validation studies in the pediatric population under the age of 18 years old assessed the performance (e.g. time difference between ivWatch detection and clinician detection of an infiltration, sensitivity and specificity) of the ivWatch Model 400.
Key Metrics
The ivWatch Model 400 detected 80.0% of infiltrations (95% Cl [51.9% to 95.7%) before detection by a clinician.
Time difference between ivWatch and clinician detection of infiltration: Red Check IV notification issued on average 29.8 hours prior to the clinician detection, 95% CI [14.8, 48.8 hours].
Sensitivity: 78.3% of infiltrations (95% CI [56.5 to 92.5%]) were detected prior to the clinician diagnosing the infiltration in the blinded non-alarming group.
False notifications: A false positive notification occurred approximately once every 4 days. A false positive notification occurred approximately once every 10 days if notifications related to painful IV flushes and device-related issues are excluded.
There were no serious adverse events during the clinical study.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
ivWatch, LLC Jaclyn Lautz Director of Regulatory Affairs and Quality Assurance 1100 Exploration Way, Suite 209 Hampton, Virginia 23666
Re: K162478
Trade/Device Name: ivWatch Model 400 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PMS Dated: November 22, 2016 Received: November 28, 2016
Dear Jaclyn Lautz:
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.
1
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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name ivWatch Model 400
Indications for Use (Describe)
The iv Watch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for the subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized water droplet shape on the left, with the letters "iv" inside the droplet. To the right of the droplet is the word "Watch" in a simple, sans-serif font. The logo is clean and modern, with a focus on the company name.
ivWatch, LLC 1 100 Exploration Way, Suite 209 Hampton, VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
TRADITIONAL 510(K) SUMMARY 1
1.1 Administrative
| Submitter Name | ivWatch, LLC |
|---|---|
| Applicant Address | 1100 Exploration Way, Suite 209 |
| Hampton, VA 23666 | |
| Phone | 855-489-2824 |
| Fax | 757-224-5009 |
| Primary Contact | Jaclyn Lautz, Ph.D., Director of Regulatory Affairs and |
| Quality Assurance | |
| Primary Contact Email | jaclyn.lautz@ivwatch.com |
| Primary Contact | |
| Phone | 855-489-2824 x7023 |
| Date Prepared | September 1, 2016 |
1.2 Subject Device
| Trade Name | ivWatch Model 400 |
|---|---|
| Manufacturer | ivWatch, LLC |
| 510(k) Number | K162478 |
| Device Class | II |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS (Peripheral Intravenous (PIV) Infiltration Monitor) |
| Classification Name | Infusion Pump |
1.3 Predicate Device
| Trade Name | ivWatch Model 400 |
|---|---|
| Manufacturer | ivWatch, LLC |
| 510(k) Number | K153605 |
| Device Class | II |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS (Peripheral Intravenous (PIV) Infiltration Monitor) |
| Classification Name | Infusion Pump |
| Clearance Information | Design modification to the sensor cable sheathing of |
| the ivWatch Model 400 (K142374) |
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Image /page/4/Picture/0 description: The image shows the logo for "ivWatch." The logo consists of a stylized teardrop shape above the letters "iv" in a sans-serif font, followed by the word "Watch" in a cursive font. The teardrop has a grid-like pattern within it. The logo is in black and white.
ivWatch IIC 1 100 Exploration Way, Suite 209 Hampton. VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
Device Description
The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use sensor receptacle.
The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical sensor cable from the patient's skin. Measured changes between the emitted and reflected signals are processed by the ivWatch signal processing algorithm to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the PIV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the PIV site for a possible infiltration event.
Indications for Use 1.5
The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.
1.6 Comparison of the Subject Device to the Predicate Device
The subject device (ivWatch Model 400) is a modification to the legally marketed ivWatch Model 400 (K153605). The subject and predicate devices consist of the same components including the ivWatch Patient Monitor, a single-use sensor receptacle and a reusable optical sensor cable. The subject and predicate devices have the same intended use which is to aid in the detection of infiltrations and extravasations during peripheral IV infusion therapy. The subject and predicate devices have the same technological characteristics and principles of operation and there have been no significant changes to the design or materials of the subject device.
This submission includes labeling modifications to the indications for use and to the MR safety information and the addition of an RFID tag in the sensor cable to track sensor cable useful life. The indications for use has been revised to extend the target patient population from patients 18 years old or greater to a patient population including both pediatrics and adults. Clinical performance testing on the pediatric patient population under the age of 18 years demonstrates that the subject device is as safe and effective as the predicate device on patients 18
5
Image /page/5/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized water droplet shape on the left, with the letters "iv" inside the droplet. To the right of the droplet, the word "Watch" is written in a simple, sans-serif font. The logo is clean and modern, with a focus on the company's name.
1 100 Exploration Way, Suite 209 Hampton. VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
years old and greater. The MR safety information for the reusable sensor cable has been revised from "MR Unsafe" to "MR Conditional" on the sensor cable label. MR safety testing has been performed and demonstrates that the subject device is as safe and effective as the predicate device with the appropriate MR safety labeling. The RFID replaces a previously used USB method for tracking sensor cable useful life.
1.7 Performance Data
1.7.1 Sterilization and Shelf Life
The ivWatch sensor receptacle is the only component of the system supplied sterile. The sensor receptacle is sterilized by ethylene oxide (EO) in compliance with ISO 11135-1 and 10993-7. In addition, the sensor receptacle passed package and sterility testing in compliance with ISO 11607-1, ASTM F1140/F1140M-13, ASTM 2096-11 and ASTM D1469-14 supporting a 2-year shelf life.
The ivWatch sensor cable is designed to be cleaned between uses and cleaning and disinfection validation testing results passed all pre-defined acceptance criteria in accordance with AAMI-TIR-2010, AAMI TIR30-2011 and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,
1.7.2 Biocompatibility
The sensor receptacle and sensor cable sheathing are classified as prolonged duration (greater than 24 hours but less than 30 days) patient-contacting components. The sensor receptacle and sensor cable of the subject device have not changed compared to the predicate device. Therefore, the biocompatibility evaluation of the patient-contacting components conducted in accordance with the FDA Guidance Document "Use of the International Standard ISO 10993-1" and ISO 10993-1, ISO 10993-5 and ISO 10993-10 has not changed.
1.7.3 Electromagnetic Compatibility (EMC) and Electrical Safety
EMC and electrical safety testing were conducted on the subject device and results show that the ivWatch Model 400 is in compliance with the requirements of IEC 60601-1-2: 3rd Ed. 2007 and ANSI/AAMI ES60601-1:2005, 3rd E.
1.7.4 Magnetic Resonance (MR) Environment Testing
The ivWatch sensor cable has been assessed in the MR imaging environment in accordance with ASTM F2052-15, ASTM F2213-06-11, ASTM F2119-07-13, and ASTM F2182- 11a. MR compatibility testing results indicate that the sensor cable is MR Conditional.
1.7.5 Software Verification and Validation Testing
Software verification and validation testing for the ivWatch Model 400 was conducted and documented in compliance with 21 CFR 820 and in accordance with the FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304.
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Image /page/6/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized teardrop shape in black, with a grid-like pattern of small squares in the upper-left portion of the teardrop. To the right of the teardrop is the word "ivWatch" in a stylized font, with the "i" and "v" in lowercase and the "W", "a", "t", "c", and "h" in lowercase. There is a small circle with an "r" inside of it to the right of the word "ivWatch".
ivWatch, LLC 1 100 Exploration Way, Suite 209 Hampton, VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
1.7.6 Performance Testing - Clinical
The predicate device submission included the clinical evaluation of the Model 400 in patients 18 years old or greater. The purpose of this 510(k) submission is to extend the Model 400 indications for use from patients 18 years old or greater to a target patient population including both pediatrics and adults. The pediatric IRB approved clinical study included in this submission demonstrates that the Model 400 is just as safe and effective in the pediatric population under the age of 18 years old as the use of the predicate device in the adult population. Safety and efficacy of the Model 400 has been demonstrated in accepted case studies representing an age distribution from 2 weeks to 17 years, patient weight measurements from 3.3 to 196.7 kg (mean, 34.5 kg), distributed skin pigmentations and similar proportions between male and female subjects.
The clinical validation studies in the pediatric population under the age of 18 years old assessed the performance (e.g. time difference between ivWatch detection and clinician detection of an infiltration, sensitivity and specificity) of the ivWatch Model 400. The ivWatch Model 400 detected 80.0% of infiltrations (95% Cl [51.9% to 95.7%) before detection by a clinician. There were no serious adverse events during the clinical study. Clinical results demonstrate that the ivWatch Model 400 is equivalent in the pediatric population as compared to the adult population.
| Item | Predicate Device
K153605 | Subject Device
K162478 | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The ivWatch Model
400 is designed to
aid in the detection
of infiltrations and
extravasations
during peripheral IV
infusion therapy. | Same | Equivalent |
| Principles of
operation | During IV fluid
infusion, the ivWatch
sensor transmits an
optical signal
through the tissue;
the optical signal is
altered if the IV fluid
is accumulating in
the tissue
underneath the
sensor, surrounding
the intended
intravenous
administration route | Same | Equivalent |
| | ivWatch, LLC
1100 Exploration Way, Suite 209
Hampton, VA 23666 | | 1.855.IVWATCH (489.224)
Fax: 757.224.5009
www.ivwatch.com |
| | which may indicate
that fluid is not
being delivered to
the intended
intravenous
administration route
(i.e., if an infiltration
or extravasation has
occurred). | | |
| Monitor | ivWatch patient
monitor | Same | Equivalent |
| Single-use, sterile
patient-
contacting
component used
to secure the
sensor-end of
the sensor cable
onto the patient's
skin | ivWatch sensor
receptacle | Same | Equivalent |
| Optical cable to
transmit visible
and near-
infrared light
signals between
the monitor and
the patient's skin | ivWatch sensor
cable | Same | Equivalent |
| Power source | External power
supply and internal
lithium backup
battery (compliant
to IEC 62133:2012) | Same | Equivalent |
| Monitor MR
safety | MR Unsafe | Same | Equivalent |
| MR safety
labeling of
sensor cable | MR Unsafe | MR Conditional
Tested in
compliance with
ASTM F2052-15,
ASTM F2213-06-11,
ASTM F2119-07-13,
and ASTM F2182-
11g | MR
compatibility
testing
demonstrated
that the sensor
cable is MR
Conditional. |
| Image: ivWatch logo | ivWatch, LLC
1100 Exploration Way, Suite 209
Hampton, VA 23666 | | 1.855.IVWATCH (489.224)
Fax: 757.224.5009
www.ivwatch.com |
| Sterility of the
ivWatch sensor
receptacle | Sterilized by
ethylene oxide (EO)
in compliance with
ISO 11135-1.
Sterilant residuals
pass the
acceptance criteria
in compliance with
ISO 10993-7. | Same | Equivalent |
| ivWatch sensor
receptacle shelf
life | 2 years
Tested and passed
all acceptance
criteria in
compliance with ISO
11607-1, ASTM 2096-
11 and ASTM 2096-
11. | Same | Equivalent |
| Biocompatibility
of prolonged
patient-
contacting
components
(Sensor
receptacle and
sensor cable) | Tested and passed
all biocompatibility
acceptance criteria
for prolonged intact
skin contact in
compliance with ISO
10993-1, ISO 10993-5
and ISO 10993-10. | Same | Equivalent |
| Reprocessing of
the ivWatch
sensor cable | Cleaning and low-
level disinfection
testing passed all
acceptance criteria
in accordance with
AAMI-TIR-2010, AAMI
TIR30-2011 and
Reprocessing
Medical Devices in
Health Care
Settings: Validation
Methods and
Labeling. | Same | Equivalent |
| Sensor Cable
Use limit | 240 hours
Sensor cable life is
tracked with a USB
key tethered to
sensor cable. | 240 hours
Sensor cable life is
tracked with RFID
communication
between RFID
chip embedded
in sensor cable | RF wireless
testing and
results are in
compliance
with IEC 60601-
1-2:3rd Ed. 2007
and FCC Part |
| | | strain relief and
the optics board
in the IPM. | 15.225 and
15.702 |
| Electromagnetic
compatibility | Tested in
compliance with no
deviations from IEC
60601-1-2: 3rd Ed.
2007 | Same | Equivalent |
| Electrical safety | Tested in
compliance with no
deviations from
ANSI/AAMI ES60601-
1:2005, 3rd ed.
(Medical Electrical
Equipment - Part 1:
General
Requirements for
Basic Safety and
Essential
Performance); IEC
60601-1: 2005 +
CORR. 1 (2006) +
CORR. 2 (2007) | Same | Equivalent |
| Radiofrequency
wireless testing | n/a | Tested in
compliance with
no deviations from
IEC 60601-1-2: 3rd
Ed. 2007 and FCC
Part 15.225 and
15.207 | The RF
communication
frequency
between the
ISO 15693 tag
and antenna
inside the
patient monitor
is not
adjustable and
does not
transmit patient
data. Testing
demonstrates
that the RF
communication
is as safe as the
predicate
device. |
| Performance
testing - Clinical | Age: Patients 18
years old or greater | Age: Pediatrics
from birth up to | The patient
population of |
| | ivWatch, LLC
1100 Exploration Way, Suite 209
Hampton, VA 23666 | 1.855.IVWATCH (489.224)
Fax: 757.224.5009
www.ivwatch.com | |
| target patient
population | medium and dark
PIV site: Hand and
forearm | years old
Skin color: Light,
medium and ark
PIV site: Hand,
forearm,
antecubital fossa,
leg and foot | device
compared to
the predicate
device differs in
age to support
safety and
efficacy in the
pediatric
population. |
| Performance
testing - Clinical
results | Sensitivity: 96.4% of
infiltrations (95% CI
[91.4% to 98.7%])
were detected in
under 10 cc of fluid
False notifications: A
false positive
notification
occurred
approximately once
every 4 days. | Time difference
between ivWatch
and clinician
detection of
infiltration: Red
Check IV
notification issued
on average 29.8
hours prior to the
clinician
detection, 95% CI
[14.8, 48.8 hours].
Sensitivity: 78.3%
of infiltrations (95%
CI [56.5 to 92.5%])
were detected
prior to the
clinician
diagnosing the
infiltration in the
blinded non-
alarming group.
False notifications:
A false positive
notification
occurred
approximately
once every 4
days. A false
positive
notification
occurred
approximately
once every 10
days if
notifications | The clinical
performance
data of the
Model 400
support the
safety and
efficacy in the
pediatric
patient
population
(from birth up
to and
including 17
years old) as
compared to
the clinical
performance
data in
patient's 18
years or
greater. The
clinical
evaluation
demonstrates
that the
ivWatch Model
400 is
substantially
equivalent to
the predicate
device
submission. |
| Image: iv Watch logo | ivWatch, LLC
1100 Exploration Way, Suite 209
Hampton, VA 23666 | 1.855.IVWATCH (489.224)
Fax: 757.224.5009
www.ivwatch.com | |
| Performance
testing - Clinical
adverse events | There were no
serious adverse
events during the
clinical study. | related to painful
IV flushes and
device-related
issues are
excluded. | There are no
new safety
issues
associated with
the use of the
device in
pediatrics. |
1.7.7 Summary Table
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8
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Image /page/9/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized black teardrop shape with small white squares inside, followed by the text "ivWatch" in a modern, sans-serif font. A vertical line is present on the right side of the logo.
10
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1.8 Conclusions
The technological characteristics and principles of operation of the ivWatch Model 400 and the predicate device are the same. The clinical data provided in the submission supports the expansion of the indications for use to now include the pediatric patient population.
The results of the clinical study and performance testing indicate that the ivWatch Model 400 is substantially equivalent to the ivWatch Model 400 (K153605). The ivWatch Model 400 performs as intended and is substantially equivalent to the legally marketed predicate device.