ACON DIGITAL THERMOMETER PROBE COVERS

K063418 · ACON Laboratories, Inc. · FLL · Feb 2, 2007 · General Hospital

Device Facts

• Record ID: K063418
• Device Name: ACON DIGITAL THERMOMETER PROBE COVERS
• Applicant: ACON Laboratories, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Feb 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The ACON™ Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.

Device Story

ACON Digital Thermometer Probe Covers are disposable plastic barriers for digital thermometers; used during oral or rectal temperature measurements. Device acts as a hygienic sheath to prevent cross-contamination between patient and thermometer probe. Operated by consumers in home settings or clinicians in clinical settings. Output is a physical barrier; does not provide diagnostic data. Benefits include reduced risk of contamination during temperature assessment.

Clinical Evidence

Bench testing only. Performance verified via probe cover leakage and validation tests. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10 standards.

Technological Characteristics

Material: Ethylene Vinyl Alcohol Copolymer film. Non-sterile. Single-use. Designed for oral/rectal digital thermometer probes. Compliance with ASTM E1104, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for use as a protective barrier for oral or rectal temperature measurements using digital thermometers in patients requiring temperature monitoring.

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

• Sanitherm Oral Disposable Thermometer Sheaths (K983406)

Submission Summary (Full Text)

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#### 5. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The Assigned 510(k) number is

K063418

# Submitter's Identification:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: [phone] Fax: [phone]

Date Prepared: November 10, 2006

#### Contact Person:

Jinn-nan Lin, Ph.D. V.P., Regulatory Affairs

## Proprietary Name of the Device:

ACONTM Digital Thermometer Probe Covers

## Common Name:

Digital Thermometer Probe Covers

### Classification Name:

Class II §880.2910 Clinical Electronic Thermometer (To be manufactured and marketed for consumer home use)

# Predicate Device:

Sanitherm Oral Disposable Thermometer Sheaths Banta Healthcare Group, LTD (Rite Aid Brand) 510(k) Number: K983406

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# Description:

The disposable digital thermometer probe covers are plastic coverings used for either oral or rectal measurements for digital thermometers. The product is non-sterile and contains latex.

### Intended Use:

The ACON101 Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.

### Comparison to Predicate Devices:

The ACON™ Digital Thermometer Probe Covers are similar to the FDA-cleared Sanitherm Oral Disposable Thermometer Sheaths for Banta Healthcare Group, LTD (K983406) (Rite Aid Brand).

A Substantial Equivalence Comparison Table for the ACON Digital Thermometer Probe Covers and the Predicate Probe Covers is presented below:

| | Sanitherm Oral Disposable<br>Thermometer Sheaths<br>(K983406) | ACON Digital Thermometer<br>Probe Covers |
|--------------------|---------------------------------------------------------------|------------------------------------------|
| Materials | Ethylene Methyl Acrylate<br>Copolymer Film | Ethylene Vinyl Alcohol<br>Copolymer Film |
| Latex Content | Latex-Free | Non Latex-Free |
| Sterility | Non-Sterile | Non-Sterile |
| Indication for Use | Oral or Rectal | Oral or Rectal |
| Usage | Single Use Only | Single Use Only |

# Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ASTM E1104 as well as ISO 10993-5 and ISO 10993-10 biocompatibility testing.

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## Conclusion:

The performance characteristics of the ACON™ Digital Thermometer Probe Covers were verified by probe cover leakage test and probe cover validation test. Testing results indicate that the ACONTM Digital Thermometer Probe Covers are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in the package insert.

The laboratory testing results demonstrated a substantial equivalency in performance between the ACON™ Digital Thermometer Probe Covers and a legally marketed predicate device, Sanitherm Oral Disposable Thermometer Sheaths for Banta Healthcare Group, LTD (K983406) (Rite Aid Brand), with the same intended use and product features. The study results also demonstrated that the ACON™ Digital Thermometer Probe Covers are safe, effective and casyto-use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Jinn-Nan Lin Vice President for Regulatory Affairs ACON Laboratories, Incorporated 4108 Sorrento Valley Boulevard San Diego, California 92121

FEB - 2 2007

Re: K063418

Trade/Device Name: ACONTM Digital Thermometer Probe Covers Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 11, 2007 Received: January 12, 2007

Dear Dr. Lin:

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 - Dr. Lin

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,

Chiu 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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#### 4. INDICATIONS FOR USE

510(k) Number (if known):

ACONTM Digital Thermometer Probe Covers Device Name:

Indications for Use:

The ACON™ Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.

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)

Anton V. Watson

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Ancol. Dental Devices

kd63418 510(k) Number:

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