(41 days)
The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are reusable 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'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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AIV Clinical Electronic Thermometer:
Acceptance Criteria and Device Performance Study for AIV Clinical Electronic Thermometer
The provided document describes a 510(k) Premarket Notification for a replacement clinical electronic thermometer. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide extensive clinical performance data against specific acceptance criteria.
Based on the document, the "acceptance criteria" are primarily implicit in the demonstration of substantial equivalence to existing predicate devices. The study proving this substantial equivalence is limited to bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a replacement device, the "acceptance criteria" are largely derived from the characteristics and performance of the predicate devices. The document explicitly states that the AIV device uses "the same type of construction and have the same technological characteristics" as the predicate devices.
| Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance (AIV Clinical Electronic Thermometer) |
|---|---|
| Intended Use: Quantitative detection of body temperature (oral, axial, rectal) | Same as Predicate: "for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally" |
| Patient Usage: Reusable | Same as Predicate: "Reusable." |
| Technical Characteristics: Thermistor technology | Same as Predicate: "Thermistor technology" |
| Design/Appearance: Probe with shaft and body assembly using a protective sheath | Same as Predicate: "Probe with shaft and body assembly that uses a protective sheath" and "Thermistor in metal tipped plastic shaft, flexible, shielded, multi conductor electrical cable and monitor connector." |
| Type of Construction: Thermistor in metal-tipped plastic shaft, flexible, shielded cable | Same as Predicate: "Thermistor in metal tipped plastic shaft, flexible, shielded, multi conductor electrical cable and monitor connector." |
| Connector Design: Selected to fit appropriate monitors | Same as Predicate: "Connectors are selected to fit the appropriate monitors" (A list of compatible monitors is provided, implying functional compatibility). |
| Cable Length: Various specified lengths | Same as Predicate: "Various specified lengths." |
| Wire Material: Braided shield, tin/copper with elastomer jacket | Same as Predicate: "Braided shield, tin/copper with elastomer jacket." |
| Sterility: Used non-sterile | Same as Predicate: "Used non-sterile." |
| Performance: Function as intended (implicitly, accuracy and reliability comparable to predicates) | "Bench Testing demonstrates that the AIV devices perform as intended." (No specific numerical performance metrics like accuracy ranges, response times, or drift are provided in this summary. This statement relies on the assumption that "as intended" means consistent with the performance of substantially equivalent predicate devices.) "These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the traditional sense of a clinical trial or a structured validation study with a defined dataset. The "study" referenced is bench testing.
- Data Provenance: The data provenance is not specified beyond "bench testing." It is not clinical data (patient data), so concepts like "country of origin" are not applicable in this context. It's an in-house prospective test by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This submission is for a medical device (thermometer) and relies on bench testing and comparison to predicate devices, not on expert clinical interpretation or ground truth establishment in the way an AI diagnostic algorithm would.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" described as the testing is not based on expert review of ambiguous cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The AIV Clinical Electronic Thermometer is a direct measurement device, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in spirit, a standalone performance was done, in that the device's performance was evaluated independently through bench testing. However, it's not an "algorithm only" performance as the device is a physical electronic thermometer. The "standalone" evaluation here refers to the device itself performing its intended function (temperature measurement) without a human's interpretative cognitive task being assisted by AI. The human is involved in placing and operating the device, but the temperature reading itself is generated by the device.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing would be established by reference temperature standards and calibrated measurement equipment. While not explicitly detailed, standard engineering and metrology practices dictate that the thermometer's readings would be compared against highly accurate and traceable temperature sources to verify its performance specifications (e.g., accuracy, precision). This is essentially physics/engineering-based ground truth, not clinical or pathology-based.
8. The Sample Size for the Training Set
Not applicable. This device is a physical electronic thermometer; it does not involve machine learning or AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.
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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
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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 | AlarisMedicalSystems | |
|---|---|---|---|
| Intended Use | for the quantitative detection of bodytemperature, which can be obtained orally,under the arm (axially) or rectally | Same | Same |
| Patient Usage | Reusable. | Same | Same |
| TechnicalCharacteristics | Thermistor technology | Same | Same |
| Design/Appearance | Probe with shaft and body assembly thatuses a protective sheath | Same | Same |
| Type of Construction | Thermistor in metal tipped plastic shaft,flexible, shielded, multi conductor electricalcable and monitor connector. | Same | Same |
| Connector Design | Connectors are selected to fit the appropriatemonitors | Same | Same |
| Cable Length | Various specified lengths. | Same | Same |
| Wire Material | Braided shield, tin/copper with elastomerjacket. | 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.
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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.
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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
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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)
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7485 Shipley Avenue · Harmans, MD · 21077 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com
§ 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.