(30 days)
No
The description mentions "ivWatch signal processing algorithms" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML development (training/test sets, specific performance metrics like AUC for classification). The signal processing appears to be based on measuring changes in optical properties and comparing them to thresholds or patterns consistent with infiltration, which is a common approach in traditional signal processing.
No
The device is indicated for detection and monitoring, not for providing therapy or treatment.
Yes
The device is indicated for the "detection of subcutaneous infiltrations and extravasations" and is used to "assess patients for subcutaneous infiltrations and extravasations." This clearly falls under the definition of a diagnostic device, which identifies specific conditions or diseases.
No
The device description explicitly states that the ivWatch Model 400 consists of hardware components: the ivWatch Patient Monitor (IPM), a reusable optical sensor cable, and a single-use Sensor Receptacle. It uses visible and near-infrared light, which requires hardware for generation and detection.
Based on the provided information, the ivWatch Model 400 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ivWatch Model 400 Function: The ivWatch Model 400 works by non-invasively monitoring human tissue using light. It does not analyze any specimens taken from the body. Its purpose is to detect changes in the tissue itself, adjacent to a PIV insertion site.
Therefore, the ivWatch Model 400 falls under the category of a medical device that performs a diagnostic function in vivo (within the living body), rather than in vitro (in a test tube or outside the body).
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 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 (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tissue adjacent to peripheral intravenous (PIV) insertion sites
Indicated Patient Age Range
adults and pediatrics
Intended User / Care Setting
healthcare practitioners who have been trained in the use of the device.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2022
ivWatch, LLC Holly Novak Vice President. Regulatory Affairs & Quality Assurance 700 Tech Center Parkway, Suite 300 Newport News, Virginia 23606
Re: K222212
Trade/Device Name: ivWatch Model 400 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PMS Dated: July 22, 2022 Received: July 25, 2022
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 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.
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 (OS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Payal Patel Assistant 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
Submission Number (if known)
Device Name
ivWatch Model 400 (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 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 iWatch 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 Subpart 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 on the left, with the letters "iv" inside. To the right of the droplet is the word "Watch" in a simple, sans-serif font. There is a vertical line on the right side of the logo.
K22212 - 510(K) SUMMARY
Administrative
Submitter Name | ivWatch®, LLC |
---|---|
Applicant Address | 700 Tech Center Parkway, Suite 300 |
Newport News, VA 23606 | |
Establishment | |
Registration | 3011490091 |
Phone | 855-489-2824 |
Fax | 757-224-5009 |
Primary Contact | Holly Novak, Vice President of Regulatory Affairs |
and Quality Assurance | |
Primary Contact Email | holly.novak@ivwatch.com |
Primary Contact Phone | 855-489-2824 x7046 |
Date | August 23, 2022 |
Subject Device
Trade Name | ivWatch® Model 400 |
---|---|
Manufacturer | ivWatch®, LLC |
510(k) Number | K222212 |
Device Class | II |
Regulation Number | 21 CFR 880.5725 |
Regulation Name | Infusion pump |
Product Code | PMS |
Common Name | Peripheral Intravenous (PIV) Infiltration Monitor |
Predicate 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 |
Common Name | 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 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. A vertical line is present on the far right side of the image.
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 Sensor Receptacle. The subject device includes the transfer of the EO sterilization from the Category A chamber method to a Category B flexible bag method. This Category B flexible bag method was the same performed under ivWatch's most recent 510K (K192385).
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 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.
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.
The indications for use of the subject device are the same as the predicate (K162478).
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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 with the letters "iv" inside. To the right of the droplet is the word "Watch" in a simple, sans-serif font. There is a vertical line on the right side of the logo.
Comparison of the Subject Device to the Predicate Devices
The subject device is a modification to the legally marketed ivWatch® Model 400. The subject device was EO sterilized using a Category B flexible bag method. The subject and predicate devices have the same technological characteristics, design, intended use and indications for use.
| Criteria | Associated
Standard | Predicate Device
Results/Comments | Subject Device
Results/Comments | Substantial
Equivalence
Discussion |
|---------------|--------------------------|--------------------------------------------------------|--------------------------------------------------------|------------------------------------------|
| Sterilization | ISO 14937
ISO 10993-7 | Pass
Sterilization SAL
and EO residual
limits | Pass
Sterilization SAL
and EO residual
limits | Equivalent |
| Parameter | Sensor Receptacle
(Predicate K162478) | Sensor Receptacle
(Subject) |
|---------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Sterilization Method | EO half-cycle overkill approach | EO half-cycle overkill approach |
| Incubation time | 7 days | 7 days |
| Minimum SAL of 10-6 |