The IRIS XP is a thermal based imaging device intended for measuring relative skin temperature generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. (for adjunctive use only)

The IRIS XP provides for use with both laptop and desktop computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements. The patient populations include all assessment age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.

The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

Device Description

IRIS-XP shows an image analysis on the display to measure the amount of infrared rays radiated from the patient. The appropriate color image according to the temperature difference is shown on the screen. The IRIS XP is intended for relative skin temperature measurements (temperature mapping) for adjunctive use only.

AI/ML Overview

The provided text is a 510(k) summary for the IRIS-XP device, which is a thermal based imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device (MEDITHERM MED2000) rather than presenting a detailed study proving the device meets specific acceptance criteria in the format requested.

Therefore, many of the requested categories cannot be directly extracted from the provided document. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the IRIS-XP to its predicate device." This means that a clinical study designed to prove the device meets acceptance criteria as typically understood for performance metrics (like sensitivity, specificity, accuracy against a ground truth) was not performed.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, or image quality against a predefined benchmark for a diagnostic task). Instead, it relies on demonstrating that its technical characteristics (specifications) are substantially equivalent to a predicate device.

The closest to "acceptance criteria" and "reported performance" are the technical specifications compared in Table 1 (page 6-7). The implicit acceptance criterion for this submission is that its technical specifications and indications for use are similar enough to the predicate device to not raise new questions of safety or effectiveness.

Acceptance Criterion (Implicitly by comparison to predicate)	Reported Device Performance (IRIS-XP)	Predicate Device (MEDITHERM MED2000)	Rationale for Substantial Equivalence (from Table 2/text)
Indications for Use	Measuring relative skin temperature, adjunctive use, clinical/hospital/acute care settings, by qualified healthcare professionals, for all age groups, providing thermal images; not for absolute temperature measurements or as a thermometry device.	Viewing and digitally storing thermal patterns; adjunctive use, clinical/hospital/acute care settings, by qualified healthcare professionals, for all age groups, providing thermal images.	The indications for use are the same.
Temperature Range	14.5°C to 40°C	0°C to 50°C	"The most important temperature range is same to predicate device." (Implies overlap/sufficiency)
Relative Temperature Measurement Accuracy	< ± 0.8 °C	< ±1℃ of indicated temperature in range (20°C to 40°C)	Superior or comparable accuracy.
Operating Temperature	10°C to 40°C	18°C to 30°C	Difference is an inherent characteristic and does not raise new safety/effectiveness questions.
Storage Temperature	-20°C to 60°C	-30°C to 80°C	Difference is an inherent characteristic and does not raise new safety/effectiveness questions.
Field of View	50°(H) x 37.5°(V) with wide angle lens	Multiple options from 11°x8° to 50°x37°	Difference is an inherent characteristic and does not raise new safety/effectiveness questions.
Focus Range	30cm to ∞	Multiple options from 30cm to ∞ to 1m to ∞	Difference is an inherent characteristic and does not raise new safety/effectiveness questions.
Electrical Safety/EMC	Complies with IEC 60601-1:2005/AM1:2012 and IEC 60601-1-2:2014	(Implied compliance for predicate, not explicitly stated in this summary)	Compliance with relevant standards.
Software Validation	Moderate level of concern software, designed per software development process, verified and validated per FDA guidance.	(Not specified for predicate in this summary)	Compliance with relevant guidance for software.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set was used, as clinical testing was not required for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set was used, and therefore no ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a thermal imaging system, not an AI-assisted diagnostic tool, and no clinical comparative effectiveness study was done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device itself is the "standalone" component here, but its performance is assessed against technical specifications, not a diagnostic algorithm's performance. The clinical use is described as "adjunctive use only" and "determined by the healthcare professional."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was effectively the technical specifications and indications for use of the predicate device, not clinical outcomes or expert consensus. Non-clinical testing focused on electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. As this is a thermal imaging device and not an AI/machine learning system trained on a dataset for diagnostic purposes, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/machine learning model.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of the IRIS-XP to a predicate device (MEDITHERM MED2000) based on comparable technical specifications and indications for use, without requiring clinical performance testing against specific clinical acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medicore Co., Ltd. % DoGyun Lim Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 REPUBLIC OF KOREA

Re: K212412

Trade/Device Name: IRIS-XP Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic System Regulatory Class: Class I, reserved Product Code: LHQ Dated: July 26, 2021 Received: August 3, 2021

Dear Dogyun Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

September 13, 2021

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K212412

Device Name IRIS-XP

Indications for Use (Describe)

The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As Required by 21 CFR 807.92]

K212412

1. Date Prepared [21 CFR 807.92(a)(a)]

July 26, 2021

Address:

Contact Name:

●

2. Submitter's Information [21 CFR 807.92(a)(1)]

0 Name of Manufacturer: Medicore Co., Ltd.
No. 801~803, Joonganginnotech, 148, sagimakgolro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of korea [Zip.13207] Kyo-Bum, Kim
0 Telephone No.: +82-2-2056-2600
Fax No.: +82-2-412-1948
O Email Address: mcbum@medi-core.co.kr
0 Registration No.: 2000010846

3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

Trade/Device Name	IRIS-XP
Common Name	Thermography system, infrared
Regulation Number	21 CFR 884.2980
Regulation Name	System, Telethermographic (Adjunctive Use)
Regulation Class	Class I
Product Code	LHQ

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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

●	510(k) Number:	K003332
●	Applicant:	Meditherm
●	Trade/Device Name:	Meditherm Med2000
●	Regulation Number:	21 CFR 884.2980
●	Regulation Name:	System, Telethermographic (Adjunctive Use)
●	Regulation Class:	Class I
●	Product Code:	LHQ

The predicate device has not been subject to a design-related recall

5. Description of the Device [21 CFR 807.92(a)(4)]

6. Indications for use [21 CFR 807.92(a)(5)]

The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

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7. Determination of Substantial Equivalence

Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]

The indications for use of IRIS-XP is the same as the predicate device.

And the temperature range and measurement accuracy of IRIS-XP are the same as the predicate device.

The IRIS-XP substantially equivalent to legally marketed predicate devices (MEDITHERM MED2000) with respect to indications for use and technology characteristics. The table below presents comparisons for each device:

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	Proposed Device	Predicate Device
Product Name	IRIS-XP	MEDITHERM MED2000
510(k) Number	Not known	K003332
Manufacturer	MEDICORE Co., Ltd.	MEDITHERM, INC
Product Code	LHQ	LHQ
Device Class	I	I
Indications for Use	We update the IFU statement as follow:The IRIS XP is a thermal based imagingdevice intended for measuring relativeskin temperature generated by the humanbody in the clinical, hospital, acute caresettings, surgery, healthcare practitionerfacilities or in any environment wherehealthcare is provided by a qualifiedhealthcare professional. (for adjunctiveuse only)The IRIS XP provides for use with bothlaptop and desktop computers. Thecomputer provides the user interface,image storage and display. Use of thisdevice is determined by the healthcareprofessional and is based upon his or herof the patient's medical condition andrequirements. The patient populationsinclude all assessment age groups fromadult to pediatric and neonatal. Thedevice is for providing thermal images ofthe human body. This device is intendedfor use by qualified healthcare personnelwho are trained in its use.The system is not intended for absolutetemperature measurements. The systemis not intended to be used as athermometry device.	The Meditherm med2000 thermal imagingsystem is a thermal based imaging deviceintended for viewing and digitally storingthermal patterns generated by the humanbody in the clinical, hospital, acute caresettings, surgery, healthcare practitionerfacilities or in any environment wherehealthcare is provided by a qualifiedhealthcare professional.The Meditherm med2000 provides for usewith both laptop and desktop computers.The computer provides the user interface,image storage and display. Use of thisdevice is determined by the healthcareprofessional and is based upon his or herof the patient's medical condition andrequirements. The patient populationsinclude all assessment age groups fromadult to pediatric and neonatal. Thedevice is for providing thermal images ofthe human body. This device is intendedfor use by qualified healthcare personnelwho are trained in its use.
Intended useenvironment	Hospital	Hospital
Specifications
Power source	Line In:100-120/200-240 VAC, 50/60 HzLine Out:100-240VAC, 50/60 Hz	100-240 VAC, 47-63 Hz
AC to DC converter	DC 12V, 3A	5VDC, minimum of 3 Watts continuous, 1Ampere surge at start-up
OperatingTemperature	10°C to 40°C	18°C to 30°C
Storagetemperature	-20°C to 60°C	-30°C to 80°C
Temperature Range	14.5°C to 40°C	0°C to 50°C
Relative< ± 0.8 °Ctemperature		<±1℃ of indicated temperature in range
	Proposed Device	Predicate Device
Measurementaccuracy		20°C to 40°C
Field of view	50°(H) x 37.5°(V) with wide angle lens	25mm: 11° x 8°
		16mm: 17° x 12°
		11mm: 25° x 18°
		8.5mm: 32° x 24°
		5.8mm: 50° x 37°
Focus range	30cm to ∞	25mm: 30cm to ∞16mm: 30cm to ∞11mm: 30cm to ∞8.5mm: 30cm to ∞5.8mm: 1m to ∞

[Table 1. Comparison of Proposed Device to Predicate Device]

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The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices

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[Table 2. Little difference with Predicate Device]

Justification to Support Substantial Equivalence

IRIS-XP is hardly different from the MEDITHERM MED2000 except for Operating temperature, storage temperature, measurement accuracy, field of view and focus range. But the above differences are inherent characteristics of device. The most important temperature range is same to predicate device. Therefore, the differences in technological characteristics do not raise different questions of safety and effectiveness.

Non-Clinical Test summary

The IRIS-XP complies with voluntary standards for electrical safety and electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

Electrical Safety, Electromagnetic Compatibility and Performance:

The IRIS-XP complies with the electrical safety and electromagnetic compatibility reguirements established by the standards.

. Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AM1:2012
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014 ●
1. Software Validation

The IRIS-XP contain MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:

"The content of premarket submissions for software contained in medical devices, on May 11, 2005"

Clinical Test Summary

Clinical testing was not required to demonstrate the substantial equivalence of the IRIS-XP to its predicate device.

8. Conclusion [21 CFR 807.92(b)(3)]

The IRIS-XP has similar intended use and technical characteristics to the predicate device. Based on those information, we conclude that the differences between the proposed device and predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness.

Regulation Number and Section

§ 884.2980 Telethermographic system.

(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.