(30 days)
The device is an digital infrared Ear Thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
The Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 are electronic thermometers using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces. The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts: a) IR Thermopile Sensor, b) ASIC, c) E2 PROM IC, d) LCD and Blacklight, e) Kev "2. Buzzer" 1.
Here's a breakdown of the acceptance criteria and study information for the Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290, based on the provided text:
Summary of Device Acceptance and Study Information
The provided 510(k) summary focuses on demonstrating substantial equivalence of the new models to a previously cleared predicate device (Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725). The key claim is that the new models are identical in functionality and performance to the predicate, with only differences in external shape, PCB layout, and some user interface ergonomics/features.
The document explicitly states that controlled human clinical studies were not conducted for the modified devices. This implies that the acceptance criteria and performance data for these new models are not directly derived from new clinical trials. Instead, the substantial equivalence relies on the unchanged core technology and performance specifications, and compliance with voluntary standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Voluntary Standards Compliance: | |
| ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Compliant |
| ASTM E1104 (Standard Specification for Clinical Thermometers, Infrared and Radiation, for Intermittent Determination of Patient Temperature) | Compliant |
| ASTM E-1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) | Compliant |
| IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) | Compliant |
| IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests) | Compliant |
| Performance Specifications (Implicity same as predicate): | "Accuracy performance, reliability and EMC testing is only applicable." - Implied to meet predicate's performance. |
| Working Environmental Specification: | 5-40°C (Unchanged from predicate) |
| Temperature Measurement Algorithm: | Unchanged from predicate |
| Software Codes: | Unchanged from predicate |
| Intended Use: | Same as predicate (neonatal, pediatric, and adult populations in the home setting) |
Important Note: The document does not explicitly list quantitative acceptance criteria for accuracy, reliability, or specific performance metrics for the new devices. It relies on the predicate device's established performance and the claim that the core technology and algorithm remain unchanged. The compliance to the ASTM and IEC standards serves as the primary acceptance criteria for the modified devices, indicating they meet established design and safety requirements for electronic clinical thermometers.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/not specified. The document explicitly states that "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices." The evaluation of these new models relies on non-clinical tests (compliance to standards, engineering verification) and the assertion that their performance is identical to the predicate.
- Data Provenance: Not applicable, as no new clinical test data was generated for these modified devices. The regulatory submission leverages the performance data of the predicate device, which is not detailed in this excerpt regarding its own clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable, as no new clinical studies were conducted for the modified devices requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Not applicable, as no new clinical studies were conducted for the modified devices requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No MRMC comparative effectiveness study was done. The document states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices".
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies that "Accuracy performance, reliability and EMC testing" was done for the modified devices. While not detailing 'standalone algorithm testing' in the modern sense of AI, it refers to the unchanged temperature measurement algorithm and software codes from the predicate device. This suggests that the core measurement logic itself was considered "standalone" and its performance was established with the predicate devices and considered directly transferable due to no changes.
7. The Type of Ground Truth Used
- For the modified devices, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Compliance with established voluntary standards (ASTM, IEC).
- The assertion of identical functionality and performance to the predicate device whose performance was previously established.
- Engineering verification and validation tests (not detailed) to confirm that the modifications did not alter original safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This device is an infrared thermometer, not an AI/machine learning model in the context that requires a "training set." The temperature measurement algorithm is described as "unchanged" from the predicate device, implying it was developed based on general physics and engineering principles for infrared thermometry, not through machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" in the context of an AI/machine learning model for this electronic thermometer. The core measurement algorithm's "ground truth" would have been established through a combination of physical principles, calibration against known temperature sources, and validation against clinical reference methods during the development of the predicate device (which is not detailed in this submission).
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EXHIBIT #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:K033818
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: December 8, 2003
Contact: Mr. Gerhard Frick
2. Name of the Device(s):
Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290
3. Information for the 510(k) Cleared Device (Predicate Device):
Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725
Device Description: 4.
The Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 are electronic thermometers using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.
The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:
- IR Thermopile Sensor a)
- b) ASIC
- C) E2 PROM IC
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- LCD and Blacklight d)
- Kev "2. Buzzer" 1 e)
5. Intended Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Comparison to the 510(k) Cleared Device (Predicate Device): 6.
The Microlife Digital Infrared Ear Thermometers, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 are substantially equivalent to the original Microlife Digital Ear Thermometer, Model IR1DE1.
The new models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 have the same intended use and are similar in design to the 510(k) cleared device.
The IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 are identical in functionality and performance with the only difference being the external shape of the devices, and PCB layout of the devices. The modifications to our original 510(k) cleared device, Model IR1DE1, include performance specifications, ergonomics of the user interface, dimensional specifications 12 sets memory recall and fever alarm function. The working environmental specification 5-400, temperature measurements algorithm and its software codes of the modified devices remains unchanged.
The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device. The Microlife devices (IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290) works with only a 1-second called a "normal" mode
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112, ASTM E1104 and ASTM E-1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements.
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Guidance documents included the "FDA Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers", "Deciding When to Submit a 510(k) for a Change to An Existing Devices", and, "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
Discussion of Clinical Tests Performed: 8.
Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices, as well as no low power test as clinical studies/low power testing were conducted for the original unmodified device and remain unchanged. Accuracy performance, reliability and EMC testing is only applicable.
9. Conclusions:
The Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 have the same intended use and technological characteristics as the unmodified model IR1DE1. Moreover, verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness. These engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2004
Microlife Intellectual Property, GmbH C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Rc: K033818
Trade/Device Name: Digital Infrared Ear Thermometer, Model IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 8, 2003 Received: December 11, 2003
Dear Ms. Goldstein-Falk:
We have reviewed your Scction 510(k) promarket 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Lehn
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 administcred 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our !abeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, plcase note the regulation contitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clas
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit B
Page 1 of 1
K-033818 510(k) Number (if known): ___
Device Name: Digital Infrared Ear Thermometer, Model IR1DC1/V971, "--IR1DG1/SKU4289 and IR1DH1/SKU4290
Indications For Use:
The device is an digital infrared Ear Thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OTC - ✓
Viola Hubbard, Interim Bureau Chief
General Hospital. Division of Anesthesiolog Infection Control, Dental
510(k) Number: K033818
§ 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.