(122 days)
Not Found
Not Found
No
The 510(k) summary describes a sterilization tray, a physical device, and contains no mention of AI, ML, image processing, or data analysis, which are typical indicators of AI/ML technology in medical devices.
No
The device is described as a tray intended to enclose and sterilize medical devices in a healthcare facility, not to provide therapy directly to a patient.
No
Explanation: The device is a tray intended to enclose medical devices for sterilization, allowing steam penetration. Its function is to facilitate sterilization, not to diagnose medical conditions.
No
The intended use describes a physical tray for sterilization, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization in a healthcare facility, allowing steam penetration. This is a physical process related to sterilizing medical equipment, not a diagnostic test performed on biological samples.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device described is a sterilization tray, which is a type of medical device used in the sterilization process, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This device is intended to enclose items that are sterilized by a health care provider to allow them to be sterilized. medical
Product codes
FRG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
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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.
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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).
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§ 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 stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Brassler USA® C/O Ms. Courtney S. Paradice 1679 Kellog Springs Drive Atlanta, Georgia 30338
Re : K983223 Dental Sterilization Tray/Cassette Trade Name: Regulatory Class: II Product Code: FRG October 30, 1998 Dated: Received: November 9, 1998
Dear Ms. Paradice:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beccron six ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . market the device reflicancy (for the indications for device is subscanciary ore) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment date or the nassified in accordance with the devices that have been roofood, Drug, and Cosmetic the esperal provisions of the reactar rood, asubject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the Act increase requeed 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 be subject to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ rederal Regulation, and determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Ms. Paradice
through 542 of the Act for devices under the Electronic Chrough J42 Of the not is provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Inis recei wire arrowk) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device assubsite 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 compreation 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from cho rumber (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Ulatowski I'ima A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page of
510(k) Number (if known): K983223:
Device Name: Surgical / dental sterilization tray
Indications For Use:
Thi is intended enclose dica m that આવે terilized ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻷ health care ત્વ L + ende ه ه allow to sed medical
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Office of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Neuse 1. Melle fer Rius.
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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K983223