(107 days)
The iv Watch 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 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 signals are processed by the ivWatch signal processing algorithm to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the PIV 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 PIV site for a possible infiltration event.
Here's a breakdown of the acceptance criteria and study information for the ivWatch Model 400, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The core of this submission is to expand the device's indications for use to include pediatric patients, demonstrating that the device is "just as safe and effective" in this population as it was in the adult population (the predicate device's cleared indication). The document focuses on demonstrating non-inferiority for the pediatric population compared to the predicate device's performance in adults.
| Acceptance Criteria Category (Implied by Comparison to Predicate) | Predicate Device Performance (Adults) K153605 | Subject Device Performance (Pediatrics) K162478 |
|---|---|---|
| Detection Speed / Timeliness | (Not explicitly stated for predicate in comparison table, but overall assumed acceptable in predicate clearance) | ivWatch detected 80.0% of infiltrations (95% CI [51.9% to 95.7%]) before detection by a clinician. Red Check IV notification issued on average 29.8 hours prior to clinician detection (95% CI [14.8, 48.8 hours]). |
| Sensitivity | 96.4% of infiltrations (95% CI [91.4% to 98.7%]) were detected in under 10 cc of fluid. | 78.3% of infiltrations (95% CI [56.5% to 92.5%]) were detected prior to the clinician diagnosing the infiltration in the blinded non-alarming group. |
| False Notifications / Specificity (Implied Inverse) | A false positive notification occurred approximately once every 4 days. | If all notifications are considered: A false positive notification occurred approximately once every 4 days. If notifications related to painful IV flushes and device-related issues are excluded: A false positive notification occurred approximately once every 10 days. |
| Safety - Serious Adverse Events | No serious adverse events during the clinical study. | No serious adverse events during the clinical study. No new safety issues associated with the use of the device in pediatrics. |
| MR Safety of Sensor Cable | MR Unsafe | MR Conditional (Tested in compliance with ASTM F2052-15, ASTM F2213-06-11, ASTM F2119-07-13, and ASTM F2182-11g). |
| Sensor Cable Use Limit Tracking | 240 hours (tracked with USB key) | 240 hours (tracked with RFID communication between RFID chip embedded in sensor cable strain relief and the optics board in the IPM). RF wireless testing in compliance with IEC 60601-1-2: 3rd Ed. 2007 and FCC Part 15.225 and 15.207. |
Note: The FDA letter explicitly notes this is a 510(k) submission, meaning the acceptance criteria are generally to demonstrate substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds for a novel device. The study aims to show that extending the indication to pediatrics does not negatively impact the device's safety and effectiveness compared to its performance in adults.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number but derived from the description: "Safety and efficacy of the Model 400 has been demonstrated in accepted case studies representing an age distribution from 2 weeks to 17 years, patient weight measurements from 3.3 to 196.7 kg (mean, 34.5 kg), distributed skin pigmentations and similar proportions between male and female subjects."
- The "95% CI" values for sensitivity (56.5% to 92.5%) for the pediatric population suggests a smaller sample size compared to the predicate's sensitivity (91.4% to 98.7%). While precise numbers aren't given, the width of the confidence interval usually correlates inversely with sample size.
- Data Provenance: The study was a "pediatric IRB approved clinical study," indicating it was prospective clinical data from a real-world healthcare setting. The country of origin is not explicitly stated, but typically FDA submissions for US market clearance involve studies conducted in the US or in compliance with international guidelines acceptable to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document refers to "clinician detection" as the benchmark for comparison.
- Number of Experts: Not explicitly stated as a fixed number for ground truth establishment. Instead, the "clinician" is the reference point for independent diagnosis.
- Qualifications: "Clinician" typically refers to trained medical professionals (e.g., nurses, doctors) responsible for patient care and PIV site assessment. No specific expert qualifications (e.g., "radiologist with 10 years of experience") are provided for establishing the ground truth of infiltration events. The normal standard of care for PIV assessment by healthcare professionals appears to be the implied ground truth.
4. Adjudication Method for the Test Set
Not specified. The phrasing "prior to the clinician diagnosing the infiltration" suggests that individual clinicians' assessments were taken as the reference point for "ground truth" rather than a consensus or adjudicated panel. The "blinded non-alarming group" indicates that clinician detection was independent of the device's alarm for a portion of the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not explicitly mentioned or presented in the context of comparing human readers with and without AI assistance. The study compares the device's detection against "clinician detection," implying a focus on the device's standalone performance or its ability to assist the clinician by alarming earlier. The study design doesn't appear to be set up to measure improvement in human reader performance directly with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, implicitly. The performance metrics such as "ivWatch detected 80.0% of infiltrations... before detection by a clinician" and "Sensitivity: 78.3% of infiltrations (95% CI [56.5 to 92.5%]) were detected prior to the clinician diagnosing the infiltration in the blinded non-alarming group" are measures of the algorithm's ability to detect events independently of, and often before, explicit human recognition, even if the device's ultimate intended use is as an adjunctive tool. The "blinded non-alarming group" specifically evaluates the device's detection capability when its alerts are not influencing the clinician.
7. Type of Ground Truth Used
The ground truth used was clinician diagnosis of an infiltration event, based on standard clinical assessment. This is implicitly the "gold standard" against which the device's detection capability is measured. There is no mention of pathology, imaging, or specific objective outcomes data being used as the primary ground truth.
8. Sample Size for the Training Set
The document does not provide specific details on the sample size for the training set. It describes the device's general principle of operation (optical changes in tissue processed by an algorithm) but does not delineate between training and testing data for the algorithm development itself. This submission refers to clinical performance testing for validation of the device in a new population, not the initial development of the algorithm.
9. How the Ground Truth for the Training Set Was Established
Similarly, the document does not describe how the ground truth for any potential training set was established. The focus of this specific 510(k) is on the clinical validation of the already developed ivWatch Model 400 for an expanded indication (pediatrics), building upon its predicate clearance. Information about algorithm training and its associated ground truth would typically be part of an earlier submission or internal documentation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
ivWatch, LLC Jaclyn Lautz Director of Regulatory Affairs and Quality Assurance 1100 Exploration Way, Suite 209 Hampton, Virginia 23666
Re: K162478
Trade/Device Name: ivWatch Model 400 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PMS Dated: November 22, 2016 Received: November 28, 2016
Dear Jaclyn 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 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,
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Tina Kiang, Ph.D. Acting 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)
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 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.
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 the droplet. To the right of the droplet is the word "Watch" in a simple, sans-serif font. The logo is clean and modern, with a focus on the company name.
ivWatch, LLC 1 100 Exploration Way, Suite 209 Hampton, VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
TRADITIONAL 510(K) SUMMARY 1
1.1 Administrative
| Submitter Name | ivWatch, LLC |
|---|---|
| Applicant Address | 1100 Exploration Way, Suite 209Hampton, VA 23666 |
| Phone | 855-489-2824 |
| Fax | 757-224-5009 |
| Primary Contact | Jaclyn Lautz, Ph.D., Director of Regulatory Affairs andQuality Assurance |
| Primary Contact Email | jaclyn.lautz@ivwatch.com |
| Primary ContactPhone | 855-489-2824 x7023 |
| Date Prepared | September 1, 2016 |
1.2 Subject 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 (Peripheral Intravenous (PIV) Infiltration Monitor) |
| Classification Name | Infusion Pump |
1.3 Predicate Device
| Trade Name | ivWatch Model 400 |
|---|---|
| Manufacturer | ivWatch, LLC |
| 510(k) Number | K153605 |
| Device Class | II |
| Regulation Number | 21 CFR 880.5725 |
| Product Code | PMS (Peripheral Intravenous (PIV) Infiltration Monitor) |
| Classification Name | Infusion Pump |
| Clearance Information | Design modification to the sensor cable sheathing ofthe ivWatch Model 400 (K142374) |
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Image /page/4/Picture/0 description: The image shows the logo for "ivWatch." The logo consists of a stylized teardrop shape above the letters "iv" in a sans-serif font, followed by the word "Watch" in a cursive font. The teardrop has a grid-like pattern within it. The logo is in black and white.
ivWatch IIC 1 100 Exploration Way, Suite 209 Hampton. VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
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. Measured changes between the emitted and reflected signals are processed by the ivWatch signal processing algorithm to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the PIV 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 PIV site for a possible infiltration event.
Indications for Use 1.5
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.
1.6 Comparison of the Subject Device to the Predicate Device
The subject device (ivWatch Model 400) is a modification to the legally marketed ivWatch Model 400 (K153605). The subject and predicate devices consist of the same components including the ivWatch Patient Monitor, a single-use sensor receptacle and a reusable optical sensor cable. The subject and predicate devices have the same intended use which is to aid in the detection of infiltrations and extravasations during peripheral IV infusion therapy. The subject and predicate devices have the same technological characteristics and principles of operation and there have been no significant changes to the design or materials of the subject device.
This submission includes labeling modifications to the indications for use and to the MR safety information and the addition of an RFID tag in the sensor cable to track sensor cable useful life. The indications for use has been revised to extend the target patient population from patients 18 years old or greater to a patient population including both pediatrics and adults. Clinical performance testing on the pediatric patient population under the age of 18 years demonstrates that the subject device is as safe and effective as the predicate device on patients 18
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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 simple, sans-serif font. The logo is clean and modern, with a focus on the company's name.
1 100 Exploration Way, Suite 209 Hampton. VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
years old and greater. The MR safety information for the reusable sensor cable has been revised from "MR Unsafe" to "MR Conditional" on the sensor cable label. MR safety testing has been performed and demonstrates that the subject device is as safe and effective as the predicate device with the appropriate MR safety labeling. The RFID replaces a previously used USB method for tracking sensor cable useful life.
1.7 Performance Data
1.7.1 Sterilization and Shelf Life
The ivWatch sensor receptacle is the only component of the system supplied sterile. The sensor receptacle is sterilized by ethylene oxide (EO) in compliance with ISO 11135-1 and 10993-7. In addition, the sensor receptacle passed package and sterility testing in compliance with ISO 11607-1, ASTM F1140/F1140M-13, ASTM 2096-11 and ASTM D1469-14 supporting a 2-year shelf life.
The ivWatch sensor cable is designed to be cleaned between uses and cleaning and disinfection validation testing results passed all pre-defined acceptance criteria in accordance with AAMI-TIR-2010, AAMI TIR30-2011 and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,
1.7.2 Biocompatibility
The sensor receptacle and sensor cable sheathing are classified as prolonged duration (greater than 24 hours but less than 30 days) patient-contacting components. The sensor receptacle and sensor cable of the subject device have not changed compared to the predicate device. Therefore, the biocompatibility evaluation of the patient-contacting components conducted in accordance with the FDA Guidance Document "Use of the International Standard ISO 10993-1" and ISO 10993-1, ISO 10993-5 and ISO 10993-10 has not changed.
1.7.3 Electromagnetic Compatibility (EMC) and Electrical Safety
EMC and electrical safety testing were conducted on the subject device and results show that the ivWatch Model 400 is in compliance with the requirements of IEC 60601-1-2: 3rd Ed. 2007 and ANSI/AAMI ES60601-1:2005, 3rd E.
1.7.4 Magnetic Resonance (MR) Environment Testing
The ivWatch sensor cable has been assessed in the MR imaging environment in accordance with ASTM F2052-15, ASTM F2213-06-11, ASTM F2119-07-13, and ASTM F2182- 11a. MR compatibility testing results indicate that the sensor cable is MR Conditional.
1.7.5 Software Verification and Validation Testing
Software verification and validation testing for the ivWatch Model 400 was conducted and documented in compliance with 21 CFR 820 and in accordance with the FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304.
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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 in black, with a grid-like pattern of small squares in the upper-left portion of the teardrop. To the right of the teardrop is the word "ivWatch" in a stylized font, with the "i" and "v" in lowercase and the "W", "a", "t", "c", and "h" in lowercase. There is a small circle with an "r" inside of it to the right of the word "ivWatch".
ivWatch, LLC 1 100 Exploration Way, Suite 209 Hampton, VA 23666
1.855.IVWATCH (489.224) Fax: 757.224.5009 www.ivwatch.com
1.7.6 Performance Testing - Clinical
The predicate device submission included the clinical evaluation of the Model 400 in patients 18 years old or greater. The purpose of this 510(k) submission is to extend the Model 400 indications for use from patients 18 years old or greater to a target patient population including both pediatrics and adults. The pediatric IRB approved clinical study included in this submission demonstrates that the Model 400 is just as safe and effective in the pediatric population under the age of 18 years old as the use of the predicate device in the adult population. Safety and efficacy of the Model 400 has been demonstrated in accepted case studies representing an age distribution from 2 weeks to 17 years, patient weight measurements from 3.3 to 196.7 kg (mean, 34.5 kg), distributed skin pigmentations and similar proportions between male and female subjects.
The clinical validation studies in the pediatric population under the age of 18 years old assessed the performance (e.g. time difference between ivWatch detection and clinician detection of an infiltration, sensitivity and specificity) of the ivWatch Model 400. The ivWatch Model 400 detected 80.0% of infiltrations (95% Cl [51.9% to 95.7%) before detection by a clinician. There were no serious adverse events during the clinical study. Clinical results demonstrate that the ivWatch Model 400 is equivalent in the pediatric population as compared to the adult population.
| Item | Predicate DeviceK153605 | Subject DeviceK162478 | Comparison |
|---|---|---|---|
| Intended use | The ivWatch Model400 is designed toaid in the detectionof infiltrations andextravasationsduring peripheral IVinfusion therapy. | Same | Equivalent |
| Principles ofoperation | During IV fluidinfusion, the ivWatchsensor transmits anoptical signalthrough the tissue;the optical signal isaltered if the IV fluidis accumulating inthe tissueunderneath thesensor, surroundingthe intendedintravenousadministration route | Same | Equivalent |
| ivWatch, LLC1100 Exploration Way, Suite 209Hampton, VA 23666 | 1.855.IVWATCH (489.224)Fax: 757.224.5009www.ivwatch.com | ||
| which may indicatethat fluid is notbeing delivered tothe intendedintravenousadministration route(i.e., if an infiltrationor extravasation hasoccurred). | |||
| Monitor | ivWatch patientmonitor | Same | Equivalent |
| Single-use, sterilepatient-contactingcomponent usedto secure thesensor-end ofthe sensor cableonto the patient'sskin | ivWatch sensorreceptacle | Same | Equivalent |
| Optical cable totransmit visibleand near-infrared lightsignals betweenthe monitor andthe patient's skin | ivWatch sensorcable | Same | Equivalent |
| Power source | External powersupply and internallithium backupbattery (compliantto IEC 62133:2012) | Same | Equivalent |
| Monitor MRsafety | MR Unsafe | Same | Equivalent |
| MR safetylabeling ofsensor cable | MR Unsafe | MR ConditionalTested incompliance withASTM F2052-15,ASTM F2213-06-11,ASTM F2119-07-13,and ASTM F2182-11g | MRcompatibilitytestingdemonstratedthat the sensorcable is MRConditional. |
| Image: ivWatch logo | ivWatch, LLC1100 Exploration Way, Suite 209Hampton, VA 23666 | 1.855.IVWATCH (489.224)Fax: 757.224.5009www.ivwatch.com | |
| Sterility of theivWatch sensorreceptacle | Sterilized byethylene oxide (EO)in compliance withISO 11135-1.Sterilant residualspass theacceptance criteriain compliance withISO 10993-7. | Same | Equivalent |
| ivWatch sensorreceptacle shelflife | 2 yearsTested and passedall acceptancecriteria incompliance with ISO11607-1, ASTM 2096-11 and ASTM 2096-11. | Same | Equivalent |
| Biocompatibilityof prolongedpatient-contactingcomponents(Sensorreceptacle andsensor cable) | Tested and passedall biocompatibilityacceptance criteriafor prolonged intactskin contact incompliance with ISO10993-1, ISO 10993-5and ISO 10993-10. | Same | Equivalent |
| Reprocessing ofthe ivWatchsensor cable | Cleaning and low-level disinfectiontesting passed allacceptance criteriain accordance withAAMI-TIR-2010, AAMITIR30-2011 andReprocessingMedical Devices inHealth CareSettings: ValidationMethods andLabeling. | Same | Equivalent |
| Sensor CableUse limit | 240 hoursSensor cable life istracked with a USBkey tethered tosensor cable. | 240 hoursSensor cable life istracked with RFIDcommunicationbetween RFIDchip embeddedin sensor cable | RF wirelesstesting andresults are incompliancewith IEC 60601-1-2:3rd Ed. 2007and FCC Part |
| strain relief andthe optics boardin the IPM. | 15.225 and15.702 | ||
| Electromagneticcompatibility | Tested incompliance with nodeviations from IEC60601-1-2: 3rd Ed.2007 | Same | Equivalent |
| Electrical safety | Tested incompliance with nodeviations fromANSI/AAMI ES60601-1:2005, 3rd ed.(Medical ElectricalEquipment - Part 1:GeneralRequirements forBasic Safety andEssentialPerformance); IEC60601-1: 2005 +CORR. 1 (2006) +CORR. 2 (2007) | Same | Equivalent |
| Radiofrequencywireless testing | n/a | Tested incompliance withno deviations fromIEC 60601-1-2: 3rdEd. 2007 and FCCPart 15.225 and15.207 | The RFcommunicationfrequencybetween theISO 15693 tagand antennainside thepatient monitoris notadjustable anddoes nottransmit patientdata. Testingdemonstratesthat the RFcommunicationis as safe as thepredicatedevice. |
| Performancetesting - Clinical | Age: Patients 18years old or greater | Age: Pediatricsfrom birth up to | The patientpopulation of |
| ivWatch, LLC1100 Exploration Way, Suite 209Hampton, VA 23666 | 1.855.IVWATCH (489.224)Fax: 757.224.5009www.ivwatch.com | ||
| target patientpopulation | medium and darkPIV site: Hand andforearm | years oldSkin color: Light,medium and arkPIV site: Hand,forearm,antecubital fossa,leg and foot | devicecompared tothe predicatedevice differs inage to supportsafety andefficacy in thepediatricpopulation. |
| Performancetesting - Clinicalresults | Sensitivity: 96.4% ofinfiltrations (95% CI[91.4% to 98.7%])were detected inunder 10 cc of fluidFalse notifications: Afalse positivenotificationoccurredapproximately onceevery 4 days. | Time differencebetween ivWatchand cliniciandetection ofinfiltration: RedCheck IVnotification issuedon average 29.8hours prior to thecliniciandetection, 95% CI[14.8, 48.8 hours].Sensitivity: 78.3%of infiltrations (95%CI [56.5 to 92.5%])were detectedprior to thecliniciandiagnosing theinfiltration in theblinded non-alarming group.False notifications:A false positivenotificationoccurredapproximatelyonce every 4days. A falsepositivenotificationoccurredapproximatelyonce every 10days ifnotifications | The clinicalperformancedata of theModel 400support thesafety andefficacy in thepediatricpatientpopulation(from birth upto andincluding 17years old) ascompared tothe clinicalperformancedata inpatient's 18years orgreater. Theclinicalevaluationdemonstratesthat theivWatch Model400 issubstantiallyequivalent tothe predicatedevicesubmission. |
| Image: iv Watch logo | ivWatch, LLC1100 Exploration Way, Suite 209Hampton, VA 23666 | 1.855.IVWATCH (489.224)Fax: 757.224.5009www.ivwatch.com | |
| Performancetesting - Clinicaladverse events | There were noserious adverseevents during theclinical study. | related to painfulIV flushes anddevice-relatedissues areexcluded. | There are nonew safetyissuesassociated withthe use of thedevice inpediatrics. |
1.7.7 Summary Table
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Image /page/9/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized black teardrop shape with small white squares inside, followed by the text "ivWatch" in a modern, sans-serif font. A vertical line is present on the right side of the logo.
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1.8 Conclusions
The technological characteristics and principles of operation of the ivWatch Model 400 and the predicate device are the same. The clinical data provided in the submission supports the expansion of the indications for use to now include the pediatric patient population.
The results of the clinical study and performance testing indicate that the ivWatch Model 400 is substantially equivalent to the ivWatch Model 400 (K153605). The ivWatch Model 400 performs as intended and is substantially equivalent to the legally marketed predicate device.
§ 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).