(245 days)
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetectTM is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
VitalDetect is a Bluetooth® connected, hand-held, portable vital sign monitor for prescription home use. The monitoring device can read physiological parameters, including: Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP), and Body Temperature (TEMP).
The device uses a lithium-polymer battery which is rechargeable by the User. The battery is replaceable only by service personnel.
The VitalDetect monitoring system consists of a measurement device with inflatable finger-cuff, 5 finger shims, USB charging cord, and a downloadable application (APP) for use on a mobile device.
Here's a breakdown of the acceptance criteria and study details for the Wellvii VitalDetect device, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VitalDetect device are primarily based on clinical accuracy, aligning with relevant ISO standards for blood pressure, pulse rate, and temperature measurement.
Table of Acceptance Criteria and Reported Device Performance:
| Vital Sign | Acceptance Criteria (Standard) | Reported Device Performance (Mean Difference/Bias & Standard Deviation) |
|---|---|---|
| NIBP – Systolic | Criterion 1: Mean difference: +/- 5 mmHg and STD: <= 8 mmHg, Criterion 2: STD <= 8 mmHg | Criterion 1: +1.66 mmHg Bias, ± 7.67 mmHg STD Criterion 2: ± 6.49 mmHg STD |
| NIBP – Diastolic | Criterion 1: Mean difference: +/- 5 mmHg and STD: <= 8 mmHg, Criterion 2: STD <= 8 mmHg | Criterion 1: +1.04 mmHg Bias, ± 6.49 mmHg STD Criterion 2: ± 5.67 mmHg STD |
| Pulse Rate | <= ± 3.0 bpm | ± 2.7 bpm |
| Temperature | <= ± 0.3 °C (36.0°C to 39.0°C), <= ± 0.3 °C (the rest) | ± 0.3 °C |
Notes on Acceptance Criteria:
- NIBP: The acceptance criteria for NIBP (Non-Invasive Blood Pressure) are implied by the reported performance and the specific mention of compliance with IEC 80601-2-30:2018, which sets these highly specific accuracy standards. The two criteria (Mean Difference and Standard Deviation for Criterion 1, and only Standard Deviation for Criterion 2) are standard for BP device validation.
- Pulse Rate and Temperature: For these parameters, the "Accuracy" values directly stated in the comparison table and the clinical testing results are considered the acceptance criteria based on standard medical device performance expectations.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of participants, but the clinical testing details mention "The VitalDetect showed compliance with basic safety and accuracy requirements of the standard," and "The study was conducted in accordance with 21 CFR 812 for Non-significant Risk Investigational Studies, following ISO 14155:2011 Clinical Investigation of medical devices for human subjects – Good clinical practice, as appropriate." The tables provided are summaries of the results, not raw data or cohort sizes. For blood pressure, ISO 80601-2-30 typically requires a minimum of 85 subjects with specific age and blood pressure distribution.
- Data Provenance: The document does not explicitly state the country of origin. However, given the FDA submission and the use of US regulatory standards (21 CFR 812), it is highly probable the study was conducted within the United States or under US-equivalent Good Clinical Practice (GCP) standards. The study was prospective as it involved "Clinical trials were completed to validate the clinical accuracy and functionality of the proposed device."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not provide information on the number of experts or their qualifications used to establish the ground truth.
- For blood pressure validation, ground truth is typically established by trained technicians or clinicians using an auscultatory method (trained observers listening for Korotkoff sounds) with a mercury sphygmomanometer or validated reference device. For temperature, a highly accurate reference thermometer is used.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method.
- For blood pressure validation studies, ground truth determination often involves at least two trained observers taking simultaneous or near-simultaneous measurements to ensure accuracy and inter-observer reliability, which acts as a form of "adjudication."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done.
- This device is a measurement device for vital signs (BP, PR, Temp), not an AI-assisted diagnostic imaging or interpretation tool. Therefore, a study comparing human readers with and without AI assistance is not applicable to its validation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, standalone performance was assessed.
- The clinical testing summarized in the table (Section 12.0) directly reports the accuracy of the VitalDetect device's measurements (NIBP, Pulse Rate, Temperature) against a true reference. This is a measure of the device's inherent, standalone performance in taking these vital sign measurements. The device is intended for the human user to operate it, but the accuracy assessment itself is of the device's capability to measure, not assist human interpretation.
7. The Type of Ground Truth Used
- Expert Consensus / Reference Standards:
- For blood pressure, the ground truth is established by an established reference method, typically the auscultatory method performed by trained observers using a reference sphygmomanometer, calibrated according to standards (e.g., as per ISO 80601-2-30).
- For pulse rate, the ground truth would be from a highly accurate reference ECG or plethysmograph.
- For temperature, the ground truth would be established using a calibrated reference thermometer (e.g., rectal or oral mercury thermometer or highly accurate electronic thermometer).
- The term "Clinical Testing" and "validate the clinical accuracy" strongly implies comparison against accepted clinical reference standards or expert measurements.
8. The Sample Size for the Training Set
- The document does not disclose any information regarding a training set.
- For a traditional vital signs monitor like the VitalDetect, the "training" (development and calibration) typically occurs during the engineering and design phase, often using laboratory measurements and sometimes human subjects for initial algorithm tuning, rather than a distinct "training set" of patient data in the way an AI/ML algorithm would. The listed clinical study is for validation after the device's design is finalized.
9. How the Ground Truth for the Training Set Was Established
- As a distinct "training set" as understood in AI/ML is not explicitly discussed, the method for establishing ground truth for such a set is not detailed.
- Any internal development and calibration (analogous to "training") would utilize highly controlled measurements against known, precise reference standards in laboratory and potentially initial human studies.
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February 2, 2024
Wellvii Inc Mark Khachaturian CEO 4521 PGA Blvd, PMB 341 Palm Beach Gardens, Florida 33418
Re: K231625
Trade/Device Name: VitalDetect Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, FLL Dated: June 2, 2023 Received: June 2, 2023
Dear Mark Khachaturian:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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. Robert T. Kazmierski -S for LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231625
Device Name Wellvii VitalDetect
Indications for Use (Describe)
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetectTM is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
| 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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Section 05.01 510(k) Summary
Submitter:
Wellvii Inc. 4521 PGA Blvd PMB 341 Palm Beach Gardens, FL 33418
Contact Person:
Mark Khachaturian, PhD CEO Wellvii Inc. Phone: +1 (561) 559-2945 E-mail: markk(@wellvii.com
Date Prepared:
November 30th, 2023
Device Trade Name:
VitalDetect™
Common Name:
Vital Signs Monitor
Classification Name:
Noninvasive blood pressure measurement system
Classification Panel:
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Wellvii Inc.
VitalDetect™
Cardiovascular
CFR Section:
21 CFR 870.1130 Non-invasive Blood Pressure (Cardiovascular Panel) 21 CFR 880.2910 Thermometer
Classification:
Class II
Product Codes:
DXN, Blood Pressure FLL, Thermometer, electronic, clinical
Predicate Devices:
Primary: All-in-One Monitor (K170047) Reference A: ARC InstaTemp MD for Temperature (K152905)
Device Description:
VitalDetect is a Bluetooth® connected, hand-held, portable vital sign monitor for prescription home use. The monitoring device can read physiological parameters, including: Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP), and Body Temperature (TEMP).
The device uses a lithium-polymer battery which is rechargeable by the User. The battery is replaceable only by service personnel.
The VitalDetect monitoring system consists of a measurement device with inflatable finger-cuff, 5 finger shims, USB charging cord, and a downloadable application (APP) for use on a mobile device.
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In the home environment, the user will have responsibility for charging it prior to use (to disable measurent lock), installing the app, pairing with the device, starting the connection. The left index finger could then be placed in the correct position for the measurement process to begin.
Predicate Devices:
The Primary predicate devices is the: All-in-One Monitor (K170047). Wellvii has also identified the following reference predicate device for the temperature feature: ARC InstaTemp MD for Temperature (K152905)
Indications for Use
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetect™ is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
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Substantial Equivalence Comparison
| Brand Name | VitalDetect(aka SmartVS/Vital Moto Mod) | All-in-One Health Monitor,PC-303 | ARC InstaTemp MD InfraredThermometer |
|---|---|---|---|
| General Characteristics | |||
| Indications forUse (Clinical use) | The Wellvii VitalDetect™ is a device designed for spotmeasurements with recorded results of non-invasiveblood pressure (NIBP), pulse rate (PR), and temperature(TMP).This device uses an infra-red sensor for non-contacttemperature measurement at the forehead. All othermeasurements use finger-based technology.The VitalDetectTM is applicable for prescription homeuse by individuals 18 years of age or older for monitoring.The device is not intended for continuous monitoring. | [i]s a device designed for spot-checkingmeasuring of the patient's physiologicalparameters, such as NIBP, SpO2, PR, and bodyTEMP.Additionally, the device is available tocommunicate with the compatible BloodGlucose Monitoring System and ECG Monitorto make the measurement.This device is applicable for adult andpediatric (age ≥3 years old) use in clinicalinstitutions and has no conditions or factors ofcontraindication. | The ARC InstaTemp is an infraredthermometer that measures temperature fromthe forehead in both infants and adultswithout contacting the human body. |
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| Technology Characteristics Comparison | ||||
|---|---|---|---|---|
| Product | Proposed Device | Primary Predicate | Reference A | Discussion |
| Brand Name | VitalDetect(aka SmartVS/Vital MotoMod) | All-in-One HealthMonitor, PC-303 | ARC InstaTemp MDInfrared Thermometer | |
| General Characteristics | ||||
| Manufacturer | Wellvii Inc. | Shenzhen Creative Industry Co.,Ltd. | ARC Devices Ltd. (predecessor toVital USA Inc) | |
| 510k number | K231625 | K170047 | K152905 | |
| RegulationNumber | 21 CFR 870.1130Cardiovascular DevicesCardiovascular DiagnosticDevices Noninvasive BPmeasurement system(performance standards) | 21 CFR 870.2300Cardiovascular DevicesPatient Monitor | 21 CFR 880.2910General HospitalODE Anesthesiology, GeneralHospital DevicesThermometer, Electronic, Clinical | |
| Class and ProductCode | Class II, DXN, DQA, FLL | Class II, MWI, DQA, DXN,FLL, NBW (glucose), DSH(ECG recorder) | Class II, FLL | |
| PatientPopulation | Adults aged 18 years andolder | Children and adults >= 3 yearsold | Both Infants and Adults | (D) Patient Types:· The Proposed target population is ≥18 yrs of age.· The Predicate is targeted for those persons ≥3 years ofage.· Reference Predicate B is targeted for both infants andadults.SUMMARY: The difference does not cause newquestions regarding safety and effectiveness becausethey are all indicated for adults. |
| ParametersMeasured | Heart Rate, Blood Pressure,and Temperature | Non-Invasive: BP, PR, SpO2,TEMP | Temperature | SAME |
| Use Location | Clinical Setting, Home Use | Clinical Setting | Clinical Setting | (D) The Proposed, Primary, and Reference devices canbe used in a clinical setting. The Proposed is aprescription home use device.SUMMARY: The difference does not cause newquestions regarding safety and effectiveness as theProposed device was tested to Home Use standards. |
| Form Factor | Handheld Device | Table Top device withAccessories | Handheld Device | (S) Similar compact form factors.SUMMARY: The difference does not cause newquestions regarding safety and effectiveness. |
| Power Source | Rechargeable lithium-polymer; low batteryindicator, | Rechargeable lithium battery 3.7DC or AC; low battery indicator;quick-button return to powersaving mode | N/A | SAME |
| Temperature | ||||
| Principle ofOperation | TEMP: (body) infraredradiation energy technologyvia the forehead; adjustedmode | N/A | TEMP: (body) infrared radiationenergy technology via the forehead;adjusted mode | SAME |
| MeasurementRange | TEMP output range:$32.0°C$ - $43.0°C$ ( $89.6°F$ -$109.4°F$ ) | N/A | TEMP output range:$32.0°C$ - $43.0°C$ ( $89.6°F$ - $109.4°F$ ) | SAME |
| Accuracy | TEMP accuracy:$±0.3°C$ ( $36.0°C$ to $39.0°C$ )$± 0.3°C$ (the rest)$±0.3°F$ ( $96.8°F$ to $102.2°F$ )$±0.3°F$ (the rest) | N/A | TEMP accuracy:$±0.3°C$ ( $36.0°C$ to $39.0°C$ )$± 0.3°C$ (the rest)$±0.3°F$ ( $96.8°F$ to $102.2°F$ )$±0.3°F$ (the rest) | SAME |
| Blood Pressure | ||||
| Principle ofOperation | Blood Pressure: The fingercuff occludes blood flow anduses the oscillometricprinciple to estimate systolicand diastolic.Measurement can be canceledby press-and-hold of thepower button. | Blood Pressure: The arm cuffoccludes blood flow and usesthe oscillometric principle toestimate systolic and diastolic.BP can be cancelled /activatedby a shortcut button. | N/A | (S) The proposed devices use the oscillometric method.(D) The Proposed device measures from the finger andthe Primacy predicate measures from the arm.SUMMARY: The differences do not raise newquestions regarding safety and effectiveness becausethey both meet the same blood pressure accuracystandard ISO 80601-2:2018. |
| MeasurementRange | 60-230 mmHg Systolic40-130 mmHg Diastolic | 60-240 mmHg30-180 mmHg | N/A | (D) The Primary predicate has larger systolic anddiastolic range.SUMMARY: The differences do not raise newquestions regarding safety and effectiveness because theProposed device will not display a result if the bloodpressure is out of its range. |
| Accuracy | BP accuracy MDV:$±5.0$ mmHg ( $± 0.67$ kPa) withSD: $≤$ 8.0 mmHg | BP accuracy MDV:$±5.0$ mmHg ( $± 0.67$ kPa) withSD: $≤$ 8.0 mmHg | N/A | SAME |
| Over PressureLimit | Active if cuff pressureexceeds 300 mmHg (adult) atany time. | Active if cuff pressure exceeds300 mmHg (adult and pediatricmodes) at any time. | N/A | SAME |
| Pulse Rate | ||||
| Principle ofOperation | Pulse Rate (PR), peakdetection of 940 nm signal | PR: photoelectric method; | N/A | SAME |
| MeasurementRange | 40-140 bpm | PR range: 30 to 240 bpm | N/A | (D) The Primary predicate has larger measurementrange.SUMMARY: The differences do not raise newquestions regarding safety and effectiveness because theProposed device will not display a result if the result isout of its range. |
| Accuracy | < ± 3.0 bpm | < ± 3 bpm | N/A | SAME |
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Safety and Performance Testing:
Safety and Performance testing was performed to ensure that the device operates within specified parameters independently with all other functions of the device operating and with respect to the predicate. Each function operated within the design parameters and within the performance criteria established by the pertinent regulatory standards and FDA guidance's. The result of these tests establishes substantial equivalency of the proposed device, the VitalDetect, with the predicate (and reference devices).
The following safety and performance tests were conducted to support the substantial equivalence determination and confirmed compliance as follows:
- Basic and Electrical Safety Testing has confirmed compliance to IEC 60601-1:2012 ● (Edition 3.1) (Attachment 17.02)
- . Electromagnetic Compatibility (EMC) Testing has confirmed compliance to:
- IEC 60601-1-2:2014-02 (Edition 4.0)
- ETSI EN 301 489-1 V2.1.1 (2017-02)
- ETSI EN 301 489-17 V3.1.1 (2016-11)
- FCC Part 15.247
- See Attachment 17.04.
- Rechargeable Lithium-Polymer Battery Testing for the VitalDetect battery has confirmed compliance to:
- . IEC 62133-2:2017 (Attachment 17.06)
- EN 61000-6-1:2007 (Attachment 17.07)
- EN 61000-6-3:2007(Attachment 17.07) ●
- . UN 38.3/Amendment 1 (Attachment 17.08)
- General Safety testing with regard to Usability has confirmed compliance with Collateral ● Standard IEC 60601-1-6:2013 (Edition 3.1) (Attachment 18.02).
- Wireless Co-existence testing: VitalDetect ANSI C63.27 Tier 2 .
- . Home Healthcare Testing has confirmed compliance with IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. (Attachment 17.03)
- Testing for ingress protection has confirmed a rating of IP22 according to IEC 60529:2013 . (Edition 2.2). (Attachment 17.02)
- . Multi-function Patient Monitoring testing has confirmed compliance with IEC 80601-2-30:2009 (Attachment 18.03).
- . Thermometer Testing has confirmed compliance with ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. (Attachment 18.05)
- .
- Blood Pressure Testing was performed according to IEC 80601-2-30:2018. Medical electrical equipment - Part 2-30 Particular requirements for basic safety and essential performance of automated noninvasive sphygmomanometers. The VitalDetect showed
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compliance with basic safety and accuracy requirements of the standard. (Attachment 18.03)
- ●
- Packaging testing of the VitalDetect unit packaging compliance to the ISTA 2A:2011 standard. (D0000458-RPT-ISTA-2A Perf Assess - Executed - SN47).
- . Clinical Testing (Section 20). Clinical trials were completed to validate the clinical accuracy and functionality of the proposed device. The study was conducted in accordance with 21 CFR 812 for Non-significant Risk Investigational Studies, following ISO 14155:2011 Clinical Investigation of medical devices for human subjects – Good clinical practice, as appropriate. The table below summarizes the study results.
| Vital Sign | Accuracy | Range |
|---|---|---|
| NIBP - Systolic | Criterion 1: +1.66 mmHg Bias | 60-230 mmHg |
| Criterion 1: ± 7.67 mmHg STD | ||
| Criterion 2: ± 6.49 mmHg STD | ||
| NIBP – Diastolic | Criterion 1: +1.04 mmHg Bias | 40-130 mmHg |
| Criterion 1: ± 6.49 mmHg STD | ||
| Criterion 2: ± 5.67 mmHg STD | ||
| Pulse Rate | ± 2.7 Arms | 40-140 bpm |
| Temperature | ± 0.3 °C | 32-43 °C |
- Risk Management activities have confirmed compliance to ISO 14971:2007 and EN . 14971:2012. The risk management file was updated for the addition of the finger shims.
- Biocompatibility Testing. The VitalDetect™ is a surface-contacting device with less . than 24 hours contact duration. The patient-contacting materials were tested in accordance with ISO 10993-1 for cytotoxicity, irritation and sensitization.
ISO 10993-5. Biological evaluation of medical devices - Part 5: Tests for in-vitro cvtotoxicity. The purpose of this study was to determine the potential of a test article extract to cause cytotoxicity. Under the conditions of this study, the test article extract showed no evidence of causing cell lysis or toxicity and met the requirements of the test since the grade was less than a grade 2 (mild reactivity). (Attachment 15.01)
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The purpose of this test is to evaluate the potential of a test article to cause skin irritation and sensitization in the guinea pig. Under the conditions of these studies, the test article extracts showed no significant evidence of causing skin sensitization (in the guinea pig) and the irritation response was negligible and met the requirements of the tests. (Attachment 15.02, Attachment 15.03). Additionally, a chemical analysis was performed on the extractions to show that they were not the result of poor manufacturing techniques (Attachment 15.05) and a risk assessment was performed of finger shim materials (Attachment 15.06).
Conclusion:
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In accordance with the Federal, Food, Drug and Cosmetic Act, 21 CFR 807 and based on the information and objective evidence provided in this premarket notification, Wellvii Inc concludes that the VitalDetect™ device is substantially equivalent to the predicate device as described herein.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.