DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030

K031905 · Actherm, Inc. · FLL · Jul 7, 2003 · General Hospital

Device Facts

• Record ID: K031905
• Device Name: DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
• Applicant: Actherm, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jul 7, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Device Story

Digital clinical thermometer (Models ACT2130, ACT2230, ACT2330, ACT3136, ACT3030) measures human body temperature. Device uses internal power source; operates via electronic sensing of temperature; provides digital readout. Intended for oral, axillary, or rectal use. Used by clinicians or patients for temperature monitoring. Output allows healthcare providers to assess patient febrile status and guide clinical management.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electronic clinical thermometer; internal battery power; digital display; oral/axillary/rectal probe configuration. Standard electronic thermistor-based sensing technology.

Indications for Use

Indicated for the measurement of human body temperature via oral, axillary, or rectal routes in patients of all ages.

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

• Actherm Digital Clinical Thermometers (K010238)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 0 7 2003

Mr. Richard Hsieh Vice President Actherm, Incorporated 6″ F, No. 85 Kuan-Min 6 Road Jubei 302 Hsinchu, CHINA (Taiwan) 302

Re: K031905

Trade/Device Name: Digital Clinical Thermometer, Model ACT 2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 6, 2003 Received: June 23, 2003

Dear Mr. Hsieh:

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. Hsieh

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/dsma/dsmamain.html

Sincerely yours,

Susan Bunce

Susan Runner, DDS, MA Interim 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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## Attachment 2

## Indications for Use Statement

| 510(k) Number (if known) | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Digital Clinical Thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030 |
| Indications for Use | The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238. |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801. 109)

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## Patina Cuente

(Division, City or RM

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031905