ivWatch

K162478 · Ivwatch, LLC · PMS · Dec 22, 2016 · General Hospital

Device Facts

• Record ID: K162478
• Device Name: ivWatch
• Applicant: Ivwatch, LLC
• Product Code: PMS · General Hospital
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

The ivWatch Model 400 provides continuous, non-invasive monitoring of tissue near PIV insertion sites to detect infiltration/extravasation. The system comprises a patient monitor (IPM), a reusable optical sensor cable, and a single-use sensor receptacle. The IPM emits visible and near-infrared light through the cable to the skin and measures reflected light. An internal signal processing algorithm analyzes changes in optical properties to identify infusate pooling in subcutaneous tissue. If an event is detected, the device triggers audible and visual notifications for the clinician. Used in healthcare settings by trained practitioners, the device aids in early detection, allowing for timely intervention to potentially reduce patient harm from infiltration. The subject device adds an RFID tag to the sensor cable for tracking useful life (replacing a USB method) and expands the indicated patient population to include pediatrics.

Clinical Evidence

Clinical study in pediatric patients (2 weeks to 17 years, weight 3.3-196.7 kg) evaluated performance. The device detected 80.0% of infiltrations (95% CI [51.9% to 95.7%]) before clinician detection. In a blinded non-alarming group, sensitivity was 78.3% (95% CI [56.5% to 92.5%]). Average detection time was 29.8 hours prior to clinician diagnosis. No serious adverse events occurred. Results support equivalence to adult clinical data.

Technological Characteristics

System includes IPM, reusable optical sensor cable, and single-use EO-sterilized sensor receptacle (ISO 11135-1). Uses visible/near-infrared light sensing. RFID tag (ISO 15693) for cable life tracking. Compliant with IEC 60601-1-2 (EMC), ANSI/AAMI ES60601-1 (Electrical Safety). Sensor cable is MR Conditional (ASTM F2052-15, F2213-06-11, F2119-07-13, F2182-11a). Biocompatibility per ISO 10993-1, -5, -10.

Indications for Use

Indicated for detection of subcutaneous infiltrations and extravasations (≤10 cc) of optically clear infusates in pediatric and adult patients with peripherally-inserted catheters (PIVs). Adjunctive to clinical assessment; not a substitute for regular clinician site inspection. For use by trained healthcare practitioners.

Regulatory Classification

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.

Predicate Devices

• ivWatch Model 400 (K153605)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Image /page/1/Picture/8 description: The image contains a signature and name. The name "Tina Kiang -S" is written in a simple, sans-serif font. To the left of the name is a complex, looping signature in black ink. The background is a light blue color.

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)

K162478

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) | <input checked="true" type="checkbox"/> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: [phone] www.ivwatch.com

### TRADITIONAL 510(K) SUMMARY 1

#### 1.1 Administrative

| Submitter Name | ivWatch, LLC |
|--------------------------|------------------------------------------------------------------------------|
| Applicant Address | 1100 Exploration Way, Suite 209<br>Hampton, VA 23666 |
| Phone | 855-489-2824 |
| Fax | 757-224-5009 |
| Primary Contact | Jaclyn Lautz, Ph.D., Director of Regulatory Affairs and<br>Quality Assurance |
| Primary Contact Email | [e-mail] |
| Primary Contact<br>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<br>the ivWatch Model 400 (K142374) |

{4}------------------------------------------------

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: [phone] 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: [phone] 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.

{6}------------------------------------------------

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: [phone] 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<br>K153605 | Subject Device<br>K162478 | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The ivWatch Model<br>400 is designed to<br>aid in the detection<br>of infiltrations and<br>extravasations<br>during peripheral IV<br>infusion therapy. | Same | Equivalent |
| Principles of<br>operation | During IV fluid<br>infusion, the ivWatch<br>sensor transmits an<br>optical signal<br>through the tissue;<br>the optical signal is<br>altered if the IV fluid<br>is accumulating in<br>the tissue<br>underneath the<br>sensor, surrounding<br>the intended<br>intravenous<br>administration route | Same | Equivalent |
| | ivWatch, LLC<br>1100 Exploration Way, Suite 209<br>Hampton, VA 23666 | | 1.855.IVWATCH (489.224)<br>Fax: [phone]<br>www.ivwatch.com |
| | which may indicate<br>that fluid is not<br>being delivered to<br>the intended<br>intravenous<br>administration route<br>(i.e., if an infiltration<br>or extravasation has<br>occurred). | | |
| Monitor | ivWatch patient<br>monitor | Same | Equivalent |
| Single-use, sterile<br>patient-<br>contacting<br>component used<br>to secure the<br>sensor-end of<br>the sensor cable<br>onto the patient's<br>skin | ivWatch sensor<br>receptacle | Same | Equivalent |
| Optical cable to<br>transmit visible<br>and near-<br>infrared light<br>signals between<br>the monitor and<br>the patient's skin | ivWatch sensor<br>cable | Same | Equivalent |
| Power source | External power<br>supply and internal<br>lithium backup<br>battery (compliant<br>to IEC 62133:2012) | Same | Equivalent |
| Monitor MR<br>safety | MR Unsafe | Same | Equivalent |
| MR safety<br>labeling of<br>sensor cable | MR Unsafe | MR Conditional<br>Tested in<br>compliance with<br>ASTM F2052-15,<br>ASTM F2213-06-11,<br>ASTM F2119-07-13,<br>and ASTM F2182-<br>11g | MR<br>compatibility<br>testing<br>demonstrated<br>that the sensor<br>cable is MR<br>Conditional. |
| Image: ivWatch logo | ivWatch, LLC<br>1100 Exploration Way, Suite 209<br>Hampton, VA 23666 | | 1.855.IVWATCH (489.224)<br>Fax: [phone]<br>www.ivwatch.com |
| Sterility of the<br>ivWatch sensor<br>receptacle | Sterilized by<br>ethylene oxide (EO)<br>in compliance with<br>ISO 11135-1.<br>Sterilant residuals<br>pass the<br>acceptance criteria<br>in compliance with<br>ISO 10993-7. | Same | Equivalent |
| ivWatch sensor<br>receptacle shelf<br>life | 2 years<br>Tested and passed<br>all acceptance<br>criteria in<br>compliance with ISO<br>11607-1, ASTM 2096-<br>11 and ASTM 2096-<br>11. | Same | Equivalent |
| Biocompatibility<br>of prolonged<br>patient-<br>contacting<br>components<br>(Sensor<br>receptacle and<br>sensor cable) | Tested and passed<br>all biocompatibility<br>acceptance criteria<br>for prolonged intact<br>skin contact in<br>compliance with ISO<br>10993-1, ISO 10993-5<br>and ISO 10993-10. | Same | Equivalent |
| Reprocessing of<br>the ivWatch<br>sensor cable | Cleaning and low-<br>level disinfection<br>testing passed all<br>acceptance criteria<br>in accordance with<br>AAMI-TIR-2010, AAMI<br>TIR30-2011 and<br>Reprocessing<br>Medical Devices in<br>Health Care<br>Settings: Validation<br>Methods and<br>Labeling. | Same | Equivalent |
| Sensor Cable<br>Use limit | 240 hours<br>Sensor cable life is<br>tracked with a USB<br>key tethered to<br>sensor cable. | 240 hours<br>Sensor cable life is<br>tracked with RFID<br>communication<br>between RFID<br>chip embedded<br>in sensor cable | RF wireless<br>testing and<br>results are in<br>compliance<br>with IEC 60601-<br>1-2:3rd Ed. 2007<br>and FCC Part |
| | | strain relief and<br>the optics board<br>in the IPM. | 15.225 and<br>15.702 |
| Electromagnetic<br>compatibility | Tested in<br>compliance with no<br>deviations from IEC<br>60601-1-2: 3rd Ed.<br>2007 | Same | Equivalent |
| Electrical safety | Tested in<br>compliance with no<br>deviations from<br>ANSI/AAMI ES60601-<br>1:2005, 3rd ed.<br>(Medical Electrical<br>Equipment - Part 1:<br>General<br>Requirements for<br>Basic Safety and<br>Essential<br>Performance); IEC<br>60601-1: 2005 +<br>CORR. 1 (2006) +<br>CORR. 2 (2007) | Same | Equivalent |
| Radiofrequency<br>wireless testing | n/a | Tested in<br>compliance with<br>no deviations from<br>IEC 60601-1-2: 3rd<br>Ed. 2007 and FCC<br>Part 15.225 and<br>15.207 | The RF<br>communication<br>frequency<br>between the<br>ISO 15693 tag<br>and antenna<br>inside the<br>patient monitor<br>is not<br>adjustable and<br>does not<br>transmit patient<br>data. Testing<br>demonstrates<br>that the RF<br>communication<br>is as safe as the<br>predicate<br>device. |
| Performance<br>testing - Clinical | Age: Patients 18<br>years old or greater | Age: Pediatrics<br>from birth up to | The patient<br>population of |
| | ivWatch, LLC<br>1100 Exploration Way, Suite 209<br>Hampton, VA 23666 | 1.855.IVWATCH (489.224)<br>Fax: [phone]<br>www.ivwatch.com | |
| target patient<br>population | medium and dark<br>PIV site: Hand and<br>forearm | years old<br>Skin color: Light,<br>medium and ark<br>PIV site: Hand,<br>forearm,<br>antecubital fossa,<br>leg and foot | device<br>compared to<br>the predicate<br>device differs in<br>age to support<br>safety and<br>efficacy in the<br>pediatric<br>population. |
| Performance<br>testing - Clinical<br>results | Sensitivity: 96.4% of<br>infiltrations (95% CI<br>[91.4% to 98.7%])<br>were detected in<br>under 10 cc of fluid<br>False notifications: A<br>false positive<br>notification<br>occurred<br>approximately once<br>every 4 days. | Time difference<br>between ivWatch<br>and clinician<br>detection of<br>infiltration: Red<br>Check IV<br>notification issued<br>on average 29.8<br>hours prior to the<br>clinician<br>detection, 95% CI<br>[14.8, 48.8 hours].<br>Sensitivity: 78.3%<br>of infiltrations (95%<br>CI [56.5 to 92.5%])<br>were detected<br>prior to the<br>clinician<br>diagnosing the<br>infiltration in the<br>blinded non-<br>alarming group.<br>False notifications:<br>A false positive<br>notification<br>occurred<br>approximately<br>once every 4<br>days. A false<br>positive<br>notification<br>occurred<br>approximately<br>once every 10<br>days if<br>notifications | The clinical<br>performance<br>data of the<br>Model 400<br>support the<br>safety and<br>efficacy in the<br>pediatric<br>patient<br>population<br>(from birth up<br>to and<br>including 17<br>years old) as<br>compared to<br>the clinical<br>performance<br>data in<br>patient's 18<br>years or<br>greater. The<br>clinical<br>evaluation<br>demonstrates<br>that the<br>ivWatch Model<br>400 is<br>substantially<br>equivalent to<br>the predicate<br>device<br>submission. |
| Image: iv Watch logo | ivWatch, LLC<br>1100 Exploration Way, Suite 209<br>Hampton, VA 23666 | 1.855.IVWATCH (489.224)<br>Fax: [phone]<br>www.ivwatch.com | |
| Performance<br>testing - Clinical<br>adverse events | There were no<br>serious adverse<br>events during the<br>clinical study. | related to painful<br>IV flushes and<br>device-related<br>issues are<br>excluded. | There are no<br>new safety<br>issues<br>associated with<br>the use of the<br>device in<br>pediatrics. |

## 1.7.7 Summary Table

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

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}------------------------------------------------

{11}------------------------------------------------

# 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.