(30 days)
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.
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.
Based on the provided FDA 510(k) summary for the ivWatch Model 400 (K222212), this submission primarily concerns a change in the sterilization method for the Sensor Receptacle component of the device. Therefore, the "study" proving the device meets acceptance criteria is specifically focused on demonstrating the equivalence of the new sterilization method to the previous one and showing that the device, with this new sterilization, still meets relevant standards for sterility and biocompatibility.
Here's an breakdown of the information requested, drawing from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO Standard) | Reported Device Performance (Subject Device) |
|---|---|
| Sterilization SAL (Sterility Assurance Level) of 10⁻⁶ (ISO 14937:2009) | Pass (<10⁻⁶) |
| EO (Ethylene Oxide) Residuals (< 4 mg) (ISO 10993-7:2008) | Pass |
| ECH (Ethylene Chlorohydrin) Residuals (< 9 mg) (ISO 10993-7:2008) | Pass |
| Overall device performance after sterilization (implied "performs as intended") | Device meets all pre-defined acceptance criteria, performs as intended. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the sterilization validation test set. Sterilization validation typically involves a statistically determined number of units. However, it mentions "half-cycle overkill approach" which is a common method for EO sterilization validation, implying a robust testing protocol.
The data provenance is not specified beyond being generated for this 510(k) submission, likely from ivWatch, LLC (Newport News, Virginia, USA). The study is prospective in the sense that it was conducted for regulatory submission for a change to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of submission (focused on sterilization) does not typically involve expert review for "ground truth" in the way a clinical study for diagnostic accuracy would. The "ground truth" here is the adherence to established international standards for sterilization and biocompatibility. The "experts" would be the metrology and microbiology professionals who conducted and validated the sterilization process and testing, though their specific number and qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are used in clinical image interpretation studies. This document concerns a physical device modification and sterilization validation, not diagnostic accuracy requiring human interpretation. Therefore, none is applicable in this context. The results are based on quantitative measurements against established chemical and biological limits.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study is not relevant to this 510(k) submission. The ivWatch Model 400 is hardware with signal processing algorithms to detect infiltrations. It is an "adjunctive device" to clinical evaluation, not an AI intended to improve human interpretation of images or data in a comparative reading study. The submission focuses on the safety and performance of the device itself, particularly after a manufacturing change (sterilization method).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The ivWatch Model 400 functions as a standalone device in its detection capability. It continuously monitors tissue optical properties and autonomously signals an alert if an infiltration is detected. The "study" mentioned here is about the sterilization of a component, not the performance of its detection algorithm. However, the device's core functionality (the algorithm processing optical signals) is designed to operate autonomously to detect changes. The overall summary states: "Measured changes between the emitted and reflected signal are processed by ivWatch signal processing algorithms to determine if an infiltration event may have occurred." This implies standalone performance of the algorithm for detection. The current submission proves that this device, with a modified sterilization, maintains its performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this particular 510(k) which is focused on sterilization, the "ground truth" is adherence to validated international standards for sterilization (ISO 14937:2009 for sterility assurance, ISO 10993-7:2008 for EO/ECH residuals). The acceptance criteria are scientifically established limits defined by these standards.
8. The sample size for the training set
This is not applicable. The ivWatch Model 400 is not described as an AI/ML device that requires a "training set" in the context of this 510(k) summary. While it uses "signal processing algorithms," these are likely deterministic or rule-based, or if they involve ML, the training data for the original algorithm would have been part of the predicate device's (K162478) submission, not detailed here for a sterilization change.
9. How the ground truth for the training set was established
Not applicable, as this submission does not describe an AI/ML model that requires a training set. The "ground truth" for the device's functional performance (detection of infiltration) would have been established through clinical studies for the original device, likely involving induced infiltrations in human subjects or animal models, confirmed by visual inspection or other clinical signs. However, this information is not part of the provided 510(k) summary for this submission (K222212), which is focused on a change in manufacturing process for a component.
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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 300Newport News, VA 23606 |
| EstablishmentRegistration | 3011490091 |
| Phone | 855-489-2824 |
| Fax | 757-224-5009 |
| Primary Contact | Holly Novak, Vice President of Regulatory Affairsand 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 | AssociatedStandard | Predicate DeviceResults/Comments | Subject DeviceResults/Comments | SubstantialEquivalenceDiscussion |
|---|---|---|---|---|
| Sterilization | ISO 14937ISO 10993-7 | PassSterilization SALand EO residuallimits | PassSterilization SALand EO residuallimits | 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 criteriato:Sterilization ISO 11135-1:2007EO Residuals ISO 10993-7:2008 | Device met acceptance criteriato:Sterilization ISO 14937:2009 andAAMI TIR56:2013EO Residuals ISO 10993-7:2008 |
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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 DeviceK162478 | Subject Device | SubstantialEquivalenceDiscussion |
|---|---|---|---|
| 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 |
| ClassificationName | Peripheral Intravenous (PIV)Infiltration Monitor | Peripheral Intravenous (PIV)Infiltration Monitor | Equivalent |
| RegulationNumber | 21 CFR 880.5725 | 21 CFR 880.5725 | Equivalent |
| Intended Use | The ivWatch Model 400 isintended to aid in thedetection of infiltrationsand extravasations duringperipheral IV infusiontherapy in pediatric andadult patients. The userprofile is healthcarepractitioners who areexperienced in IVadministration andmanagement and located athospitals and similarmedical care facilities. | The ivWatch Model 400 isintended to aid in thedetection of infiltrations andextravasations duringperipheral IV infusiontherapy in pediatric andadult patients. The userprofile is healthcarepractitioners who areexperienced in IVadministration andmanagement and located athospitals and similarmedical care facilities. | Equivalent |
| Indicationsfor Use | The ivWatch Model 400 isindicated for the detectionof subcutaneousinfiltrations andextravasations of 10 cc orless of optically clearinfusates, as an adjunctivedevice to the clinicalevaluation in the healthcaresetting of adults andpediatrics with peripherally-inserted catheters (PIVs). | The ivWatch Model 400 isindicated for the detectionof subcutaneousinfiltrations andextravasations of 10 cc orless of optically clearinfusates, as an adjunctivedevice to the clinicalevaluation in the healthcaresetting of adults andpediatrics with peripherally-inserted catheters (PIVs). | Equivalent |
| Item | Predicate DeviceK162478 | Subject Device | SubstantialEquivalenceDiscussion |
| The device is indicated toassess patients forsubcutaneous infiltrationsand extravasations butshould not serve as asubstitute for regularclinician assessment of thePIV site. The ivWatch Model400 is intended for use byhealthcare practitionerswho have been trained inthe use of the device. | The device is indicated toassess patients forsubcutaneous infiltrationsand extravasations butshould not serve as asubstitute for regularclinician assessment of thePIV site. The ivWatch Model400 is intended for use byhealthcare practitionerswho have been trained inthe use of the device. | ||
| Principles ofOperation | During IV fluid infusion, theivWatch sensor transmits anoptical signal through thetissue; the optical signal isaltered if the IV fluid isaccumulating in the tissueunderneath the sensor,surrounding the intendedintravenous administrationroute, which may indicatethat fluid is not beingdelivered to the intendedintravenous administrationroute (i.e., if an infiltrationor extravasation hasoccurred). | During IV fluid infusion, theivWatch sensor transmits anoptical signal through thetissue; the optical signal isaltered if the IV fluid isaccumulating in the tissueunderneath the sensor,surrounding the intendedintravenous administrationroute, which may indicatethat fluid is not beingdelivered to the intendedintravenous administrationroute (i.e., if an infiltration orextravasation hasoccurred). | Equivalent |
| Mechanism ofAction | Device is turned on; sensoris placed near the IVinsertion site; a baseline isestablished andcharacteristics of the tissuearound the IV site aremonitored for deviationsbeyond preset thresholdvalues. | Device is turned on; sensoris placed near the IVinsertion site; a baseline isestablished andcharacteristics of the tissuearound the IV site aremonitored for deviationsbeyond preset thresholdvalues. | Equivalent |
| SystemComponents | ivWatch Patient Monitor,Sensor Receptacle, andOptical Sensor Cable. | ivWatch Patient Monitor,Sensor Receptacle, andOptical Sensor Cable. | Equivalent |
| Item | Predicate DeviceK162478 | Subject Device | SubstantialEquivalenceDiscussion |
| SterilizationMethod | Category A, EO Chambermethod | Category B, Flexible Bagmethod | Although themethod of EOsterilization differsbetween thesubject andpredicate devices,the subject devicewas tested toconfirm aminimum SAL of10-6 in compliancewith ISO14937:2009 usingthe overkillmethod. EO/ECHresiduals werealso tested andpassed theallowable limitsper ISO 10993-7:2008. Testresults verify thesterilizationmethods of thepredicate andsubject device areequivalent |
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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. 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.
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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).
§ 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).