CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413

K070342 · American I.V. Products, Inc. · FLL · Mar 19, 2007 · General Hospital

Device Facts

• Record ID: K070342
• Device Name: CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
• Applicant: American I.V. Products, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Mar 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended 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.

Device Story

AIV Clinical Electronic Thermometers are reusable replacement probes for existing temperature monitoring systems. The device consists of a thermistor sensor housed in a metal-tipped plastic shaft, connected via a shielded multi-conductor cable to a monitor. Some models include a heating resistor to accelerate measurement. In operation, the probe is inserted into a protective sheath (not supplied) and used by trained medical personnel to measure patient temperature. The thermistor signal is transmitted to the host monitor, which processes and displays the temperature reading. The device is used in clinical settings, physician offices, or alternate care environments. The output assists clinicians in patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through design equivalence and bench testing to demonstrate the device performs as intended.

Technological Characteristics

Reusable clinical electronic thermometer probe; thermistor sensing technology; metal-tipped plastic shaft; shielded multi-conductor cable with monitor-specific connectors; includes heating resistor in some models for rapid measurement; used with non-sterile protective sheaths.

Indications for Use

Indicated for quantitative body temperature measurement (oral, axillary, or rectal) in clinical, physician office, or alternate care settings by trained medical personnel.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Critikon Company (K992638, K874378)
• Alaris Medical Systems (K050230, K955846, K860436)

Submission Summary (Full Text)

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K070342

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: [phone] ext. 131 Fax: [phone] e-mail: [e-mail]

### 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 | Alaris<br>Medical<br>Systems |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------|------------------------------|
| Intended Use | for the quantitative detection of body<br>temperature, which can be obtained orally,<br>under the arm (axially) or rectally | Same | Same |
| Patient Usage | Reusable. | Same | Same |
| Technical<br>Characteristics | Thermistor technology | Same | Same |
| Design/Appearance | Probe with shaft and body assembly that<br>uses a protective sheath | Same | Same |
| Type of Construction | Thermistor in metal tipped plastic shaft,<br>flexible, shielded, multi conductor electrical<br>cable and monitor connector. | Same | Same |
| Connector Design | Connectors are selected to fit the appropriate<br>monitors | Same | Same |
| Cable Length | Various specified lengths. | Same | Same |
| Wire Material | Braided shield, tin/copper with elastomer<br>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.

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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 [phone]. 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 [phone] or [phone] 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