(330 days)
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No
The 510(k) summary describes a chemical sterilization test kit and makes no mention of AI or ML technology.
No
This device is a test kit used to confirm sterilization conditions for a sterilization system, not to treat a medical condition or disease.
No
The device is used to confirm sterilization conditions, not to diagnose a disease or condition in a patient.
No
The device is described as a "Culture Test Kit" and is intended for use with a "liquid chemical sterilization system." This strongly suggests it involves physical components (like culture media, indicators, etc.) and is not solely software. The lack of any mention of software in the description further supports this conclusion.
Based on the provided information, the Raven ProPACT Peracetic Acid Culture Test Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kit is used to "provide independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle." This involves testing a sample (likely from the sterilization process) in vitro (outside of a living organism) to determine the effectiveness of the sterilization.
- Culture Test Kit: The name itself, "Culture Test Kit," implies the use of biological cultures to assess the presence or absence of viable microorganisms, which is a common method in IVD testing for sterilization validation.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this kit isn't directly diagnosing a disease in a patient, it's used to validate a process (sterilization) that is critical for preventing the transmission of disease. This falls under the broader scope of IVD use in ensuring the safety and effectiveness of medical procedures and devices.
N/A
Intended Use / Indications for Use
The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.
Product codes
MRB
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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Ms. Wendy Royalty-Hann Quality Assurance/Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
Re: K031114
Trade/Device Name: Raven ProPACT Peracetic acid Culture Test kit Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: MRB Dated: January 13, 2004 Received: January 14, 2004
Dear Ms. Royalty-Hann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yourse determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale conmistee procted fridge been reclassified in accordance with the provisions of Allendinents, or to dovrees that in to Act (Act) that do not require approval of a premarket the Federal I 000; Drag, Drag, therefore, market the device, subject to the general approval application (1 Mill). The general controls provisions of the Act include controls provisions of the ristration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (FMA), it may oe subject to back adata actuations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
1
Page 2 - Ms. Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements Incall that I DA nas made a deceminations administered by other Federal agencies. of the Act of ally i edelta batales and regirements, including, but not limited to: registration You must comply with an the Hee Process roq 21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 067), acciity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of other (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to organ 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 regulation (21 CFR Part 801), If you desire spooline ad 100 to 100 to 100 m 100 m 100 m me more the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clair Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K031114
Device Name: Raven ProPACT Peracetic Acid Culture Test Kit
Indications For Use: The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marshall D. Zone, Branch Chief
Page 1 of
(Division Sighton) Sign-Off, General Hosp Infection Control, Denta
510(k) Number: K031114