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.

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.

AI/ML Overview

The provided text describes the performance data for the ivWatch Model 400 with Device Accessories, focusing on its ability to detect infiltrations and extravasations.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (Implied/Stated)	Reported Device Performance
False Notifications (Non-infiltrated tissue)	False Red Notifications	Not explicitly stated, but lower is better.	Once every 6.29 days (6 false notifications in 922 hours)
	False Yellow Notifications	Not explicitly stated, but lower is better.	Once every 4.78 days (8 false notifications in 922 hours)
Detection of Early Stage Infiltrations	Percentage of early stage infiltrations detected (Red and Yellow notifications)	Not explicitly stated, but high percentage is desired.	99.0% (97/98, 95% CI: 94.5% to 100.0%)
Volume of Infiltrated Saline at Notification	Average volume (Red Notification)	Not explicitly stated, but lower volume is desired for early detection.	2.13 mL
	Average volume (Yellow Notification)	Not explicitly stated, but lower volume is desired for early detection.	2.02 mL
Safety	New safety issues identified	No new safety issues	No new safety issues identified
	Adverse events	No adverse events	No adverse events during clinical studies

Note on Acceptance Criteria: The document does not explicitly list numerical acceptance criteria for many of the performance metrics. Instead, it presents the results of the performance testing and implies that these results demonstrate the device meets an acceptable level of performance, similar to the predicate device, thereby supporting its substantial equivalence. The "Pass" or "Compliant" remarks in the summary table for other tests (EMC, Biocompatibility, etc.) serve as their acceptance criteria.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "series of five verification and two validation IRB-approved clinical studies." However, specific patient numbers for these studies are not provided.
  - For the non-infiltrated tissue study, it states "6 false red notifications in 922 hours" and "8 false yellow notifications in 922 hours." This suggests the "922 hours" represents the cumulative observation time across participants in that specific validation study. The number of individual patients or IV sites contributing to these hours is not specified.
  - For the infiltrated tissue study, it reports "99.0% (97/98)" detection, indicating that 98 infiltration events were analyzed in this validation study. It doesn't specify if these 98 events came from 98 different patients or multiple events from fewer patients.
- Data Provenance: Not explicitly stated, but implied to be prospective clinical studies conducted for the device development and validation. The country of origin is not specified but given the FDA submission, it is likely that parts of these studies, or at least the analysis, were conducted in the US or in a manner compliant with US regulatory guidelines.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. It mentions the device should be used as "an adjunctive device to the clinical evaluation" and "should not serve as a substitute for regular clinician assessment." This implies that clinical evaluation by healthcare practitioners would be the reference for ground truth on infiltration events, but no specific team or panel of experts is described for this purpose in the context of the study's ground truth establishment.
Adjudication Method for the Test Set:
- No specific adjudication method (e.g., 2+1, 3+1) is mentioned for establishing the ground truth of infiltration events in the clinical studies. The reliance on "clinical evaluation" suggests standard clinical practice for identifying infiltrations.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. The study focuses on the device's standalone performance in detecting infiltrations rather than its impact on human reader performance. This device is described as an "adjunctive device" meant to provide alerts, not to replace human assessment, so a human-in-the-loop MRMC study might not be directly relevant to its primary function or regulatory pathway.
Standalone (Algorithm Only) Performance:
- Yes, the performance data provided appears to be for the standalone performance of the algorithm and device. The device itself emits notifications (audible and visual) based on its internal analysis of optical signals. The reported percentages and volumes (e.g., 99.0% detection, average 2.13 mL for red notifications) refer to the device's direct output, not its interaction with a human reader's interpretation.
Type of Ground Truth Used:
- The ground truth for infiltration events appears to be based on clinical evaluation of actual or simulated infiltrations in patients. The document refers to "early stage infiltrations" and "infiltrated saline," suggesting direct observation or controlled induction of infiltrations confirmed by clinical signs, rather than solely pathology or outcomes data.
Sample Size for the Training Set:
- The document does not provide a specific sample size for the training set. It mentions "a series of five verification and two validation IRB-approved clinical studies were performed for the development and validation." This implies that data from some of these studies (likely verification studies) might have been used for development and refinement of the device's algorithms, which would include training. However, explicit training set details are missing.
How the Ground Truth for the Training Set Was Established:
- Similar to the test set, the method for establishing ground truth for any potential training data is not explicitly detailed. Given the nature of the device and its function, it can be inferred that ground truth was established through clinical observation and assessment by healthcare professionals of IV sites. This would involve noting when an infiltration occurred, confirming it, and correlating it with the device's readings.

Summary

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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

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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

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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 andQuality 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: ExtensionModule, 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

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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	SubstantialEquivalenceDiscussion
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) InfiltrationMonitor	Peripheral Intravenous (PIV) InfiltrationMonitor	Equivalent
Regulation Number	21 CFR 880.5725	21 CFR 880.5725	Equivalent
Intended Use	The ivWatch Model 400 is intended to aidin the detection of infiltrations andextravasations during peripheral IVinfusion therapy in pediatric and adultpatients. The user profile is healthcarepractitioners who are experienced in IVadministration and management andlocated at hospitals and similar medicalcare facilities.	The ivWatch Model 400 is intended to aid inthe detection of infiltrations andextravasations during peripheral IV infusiontherapy in pediatric and adult patients. Theuser profile is healthcare practitioners whoare experienced in IV administration andmanagement and located at hospitals andsimilar medical care facilities.	Equivalent
Item	Predicate Device K162478	Subject DeviceK192385	SubstantialEquivalenceDiscussion
Indications for Use	The ivWatch Model 400 is indicated forthe detection of subcutaneousinfiltrations and extravasations of 10 cc orless of optically clear infusates, as anadjunctive device to the clinicalevaluation in the healthcare setting ofadults and pediatrics with peripherallyinserted catheters (PIVs). The device isindicated to assess patients forsubcutaneous infiltrations andextravasations but should not serve as asubstitute for regular clinician assessmentof the PIV site. The ivWatch Model 400 isintended for use by healthcarepractitioners who have been trained inthe use of the device.	The ivWatch Model 400 is indicated for thedetection of subcutaneous infiltrations andextravasations of 10 cc or less of opticallyclear infusates, as an adjunctive device tothe clinical evaluation in the healthcaresetting of adults and pediatrics withperipherally inserted catheters (PIVs). Thedevice is indicated to assess patients forsubcutaneous infiltrations and extravasationsbut should not serve as a substitute forregular clinician assessment of the PIV site.The ivWatch Model 400 is intended for useby healthcare practitioners who have beentrained 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 DeviceResults/Comments	Subject DeviceResults/Comments	SubstantialEquivalenceDiscussion
Basic Safety	EN/IEC 60601-1	PassDevice has no essentialperformance	PassDevice has no essentialperformance	Equivalent
EMC	EN/IEC 60601-1-2	Pass Class A Group 1	Pass Class A Group 1	Equivalent
Criteria	Associated Standard	Predicate DeviceResults/Comments	Subject DeviceResults/Comments	SubstantialEquivalenceDiscussion
Packaging/Shipping	ASTM D1469	Compliant to ASTMStandard Assurance Level1	Compliant to ASTMStandard Assurance Level 1	Equivalent
Aging	ISO 11607-1ASTM F1140ASTM F2096	Pass	Pass	Equivalent
Biocompatibility	ISO 10993-5 Cytotoxicity ISO10993-10 Sensitization andIrritation	PassDevices are non-toxic,non-sensitizer, and non-irritant	PassDevices are non-toxic,non-sensitizer, and non-irritant	Equivalent
Sterilization	ISO 11135ISO 10993-7	PassSterilization SAL and EOresidual limits	PassSterilization SAL and EOresidual limits	Equivalent
Low Level Disinfectionand Cleanability	AAMI TIR12AAMI TIR30	PassSix (6) log reduction inmicrobial levels, passprotein and hemoglobinresiduals	PassSix (6) log reduction inmicrobial levels, passprotein and hemoglobinresiduals	Equivalent
Usability	FDA Guidance: ApplyingHuman Factors and UsabilityEngineering to MedicalDevices	Device found to be safeand effective for theintended users, uses, anduse environments	Device found to be safe andeffective for the intendedusers, uses, and useenvironments	Equivalent
Criteria	Associated Standard	Predicate DeviceResults/Comments	Subject DeviceResults/Comments	SubstantialEquivalenceDiscussion
Software	IEC 62304	Software design,development andvalidation is compliant toIEC 62304	Software design,development andvalidation is compliant toIEC 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

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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.

Regulation Number and Section

§ 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).