(69 days)
Not Found
Not Found
No
The 510(k) summary describes a sterilizable instrument cassette for ultrasonic cleaning and steam sterilization, with no mention of AI or ML technology.
No
The device is described as an instrument cassette used for cleaning and sterilizing dental/medical instruments, not for diagnosing, treating, or preventing disease in a patient.
No
The device is used for cleaning and sterilizing instruments, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a "Sterilizable Instrument Cassette," which is a physical hardware component used for cleaning and sterilizing instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the ultrasonic cleaning and steam sterilization of dental/medical instruments. This is a process performed on instruments outside of the body to prepare them for use, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is a tool used in the process of preparing medical instruments, which falls under the category of medical devices, but not specifically IVDs.
N/A
Intended Use / Indications for Use
The BioSonic UC-70 Sterilizable Instrument Cassette (The Cassette) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments in a 132°C gravity cycle for 12 minutes.
Product codes
FRG
Device Description
BioSonic UC-70 Sterilizable Instrument Cassette
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1999
Mr. H. J. Vogelstein Official Correspondent Coltene/Whaledent®, Inc. 750 Corporate Drive Mahwah, New Jersey 07430
K993255 Re : Trade Name: BioSonic UC-70 Sterilizable Instrument Cassette II Requlatory Class: Product Code: FRG Dated: September 24, 1999 Received: September 28, 1999
Dear Mr. Vogelstein:
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 The general controls provisions of the Act 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. ದ 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 requlation may result in requlatory 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
1
Page 2 - Mr. Vogelstein
obligation you might have under sections 531 through 542 of obligation you might have ander bestronic Product Radiation the Act for devices and ther Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis recei will arrow your our on one fication. The FDA described in your six in puivalence of your device to a legally Finding of Subbeancial Squaresults in a classification for your marketed predicate device 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 regulacion (ir devices), please contact the Office of VILID draghobere at (301) 594-4692. Additionally, for questions on compriance as (od advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercrow, MacFR 807.97). Other general information on your responsibilities under the Act may be information on your iddings of Small Manufacturers Assistance obcarned from che bivir (800) 638-2041 or (301) 443-6597 or at at its coll free namber (o:t)/www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
/27/1999 16:37 12015292118 10/27/89 2301 480 3002 14:01
510(k) Number (if known):
K993255
BioSonic UC-70 Sterilizable Device Name: Instrument Cassette
Indications For Use:
The BioSonic UC-70 Sterilizable Instrument Cassette (The Cassette) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments in a 132°C gravity cycle for 12 minutes.
(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
(Optional Formal 1-2-96)
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number