(189 days)
Not Found
No
The device description and performance studies focus on a chemical reaction and color change, with no mention of AI or ML.
No
The device is a chemical indicator for monitoring the efficacy of steam sterilization cycles, not a device used for treating a disease or condition.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition in a patient. The ProChem EXT is an integrating chemical indicator used to monitor the efficacy of steam sterilization cycles for equipment, not to diagnose a patient.
No
The device description clearly states it is a "16 mm x 97 mm strip" made of "paper" with "chemical indicator ink," indicating a physical, hardware-based device.
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 the efficacy of steam sterilization cycles. This is a process control for sterilizing medical devices or other items, not a test performed on a biological sample from a human or animal to diagnose a condition, monitor a treatment, or screen for a disease.
- Device Description: The device is a chemical indicator that changes color based on exposure to steam sterilization parameters. It does not interact with biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, diagnosing conditions, or providing information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Raven ProChem EXT chemical integrator is an integrating chemical indicator intended for monitoring the efficacy of steam sterilization cycles, gravity displacement at 121°C, 20 minutes and prevacuum cycles: 121°C, 20 minutes; 132°C, 8.5 minutes; 134°C, 7.5 minutes and 135°C, 7 minutes.
Product codes
JOJ
Device Description
ProChem EXT is a 16 mm x 97 mm strip with a 2 mm x 77 mm chemical indicator ink strip printed below a reference triangle exhibiting the endpoint color.
The ProChem EXT consists of a paper strip printed with a chemical indicator ink. A chemical reaction occurs changing the ink color from green to black when exposed to the critical parameters of a steam sterilization process.
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
Performance testing was conducted in accordance with ANSI/AAMI ST 60 - 1996 in an AAMI compliant steam resistometer using 3 separate production lots of chemical integrators. The performance of the ProChem EXT was equivalent to that of the predicate device and meets the requirements of Class 5 indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60:1996.
Key Metrics
Not Found
Predicate Device(s)
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
510(k) Summary of Safety and Effectiveness
510(k) Notification ProChem EXT - Chemical Integrator
| Submitted by: | Raven Biological Laboratories
8607 Park Drive
Omaha, NE 68127 | MAR 15 200 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact: | Wendy Royalty-Hann
Quality Assurance/Regulatory Affairs Manager
Or
Robert V. Dwyer, Jr.
President
Phone: (402) 593-0781
Fax: (402) 593-0921 | |
| Prepared on: | May 3, 2006 | |
| Device: | Trade name: ProChem EXT Chemical Integrator
Common name: Physical/chemical sterilization
process indicator | |
| Classification: | Class II | |
| Predicate Device: | TST Control Integrator for Steam Autoclave
510(k) #K965154, K002937 & K902958 | |
DEVICE DESCRIPTION
ProChem EXT is a 16 mm x 97 mm strip with a 2 mm x 77 mm chemical indicator ink strip printed below a reference triangle exhibiting the endpoint color.
INTENDED USE
ProChem EXT is an integrating indicator that changes color from green to black when exposed to the following conditions:
- 121ºC, 20 min., steam sterilizers �
- 132ºC, 8.5 min., steam sterilizers �
- 134°C, 7.5 min., steam sterilizers .
- 135°C, 7 min., steam sterilizers ●
1
TECHNOLOGICAL CHARACTERISTICS
The ProChem EXT consists of a paper strip printed with a chemical indicator ink. A chemical reaction occurs changing the ink color from green to black when exposed to the critical parameters of a steam sterilization process.
PERFORMANCE TESTING AND SUBSTANTIAL EQUIVALENCE
Performance testing was conducted in accordance with ANSI/AAMI ST 60 - 1996 in an AAMI compliant steam resistometer using 3 separate production lots of chemical integrators. The performance of the ProChem EXT was equivalent to that of the predicate device and meets the requirements of Class 5 indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60:1996.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2007
Ms. Wendy Royalty-Hann Quality Assurance/Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
Re: K062651
Trade/Device Name: ProChem EXT Chemical Integrator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process Indicator Regulatory Class: II Product Code: JOJ Dated: February 26, 2007 Received: February 27, 2007
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.
3
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Cuvls
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
4
Indications for Use Statement
510(k) Number K062651
ProChem EXT Chemical Integrator Device Name
- Raven ProChem EXT chemical integrator is an integrating Indications for chemical indicator intended for monitoring the efficacy of steam sterilization cycles, gravity displacement at 121°C, 20 minutes and prevacuum cycles: 121℃, 20 minutes; 132℃, 8.5 minutes; 134℃, 7.5 minutes and 135℃, 7 minutes.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula t Murphy, 10