(78 days)
The device is a clinical electronic 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 device TT-001 is an electronic thermometer using an infrared sensor to detect body temperature from the auditory canal. Its operation is based in the measuring the natural thermalradiation emanating from the tympanic membrane and the adjacent tissue. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The waveguide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the waveguide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor. To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second.
The provided submission, K101322, for the Joinsoon Electronics Mfg. Co., Ltd. Infrared Ear Thermometer, Model TT-001, primarily focuses on demonstrating substantial equivalence to a predicate device (TempTeller - Infrared Ear Thermometer, Models CT-31/32DX/32/32DX, K030299) rather than detailing a specific clinical study with acceptance criteria.
The submission states that "bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness." This implies that the performance was evaluated against established standards and internal testing, rather than a clinical trial directly measuring accuracy against a ground truth from human experts.
Therefore, much of the requested information regarding acceptance criteria, study design, and expert involvement is not explicitly available in the provided 510(k) summary.
However, based on the information provided, here's what can be inferred and stated:
Acceptance Criteria and Device Performance
The submission indicates compliance with ASTM E1965-98 for evaluating infrared thermometers. This standard sets the clinical accuracy requirements for such devices. While the specific numerical acceptance criteria from ASTM E1965-98 are not detailed in the summary, they would typically involve limits on the difference between the device's reading and a reference temperature.
The submission does not report specific numerical device performance metrics (e.g., mean difference, standard deviation of differences, clinical accuracy within a certain range). It only states that the device's characteristics "do not raise any new questions of safety or effectiveness," implying it met the relevant performance standards.
| Acceptance Criteria (Based on ASTM E1965-98 - General Expectation, not explicitly stated in submission) | Reported Device Performance (Implied from Submission) |
|---|---|
| Clinical Accuracy: Within specified limits compared to a reference temperature (e.g., ± 0.2°C or ± 0.4°F in a certain temperature range). | Device performance aligns with predicate and meets applicable voluntary standards (ASTM E1965-98), ensuring no new questions of safety or effectiveness are raised. Specific numerical performance not provided. |
| Repeatability/Reproducibility: Consistent readings within specified limits. | Implied to meet standards. Specific data not provided. |
| Measurement Range: Capable of measuring temperatures within the specified clinical range. | Implied to meet standards. Specific data not provided. |
| Environmental Conditions: Performance maintained across specified environmental conditions (temperature, humidity). | Implied to meet standards. Specific data not provided. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- The 510(k) summary mentions "bench testing" but does not provide details on test set sample sizes or data provenance (e.g., country of origin, retrospective or prospective). This type of information would typically be in the full submission, but not in the summary. For thermometer evaluations against ASTM E1965, a specific number of subjects are usually required for clinical accuracy testing, often involving multiple readings.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a bench/laboratory performance study against a reference standard, not a study requiring expert interpretation of medical images or conditions. The "ground truth" for thermometer accuracy assessment is typically a highly accurate reference thermometer measurement, not an expert medical opinion.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., radiology studies). For thermometer calibration and accuracy testing, a comparison is made to a calibrated reference temperature source.
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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. This device is an infrared ear thermometer, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance evaluation against ASTM E1965-98 would be a standalone evaluation of the device's accuracy without a "human-in-the-loop" in the context of interpretation. The human uses the device, but the device's measurement is assessed independently.
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The type of ground truth used:
- Calibrated reference temperature or blackbody source, as per international standards like ASTM E1965-98. This standard includes sections for both laboratory and clinical accuracy testing. Clinical accuracy would involve comparison to a "standard clinical thermometer" (e.g., rectal thermometer in a controlled setting) or a highly accurate core body temperature measurement.
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The sample size for the training set:
- Not applicable. Infrared ear thermometers are typically calibrated during manufacturing rather than "trained" with a dataset in the AI sense. Their operation is based on fundamental physical principles (infrared radiation detection) and algorithms converting raw sensor data to a temperature reading.
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How the ground truth for the training set was established:
- Not applicable. (See point 7). Calibration during manufacturing would involve highly accurate reference temperature sources.
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Klo1322
510(k) Summary
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date prepared: May 5, 2010.
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- Applicant:
Joinsoon Electronics MFG. Co., Ltd. 19F., No. 79, Sec. 1, Sintai 5th Rd., Sijhih City, Taipei County 221, Taiwan, R.O.C. Phone: +886-2-2698-4882 Fax: +886-2-2698-4883
- Applicant:
JIII 2.8 2010
2. Submitter:
Mr. Jigar Shah Official Correspondent for Joinsoon Electronics MFG. Co., Ltd. mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 Jigar@mdiconsultants.com
3. Trade/proprietary Name: Joinsoon Electronics Mfg. Co., Ltd. Infrared Ear Thermometer, Model TT-001
4. Classification name:
Common Name: Clinical Electronic Thermometer Regulation: 21 CFR Part 880.2910
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- Product Code: FLL
6. Predicate Devices:
TempTeller - Infrared Ear Thermometer, Models CT-31/32DX/32/32DX Cleared 510(k) number: K030299
7. Device Description
The device TT-001 is an electronic thermometer using an infrared sensor to detect body temperature from the auditory canal. Its operation is based in the measuring the natural thermalradiation emanating from the tympanic membrane and the adjacent tissue.
The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The waveguide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without
1
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contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the waveguide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor.
To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second.
The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device.
8. Intended Use:
The device is a clinical electronic 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.
9. Substantial Equivalence Discussion:
The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TT-001 is substantially equivalent to the original 510(K) 030299, Model CT-32DX in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc.,
The only differences in the predicate version of the Digital thermometer are PCB layout involving Performance Specifications and Housing for Ergonomics of the Patient-Ul.
The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device.
10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC60601-1 and IEC60601-1-2 requirements.
Guidance documents included the "FDA Guidance on the content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".
11. Conclusion:
The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TT-001 has the same intended use and similar technological characteristics as the Predicate device. Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus the Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TT-001, is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, bold line drawing. The bird appears to be in flight or poised for flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Joinsoon Electronics Manufacturing Company Limited C/O Mr. Jigar Shah Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
JUL 28 2009
Re: K101322
Trade/ Device Name: Infrared Ear Thermometer, Model TT-001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 24, 2010 Received: June 28, 2010
Dear Mr. Shah:
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.
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Page 2- Mr. Shah
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runne
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known):
JUL 28 2010
Unknown at this time
Device Name:
K 10/322
Joinsoon Electronics Mfg. Co., Ltd. Infrared Ear Thermometer. Model TT-001
Indications for Use:
The device is a clinical electronic 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ai C. 7/28/10
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K/01322
§ 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.