(41 days)
No
The description details a standard electronic thermometer using a thermistor sensor and cable, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is used for diagnosing (quantitatively detecting body temperature), not for treating a disease or condition.
No
Explanation: The device is an electronic thermometer used for the quantitative detection of body temperature. While temperature measurement is a vital sign used in diagnosis, the device itself only measures a physiological parameter. It does not analyze data or interpret findings to provide a diagnosis.
No
The device description explicitly details physical components like a thermistor temperature sensor, metal-tipped plastic shaft, plastic body, shielded multi-conductor cable, and potentially a heating resistor, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is an electronic thermometer used to measure body temperature directly from the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states the device is for the "quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally." These are direct measurements on the patient.
Therefore, since the device measures a physiological parameter directly from the patient's body rather than analyzing a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are rousable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.
Product codes
FLL
Device Description
AIV's Clinical Electronic Thermometers (also referred to as Temperature Probes) are replacement thermometers for temperature monitoring/measuring systems. The device is reusable. The devices are electronic thermometers using a thermistor as the temperature sensor. The devices are placed inside a protective sheath (not manufactured or supplied by AIV). Then the thermometer is used on the patient by trained medical personnel. The sensor output is displayed on a monitor/measuring system (not manufactured or supplied by AIV).
The probe consists of a thermistor located in a metal tipped plastic shaft which is attached to a plastic body that allows the protective sheath (not supplied by AIV; this component actually touches the patient) to be gripped and ejected off the probe. A shielded multi-conductor cable is used to conduct thermistor signals to the connector for the monitor/measuring system. Some models include a heating resistor that allows a more rapid temperature measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, under the arm (axially) or rectally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting, physicians' offices or other alternate care settings.
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)
- AIV design is equivalent to predicate device design.
- Bench Testing demonstrates that the AIV devices perform as intended.
- These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K992638, K874378, K050230, K955846, K860436
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for AIV, which is a black star above the letters "aiv" in a stylized font. Below the logo, the text "Supporting Clinical Engineering Worldwide" is written in a smaller, sans-serif font. The logo is simple and professional, and the text clearly communicates the company's mission.
Appendix C Page 1 of 2
510(k) Summary
Submitter Information:
American IV Products, Inc. 7485 Shipley Avenue Harmans, MD 21077
Contact:
John Taylor Director of Engineering Telephone: 410-787-1300 ext. 131 Fax: 410-787-1337 e-mail: itaylor@aiv-inc.com
Date Prepared:
February 5, 2007
Product Name:
Classification Name: Clinical Electronic Thermometer Common Name: Clinical Electronic Thermometer Proprietary Name: Clinical Electronic Thermometer
Predicate Device:
These AIV devices are Substantially equivalent to the following legally marketed devices:
Critikon Company : K992638, K874378
P/N - 8813 & 8814
Alaris Medical Systems: K050230, K955846, K860436
P/N - 2885, 2886, 2887, 2888, 3880L, 3882L
Description:
AIV's Clinical Electronic Thermometers (also referred to as Temperature Probes) are replacement thermometers for temperature monitoring/measuring systems. The device is reusable. The devices are electronic thermometers using a the temperature sensor. The devices are placed inside a protective sheath (not manufactured or supplied by AIV). Then the thermometer is used on the patient by trained medical personnel. The sensor is displayed on a monitor/measuring system (not manufactured or supplied by AIV).
The probe consists of a thermistor located in a metal tipped plastic shaft is attached to a plastic body that allows the protective sheath (not supplied component that actually touches the patient) to be gripped and ejected off the probe. A shielded multi-conductor cable is used to conduct thermistor signals to the connector for the monitor/measuring system. Some a heating resistor that allows a more rapid temperature measurement.
7485 Shipley Avenue · Harmans, MD · 21077 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com
MAR 1 9 2007
1
The AIV Temperature Probes use the same type of construction and have the same technological characteristics as the predicate devices.
The Temperature Probes are limited by the indications for use of the connected monitoring or measuring equipment.
Intended Use:
The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The device is intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.
Comparison to Predicate Device:
| | AIV | Critikon | Alaris
Medical
Systems |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------|------------------------------|
| Intended Use | for the quantitative detection of body
temperature, which can be obtained orally,
under the arm (axially) or rectally | Same | Same |
| Patient Usage | Reusable. | Same | Same |
| Technical
Characteristics | Thermistor technology | Same | Same |
| Design/Appearance | Probe with shaft and body assembly that
uses a protective sheath | Same | Same |
| Type of Construction | Thermistor in metal tipped plastic shaft,
flexible, shielded, multi conductor electrical
cable and monitor connector. | Same | Same |
| Connector Design | Connectors are selected to fit the appropriate
monitors | Same | Same |
| Cable Length | Various specified lengths. | Same | Same |
| Wire Material | Braided shield, tin/copper with elastomer
jacket. | Same | Same |
| Sterility | Used non-sterile. | Same | Same |
Performance Data and Conclusions:
- AIV design is equivalent to predicate device design. .
- . Bench Testing demonstrates that the AIV devices perform as intended.
- These devices do not raise new issues of safety and effectiveness, nor do they alter the . fundamental technology of the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Mr. John Taylor Director of Engineering & Acting Head of Regulatory Affairs American I.V. Products, Incorporated 7485 Shipley Avenue Harmans, Maryland 21077
Re: K070342
Trade/Device Name: Clinical Electronic Thermometer, Models TP11403 to TP11413 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 5, 2007 Received: February 6, 2007
Dear Mr. Taylor:
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.
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.
3
Page 2 - Mr. Taylor
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); 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 labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Smite of Michae Omd.
Chiú 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
4
Appendix B Page 1 of 1
Indications for Use
Page 1 of
K070342_ 510(k) Number (if known):
Clinical Electronic Thermometer Device Name:
Indications For Use:
The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are rousable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.
| AIV Part # | Temperature Monitor/Display |
|---|---|
| TP11403 | Critikon Dinamap Pro 200/400, Cardinal Health Vital Check (IVAC) Series 4400 & 4500, Criticare Vital Care 506 |
| TP11404 | Critikon Dinamap Pro 200/400, Cardinal Health Vital Check (IVAC) Series 4400 & 4500, Criticare Vital Care 506 |
| TP11405 | Alaris TurboTemp 2180CX01EE & 2180C |
| TP11406 | Alaris TurboTemp 2180CX01EE |
| TP11407 | Alaris TurboTemp 2185BX01EE & 2185B |
| TP11408 | Alaris TurboTemp 2185BX01EE |
| TP11409 | Critikon Dinamap 8100T |
| TP11410 | Critikon Dinamap 8100T |
| TP11411 | Critikon Dinamap XL and 9300 Series |
| TP11412 | Critikon Dinamap XL and 9300 Series |
| TP11413 | Critikon Dinamap XL and 9300 Series |
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anin Om
in words and figures
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7485 Shipley Avenue · Harmans, MD · 21077 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com