SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR

K983406 · Banta Healthcare Group, Ltd. · FLL · Oct 19, 1998 · General Hospital

Device Facts

• Record ID: K983406
• Device Name: SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR
• Applicant: Banta Healthcare Group, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Oct 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury thermometers. These sheaths are non-sterile and are intended for single patient use only.

Device Story

SaniTherm Disposable Thermometer Sheaths are plastic barrier covers for oral or rectal, digital or mercury thermometers. Used in clinical settings to prevent cross-contamination between patients. Device is non-sterile and intended for single-use. Healthcare providers or patients apply the sheath over the thermometer probe before measurement and discard after use. The barrier prevents direct contact between the thermometer and the patient, reducing the risk of infection transmission.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: ethylene methyl acrylate copolymer film. Form factor: disposable plastic sheath. Non-sterile. No electronic components or software.

Indications for Use

Indicated for use as a protective barrier accessory for oral or rectal, digital or mercury thermometers for single patient use.

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

• Abco Dealers (K871465)
• Medline Industries, Inc. (K772385)

Submission Summary (Full Text)

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007-14-1998 രും പട്ട BANTA Healthcare Products

> 570 ENTERPRISE NEENAH, WI 54956 920/751-4300 Fax: [phone]

K983406

OCT 1 9 1998

... .

## SUMMARY OF SAFETY AND EFFECTIVENESS:

September 21, 1998

- Company Information: 1. Banta Healthcare Products 570 Enterprise Neenah, WI 54958 Registration #: 2182318 [phone] Phone: [phone] Fax: Contact Name: Richard Peppard Contact Title: QA/RA Manager
2. DEVICE NAME: PROPRIETARY NAME:

> COMMON NAME: CLASS: PRO CODE: PERFORMANCE STANDARDS:

Thamometer Sheaths SaniTherm Themometer Sheaths, Oral and Rectal, Digital and Mercurv Themometer Sheaths 11 FLL and FLK None

- 3. Manufacturing Site Information: Banta Healthcare Products 570 Enterprise Neenah, WI 54958 Registration #: 2182318 [phone] Phone: [phone] Fax: Contact Name: Richard Peppard Contact Title: QA/RA Manager
- 4. Y2K: This product is not affected by Y2K.
- ഗ് Latex Content: This product and its packaging are latex-free.
- ક. Device Description: SaniTherm Disposable Thermometer Sheaths are plastic coverings used for either oral or recal, mercury or digital thermometers. Digital Thermometer Sheaths may not be suitable for use with all clinical thermometers. Example - Clinical thermometers which employ rigid plastic sheaths.
- 7. Sterilization Information: This product is not sold sterile.

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Image /page/1/Picture/0 description: The image contains the text "BANTA Healthcare Products". The word "BANTA" is in a larger, bold font compared to "Healthcare Products". The text is horizontally aligned and appears to be a logo or brand name.

570 ENTERPRISE NEENAH, WI 64958 920/751-4300 Fax: [phone]

Image /page/1/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '9', then '83406'. The characters are written in a dark ink, and the image has a white background.

## Product Specifications 8. Banta Thermometer Sheaths are made from ethylene methyl acrylate copolymer film.

- Intended Use/Indications for Use g. These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury themometers. These sheaths are non-sterile and are intended for single patient use only.
- 10. Substantial Equivalence These devices are substantially equivalent to other similar devices currently on the market. (Abco Dealers, K871465 and Mediine Industries, Inc., K772385). Banta Digital and Mercury Thermometer Sheaths are Identical in respect to materials, construction and manufacturing process. Size may be vary to accommodate differences in Digital and Mercury Thermometers.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around it. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, composed of three intertwined strands.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 19 1998

Richard Peppard Mr. OA/RA Manager BANTA Healthcare Products 570 Enterprise Neenah, Wisconsin 54956

Re : K983406 Trade Name: SaniTherm® Disposable Thermometer Sheaths Regulatory Class: II Product Code: FLL Dated: September 21, 1998 Received: September 28, 1998

Dear Mr. Peppard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Peppard

This letter will allow you to beqin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdatgov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Dire ctor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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S70 ENTERPRISE NEENAH, WI 54956 820/751-4300 Fax: [phone]

INTENDED USE:

Page 1 of 1

510(k) Number (if known): K9,93406

Device Name: Thermometer Sheaths

Indications for Use;

These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury thermometers, These sheaths are non-sterile and are intended for single patient use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
*Olivia Cucenta*

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_4 983406

(Optional Format 1-2-96)

SUBSTANTIAL EQUIVALENCE: