(69 days)
Not Found
Not Found
No
The 510(k) summary describes a sterilization container system, which is a physical device for sterilizing instruments. There is no mention of software, data processing, or any terms related to AI/ML.
No
The device is a sterilization container system, not a device used for therapeutic treatment of a patient.
No
The device is described as a reusable rigid sterilization container system for surgical instruments, not for diagnosing medical conditions.
No
The device description and intended use clearly describe a physical, reusable rigid sterilization container system, 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 for the sterilization of surgical instruments. This is a process performed on medical devices, not on biological samples from a patient to diagnose a condition.
- Device Description: While not found, the intended use clearly points to a sterilization container, which is a physical device used in a sterilization process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing diseases, or any other activity typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health, such as diagnosing a disease or monitoring a condition. The SteriTite "11 product line does not fit this description.
N/A
Intended Use / Indications for Use
The SteriTite "11 product line is a Reusable Rigid Sterilization Container system intended to be used for the sterilization of surgical instruments for a hospital or other health care institution.
Product codes
FRG
Device Description
SteriTite™ Rigid Sterilization Containers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or other health care institution.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1997
Case Medical, Incorporated C/O Mr. Larry R. Pilot McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, DC 20006-1108
Re: K974638 Steritite™ Rigid Sterilization Containers Trade Name: Model SC04Q Requlatory Class: II Product Code: FRG Dated: October 10, 1997 Received: October 10, 1997
Dear Mr. Pilot:
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, qood 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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Reqister. Please note: this response to your premarket notification submission does
1
Page 2 - Mr. Pilot
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 requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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.fda.qov/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 Radioloqical Health
Enclosure
2
5 10(k) Number (if known):
Device Name: SteriTite "N' Rigid Sterilization Container System Madel SCO40 "
Indications For Usc:
The SteriTite "11 product line is a Reusable Rigid Sterilization Container system intended to be used for the sterilization of surgical instruments for a hospital or other health care institution.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDIUI, Office of Device Evaluation (ODE)
Chine S. Lin
(Division Sign-Oll) Division of Dental, Infection Control, and Oeneral Hospital Deyices 510(k) Number _
Prescription Usc (Per 21 CFR 801.109) ()[{
Over-The-Counter Use X
(Upliunal Formal 1-2-96)