(98 days)
No
The document describes "ivWatch signal processing algorithms" but does not mention AI, ML, or related terms. The description focuses on measuring and processing changes in optical properties using visible and near-infrared light.
No.
The device is indicated for detection or monitoring of medical conditions, not for providing treatment.
Yes
The device is indicated for the "detection of subcutaneous infiltrations and extravasations" and "to assess patients for the subcutaneous infiltrations and extravasations", which are diagnostic functions.
No
The device description explicitly states it includes hardware components such as a Patient Monitor, Fiber Optic Sensor Cable, disposable Sensor Receptacle, Extension Module, Patient Cable, and SmartTouch Sensor. It also describes the use of visible and near-infrared light, which requires hardware.
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 collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- ivWatch Model 400 Function: The ivWatch Model 400 works by non-invasively monitoring human tissue adjacent to a PIV insertion site using light. It does not collect or analyze specimens from the body. Its purpose is to detect changes in the tissue's optical properties that may indicate infiltration or extravasation.
Therefore, the ivWatch Model 400 falls under the category of a non-invasive medical device used for monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / 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 and iron sucrose infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for the subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.
Product codes
PMS
Device Description
The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The predicate device includes a Patient Monitor, a Fiber Optic Sensor Cable, and a disposable Sensor Receptacle. Under K192385 the system was expanded to add three Device Accessories including an Extension Module, a Patient Cable and SmartTouch Sensor. The Device Accessories expand system's functionality to support two sensor technologies (fiber optic and electronic).
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 ivWatch Patient Monitor (IPM) contains an optical system that generates visible and near-infrared light signals that are sent through the sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible and near-infrared light
Anatomical Site
Human tissue adjacent to peripheral intravenous (PIV) insertion sites
Indicated Patient Age Range
pediatrics and adult patients
Intended User / Care Setting
healthcare practitioners who are experienced in IV administration and management and located at 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Bench testing
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results: Data supports the update to the ivWatch Patient Monitoring System's Indications for Use to detect iron sucrose infusions in addition to optically clear infusions. Iron concentrations from 1mg/ml to 20mg/ml were tested. Results showed: Mean signal drops Saline: 23.7% (std: 6.79%) Iron: 47.1% (std: 7.97%) Iron injection signals not weaker than saline signals (p≈1.000) Diluted iron signal (1mg/ml) is stronger signal than saline. Signal strength increases with higher concentration of iron.
Study Type: Clinical studies
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results: A series of IRB-approved clinical studies were performed for the verification and validation of the ivWatch Model 400 with Device Accessories. All submitted clinical studies were conducted in the United States and in compliance with 21 CRF 50, 21 CFR 54, 21 CFR 56 and 21 CRF 812, ICH E6 and ISO 14155. The results demonstrated that the ivWatch Model 400 with Device Accessories meets the devices intended use and raises no concerns regarding safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean signal drops Saline: 23.7% (std: 6.79%)
Iron: 47.1% (std: 7.97%)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
March 15, 2024
ivWatch, LLC Holly Novak Vice President, Regulatory Affairs & Quality Assurance 700 Tech Center Parkway Suite 300 Newport News, Virginia 23606
Re: K233881
Trade/Device Name: ivWatch® Model 400 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: PMS Dated: February 16, 2024 Received: February 16, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-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 Advice (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,
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K233881
Device Name ivWatch® Model 400
Indications for Use (Describe)
The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear and iron sucrose 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 iv Watch Model 400 is intended for use by healthcare practitioners who have been tramed in the use of the device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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K233881 - 510(K) SUMMARY
| Device Submitter | ivWatch, LLC | |
|---|---|---|
| 700 Tech Center Parkway, Suite 300 | ||
| Newport News, VA 23606 | ||
| Contact Person | Holly Novak, Vice President of Regulatory Affairs | |
| and Quality Assurance | ||
| holly.novak@ivwatch.com 855-489- | ||
| 2824 x7046 | ||
| Fax: 757-224-5009 | ||
| Date Prepared | December 07, 2023 |
Subject Device
| Trade Name | ivWatch® Model 400 |
|---|---|
| Device Class | II |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS |
| Common Name | Peripheral Intravenous (PIV) Infiltration Monitor |
| Classification Name | Infusion pump |
Predicate Device
| Trade Name | ivWatch® Model 400 |
|---|---|
| 510(k) Number | K192385 |
| Device Class | II |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS |
| Common Name | Peripheral Intravenous (PIV) Infiltration Monitor |
| Classification Name | Infusion pump |
5
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 predicate device includes a Patient Monitor, a Fiber Optic Sensor Cable, and a disposable Sensor Receptacle. Under K192385 the system was expanded to add three Device Accessories including an Extension Module, a Patient Cable and SmartTouch Sensor. The Device Accessories expand system's functionality to support two sensor technologies (fiber optic and electronic).
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 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The ivWatch Patient Monitor (IPM) contains an optical system that generates visible and near-infrared light signals that are sent through the sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by 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.
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 (K192385).
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 and iron sucrose 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.
6
The indications for use of the subject device are the predicate (K192385), with the addition of iron sucrose as an indicated infusate.
Comparison of the Subject Device to the Predicate Devices
The subject device includes all the same device accessories as the predicate. Under this 510K submission, the only change is to the Indications for use to add iron sucrose as an indicated infusate. There are no changes to the devices.
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Image /page/7/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized teardrop shape on the left, with the letters "iv" inside the teardrop. To the right of the teardrop is the word "Watch" in a sans-serif font. The logo is simple and modern, and the use of the teardrop shape likely represents intravenous fluids.
ivWatch, LLC 700 Tech Center Parkway, Suite 300 Newport News, VA 23606
1.855.IVWATCH (489.2824) Fax: 757.224.5009 www.ivwatch.com
Summary Table
| Item | Predicate Device
K192385 | Subject Device | Substantial
Equivalence
Discussion |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ivWatch Model 400 | Same | Equivalent |
| Manufacturer | ivWatch, LLC | Same | Equivalent |
| 510(k) Number | K192385 | K233881 | N/A |
| Product Code | PMS | Same | Equivalent |
| Device Class | II | Same | Equivalent |
| Common Name | Peripheral Intravenous (PIV) Infiltration
Monitor | Same | Equivalent |
| Regulation Number | 21 CFR 880.5725 | Same | 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. | Same | Equivalent |
| 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 | The ivWatch Model 400 is indicated for
the detection of subcutaneous
infiltrations and extravasations of 10 cc
or less of optically clear and iron sucrose
infusates, as an adjunctive device to the | Equivalent
Bench testing results
support device
detection of iron |
| Item | Predicate Device
K192385 | Subject Device | Substantial
Equivalence
Discussion |
| | 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. | 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. | sucrose; iron infusate
do not impact device
safety or effectiveness |
| Sterilization | The SmartTouch Sensor and Sensor
Receptacles are sterilized using the EO
half-cycle overkill approach. A minimum
SAL of
$10^{-6}$ per ISO 11135, EO residuals of