(96 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to a sterilization process, which is a purely chemical reaction and does not involve AI/ML.
No
This device is a chemical indicator used to determine if an object has been exposed to a sterilization process, not to treat a condition or disease.
No
This device is a chemical indicator used to verify exposure to a sterilization process, not to diagnose a medical condition in a patient. It distinguishes between processed and unprocessed units.
No
The device is a physical chemical indicator that changes color based on exposure to a sterilization process, not a software program.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vaporized hydrogen peroxide sterilization process indicator." Its purpose is to indicate whether a sterilization process has occurred, not to diagnose any condition or analyze a sample from the human body.
- Device Description: The description details a chemical indicator that changes color based on exposure to a sterilization process. This is a quality control tool for sterilization, not a diagnostic test.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
- Regulatory Classification: The device is described as a "Class 1 vaporized hydrogen peroxide sterilization process indicator" in accordance with ISO 11140-1:2005. This classification is for sterilization indicators, not IVD devices.
In summary, the Verify® V-PRO Chemical Indicator is a device used to monitor the effectiveness of a sterilization process, which is a completely different function from an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Verify® V-PRO Chemical Indicator (Version 1) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2) are Class 1 vaporized hydrogen peroxide sterilization process indicators. They are designed to distinguish between processed and unprocessed units when placed within (Version 1) or affixed to (Version 2) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process. This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization system at 50 °C using Vaprox™ HC Sterilant.
Product codes
JOJ
Device Description
The Verify® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to an Amsco V-PRO 1 Low Temperature Sterilizer cycle. When exposed, the indicator exhibits a visible color change from magenta to yellow.
The Verify® V-PRO Chemical Indicator is provided as two formats:
- Version 1: Verify® V-PRO Chemical Indicator .
- Version 2: Verify® V-PRO Chemical Indicator Adhesive Label .
The Version 1: Verify® V-PRO Chemical Indicator is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to an inert polymeric substrate; the indicator spot is laminated with a transparent laminate.
The Version 2: Verify® V-PRO Chemical Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.
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 to verify that the proposed Verify® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI ISO 11140-1:2005. Additional testing was completed to simulate typical in-use applications and testing was also performed to investigate the effects of exposure to UV, visible light and aggressive chemicals to the performance of the Verify® V-PRO Chemical Indicator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K072510 STERIS®
510(k) Summary For Verify® V-PRO Chemical Indicator -Versions 1 and 2-
DEC 1 1 2007
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Jack Scoville. Fellow Regulatory Affairs Telephone: (440) 392-7330 Fax No: (440) 357-9198
September 05, 2007 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
1. Device Name
| Trade Name: | Verify® V-PRO Chemical Indicator. |
|---|---|
| Models: | Version 1: Verify® V-PRO Chemical Indicator. |
| Version 2: Verify® V-PRO Chemical Indicator Adhesive Label. | |
| Common Name: | Chemical Indicator. |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR |
| 880.2800 (b), Product Code JOJ). |
2. Predicate Device
Chemical Indicator Component of the STERRAD® CycleSure™ Biological Indicator (K994055)
3. Device Description
The Verify® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to an Amsco V-PRO 1 Low Temperature Sterilizer cycle. When exposed, the indicator exhibits a visible color change from magenta to yellow.
The Verify® V-PRO Chemical Indicator is provided as two formats:
- Version 1: Verify® V-PRO Chemical Indicator .
- Version 2: Verify® V-PRO Chemical Indicator Adhesive Label .
The Version 1: Verify® V-PRO Chemical Indicator is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to an inert polymeric substrate; the indicator spot is laminated with a transparent laminate.
The Version 2: Verify® V-PRO Chemical Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.
4. Intended Use:
The Verify® V-PRO Chemical Indicator (Version 1) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2) are Class 1 vaporized hydrogen peroxide sterilization process indicators. They are designed to distinguish between
2
processed and unprocessed units when placed within (Version 1) or affixed to (Version 2) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process. This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization system at 50°C using Vaprox™ HC Sterilant.
Description of Safety and Substantial Equivalence 5.
The proposed and predicate devices are single use process indicators for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The differences between the proposed Verify® V-PRO Chemical Indicator and the predicate device are limited to differences in design, material, and parameters of the sterilization cycles these indicators are designed to monitor. These differences do not raise any new issues of safety and efficacy.
Performance Testing 6.
Performance testing was conducted to verify that the proposed Verify® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSVAAMI ISO 11140-1:2005. Additional testing was completed to simulate typical in-use applications and testing was also performed to investigate the effects of exposure to UV, visible light and aggressive chemicals to the performance of the Verify® V-PRO Chemical Indicator.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, arranged in a cascading manner.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2007
Mr. Jack Scoville Fellow, Regulatory Affairs STERIS. Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K072510
Trade/Device Name: Verify® V-PRO Chemical Indicator (Versions 1 and 2) Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 20, 2007 Received: November 21, 2007
Dear Mr. Scoville:
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.
4
Page 2 - Mr. Scoville
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,
Judite y. Michau Cais
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
5
Indications for Use
510(k) Number (if known): K072510
Device Name: Verify® V-PRO Chemical Indicator (Versions 1 and 2).
Indications For Use:
The Verify® V-PRO Chemical Indicator (Version 1) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2) are Class 1 vaporized hydrogen peroxide sterilization process indicators. They are designed to distinguish between processed and unprocessed units when placed within (Version 1) or affixed to (Version 2) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to vellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process. This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization system at 50 °C using Vaprox™ HC Sterilant.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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 R. Murphey, MD
K 072510