ivWatch Model 400
Device Facts
| Record ID | K153605 |
|---|---|
| Device Name | ivWatch Model 400 |
| Applicant | Ivwatch, LLC |
| Product Code | PMS · General Hospital |
| Decision Date | Feb 11, 2016 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
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, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand. 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 physicians, or under the direction of a physician, who have been trained in the use of the ivWatch Model 400.
Device Story
Device provides continuous, noninvasive monitoring of tissue near PIV insertion sites to detect infiltration/extravasation. System comprises ivWatch Patient Monitor (IPM), reusable optical sensor cable, and single-use sensor receptacle. IPM emits visible and near-infrared light through cable to skin; measures reflected light. Proprietary signal processing algorithms analyze changes in optical properties to identify infusate pooling. If infiltration detected, IPM triggers audible/visual notifications for clinician inspection. Used in hospital settings by trained physicians or under physician direction. Output aids clinical decision-making by providing early warning of potential infiltration events, potentially benefiting patients by reducing complications associated with extravasation.
Clinical Evidence
No clinical data. Bench testing only. Biocompatibility testing (sensitization, irritation, cytotoxicity) per ISO 10993-10:2010 and ISO 10993-5:2009 passed. Reprocessing validation (low-level disinfection and cleaning) per AAMI TIR12-2010 and AAMI TIR30-2011 passed.
Technological Characteristics
System includes IPM, reusable optical sensor cable, and single-use sensor receptacle. Sensor cable sheathing uses Pellethane 80AE with 2.7% Propell and Pantone 646C colorant. Sensing principle: visible and near-infrared light reflectance. Connectivity: proprietary signal processing. Sterilization/Reprocessing: low-level disinfection and cleaning validation per AAMI standards.
Indications for Use
Indicated for detection of subcutaneous infiltrations and extravasations (≤10 cc) of optically clear, uncolored infusates in hospital patients ≥18 years old with PIVs on the forearm or dorsal hand. Adjunctive to clinical assessment; not a substitute for regular site inspection.
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 (K142374)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2016
ivWatch, LLC Ms. Jaclyn Lautz Director of Regulatory Affairs and Quality Assurance 469 Mclaws Circle Williamsburg, Virginia 23185
Re: K153605 Trade/Device Name: ivWatch Model 400 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: PMS Dated: January 12, 2016 Received: January 14, 2016
Dear Ms. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K153605
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, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand.
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 iv Watch Model 400 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the iv Watch Model 400.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a 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. The logo is simple and modern, and it is likely used to represent a company or product related to intravenous therapy or monitoring.
ivWatch, LLC 469 McLaws Circle Williamsburg, VA 23185
1.855.IVWATCH (489.2824) Fax: 757.645.4760 www.ivwatch.com
### 7 SPECIAL 510(K) SUMMARY
## 7.1 Administrative
| Submitter Name | ivWatch, LLC |
|-----------------------|--------------------------------------------------------------------------|
| Applicant Address | 469 McLaws Circle<br>Williamsburg, VA 23185 |
| Phone | 855-489-2824 |
| Fax | 757-645-4760 |
| Primary Contact | Jaclyn Lautz, Director of<br>Regulatory Affairs and Quality<br>Assurance |
| Primary Contact Email | jaclyn.lautz@ivwatch.com |
| Primary Contact Phone | 855-489-2824 x7023 |
| Date Prepared | January 12, 2016 |
#### 7.2 Device
| Trade Name | ivWatch Model 400 |
|---------------------|------------------------------------------------------------|
| Manufacturer | ivWatch, LLC |
| 510(k) Number | K153605 |
| Device Class | II |
| Classification Name | Infusion Pump |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS (Peripheral Intravenous<br>(PIV) Infiltration Monitor) |
#### 7.3 Predicate Device
| Trade Name | ivWatch Model 400 |
|---------------------|--------------------------------------|
| Manufacturer | ivWatch, LLC |
| 510(k) Number | K142374 |
| Device Class | II |
| Classification Name | Infusion Pump |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | MRZ (Accessories, Pump,<br>Infusion) |
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Image /page/4/Picture/0 description: The image shows the logo for IV Watch. The logo consists of a stylized black teardrop shape with a grid pattern in the upper left corner. The text "ivWatch" is written in a modern, sans-serif font to the right of the teardrop shape. The "i" and "v" are connected, and the "W" is stylized with a curved line.
ivWatch IIC 469 McLaws Circle Williamsburg, VA 23185
1.855.IVWATCH (489.2824) Fax: 757.645.4760 www.ivwatch.com
# 7.4 Device Description
The ivWatch Model 400 is a medical device that provides continuous, noninvasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites on the forearm and dorsal aspect of the hand 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 signal are processed by proprietary ivWatch signal processing algorithms to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the peripheral IV 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 peripheral IV site for a possible infiltration event.
#### Indications For Use 7.5
The indications for use are identical to the predicate device.
The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand. 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 physicians, or under the direction of a physician, who have been trained in the use of the ivWatch Model 400.
## 7.6 Comparison of Modified Device with the Predicate Device
The subject device has the same technological characteristics and intended use as compared to the predicate device (K142374). The ivWatch Model 400 consists of the ivWatch patient monitor, a single-use sensor receptacle and a reusable optical sensor cable. There have been no changes to the ivWatch patient monitor and the single-use sensor receptacle of the subject device compared to the predicate device submission. The sensor cable of the subject device is the only component of the ivWatch Model 400 that has been modified. Specifically, the sensor cable sheathing, which is the outer protective layer encasing the flexible glass fibers, has been modification of the subject device's sheathing includes removing an additive and changing the colorant.
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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 modern, sans-serif font. There is a small trademark symbol after the word "Watch".
ivWatch IIC 469 McLaws Circle Williamsburg, VA 23185
| Item | Predicate Device - ivWatch<br>Model 400<br>K142374 | Subject Device – ivWatch<br>Model 400<br>K153605 | |
|--------------------------------------------------------|----------------------------------------------------|--------------------------------------------------|---------------------------------|
| Monitor | ivWatch Patient Monitor | ivWatch Patient Monitor | |
| Sterile, disposable<br>patient-contacting<br>component | ivWatch Sensor Receptacle | ivWatch Sensor Receptacle | |
| Sensor<br>Cable | Formulation | Pellethane 80AE<br>Biosafe<br>2.7% Propell | Pellethane 80AE<br>2.7% Propell |
| | Colorant | Pantone 2975C | Pantone 646C |
| | Extrusion<br>Method | Co-extrusion | Single extrusion |
#### Performance Data 7.7
ivWatch has performed the following non-clinical/design verification testing based on the risk analysis conducted. The 510(k) submission included a summary of these design control activities to assure that the risks were adequately mitigated. The risks identified included biocompatibility and reprocessing. The mitigation for biocompatibility risks was to repeat the testing that was previously performed on the sensor cable sheathing of the predicate device per ISO 10993-1: Biological evaluation of medical devices, Part 1: Evaluation and testing. The reprocessing risks were mitigated by repeating the low-level disinfection validation and cleaning validation that was performed on the sensor cable of the predicate. The results of these tests demonstrate that the sensor cable modification of the ivWatch Model 400 is substantially equivalent to the sensor cable of the predicate device based on predetermined acceptance criteria. Clinical testing was not required for this submission.
| Performance Characteristic | Acceptance Criteria | Result | |
|----------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------|------|
| Biocompatibility<br>Testing<br>Performed on<br>the sheathing<br>of the sensor<br>cable | Sensitization | Per ISO 10993-10:2010, Non-<br>sensitizer | Pass |
| | Irritation | Per ISO 10993-10:2010, Non-<br>irritant | Pass |
| | Cytotoxicity | Per ISO 10993-5:2009, Non-toxic | Pass |
| Reprocessing<br>Validation<br>Performed on<br>the sensor | Low Level<br>Disinfection | Per AAMI TIR12 -2010, AAMI<br>TIR30-2011 and Reprocessing<br>Medical Devices in Health<br>Care Settings: Validation | Pass |
| | Cleaning | | Pass |
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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 three small white squares inside, followed by the text "ivWatch" in a clean, sans-serif font. A vertical black line is present on the right side of the logo.
ivWatch, LLC 469 McLaws Circle Williamsburg, VA 23185
1.855.IVWATCH (489.2824) Fax: 757.645.4760 www.ivwatch.com
cable
Methods and Labeling
### 7.8 Conclusions
The risks associated with the modified ivWatch Model 400 have been identified and the design control activities demonstrate adequate risk mitigation. The modified ivWatch Model 400 is substantially equivalent to the predicate device.
