(86 days)
Not Found
No
The device is a simple chemical indicator tape that changes color based on exposure to sterilization processes. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
This device is an indicator tape used to confirm sterilization processes, not to treat a medical condition.
No
The device is a chemical indicator tape used to confirm exposure to sterilization processes, not to diagnose a medical condition or disease.
No
The device is a physical indicator tape made of paper and adhesive, 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 to seal packs and provide visual evidence of exposure to sterilization processes (steam and chemical vapor). This is a process indicator, not a diagnostic test performed on biological samples.
- Device Description: The device is a tape with a chemical indicator that changes color. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or predicting disease
- Determining the state of health
The device is clearly intended for monitoring the sterilization process of medical devices or other items, which falls under the category of sterilization process indicators, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
ProChem Indicator Tape is process chemical indicator tape designed to hold packages together and distinguish processed packages/trays from unprocessed packages/trays.
Raven ProChem Indicator Tape is a process chemical indicator tape intended to seal packs and provide visual evidence that packs have been exposed when subjected to steam sterilization (121°C gravity cycles and 121°C – 134°C pre-vacuum cycles) processes as well as Harvey Chemiclave® chemical vapor sterilization process.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
ProChem Indicator Tape is a saturated crepe paper printed with white indicator lines that turn to dark brown/black upon exposure to saturated steam or Chemiclave® chemical vapor sterilization. It is coated on the back with a dry natural rubber based adhesive for adherence to packs/packages.
The ProChem Indicator Tape consists of a saturated crepe paper printed with white indicator lines that turn to dark brown/black once an autoclave process or Chemiclave® chemical vapor process is completed. The tape is coated on the back with a dry natural rubber based adhesive.
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)
Performance testing was conducted in accordance with ANSI/AAMI/ISO 11140-1:2005 in an AAMI compliant steam resistometer using 3 separate production lots of chemical indicator tapes. The performance of the ProChem Indicator Tape was equivalent to that of the predicate device and meets the requirements of Class 1 indicators as defined in ANSI/AAMI/ISO 11140-1:2005.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
K 080307
510(k) Summary of Safety and Effectiveness
MAY - 1 2008
510(k) Notification ProChem Indicator Tape - Process Indicator
Submitted by:
Contact:
Raven Biological Laboratories 8607 Park Drive Omaha, NE 68127
Wendy Royalty-Hann Quality Assurance/Regulatory Affairs Manager
Or
Robert V. Dwyer, Jr. President
Phone: (402) 593-0781 Fax: (402) 593-0921
Prepared on:
Device:
Trade name: ProChem Indicator Tape, Models CI-STP, CI-STP-EA, CI-STP 12, CI-STP-12EA, CI-STP-24, CI-STP-24EA Common name: Physical/chemical sterilization process indicator
Classification:
Class II
Predicate Device:
Steritec Sterilization Process Indicator Tapes Models Cl 122 and Cl 123, 510(k) #K003002
DEVICE DESCRIPTION
ProChem Indicator Tape is a saturated crepe paper printed with white indicator lines that turn to dark brown/black upon exposure to saturated steam or Chemiclave® chemical vapor sterilization. It is coated on the back with a dry natural rubber based adhesive for adherence to packs/packages.
INTENDED USE
ProChem Indicator Tape is process chemical indicator tape designed to hold packages together and distinguish processed packages/trays from unprocessed packages/trays.
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TECHNOLOGICAL CHARACTERISTICS
The ProChem Indicator Tape consists of a saturated crepe paper printed with white indicator lines that turn to dark brown/black once an autoclave process or Chemiclave® chemical vapor process is completed. The tape is coated on the back with a dry natural rubber based adhesive.
PERFORMANCE TESTING AND SUBSTANTIAL EQUIVALENCE
Performance testing was conducted in accordance with ANSI/AAMI/ISO 11140-1:2005 in an AAMI compliant steam resistometer using 3 separate production lots of chemical indicator tapes. The performance of the ProChem Indicator Tape was equivalent to that of the predicate device and meets the requirements of Class 1 indicators as defined in ANSI/AAMI/ISO 11140-1:2005.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic element resembling a bird or abstract human form, positioned to the right. To the left of the graphic is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2008
Ms. Wendy Royalty-Hann Quality Assurance/ Regulatory Affairs Manager Raven Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
Re: K080307
Trade/Device Name: ProChem Indicator Tape Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: April 9, 2008 Received: April 10, 2008
Dear Ms. Royalty-Hann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Ms. Royalty-Hann
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note 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 Division 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/industry/support/index.html.
Sincerely yours.
Syrtie Y. Michie Omd.
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
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Indications for Use Statement
510(k) Number
Device Name
ProChem Indicator Tape
Indications for
Raven ProChem Indicator Tape is a process chemical indicator tape intended to seal packs and provide visual evidence that packs have been exposed when subjected to steam sterilization (121°C gravity cycles and 121°C – 134°C pre-vacuum cycles) processes as
well as Harvey Chemiclave® chemical vapor sterilization process.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of GDRH, Office of Device Evaluation (ODE)
Shela A. Murphy, MS
(Division Sign-Off)
AND/OR
Division of Anesthesiology. General Hospital Infection Control, Dental Devices
K 080307 510(k) Number:
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