(21 days)
Not Found
No
The document describes a simple plastic sheath for thermometers and contains no mention of AI, ML, or any related technologies.
No
The device is described as a barrier (sheath) for thermometers and does not provide any therapeutic function.
No
Explanation: The device, SaniTherm Disposable Thermometer Sheaths, is described as a barrier or plastic covering for thermometers. Its intended use is as an accessory to thermometers for hygiene purposes, not to diagnose a medical condition.
No
The device description clearly states it is a physical product ("plastic coverings") and an accessory to physical thermometers, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a barrier for thermometers used for oral or rectal temperature measurement. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description confirms it's a plastic covering for thermometers.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL, FLK
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.
Banta Thermometer Sheaths are made from ethylene methyl acrylate copolymer film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral or rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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.
3
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
4
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: