(191 days)
Not Found
No
The device description and performance studies focus on a biological indicator that changes color based on sterilization effectiveness, with no mention of AI or ML.
No.
This device is designed to monitor the efficacy of sterilization processes for medical devices, rather than directly diagnosing, treating, or preventing disease in patients.
No
This device is a biological indicator used to monitor the effectiveness of a sterilization process, not to diagnose a medical condition in a patient.
No
The device description clearly outlines a physical biological indicator (SCBI) that is placed in a sterilizer, activated, and incubated. It involves physical components and chemical reactions, not solely 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 monitor a sterilization process for medical devices. It's assessing the effectiveness of the sterilization equipment, not diagnosing a condition or providing information about a patient's health.
- Device Description: The device description clearly outlines its function as a biological indicator to verify the killing of microorganisms during sterilization. The color change indicates whether the sterilization process was successful in inactivating the biological indicator, not a diagnostic result related to a patient.
- Lack of Patient Interaction: The device is used with medical devices being sterilized, not directly with a patient or a patient sample.
- No Diagnostic Purpose: The outcome (color change) indicates the efficacy of the sterilization process, not a medical diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PROTM 1 Low Temperature Sterilization System.
Product codes
FRC
Device Description
The Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2 Sterilization Processes is used by healthcare providers to monitor the Amsco V-PROTM 1 Low Temperature Sterilizer. It is designed to accompany medical devices placed in the sterilizer.
The user places the packaged Verify SCBI for VH2O2 into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55 - 60 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure of sterilization if the media changes from purple to yellow and/or if the media is turbid.
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
healthcare providers
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)
Summary of Nonclinical Tests:
| Test | Result |
|---|---|
| Viable Population Assay | Pass |
| Within Specification | |
| Resistance | Pass |
| Within Specification | |
| Growth Inhibition by Carrier and | |
| Pack Materials | Pass |
| No Inhibition | |
| Holding Time Assessment | Pass |
| 72 Hour Hold Time Established | |
| Effect of Media Additives | Pass |
| No Effect of Additives | |
| Incubation Time Validation | Pass |
| 4 day Incubation | |
| Effect of Sterilization Process on | |
| Recovery Media | Pass |
| No Affect | |
| Stability of Biological Read | Pass |
| Stable for 7 Days | |
| Controls | Pass |
| Viability and Media Sterility Demonstrated | |
| Media Volume | Pass |
| Adequate Volume for Incubation Conditions | |
| Throughput Indicator Color | |
| Change | Pass |
| Color Change Demonstrated under Worst | |
| Case Exposure Conditions | |
| Stability Evaluation | Pass |
| On Going Stability Evaluation | |
| Worst Case Location In V-PRO | |
| Sterilization Chamber | Pass |
| Middle of Top Shelf is the Worst Case | |
| Location |
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
Image /page/0/Picture/12 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the "S". Below the word "STERIS" is a graphic of several horizontal, wavy lines stacked on top of each other.
510(k) Summary For
MAY 2 8 2008
Verify® Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459
Contact:
John R. Scoville. Fellow Regulatory Affairs Telephone: (440) 392-7330 Fax No: (440) 357-9198
May 16, 2008 Submission Date:
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
1
1. Device Name
| Trade Name: | Verify® Self-Contained Biological Indicator for
Vaporized VH2O2 Sterilization Processes |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator (BI) |
| Classification Name: | Indicator, Biological Sterilization Process
(21 CFR 880.2800, FRC). |
2. Predicate Device
STERRAD® Cyclesure™ Biological Indicator, K994055, Feb 13, 2002 STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 STERRAD® Cyclesure Biological Indicator, K071014 May 24, 2007
3. Description of Device
The Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2 Sterilization Processes is used by healthcare providers to monitor the Amsco V-PROTM 1 Low Temperature Sterilizer. It is designed to accompany medical devices placed in the sterilizer.
The user places the packaged Verify SCBI for VH2O2 into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55 - 60 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure of sterilization if the media changes from purple to yellow and/or if the media is turbid.
4. Intended Use
The Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PRO 1 Low Temperature Sterilization System.
2
Description of Safety and Substantial Equivalence 5.
The Verify SCBI for VH2O2 has the same or similar intended use, accessories, viable population, resistance characteristics, culture conditions, primary and secondary packaging, and storage conditions as compared to its predicate device the STERRAD CycleSure Biological Indicator.
Summary of Nonclinical Tests:
| Test | Result |
|---|---|
| Viable Population Assay | Pass |
| Within Specification | |
| Resistance | Pass |
| Within Specification | |
| Growth Inhibition by Carrier and | |
| Pack Materials | Pass |
| No Inhibition | |
| Holding Time Assessment | Pass |
| 72 Hour Hold Time Established | |
| Effect of Media Additives | Pass |
| No Effect of Additives | |
| Incubation Time Validation | Pass |
| 4 day Incubation | |
| Effect of Sterilization Process on | |
| Recovery Media | Pass |
| No Affect | |
| Stability of Biological Read | Pass |
| Stable for 7 Days | |
| Controls | Pass |
| Viability and Media Sterility Demonstrated | |
| Media Volume | Pass |
| Adequate Volume for Incubation Conditions | |
| Throughput Indicator Color | |
| Change | Pass |
| Color Change Demonstrated under Worst | |
| Case Exposure Conditions | |
| Stability Evaluation | Pass |
| On Going Stability Evaluation | |
| Worst Case Location In V-PRO | |
| Sterilization Chamber | Pass |
| Middle of Top Shelf is the Worst Case | |
| Location |
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black, set against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jack Scoville Fellow, Regulatory Affairs STERIS, Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
MAY 2 8 2008
Re: K073244
:
Trade/Device Name: Verify Self-Contained Biological Indicator for Vaporized VH202 Sterilization Processes Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: April 30, 2008 Received: May 1, 2008
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 clectronic 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,
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
K073244 510(k) Number (if known):
Device Name:
Verify Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes
Indications For Use:
The Verify Self-Contained Biological Indicator for Vaporized | VH2O2 Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco V-PROTM 1 Low Temperature Sterilization System.
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 A. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073244
Page 1 of 1
CONFIDENTIAL
May 16, 2008
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