(41 days)
Not Found
No
The summary mentions "image analysis" but provides no details suggesting the use of AI/ML algorithms for this analysis. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
No
The device is described as an imaging device for measuring relative skin temperature (temperature mapping) and is specifically stated to be "for adjunctive use only" and "not intended for absolute temperature measurements" or "to be used as a thermometry device," which indicates it is for diagnostic or assessment purposes rather than providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended for measuring relative skin temperature generated by the human body" and that its "use is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements." While it specifically states it's "not intended for absolute temperature measurements" or as a "thermometry device," measuring relative skin temperature for a healthcare professional to assess a patient's condition falls under the umbrella of diagnostic use, even if it's for "adjunctive use only." Such measurements can aide in identifying abnormalities or tracking disease progression, which are functions of diagnostic devices.
No
The device description explicitly states "The IRIS XP is a thermal based imaging device," indicating it includes hardware for capturing thermal images, not just software for processing them.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body.
- IRIS XP Function: The IRIS XP is a thermal imaging device that measures relative skin temperature on the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for measuring relative skin temperature generated by the human body, not for analyzing biological samples.
- Device Description: The description reinforces that it measures infrared rays radiated from the patient's skin.
Therefore, the IRIS XP falls under the category of a medical device used for external assessment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LHQ
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Thermal imaging
Anatomical Site
Human body
Indicated Patient Age Range
all assessment age groups from adult to pediatric and neonatal.
Intended User / Care Setting
Qualified healthcare professional / clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K212412
Device Name IRIS-XP
Indications for Use (Describe)
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.
| 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 |
4
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)]
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.
6. Indications for use [21 CFR 807.92(a)(5)]
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.
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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 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 computers. The | ||
| 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. | The Meditherm med2000 thermal imaging | |
| system is a thermal based imaging device | ||
| intended for viewing and digitally storing | ||
| thermal patterns 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. | ||
| The Meditherm med2000 provides for use | ||
| with both laptop and desktop computers. | ||
| The 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. | ||
| Intended use | ||
| environment | Hospital | Hospital |
| Specifications | ||
| Power source | Line In: | |
| 100-120/200-240 VAC, 50/60 Hz | ||
| Line 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, 1 |
| Ampere surge at start-up | ||
| Operating | ||
| Temperature | 10°C to 40°C | 18°C to 30°C |
| Storage | ||
| temperature | -20°C to 60°C | -30°C to 80°C |
| Temperature Range | 14.5°C to 40°C | 0°C to 50°C |
| Relative |