(293 days)
The ARC InstaTemp™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body.
The ARC InstaTemp MD™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body. It is intended for use by a Health Care Professional in a clinical environment. This device is not intended for home use.
The ARC Non-Touch Thermometer is a fast, accurate and non-intrusive device for measuring a person's temperature. It uses infrared sensor technology to detect the radiated infrared energy emitted from the forehead. Therefore as soon as the sensor is held near the forehead and activated, the temperature measurement is taken by detection of the emitted infrared heat generated by the arterial blood flow.
The ARC Non-Touch Thermometer uses sensor technology that detects the emitted heat from the temporal artery in the forehead from a distance of approximately 1 inch. Once recorded an internal algorithm converts this forehead surface temperature into human body temperature and it is this temperature that is then presented to the user on the LCD screen. This temporal artery detection mechanism and the resulting conversion to body temperature characterizes the ARC Non-Touch Thermometers as an adjusted mode clinical thermometer as per ISO 80601-2-56.
The document describes the acceptance criteria and the study that proves the device meets the criteria for the ARC InstaTemp™ Non-touch Thermometer and ARC InstaTemp™ MD Non-touch Thermometer.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Predicate Device K090361) | Reported Device Performance (ARC InstaTemp™ / ARC InstaTemp MD™) | Notes |
|---|---|---|---|
| Accuracy | ± 0.3ºC | ± 0.2ºC | The sponsor states that this was "Verified by compliance testing to IEC 60601-1." This indicates that the new device meets or exceeds the accuracy of the predicate, and this was confirmed through a standardized compliance test. The clinical performance data confirms the accuracy and reproducibility for both febrile and non-febrile patients, indicating that the device's enhanced accuracy is validated in a real-world setting. This suggests that the device's accuracy is not just a theoretical improvement but one that performs robustly across different patient states. |
| Precision | ± 0.3ºC (34-35.9ºC) ± 0.2ºC (36-39ºC) ± 0.3ºC (39-42.5ºC) | ± 0.2ºC | The sponsor states that this was "Verified by compliance testing to IEC 60601-1." This indicates that the new device meets or exceeds the precision of the predicate, and this was confirmed through a standardized compliance test. The clinical performance data confirms the accuracy and reproducibility for both febrile and non-febrile patients, indicating that the device's enhanced precision is validated in a real-world setting. |
| Measurement Method | Infrared sensor detecting emitted heat from temporal artery, converts forehead surface temperature to body temperature. | Infrared sensor detecting emitted heat from temporal artery, converts forehead surface temperature to body temperature. | Same. This indicates that the fundamental technology for temperature measurement and conversion is identical to the predicate, which supports the claim of substantial equivalence. |
| Range (Body Mode) | 32-42.9ºC | 32-42.8ºC | Same. Although there's a slight difference in the upper limit (42.9ºC vs 42.8ºC), this minor variation is generally considered acceptable within the context of clinical thermometry, especially since the overall operating range covers typical fever temperatures. As stated by the sponsor, the range is considered "same," which suggests clinical equivalence. |
| Measurement Distance | 5-8cm | 1-3cm | The sponsor states this is "acceptable" and notes that "Reduction of the measurement distance reduces the noise due to ambient temperature. 1-3cm is a comfortable distance for the user to operate these thermometers." This indicates a design improvement that enhances usability and potentially measurement accuracy by minimizing environmental interference. |
| Power Supply | 2 x AA Battery | 2 x AAAA Battery | The sponsor states this is "acceptable" and notes that "The batteries were verified as being acceptable as part fulfillment of compliance testing to IEC 60601-1." This change in battery type is a non-clinical difference that does not impact the core function or safety when verified through a recognized standard. |
| Operating Temperature | 10ºC to 40ºC | 10ºC to 40ºC | Same. |
| Display | LCD | LCD | Same. |
| Display Resolution | 0.1ºC | 0.1ºC | Same. |
| Celsius/Fahrenheit | Yes | Yes | Same. |
| LED Backlight | Yes | Yes | Same. |
| Automatic Stop | 5 seconds | 4 + 0.5 seconds | Same. A minor difference in automatic shut-off time, but still consistent in offering an automated power-saving feature. The sponsor states "Same." |
| Dimensions | 196x150x50mm (LxWxH) | 129x35x13mm (LxWxH) | The sponsor states this is "acceptable" and notes that "The changes in dimensions have no effect on functionality of the thermometer. The modified dimensions are deemed acceptable as the unit can be used by a single operator in the same way as the predicate." The smaller dimensions likely represent an improvement in design and portability and do not negatively impact the device's core function. |
| Material in contact with operator's hand | ABS | Polycarbonate | The sponsor states this change is acceptable, noting that "Both ABS and Polycarbonate are used widespread in the medical device field and neither have any concerns from a user safety viewpoint. In addition the material does not affect the performance of the device." Biocompatibility testing was successfully completed per ISO 10993-5:2009 and ISO 10993-10:2010. This indicates that despite the material change, the device adheres to safety standards for patient interaction. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 136 subjects.
- Data Provenance: Not explicitly stated, but the "clinical trial" suggests prospective data collection specifically for validating the device's clinical performance. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The term "ground truth" as it relates to expert consensus for a test set is typically used in the context of diagnostic imaging or AI applications where human interpretation needs to be validated. For a thermometer, the "ground truth" would typically be established by a reference temperature measurement method, not through expert consensus on the device's reading. The document refers to "clinical accuracy validation as defined in ISO 80601-2-56," which implies comparison against a calibrated reference temperature source, likely in a controlled clinical setting.
4. Adjudication Method for the Test Set:
- Adjudication method for the test set is not applicable and therefore not provided as this is a device for measuring temperature, not for making subjective diagnoses based on images or other complex data requiring expert review and consensus. The accuracy is assessed against a traceable reference standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs. without AI Assistance:
- An MRMC comparative effectiveness study is not applicable as this describes a standalone thermometer device, not an AI-assisted diagnostic tool that would involve human readers interpreting data. Therefore, no effect size of human improvement with AI is provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, a standalone performance study was done. The device itself (ARC InstaTemp™ / ARC InstaTemp MD™) is a standalone infrared thermometer. Its performance, including accuracy and precision, was evaluated directly through bench testing (ASTM E1965-98) and a clinical trial. The "algorithm" here refers to the internal conversion of forehead surface temperature to human body temperature.
7. The Type of Ground Truth Used:
- The ground truth for the device's accuracy and precision was established through clinical accuracy validation as defined in ISO 80601-2-56. This standard typically requires comparison against a highly accurate and traceable reference thermometer, often an electronic thermometer measuring core body temperature, in a controlled environment with human subjects. The aim is to verify that the device's measurements reflect actual body temperature with acceptable deviation.
8. The Sample Size for the Training Set:
- The document does not specify a separate training set or its sample size. This type of device relies on a fixed algorithm (converting surface temperature to body temperature) rather than a machine learning model that would require a distinct training set. The algorithm itself is likely based on physiological principles and validated against extensive prior research or internal data during its development, not through a 'training set' in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established:
- Since a separate "training set" in the context of machine learning is not applicable to this device as described, the method for establishing its ground truth is not provided. The device's internal algorithm for converting forehead temperature to body temperature would have been developed and refined based on established thermophysiological models and potentially internal empirical data, validated through bench and clinical testing against reference standards.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
ARC Devices Limited Mr. Gary Brogan Director of Quality and Regulatory Affairs 2 Deerpark Industrial Estate Oranmore, Co. Galway Ireland
Re: K152905
Trade/Device Name: ARC InstaTemp™ Non-touch Thermometer, ARC InstaTemp™ MD Non-touch Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 10, 2016 Received: June 16, 2016
Dear Mr. Brogan:
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.
{1}------------------------------------------------
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 (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 yours,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152905
Device Name ARC InstaTemp™ Non-Touch Thermometer
Indications for Use (Describe)
The ARC InstaTemp™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body.
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
2 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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152905
Device Name
ARC InstaTemp MD™ Non-Touch Thermometer
Indications for Use (Describe)
The ARC InstaTemp MD™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body. It is intended for use by a Health Care Professional in a clinical environment. This device is not intended for home use.
| 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
view 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."
{4}------------------------------------------------
510(k) Summary (21 CFR 807.92) K152905
I. SUBMITTER
ARC Devices Limited, 2 Deerpark Industrial Estate, Oranmore, Co Galway, Ireland
Phone: +353 91 653 155 Fax: +353 91 653 155
Contact Person: Gary Brogan Director or Quality and Regulatory Affairs,
Date Prepared: July 20, 2016
II. DEVICE
Name of Devices: ARC InstaTemp™ Non-Touch Thermometer ARC InstaTemp MD™ Non-Touch Thermometer
Common or Usual Name: Infrared Thermometer
Classification Name: 21 CFR 880.2910 (Clinical Electronic Thermometer)
Regulatory Class: Class II
Product Code: FLL
III. PREDICATE DEVICE
Rycom Electron Technology Limited, RC002 Remote Infrared Thermometer, K090361, cleared 16th June 2010.
IV. DEVICE DESCRIPTION
The ARC Non-Touch Thermometer is a fast, accurate and non-intrusive device for measuring a person's temperature. It uses infrared sensor technology to detect the radiated infrared energy emitted from the forehead. Therefore as soon as the sensor is held near the forehead and activated, the temperature measurement is taken by detection of the emitted infrared heat generated by the arterial blood flow.
The ARC Non-Touch Thermometer uses sensor technology that detects the emitted heat from
{5}------------------------------------------------
the temporal artery in the forehead from a distance of approximately 1 inch. Once recorded an internal algorithm converts this forehead surface temperature into human body temperature and it is this temperature that is then presented to the user on the LCD screen. This temporal artery detection mechanism and the resulting conversion to body temperature characterizes the ARC Non-Touch Thermometers as an adjusted mode clinical thermometer as per ISO 80601-2-56. This is the same principle of operation as the listed predicate device, K090361.
The ARC Non-Touch Thermometer is indicated for the measurement and display of human body temperature for patients of all ages. It can be used by responsible adults at home or by health care professionals in a clinical environment. In order to serve both these markets, ARC Devices have developed two separate models, the ARC InstaTemp™ Non-Touch Thermometer for home use and the ARC InstaTemp MD™ Non-Touch Thermometer for professional use. Both models have the same purpose, design, materials, energy source and function and also possess the same features related to safety and effectiveness. It is for this reason that the two models are included in the one 510k pre-market submission. This is in compliance with, Guidance for Industry and FDA Staff, Bundling Multiple Device or Multiple Indications in a Single Submission, June 22, 2007. The differences between both models while minor in nature and have been introduced to make the device more suitable for professional use as opposed to home use.
V. INDICATIONS FOR USE
The ARC InstaTemp™ is an infrared thermometer that measures temperature from the forehead in both infants and adults without contacting the human body.
The ARC InstaTemp MD™ is an infrared thermometer that measures temperature from the forehead in both infants and adults without contacting the human body. It is intended for use by a Health Care Professional in a clinical environment. This device is not intended for home use.
The ARC InstaTemp™ and InstaTemp MD™ devices intentions for use are different from the predicate intentions for use statement because the user environments are specific to either home use or clinical use, whereas the predicate device can be used in either home use or clinical use. This difference does not raise new questions regarding safety and effectiveness because the technology is similar, the bodily measurement site is identical, and the user environments are the same but limited to specific devices.
{6}------------------------------------------------
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Parameter | RC002 Remote InfraredThermometer | ARC InstaTemp™Non-TouchThermometer | ARC InstaTemp MD™Non-TouchThermometer | Comparison |
|---|---|---|---|---|
| MeasurementMethod | RC002 Remote InfraredThermometer uses aninfrared sensor to detectand record the emittedheat from the temporalartery in the forehead. Inthe 'body' function itconverts this foreheadsurface temperature intobody temperature and it isthis temperature that isthen presented to the useron the LCD screen. | ARC InstaTemp™Non-Touch Thermometeruses an infrared sensor todetect and record theemitted heat from thetemporal artery in theforehead. It then convertsthis forehead surfacetemperature into humanbody temperature and it isthis temperature that is thenpresented to the user onthe LCD screen. | ARC InstaTemp MD™Non-Touch Thermometeruses an infrared sensor todetect and record theemitted heat from thetemporal artery in theforehead. It then convertsthis forehead surfacetemperature into humanbody temperature and it isthis temperature that is thenpresented to the user onthe LCD screen. | Same |
| Range | In Body Mode: 32-42.9ºC | 32-42.8ºC | 32-42.8ºC | Same |
| Parameter | RC002 Remote InfraredThermometer | ARC InstaTemp™Non-TouchThermometer | ARC InstaTemp MD™Non-TouchThermometer | Comparison |
| Accuracy | $\pm$ 0.3ºC | $\pm$ 0.2ºC | $\pm$ 0.2ºC | Verified bycompliancetesting to IEC60601-1. |
| Precision | $\pm$ 0.3ºC (34-35.9ºC)$\pm$ 0.2ºC (36-39ºC)$\pm$ 0.3ºC (39-42.5ºC) | $\pm$ 0.2ºC | $\pm$ 0.2ºC | Verified bycompliancetesting to IEC60601-1. |
| MeasurementDistance | 5-8cm | 1-3cm | 1-3cm | Acceptable |
| Power supply | 2 x AA Battery | 2 x AAAA Battery | 2 x AAAA Battery | Acceptable |
| Operating | 10ºC to 40ºC | 10ºC to 40ºC | 10ºC to 40ºC | Same |
| Display | LCD | LCD | LCD | Same |
| Display | 0.1ºC | 0.1ºC | 0.1ºC | Same |
| Celsius /Fahrenheit | Yes | Yes | Yes | Same |
| Led Backlight | Yes | Yes | Yes | Same |
| Automatic Stop | 5 seconds | 4 + 0.5 seconds | 4 + 0.5 seconds | Same |
| Dimensions | 196x150x50mm(LxWxH) | 129x35x13mm(LxWxH) | 129x35x13mm(LxWxH) | Acceptable |
The following technological differences exist for the ARC Non-Touch Thermometers and its predicate device.
- The accuracy and precision is 0.2℃ across the full range as opposed to 0.3℃ for the ● predicate - This was verified during compliance testing to IEC 60601-1
- . The size of the battery used to power the device - The batteries were verified as being acceptable as part fulfillment of compliance testing to IEC 60601-1.
{7}------------------------------------------------
- . The recommended measurement distance - Reduction of the measurement distance reduces the noise due to ambient temperature. 1-3cm is a comfortable distance for the user to operate these thermometers.
- Dimensions of the devices The changes in dimensions have no effect on functionality . of the thermometer. The modified dimensions are deemed acceptable as the unit can be used by a single operator in the same way as the predicate.
Upon review of these technological differences, it can be concluded that they do not affect the core function of the device. In addition as both the subject and the predicate devices meet the same FDA recognized consensus standards, it can be concluded that the subject devices are substantially equivalent to the predicate device.
VII. COMPARISON OF MATERIALS USED WITH THE PREDICATE DEVICE
| RC002 Remote InfraredThermometer | ARC InstaTemp™Non-Touch Thermometer | ARC InstaTemp MD™Non-Touch Thermometer |
|---|---|---|
| Materials of Components in contactwith the operators hand: | Materials of Components in contactwith the operators hand: | Materials of Components in contactwith the operators hand: |
| Acrylonitrile butadiene styrene(ABS) | Upper Housing – Polycarbonate | Upper Housing - Polycarbonate |
| Lower Housing - Polycarbonate | Lower Housing - Polycarbonate | |
| Button - Polycarbonate | Button - Polycarbonate | |
| LCD Screen - Polycarbonate | LCD Screen - Polycarbonate |
As can be reviewed in the table, the material in contact with the operators hand is ABS in the predicate device while it is Polycarbonate in the ARC Non-Touch Thermometer. The contact duration throughout the lifetime of the device would be <24hours and the device would always be in contact with intact skin.
Both ABS and Polycarbonate are used widespread in the medical device field and neither have any concerns from a user safety viewpoint. In addition the material does not affect the performance of the device. That aside biocompatibility testing, per ISO 10993-5:2009 and ISO 10993-10:2010 has been completed on both the ARC InstaTemp™ and the ARC InstaTemp MD™ to demonstrate that no biocompatibility concerns exist that affect the substantial equivalence claim.
VIII.BIOCOMPATIBILITY
The ARC Non-Touch Thermometer is manufactured from an outer casing of polycarbonate that comes into direct contact with the operator's hand. For this reason, and in order to maintain compliance to ASTM E1965. GLP Biocompatibility testing in compliance to ISO 10993-5:2009 (cytotoxicity analysis) and ISO 10993-10:2010 (skin irritation analysis) was carried out on both the ARC InstaTemp™ and the ARC InstaTemp MD™. This testing concluded that no biocompatibility issues exist with the ARC Non-Touch Thermometer.
{8}------------------------------------------------
IX. NON-CLINICAL PERFORMANCE DATA
The following non-clinical performance data was provided in support of the substantial equivalence determination:
Software Verification and validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDAs Guidance for Industry and FDA Staff 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'. The software for this device was considered as a 'moderate' level of concern since a malfunction of, or a latent design flaw in, the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing was conducted for the ARC Non-Touch Thermometer. This testing concluded that the device is in compliance with IEC 60601-1. IEC 60601-1-11 (2010) and ISO80601-2-56 standards for safety and IEC 60601-1-2 standard for EMC.
Bench Performance Testing
The following bench testing was performed to support substantial equivalence
- ASTM E1965-98 (Reapproved 2009), Standard Specification for Infrared Thermometers . for Intermittent Determination of Patient Temperature.
- . Software / Algorithm report / Comparison Report with an identical device to the predicate.
X. CLINICAL PERFORMANCE DATA
A clinical trial was completed on 136 subjects which verified the clinical performance by way of a clinical accuracy validation as defined in ISO 80601-2-56, section 201.102. The test report concluded that based on the required sample sizes as mandated by the standard that the ARC Devices Non-Touch Thermometer has levels of reproducibility and accuracy, for both febrile and non-febrile patients that are in keeping with the existing devices that are in widespread hospital practice. This clinical trial demonstrates that the ARC Devices Thermometer performs in the clinical setting and so substantial equivalence can be drawn to the predicate.
XI. CONCLUSIONS
The ARC Non-Touch Thermometer, has the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety through the successful testing to IEC 60601-1, IEC 60601-1-11 (2010) and ISO80601-2-56 along with successful testing to the electromagnetic standard IEC 60601-1-2. Furthermore, the subject device also meets the specific requirements of ASTM E1965-98.
Taking this information into account, it is concluded that the ARC Non-Touch Thermometer which includes both the ARC InstaTemp™ Non-Touch Thermometer and the ARC InstaTemp MD™ Non-Touch Thermometer, are substantially equivalent to the predicate device, the RC002 Remote Infrared Thermometer (K090361)
§ 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.