(100 days)
No
The device is a biological indicator challenge pack used for qualification testing of sterilizers. Its function is based on chemical and biological reactions, not AI/ML processing of data. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML devices.
No.
This device is designed for qualification testing of sterilization systems, not for treating diseases or health conditions in patients.
Yes
Explanation: The device is used for "qualification testing" of sterilization systems and indicates "a pass if the media remains orange and non-turbid" or "a failure if the media changes from orange to yellow and/or if the media is turbid." This process determines the state or performance of the sterilization system, which aligns with the definition of a diagnostic device.
No
The device is a physical challenge pack containing a chemical indicator and a biological indicator, requiring incubation and visual inspection for results. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for qualification testing of sterilization systems (Amsco V-PRO sterilizers). It is used to assess the performance of the sterilizer itself, not to diagnose a condition or disease in a patient.
- Device Description: The device contains a chemical indicator and a biological indicator. These are used to monitor the effectiveness of the sterilization process by checking if the sterilant has reached and killed the biological indicators. This is a quality control measure for the sterilization equipment.
- No Patient Interaction: The device is placed in the sterilizer chamber and the indicators are retrieved and processed. There is no interaction with a patient or patient sample.
- No Diagnostic Purpose: The results of the test (color change of the chemical indicator, growth or no growth of the biological indicator) indicate whether the sterilization cycle was successful, not a medical condition of a patient.
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 Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618) and Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1 and V-PRO 1 Plus Sterilizers.
The Verify Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes is intended for qualification testing of the following cycles.
| Sterilization Cycle | Sterilant/
Injection
(g) | #
Injections | Sterilant
Exposure Time
(min) |
|---|---|---|---|
| Amsco V-PRO 1 Cycle | 2.1 | 4 | 32 |
| Amsco V-PRO 1 Plus Lumen Cycle | 2.1 | 4 | |
| Amsco V-PRO 1 Plus Non Lumen Cycle | 2.1 | 4 | 12 |
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is used by healthcare providers for qualification testing of the Amsco V-PRO1M 1 Low Temperature Sterilization System and the Amsco® V-PROTM 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen Cycles) following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The user places the Verify Biological Indicator Challenge Pack into the Amsco V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the Verify V-PRO Chemical Indicator (CI) and the Verify V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is accessed for a passing color change immediately and 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 media 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 ℃ for 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure if the media changes from orange 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 |
|---|---|
| Resistance Characterization | Pass Challenge Pack resistance is equivalent or greater than the biological model used to validate the Non Lumen Cycle of the V-PRO 1 Plus Low Temperature Sterilization System. |
| Simulated Use Evaluation | Pass The Verify V-PRO CI and Verify V24 SCBI yielded passing results when evaluated under worst case simulated use conditions. |
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 For
Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes
DEC 30 "300
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459
Contact:
Robert F. Sullivan. Senior Director, FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198
Submission Date:
December 28, 2009
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
December 28, 2009
1
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Verify" Biological Indicator Challenge Pack for Vaporized MH2O2 Sterilization Processes
1. Device Name
| Trade Name: | Verify® Biological Indicator Challenge Pack for
Vaporized VH2O2 Sterilization Processes | | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Common/usual Name: | Biological Indicator (BI) Process Challenge Device | | |
| Classification Name: | Indicator, Biological Sterilization Process
(21 CFR 880.2800, FRC) | | |
2. Predicate Device
Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes, K073618, January 7, 2009. Cleared as Verify Sirius Biological Indicator Challenge Pack.
3. Description of Device
The Verify Biological Indicator Challenge Pack for Vaporized |VH2O2 Sterilization Processes is used by healthcare providers for qualification testing of the Amsco V-PRO1M 1 Low Temperature Sterilization System and the Amsco® V-PROTM 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen Cycles) following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The user places the Verify Biological Indicator Challenge Pack into the Amsco V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the Verify V-PRO Chemical Indicator (CI) and the Verify V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is accessed for a passing color change immediately and 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 media 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 ℃ for 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure if the media changes from orange to yellow and/or if the media is turbid.
2
Intended Use 4.
The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PROM 1 (cleared under K073618) and Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.
The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1 and V-PRO 1 Plus Sterilizers.
The Verify Biological Indicator Challenge Pack for Vaporized | VH2O2 Sterilization Processes is intended for qualification testing of the following cycles:
| Sterilization Cycle | Sterilant/
Injection
(g) | #
Injections | Sterilant
Exposure Time
(min) |
|--------------------------------------------------------|--------------------------------|-----------------|-------------------------------------|
| Amsco V-PRO 1 Cycle,
Amsco V-PRO 1 Plus Lumen Cycle | 2.1 | 4 | 32 |
| Amsco V-PRO 1 Plus Non Lumen Cycle | 2.1 | 4 | 12 |
ર. Description of Safety and Substantial Equivalence
No substantial changes were made to the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes design, cleared in K073618, for qualification in the V-PRO 1 Plus Sterilizer Non Lumen Cycle. The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes does not raise any new issues of safety and efficacy.
Summary of Nonclinical Tests:
| Test | Result |
|---|---|
| Resistance | |
| Characterization | Pass |
| Challenge Pack resistance is equivalent or greater than the biological | |
| model used to validate the Non Lumen Cycle of the V-PRO 1 Plus | |
| Low Temperature Sterilization System. | |
| Simulated Use | |
| Evaluation | Pass |
| The Verify V-PRO CI and Verify V24 SCBI yielded passing results | |
| when evaluated under worst case simulated use conditions. |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. Robert F. Sullivan Senior Director Steris Corporation 5960 Heisley Road Mentor, Ohio 44060
DEC 3 0 2009
Re: K092906
Trade/Device Name: Verify® Biological Indicator challenge Pack for Vaporized VH2O2 Sterilization Processes Regulation Number: 21CFR 880.2800
Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: December 16, 2009 Received: December 17, 2009
Dear Mr. Sullivan:
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.
4
Page 2- Mr. Sullivan
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
hh fo.
Anthony D. Watson, B.S., M.S., M.B.A. 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): K092906
Device Name: Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes
Indications For Use:
The Verify Biological Indicator Challenge Pack for Vaporized |VH2O2 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618) and Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO 1 and V-PRO 1 Plus Sterilizers.
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 In Vitro Diagnostic Devices (OIVD)
gnostic Devices (OVD)
Elizabet F. Claverie-Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(k)
510(k) Number: K092906
Page 1 of 2
A-2
6
Indications for Use (continued)
The Verify Biological Indicator Challenge Pack for Vaporized | H2O2 Sterilization Processes is intended for qualification testing of the following cycles.
| Sterilization Cycle | Sterilant/
Injection
(g) | #
Injections | Sterilant
Exposure Time
(min) |
|------------------------------------|--------------------------------|-----------------|-------------------------------------|
| Amsco V-PRO 1 Cycle | 2.1 | 4 | 32 |
| Amsco V-PRO 1 Plus Lumen Cycle | 2.1 | 4 | |
| Amsco V-PRO 1 Plus Non Lumen Cycle | 2.1 | 4 | 12 |
Page 2 of 2