(205 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology commonly associated with AI/ML in medical devices. The device description is also not available, which would be a key place to find such information.
No
The device is described as a "Process Challenge Device" used to monitor sterilization cycles, not to treat a medical condition or ailment.
No
Explanation: The device is a sterilization process challenge device used to monitor the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient.
No
The device is described as a "Process Challenge Device" and is intended to be used "in conjunction with RSI Rapid Indicators". This strongly suggests a physical device (the Process Challenge Device) and physical indicators, not a software-only solution. The lack of any mention of software in the provided text further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to monitor the effectiveness of steam sterilization cycles. This is a process control function, not a diagnostic test performed on a biological sample to diagnose a disease or condition.
- Lack of Biological Sample: IVDs are designed to test biological samples (like blood, urine, tissue, etc.). The description doesn't mention any interaction with biological samples.
- Focus on Sterilization Process: The device is used "in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization," further emphasizing its role in monitoring a sterilization process, not a patient's health status.
Therefore, based on the provided text, the RSI Process Challenge Device falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.
Product codes
JOJ
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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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§ 880.2800 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 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" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract, curved shapes that resemble human figures or birds in flight. The shapes are stacked vertically and slightly offset from each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1999
Mr. Matthew G. Sliva Manager, Quality Assurance North American Science Associates, Incorporated 2261 Tracy Road Northwood, Ohio 43619-1397
Re : ку83451 Trade Name: RSI® Process Challenge Device for Monitoring Steam Sterilization Process Regulatory Class: II Product Code: JOJ Dated: February 9, 1999 Received: February 11, 1999
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, 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 regulation may result in regulatory action. Won end Son, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your device in premarket notification submission does 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 regulations.
1
Page 2 - Mr. Sliva
This letter will allow you to begin marketing your device as This letter will allow your results notification. The FDA described in your 510(K) prematic norresonevice to a legally
finding of substantial equivalence of your sizes in for your marketed predicate device results in a classification for your marketed predicate device results in a crabbillability. The market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 Crk Parc bor anase contact the Office of
vitro diagnostic devices), please contact the for questi vitro diagnostic devices), prease consuly, for questions on Compliance at (3017 394-4022. Addresses 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 encitied, "Missianisms ») . Other general
premarket notification" (21 CFR 807.97). "Other general information on your responsibilities under the Act may be information on your responsibilities ander one order assistance obtained from the Division of Smart Manara (301) 443-6597 or at
at its toll-free number (800) 638-2041 or (300) . at its toll-free number (800) 638-2041 02 1902) 180 11.
its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image is a logo for NAMSA, which stands for North American Science Associates. The logo is in black and white and features the company's name in a bold, sans-serif font. Below the name is the tagline "World Leader in Testing Services for the Medical Device Industry.". The TM symbol is located to the right of the last letter of the company name.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: RSI® Process Challenge Device for Steam Sterilization (132°C/134°C Vacuum Assisted)
Indications for Use:
RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clum S. Lin
(Division Sign-Off)
Division of Dental, Infection Control. and General Hospit 510(k) Number
Prescription Use 99~ (Per 21 CFR 801.109)
OR
Over-The-Counter Use 99~ X
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