(21 days)
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.
SaniTherm Disposable Thermometer Sheaths are plastic coverings used for either oral or rectal, 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. Banta Thermometer Sheaths are made from ethylene methyl acrylate copolymer film.
The provided document is a 510(k) premarket notification for "SaniTherm Disposable Thermometer Sheaths". This document outlines the general information about the device and its substantial equivalence to other devices already on the market.
Crucially, this document does not describe specific acceptance criteria and a study demonstrating the device meets those criteria, as it focuses on establishing substantial equivalence rather than reporting on a specific performance study with defined metrics.
Therefore, I cannot provide the requested information in the format specified because the source material does not contain it. The document affirms the device's substantial equivalence to existing predicate devices (Abco Dealers, K871465 and Mediine Industries, Inc., K772385) in terms of materials, construction, and manufacturing process. It also states its intended use as a barrier for thermometers.
Based on the provided text, the following information is either not present or not applicable in the context of a performance study:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence to existing devices, not unique performance claims with specific metrics.
- Sample size used for the test set and the data provenance: Not provided. No specific performance study is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a thermometer sheath, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
Summary of what is available in the document related to the device:
- Device Name: SaniTherm Disposable Thermometer Sheaths
- Proprietary Name: SaniTherm Themometer Sheaths, Oral and Rectal, Digital and Mercury
- Common Name: Thermometer Sheaths
- Intended Use/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 themometers. These sheaths are non-sterile and are intended for single patient use only.
- Material: Ethylene methyl acrylate copolymer film.
- Sterilization: Not sold sterile.
- Latex Content: Latex-free.
- Substantial Equivalence: To Abco Dealers, K871465 and Mediine Industries, Inc., K772385. Identical in materials, construction, and manufacturing process. Size may vary for different thermometer types.
For a device like a thermometer sheath, the "acceptance criteria" and "performance study" would typically relate to physical properties (e.g., tear strength, barrier effectiveness against liquids/pathogens, compatibility with thermometers) rather than diagnostic accuracy or AI performance. This 510(k) document indicates that such performance characteristics are implicitly met because the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.
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007-14-1998 രും പട്ട BANTA Healthcare Products
570 ENTERPRISE NEENAH, WI 54956 920/751-4300 Fax: 820/751-4370 800/215-5464
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 (920) 751-4300 Phone: (920) 751-4370 Fax: Contact Name: Richard Peppard Contact Title: QA/RA Manager
- 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
-
- Manufacturing Site Information: Banta Healthcare Products 570 Enterprise Neenah, WI 54958 Registration #: 2182318 (920) 751-4300 Phone: (920) 751-4370 Fax: Contact Name: Richard Peppard Contact Title: QA/RA Manager
-
- 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.
-
- 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: 920/751-4370 800/215-5484
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.
-
- 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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: 920/751-4370 800/215-5464
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:
§ 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.