Who is the manufacturer of ivWatch Model 400?

Ivwatch, LLC filed the 510(k) submission for ivWatch Model 400 (K222212).

What is the FDA product code for ivWatch Model 400?

PMS. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for ivWatch Model 400?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like ivWatch Model 400?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ivWatch Model 400

K222212 · Ivwatch, LLC · PMS · Aug 24, 2022 · General Hospital

Device Facts

Record ID	K222212
Device Name	ivWatch Model 400
Applicant	Ivwatch, LLC
Product Code	PMS · General Hospital
Decision Date	Aug 24, 2022
Decision	SESE
Submission Type	Special
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 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.

Device Story

ivWatch Model 400 provides continuous, non-invasive monitoring of tissue near PIV insertion sites to detect infiltration/extravasation. System includes Patient Monitor (IPM), reusable fiber optic sensor cable, and single-use sensor receptacle. IPM emits visible and near-infrared light through cable to skin; measures reflected light. Signal processing algorithms analyze changes in optical properties to identify infusate pooling. If detected, device triggers audible/visual alarms for clinician inspection. Used in healthcare settings by trained practitioners. Output aids clinical decision-making regarding PIV site management; benefits patients by enabling early detection of infiltration events.

Clinical Evidence

Bench testing only. Validation performed for sterilization (ISO 14937) and EO/ECH residuals (ISO 10993-7) to confirm the Category B flexible bag method achieves a minimum SAL of 10^-6 and meets allowable residual limits.

Technological Characteristics

System components: Patient Monitor, reusable fiber optic sensor cable, single-use sensor receptacle. Sensing principle: visible and near-infrared light reflectance. Sterilization: EO (Category B flexible bag method) per ISO 14937 and ISO 10993-7. Connectivity: not specified. Algorithm: signal processing for optical property changes.

Indications for Use

Indicated for detection of subcutaneous infiltrations and extravasations (≤10 cc of optically clear infusates) in adults and pediatrics with peripherally-inserted catheters (PIVs). Adjunctive to clinical evaluation; not a substitute for regular clinician assessment. 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 (K162478)

Submission Summary (Full Text)

{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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use Submission Number (if known) K222212 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) #### 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 PRAStaff(@fda.hhs.gov "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. 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 | {4}------------------------------------------------ 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). {5}------------------------------------------------ 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 | <10-6 | <10-6 | | EO Residual (Limit: < 4 mg) | Pass | Pass | | ECH Residual (Limit: < 9 mg) | Pass | Pass | | Testing | Device met acceptance criteria to: Sterilization ISO 11135-1:2007 EO Residuals ISO 10993-7:2008 | Device met acceptance criteria to: Sterilization ISO 14937:2009 and AAMI TIR56:2013 EO Residuals ISO 10993-7:2008 | {6}------------------------------------------------ Image /page/6/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 simple, sans-serif font. There is a vertical line on the right side of the logo. # Summary Table | Item | Predicate Device K162478 | Subject Device | Substantial Equivalence Discussion | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | ivWatch Model 400 | ivWatch Model 400 | Equivalent | | Manufacturer | ivWatch, LLC | ivWatch, LLC | Equivalent | | 510(k) Number | K162478 | K222212 | N/A | | Product Code | PMS | PMS | Equivalent | | Device Class | II | II | Equivalent | | Type of Use | Prescription Use (RX) | Prescription Use (RX) | Equivalent | | Classification Name | Peripheral Intravenous (PIV) Infiltration Monitor | Peripheral Intravenous (PIV) Infiltration Monitor | Equivalent | | Regulation Number | 21 CFR 880.5725 | 21 CFR 880.5725 | 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. | 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. | 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 setting of adults and pediatrics with peripherally- inserted catheters (PIVs). | 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). | Equivalent | | Item | Predicate Device K162478 | Subject Device | Substantial Equivalence Discussion | | | 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. | 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. | | | Principles of Operation | During IV fluid infusion, the ivWatch sensor transmits an optical signal through the tissue; the optical signal is altered if the IV fluid is accumulating in the tissue underneath the sensor, surrounding the intended intravenous administration route, which may indicate that fluid is not being delivered to the intended intravenous administration route (i.e., if an infiltration or extravasation has occurred). | During IV fluid infusion, the ivWatch sensor transmits an optical signal through the tissue; the optical signal is altered if the IV fluid is accumulating in the tissue underneath the sensor, surrounding the intended intravenous administration route, which may indicate that fluid is not being delivered to the intended intravenous administration route (i.e., if an infiltration or extravasation has occurred). | Equivalent | | Mechanism of Action | Device is turned on; sensor is placed near the IV insertion site; a baseline is established and characteristics of the tissue around the IV site are monitored for deviations beyond preset threshold values. | Device is turned on; sensor is placed near the IV insertion site; a baseline is established and characteristics of the tissue around the IV site are monitored for deviations beyond preset threshold values. | Equivalent | | System Components | ivWatch Patient Monitor, Sensor Receptacle, and Optical Sensor Cable. | ivWatch Patient Monitor, Sensor Receptacle, and Optical Sensor Cable. | Equivalent | | Item | Predicate Device K162478 | Subject Device | Substantial Equivalence Discussion | | Sterilization Method | Category A, EO Chamber method | Category B, Flexible Bag method | Although the method of EO sterilization differs between the subject and predicate devices, the subject device was tested to confirm a minimum SAL of 10-6 in compliance with ISO 14937:2009 using the overkill method. EO/ECH residuals were also tested and passed the allowable limits per ISO 10993- 7:2008. Test results verify the sterilization methods of the predicate and subject device are equivalent | {7}------------------------------------------------ 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. The letters "Watch" are to the right of the teardrop, with a small dot after the word. The logo is simple and modern, and the teardrop shape likely represents intravenous fluids. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a black teardrop shape with the letters "iv" inside, with the "i" made up of small squares. To the right of the teardrop is the word "Watch" in a simple, sans-serif font. The logo is clean and modern, and the teardrop shape likely represents intravenous fluids. #### Conclusions The technological characteristics, principles of operation and intended use of the ivWatch® Model 400 subject device and the predicate device are the same. Test results show that the ivWatch® Model 400 subject device meets all pre-defined acceptance criteria. The ivWatch® Model 400 subject device performs as intended, does not pose any additional risk to patient safety, and is substantially equivalent to the legally marketed predicate device (K162478).

ivWatch Model 400

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