(302 days)
Not Found
No
The device description and intended use describe a chemical indicator for steam sterilization, which does not involve AI or ML technology. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no mention of image processing or data analysis that would suggest the use of these technologies.
No
The device is described as an air removal indicator and a test pack for assessing sterilizer performance, not a device used for treating a disease or condition in a patient.
No
This device is an air removal indicator used to assess the performance of a sterilizer, not to diagnose a medical condition in a patient.
No
The device description clearly indicates it is a physical test pack (Bowie & Dick type test) used in a sterilizer, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assess the performance of a sterilizer, specifically its ability to remove air and allow steam penetration. This is a quality control measure for a medical device (the sterilizer), not a test performed on a biological sample from a patient to diagnose a condition or provide information about their health.
- Device Description: The description clearly states it's a "Bowie & Dick type test for prevacuum steam sterilizers" and a "class 2 indicator" according to sterilization standards (AAMI/ANSI/ISO 11140-1 and 11140-5). These standards are related to sterilization processes, not in vitro diagnostics.
- Lack of Biological Sample: There is no mention of the device being used with any biological sample (blood, urine, tissue, etc.) from a patient. IVDs are designed to analyze such samples.
- Purpose: The purpose is to verify the functionality of a piece of equipment used in healthcare, not to provide diagnostic information about a patient.
In summary, the Once-A-Day® Vertos™ Test Pack is a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.
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
health care provider
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)
Not Found
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
510(k) Summary
Submitted by Propper Manufacturing Company, Inc. 36-04 Skillman Avenue. Address: Long Island City, New York 11101 (800) 832-4300 or (718) 392-6650 Telephone: JUL - 8 2009 (718) 482-8909 Facsimile: Marian M. Schuman, Executive V.P. / General Counsel Contact Name:
Date Submitted: September 8, 2008
Once-A-Day® Vertos™ Test Pack Trade Name: Chemical Sterilization Process Indicator (Bowie & Dick Test Pack) Common Name:
Product Code / Regulation: JOJ / 21 C.F.R. 880.2800
Description: The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.
Intended Use: The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick. Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An inefficient air removal stage, an air leak, or non-condensable gases in the steam supply are some of the conditions that could cause an incomplete change in the air removal indicator, e.g., uneven color change. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.
Substantial Equivalence:
The Once-A-Day® Vertos™ Test Pack is similar in intended use and operating characteristics to Propper's once-a-day® Bowie and Dick Test Pack, K961156. Substantial equivalence to the predicate
1
device was evaluated according to the FDA guidance document "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol with three abstract shapes, possibly representing human figures or elements of health and well-being. The text is in a sans-serif font and is arranged to follow the curve of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marian M. Schuman Executive Vice President/General Counsel Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101
JUL - 8 2009
Re: K082620
Trade/Device Name: Once-A-Day® Vertos™ Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 12, 2009 Received: June 16, 2009
Dear Ms, Schuman:
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 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. Schuman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Anthony D. Watson (or
Susan Runner, D.D.S., M.A. Acting 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
510(k) Number (if known): K082620
Device Name: Once-A-Day® Vertos™ Test Pack
Intended Use:
The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and por ous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.
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)
Shule A. Murphy, MD
(Division Sign-Off)
Page I of I
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082620
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