(236 days)
Not Found
None
No
The summary describes a process indicator, which is a simple chemical or physical indicator, and contains no mention of AI, ML, or any related concepts.
No
The device is described as a "Process indicator" used to demonstrate exposure to a process and distinguish between processed and unprocessed units, not for treating any medical condition.
No
Explanation: The device, described as a "process indicator," is intended to demonstrate exposure to a process and distinguish between processed and unprocessed units. This function relates to quality control or process validation rather than diagnosing a medical condition in a patient.
Unknown
The provided text is a 510(k) summary template with most sections marked as "Not Found" or "Not Applicable". It only describes the intended use of "process indicators" which are typically physical items used to demonstrate exposure to a process (like sterilization). Without a device description, it's impossible to determine if this is a software-only device or a physical indicator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to demonstrate exposure to a process and distinguish between processed and unprocessed units. This is a quality control or process monitoring function, not a diagnostic test performed on biological samples to determine the state of health or disease.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health or disease status
- Diagnostic testing
The device described is a process indicator, which is a type of quality control tool used in various settings (like sterilization or manufacturing) to confirm that a specific process has occurred.
N/A
Intended Use / Indications for Use
Process indicators are intended for the use with individual units, to demonstrate that the unre has been exposed to a process at stated expect conditions and distinguish be stated conditions.
Product codes
JOJ
Device Description
Not Found
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is presented in a straightforward, unadorned manner. The words are arranged horizontally, with 'Public Health' on the first line and 'Service' on the second line.
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
0 1000 FEB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcia Frieze Vice President Case Medical, Incorporated® 65 Railroad Avenue Ridgefield, New Jersey 07657-0402
Re : K982151 Steritite Process Indicator Accessories Trade Name: Requlatory Class: II Product Code: JOJ November 16, 1998 Dated: Received: November 17, 1998
Dear Ms. Frieze:
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 Regulations, 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 requlation 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
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Page 2 - Ms. Frieze
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene office or compiland, "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) 638-2041g or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Directd Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Process indicators are intended for the use with individual units, to Process Indicators are Intented for aposed to a process at stated demonstrate that the unre has been expect conditions and distinguish be stated conditions.
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Concurrence of CDIVH, Office of Device Evaluation (ODE)
Olin Si Lin
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of Septital Devices
510(k) Number
Prescription Use (Pcr 21 CFR 801.109) ાર
Over-The-Counter Use_/
(Optional Form:
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number _