(303 days)
Not Found
No
The summary describes embedded software analyzing data, but there is no mention of AI, ML, or related concepts like training sets, test sets, or specific algorithms typically associated with AI/ML. The analysis appears to be based on changes in optical properties and diffuse reflectance, which is a more traditional signal processing approach.
No
The device is indicated for detection of infiltrations and extravasations and provides alerts to clinicians, but it does not directly treat or provide therapy to the patient. It aids in diagnosis and monitoring.
Yes
The device is indicated for the "detection of subcutaneous infiltrations and extravasations," "to assess patients for subcutaneous infiltrations and extravasations," and provides "non-invasive monitoring of human tissue... to aid in the early detection of infiltration and extravasation events." These functions clearly describe a diagnostic purpose.
No
The device description explicitly states that the device consists of hardware components including a Patient Monitor, Fiber Optic Sensor Cable, Sensor Receptacle, Extension Module, Patient Cable, and SmartTouch™ Sensor, in addition to embedded software.
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 devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- ivWatch Model 400 Function: The ivWatch Model 400 works by using light to measure changes in the optical properties of human tissue adjacent to a PIV insertion site. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to detect subcutaneous infiltrations and extravasations in situ (within the body), not by analyzing a sample outside 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 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 predicate device (K162478), the ivWatch® Model 400, consists of the ivWatch® Patient Monitor, a reusable Fiber Optic Sensor Cable and a single-use sterile Sensor Receptacle. The subject device includes the addition of Device Accessories to the ivWatch® Model 400 including an Extension Module, reusable Patient Cable and a single-use electronic SmartTouch™ Sensor. The Device Accessories expand the current ivWatch® Model 400 architecture to support the reusable Fiber Optic Sensor (predicate device) and an electronic single-use sterile SmartTouch™ Sensor (subject device). Both the predicate and subject device provide continuous, non-invasive monitoring of human tissue adjacent to peripheralintravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events.
The ivWatch® Model 400 with Device Accessories uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. Light signals generated by the SmartTouch™ Sensor are sent to the patient's tissue near an PIV site. Changes to the light signals are received by the SmartTouch™ Sensor and electrical signals are transferred through the Patient Cable to the Extension Module where embedded software analyzes the data to determine whether conditions indicate that an infiltration event may have occurred. The information is then sent from the Extension Module to the ivWatch® Patient Monitor for display. If changes in the diffuse reflectance in the tissue near the PIV site are consistent with an infusate pooling in the subcutaneous tissue, the ivWatch® Patient Monitor emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible and near-infrared light
Anatomical Site
Tissue adjacent to peripheral intravenous (PIV) insertion sites
Indicated Patient Age Range
Adults and pediatrics
Intended User / Care Setting
Healthcare practitioners who have been trained in the use of the device, in the healthcare setting (hospitals and similar medical care facilities).
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
Bench Testing: Optical safety testing was performed on the subject device and indicated that the optical radiation emitted by the SmartTouch™ Sensor is significantly less than the limits defined in ANSI Z136.1 (2014).
Clinical Studies: A series of five verification and two validation IRB-approved clinical studies were performed for the development and validation of the modified ivWatch® Model 400 with Device Accessories.
Device validation for non-infiltrated tissue study: A false notification was recorded once every 6.29 days, on average (6 false red notifications in 922 hours) and a false yellow notification was issued once every 4.78 days, on average (8 false yellow notifications in 922 hours).
Device Validation for Infiltrated Tissue study: The SmartTouch issued red and yellow notifications for 99.0% (97/98, 95% confidence interval: 94.5% to 100.0%) of early stage infiltrations. The infiltration rate was selected from a range extending from 5 ml/hr to 150 ml/hr.
An analysis of the detected volume indicated the SmartTouch sensor issued red and yellow notifications at an average of 2.13 mL and 2.02 mL of infiltrated saline, respectively.
No new safety issues or adverse events were identified during any of the verification and validation clinical studies.
Key Metrics
False notification rate (non-infiltrated tissue): 1 false red notification every 6.29 days; 1 false yellow notification every 4.78 days.
Detection rate (infiltrated tissue): 99.0% (97/98, 95% confidence interval: 94.5% to 100.0%) for early stage infiltrations.
Average detected volume: 2.13 mL (red notification) and 2.02 mL (yellow notification) of infiltrated saline.
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
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July 2, 2020
ivWatch, LLC Holly Novak Director Regulatory Affairs and Quality Assurance 630 Hofstadter Road. Suite 300 Newport News, Virginia 23606
Re: K192385
Trade/Device Name: ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PMS Dated: May 29, 2020 Received: June 1, 2020
Dear Holly Novak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tina Kiang, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ivWatch Model 400 Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
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 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 Subnart 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 in black, with the letters "iv" in white inside the droplet. To the right of the droplet is the word "Watch" in a cursive font, also in black. The logo is simple and modern, and the use of the water droplet suggests a connection to fluids or hydration.
ivWatch,LLC 630 Hofstadter Road, Suite 300 Newport News, VA 23606
510(K) SUMMARY
7.1 Submitter
| Submitter Name | ivWatch, LLC |
|---|---|
| Submitter Address | 630 Hofstadter Road, Suite 300 |
| Newport News, VA 23606 | |
| Establishment Registration | 3011490091 |
| Phone | 855-489-2824 |
| Fax | 757-224-5009 |
| Primary Contact | Holly Novak, Vice President, Regulatory Affairs and |
| Quality Assurance | |
| Primary Contact Email | holly.novak@ivwatch.com |
| Primary Contact Phone | 855-489-2824 x7046 |
| Date Prepared | June 18, 2020 |
7.2 Subject Device
| Trade Name | ivWatch® Model 400 Device Accessories: Extension
Module, Patient Cable and SmartTouch™ Sensor |
|-----------------------|--------------------------------------------------------------------------------------------------|
| Manufacturer | ivWatch, LLC |
| 510(k) Number | K192385 |
| Device Class | II |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS |
| Device Classification | Peripheral Intravenous (PIV) Infiltration Monitor |
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Image /page/4/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a black teardrop shape with the letters "iv" in white inside the teardrop. To the right of the teardrop is the word "Watch" in a stylized font, also in black. The logo is simple and modern, and the teardrop shape likely represents intravenous fluids, which is the company's area of expertise.
Watch,LLC 30 Hofstadter Road, Suite 300 Newport News,
| Trade Name | ivWatch® Model 400 |
|---|---|
| Manufacturer | ivWatch, LLC |
| 510(k) Number | K162478 |
| Device Class | II |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS |
| Device Classification | Peripheral Intravenous (PIV) Infiltration Monitor |
7.3 Predicate Device
7.4 Device Description
The predicate device (K162478), the ivWatch® Model 400, consists of the ivWatch® Patient Monitor, a reusable Fiber Optic Sensor Cable and a single-use sterile Sensor Receptacle. The subject device includes the addition of Device Accessories to the ivWatch® Model 400 including an Extension Module, reusable Patient Cable and a single-use electronic SmartTouch™ Sensor. The Device Accessories expand the current ivWatch® Model 400 architecture to support the reusable Fiber Optic Sensor (predicate device) and an electronic single-use sterile SmartTouch™ Sensor (subject device). Both the predicate and subject device provide continuous, non-invasive monitoring of human tissue adjacent to peripheralintravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events.
The ivWatch® Model 400 with Device Accessories uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. Light signals generated by the SmartTouch™ Sensor are sent to the patient's tissue near an PIV site. Changes to the light signals are received by the SmartTouch™ Sensor and electrical signals are transferred through the Patient Cable to the Extension Module where embedded software analyzes the data to determine whether conditions indicate that an infiltration event may have occurred. The information is then sent from the Extension Module to the ivWatch® Patient Monitor for display. If changes in the diffuse reflectance in the tissue near the PIV site are consistent with an infusate pooling in the subcutaneous tissue, the ivWatch® Patient Monitor emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.
5
Image /page/5/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized black teardrop shape with three small squares inside, followed by the text "ivWatch" in a stylized font. The "i" and "v" are connected, and the "Watch" is written in a flowing script.
80 Hofstadter Road, Suite 300 Newport News,
7.5 Intended Use
The ivWatch Model 400 is intended to aid in the detection of infiltrations and extravasations during peripheral IV infusion therapy in pediatric and adult patients. The user profile is healthcare practitioners who are experienced in IV administration and management and located at hospitals and similar medical care facilities.
The intended use of the subject device is the same as the predicate (K162478).
7.6 Indications for Use
The ivW atch 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 pediatics 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 reqular clinician assessment of the PIV site. The ivW atch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.
The indications for use of the subject device is the same as the predicate (K162478).
7.7 Comparison of the Subject Device to the Predicate Devices
The subject device (ivWatch® Model 400 Device Accessories) is a modification to the legally marketed ivWatch® Model 400. The subject device expands the functionality of the ivWatch® Model 400 (predicate) with the addition of three device accessories: Extension Module, Patient Cable and SmartTouch™ Sensor. The subject and predicate devices have the same technological characteristics, intended use and indications for use.
The subject and predicate devices share the same technological elements:
- . Sensor is placed near the IV insertion site to emit optical signals and detect changes in the diffuse reflectance of the tissue.
- . The optical signals emitted and detected by the sensor are visible and nearinfrared light signals.
- . The optical signal received by the sensor is altered if the IV fluid accumulates in the tissue surrounding the intended intravenous administration route underneath the sensor.
- . The reflected optical signal from the tissue is sent back to the device for analysis by ivWatch's algorithm to determine if an infiltration may have occurred.
- . Software in the Patient Monitor controls the user interface including the issuance of audible and visual notifications for a possible infiltration event.
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Image /page/6/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized black teardrop shape with the letters "iv" inside, with the "i" being dotted with small squares. To the right of the teardrop is the word "Watch" in a cursive font. The logo is simple and modern, and the use of the teardrop shape suggests a connection to fluids or liquids.
The following technical differences exist between the subject and predicate devices:
- . The subject device has the optical components at the SmartTouch™ Sensor head while the predicate device has the optical componentsin the Patient Monitor.
- . Light is generated and detected in the subject device SmartTouch™ Sensor head while the predicate device light generation and detection is at the Patient Monitor.
- . Electrical signals are transmitted to and from the SmartTouch™ Sensor head through the Patient Cable to the Extension Module for signal processing. The predicate device light signals are transmitted through the Fiber Optic Sensor Cable to the patient's skin and simultaneously reflected light signal from the patient's skin are transmitted back to the Patient Monitor for data analysis.
- . The patient contacting SmartTouch™ Sensor (subject) is dimensionally smaller than the Sensor Receptacle (predicate).
- . The predicate device uses fiber optics to transmit the signal, while the subject devices uses an electronic signal.
7.8 Performance Data
The subject device underwent the exact same performance testing as the predicate device in support of substantial equivalence. A summary of the completed testing is provided below.
7.8.1 Sterilization and Shelf Life
The SmartTouch™ Sensor is sterilized by ethylene oxide (EO) ) per ISO 14937-1:2009 and AAMI TIR56:2013 (R2016). EO and ethylene chlorohydrin residuals are in compliance with ISO 10993-7:2008. In addition, the SmartTouch™ Sensor passed package testing in compliance with ISO 11607-1:2006/A1:2014, ASTM F1140/F1140M-13, ASTM F2096-11 and ASTM D4169-16.
The Patient Cable is designed to be cleaned and disinfected between uses. Cleaning and low-level disinfection validation testing passed all pre-defined acceptance criteria in compliance with AAMI TIR12-2010 and AAMI TIR30-2011.
7.8.2 Biocompatibility
The SmartTouch™ Sensor and Patient Cable are classified as having prolonged duration (greater than 24 hours but less than 30 days) patient-contacting components. Biocompatibility testing was conducted in compliance with ISO 10993-1:2018, 10993-5:2009, 10993-10:2010. Results show that the patient contacting components of the SmartTouch™ Sensor and Patient Cable pass all
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Image /page/7/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized water droplet shape at the top left, with the letters "iv" inside the droplet. To the right of the droplet, the word "Watch" is written in a flowing, cursive-like font. The logo is simple, modern, and easily recognizable.
pre-defined acceptance criteria defined for cytotoxicity, sensitization and irritation testing.
7.8.3 Electromagnetic Compatibility (EMC) and Electrical Safety
EMC and electrical safety testing were conducted on the Extension Module (subject device) while connected to the Patient Monitor (predicate device) and results show that the ivWatch® Model 400 with Device Accessories complies with the requirements of EN / IEC 60601-1-2 4th Edition and IEC 60601-1 3rd Edition.
7.8.4 Software Verification and Validation Testing
Software verification and validation testing were conducted on the Extension Module (subject device) while connected to the Patient Monitor (predicate device) for the ivWatch® Model 400 and documentation was provided in accordance FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304.
Cybersecurity was provided in accordance of " Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" Guidance document.
7.8.5 Performance Testing
7.8.5.1 Bench Testing
Optical safety testing was performed on the subject device and indicated that the optical radiation emitted by the SmartTouch™ Sensor is significantly less than the limits defined in ANSI Z136.1 (2014).
7.8.5.2 Clinical Studies
A series of series of five verification and two validation IRB-approved clinical studies were performed for the development and validation of the modified ivWatch® Model 400 with Device Accessories.
The device validation for non-infiltrated tissue study showed a false notification was recorded once every 6.29 days, on average (6 false red notifications in 922 hours) and a false yellow notification wasissued once every 4.78 days, on average (8 false yellow notifications in 922 hours).
In the Device Validation for Infiltrated Tissue study, the SmartTouch issued red and yellow notifications for 99.0% (97/98, 95% confidence interval: 94.5% to 100.0%) of early stage infiltrations. The infiltration rate was selected from a range extending from 5 ml/hr to 150 ml/hr. An analysis of the detected volume indicated the SmartTouch sensor issued red and yellow notifications at an average of 2.13 mL and 2.02 mL of infiltrated saline, respectively.
There were no new safety issues identified and no adverse events during any of the verification and validation clinical studies.
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Image /page/8/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized black teardrop shape on the left, with the letters "iv" inside the teardrop. To the right of the teardrop is the word "Watch" in a simple, sans-serif font. A vertical line is on the right side of the logo.
ivWatch,LLC 630 Hofstadter Road, Suite 300 Newport News, VA 23606
7.8.6 Summary
The results of the performance testing indicate that the ivWatch® Model 400 with Device Accessories is substantially equivalent to the predicate device (K162478) and raises no concerns regarding safety and effectiveness.
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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 a grid pattern inside, followed by the text "ivWatch" in a clean, sans-serif font. A vertical line is present to the right of the text, possibly indicating a separation or continuation of the brand identity.
7.9 SummaryTable
| Item | Predicate Device K162478 | Subject Device K192385 | Substantial
Equivalence
Discussion |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Trade Name | ivWatch Model 400 | ivWatch Model 400 Device Accessories | N/A |
| Manufacturer | ivWatch, LLC | ivWatch, LLC | Equivalent |
| 510(k) Number | K162478 | K192385 | N/A |
| Product Code | PMS | PMS | Equivalent |
| Device Class | II | II | Equivalent |
| Classification Name | Peripheral Intravenous (PIV) Infiltration
Monitor | Peripheral Intravenous (PIV) Infiltration
Monitor | Equivalent |
| Regulation Number | 21 CFR 880.5725 | 21 CFR 880.5725 | Equivalent |
| Intended Use | The ivWatch Model 400 is intended to aid
in the detection of infiltrations and
extravasations during peripheral IV
infusion therapy in pediatric and adult
patients. The user profile is healthcare
practitioners who are experienced in IV
administration and management and
located at hospitals and similar medical
care facilities. | The ivWatch Model 400 is intended to aid in
the detection of infiltrations and
extravasations during peripheral IV infusion
therapy in pediatric and adult patients. The
user profile is healthcare practitioners whoare experienced in IV administration and
management and located at hospitals and
similar medical care facilities. | Equivalent |
| Item | Predicate Device K162478 | Subject Device
K192385 | Substantial
Equivalence
Discussion |
| Indications for Use | 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. | 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. | Equivalent |
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Image /page/10/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized teardrop shape in black, with the letters "iv" in white inside the teardrop. To the right of the teardrop is the word "Watch" in black, with a small circle after the word. The logo is simple and modern, and the use of the teardrop shape suggests a connection to intravenous fluids.
ivWatch,LLC 630 Hofstadter Road, Suite 300 New port News, VA 23606
| Criteria | Associated Standard | Predicate Device
Results/Comments | Subject Device
Results/Comments | Substantial
Equivalence
Discussion |
|--------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------|
| Basic Safety | EN/IEC 60601-1 | Pass
Device has no essential
performance | Pass
Device has no essential
performance | Equivalent |
| EMC | EN/IEC 60601-1-2 | Pass Class A Group 1 | Pass Class A Group 1 | Equivalent |
| Criteria | Associated Standard | Predicate Device
Results/Comments | Subject Device
Results/Comments | Substantial
Equivalence
Discussion |
| Packaging/Shipping | ASTM D1469 | Compliant to ASTM
Standard Assurance Level
1 | Compliant to ASTM
Standard Assurance Level 1 | Equivalent |
| Aging | ISO 11607-1
ASTM F1140
ASTM F2096 | Pass | Pass | Equivalent |
| Biocompatibility | ISO 10993-5 Cytotoxicity ISO
10993-10 Sensitization and
Irritation | Pass
Devices are non-toxic,
non-sensitizer, and non-
irritant | Pass
Devices are non-toxic,
non-sensitizer, and non-
irritant | Equivalent |
| Sterilization | ISO 11135
ISO 10993-7 | Pass
Sterilization SAL and EO
residual limits | Pass
Sterilization SAL and EO
residual limits | Equivalent |
| Low Level Disinfection
and Cleanability | AAMI TIR12
AAMI TIR30 | Pass
Six (6) log reduction in
microbial levels, pass
protein and hemoglobin
residuals | Pass
Six (6) log reduction in
microbial levels, pass
protein and hemoglobin
residuals | Equivalent |
| Usability | FDA Guidance: Applying
Human Factors and Usability
Engineering to Medical
Devices | Device found to be safe
and effective for the
intended users, uses, and
use environments | Device found to be safe and
effective for the intended
users, uses, and use
environments | Equivalent |
| Criteria | Associated Standard | Predicate Device
Results/Comments | Subject Device
Results/Comments | Substantial
Equivalence
Discussion |
| Software | IEC 62304 | Software design,
development and
validation is compliant to
IEC 62304 | Software design,
development and
validation is compliant to
IEC 62304 | Equivalent |
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Image /page/11/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized teardrop shape with the letters "iv" inside, and the word "Watch" to the right of the teardrop. The teardrop is black, and the letters and word are white.
ivWatch,LLC 630 Hofstadter Road, Suite 300 New port News, VA 23606
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Image /page/12/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized black teardrop shape with the letters "iv" in white inside. To the right of the teardrop is the word "Watch" in black, with a small circle after the word. The logo is simple and modern, and the use of the teardrop shape suggests a connection to fluids or liquids.
ivWatch,LLC 630 Hofstadter Road, Suite 300 New port News, VA 23606
13
Image /page/13/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized black teardrop shape with small squares inside, followed by the text "ivWatch" in a modern, sans-serif font. The "i" and "v" are connected, and the "W" in "Watch" is stylized with curved lines.
ivWatch,LLC 630 Hofstadter Road, Suite 300 New port News, VA 23606
7.10 Conclusions
The technological characteristics, principles of operation and intended use of the ivWatch® Model 400 with Device Accessories and the predicate device are the same. Differences between the subject and predicate devices were addressed through verification, validation and performance testing. Test results show that the ivWatch® Model 400 with Device Accessories meets all pre-defined acceptance criteria. The ivWatch® Model 400 with Device Accessories performs as intended, does not pose a risk to patient safety, and is substantially equivalent to the legally marketed predicate device.