(445 days)
Not Found
Not Found
No
The summary describes a bacterial enzyme indicator for monitoring steam sterilization, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is used for monitoring sterilization processes, not for treating diseases or conditions in patients.
No
The device is described as an "interactive, bacterial enzyme indicator" used for monitoring "saturated steam sterilization processes." It is not used to diagnose a medical condition in a patient.
No
The device description and intended use clearly indicate a physical, multiple, interactive, bacterial enzyme indicator used for monitoring sterilization processes, 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 to monitor saturated steam sterilization processes. This is a quality control measure for sterilization equipment, not a test performed on a biological sample from a human or animal to diagnose a condition, monitor treatment, or screen for disease.
- Device Description: The description "multiple, interactive, bacterial enzyme indicator" further supports its role in monitoring sterilization effectiveness, likely by detecting the presence or absence of bacterial enzymes after the sterilization process.
- Lack of IVD Characteristics: The document lacks any mention of:
- Testing biological samples (blood, urine, tissue, etc.)
- Diagnosing, treating, or monitoring a medical condition
- Patient age range or anatomical site
- Performance metrics typically associated with diagnostic tests (sensitivity, specificity, etc.)
Therefore, the RSI Rapid Indicator is a device used in a laboratory or healthcare setting, but its function is related to quality control of sterilization, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.
Product codes
MTC
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 (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
§ 880.2800 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/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 26 1997
Mr. Matthew G. Sliva Manager, Quality Assurance North American Science Associates, Incorporated 2261 Tracy Road Northwood, Ohio 43619
K962649 Re : RSI™ Rapid Indicator for Monitoring Steam Trade Name: Sterilization Regulatory Class: II Product Code: MTC Dated: July 21, 1997 Received: July 22, 1997
Dear Mr. Sliva:
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, Druq, 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, labelinq, and prohibitions aqainst 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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
1
Page 2 - Mr. Sliva
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 begin 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.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Chilatrust
Timothy A. Ulatowski
Diredtor 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): _K962649
Device Name: RSI, Rapid Indicator
Indications for Use:
RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. him
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)