(150 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators for sterilization, with no mention of AI or ML technologies.
No
This device is a biological indicator used to monitor the effectiveness of sterilization systems, not to directly treat a patient or disease.
No
The device is a biological indicator used to monitor the effectiveness of sterilization cycles and for qualification testing of sterilization systems. It assesses the performance of a sterilizing process, rather than diagnosing a medical condition in a patient.
No
The device description clearly indicates a physical biological indicator (SCBI) and a challenge pack, which are hardware components used in sterilization monitoring.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring and qualification testing of sterilization cycles in medical device sterilizers. It is used to assess the effectiveness of the sterilization process, not to diagnose a condition or disease in a patient.
- Device Description: The description details how the biological indicator works by detecting the survival of bacterial spores after a sterilization cycle. A color change in the growth media indicates whether the sterilization was successful. This is a quality control measure for the sterilization equipment, not a diagnostic test on a biological sample from a patient.
- Lack of IVD Characteristics: The description does not mention analyzing human biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, treatment, or prevention of disease.
Therefore, the VERIFY® V24 Self-Contained Biological Indicator and Challenge Pack are devices used in the sterilization process of medical equipment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:
- · Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer
The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.
Product codes
FRC
Device Description
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer. The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator 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 VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media. The activated SCBI is incubated at 55-60°C for >= 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
The VERIFY V24 Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, 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 V24 Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed 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 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°C for >= 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization 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 facilities
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)
VERIFY V24 Self-Contained Biological Indicator:
Performance testing to demonstrate substantial equivalence to the predicate has been completed.
- 1/4, 1/2 & 3/4 Cycle Performance: The performance of the VERIFY V24 Self-Contained Biological Indicator in 1/4, 1/2 or 3/4 cycles was evaluated. Partial positive results were obtained in the 1/4 and 1/2 cycles and all negative results were obtained in the 3/4 cycle evaluations. (PASS)
- Growth Inhibition: Uninoculated VERIFY V24 Self-Contained Biological Indicators were processed in a Fast Non Lumen Cycle and inoculated with low numbers (= 97% correspondence between the 24-hour results and the conventional incubation time of 7 days. (PASS)
- Viable spore population: The viable spore population found in the VERIFY V24 Self-Contained Biological indicator must fall between 2.0 – 3.4 x 10^6 spore/SCBI. (PASS)
- D-value: D-value testing was performed per the FDA guidance on BI submissions. For the VERIFY V24 Self-Contained Biological Indicator, the D-value must be 4-8 seconds. (PASS)
- Survival Time: Survival time testing was performed per the FDA guidance on BI submissions. For the VERIFY V24 Self-Contained Biological Indicator, the survival time must be 4-30 seconds. (PASS)
- Kill Time: Kill time testing was performed per the FDA guidance on BI submissions. For the VERIFY V24 Self-Contained Biological Indicator, the kill time must be
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2018
STERIS Corporation Ms. Jennifer Nalenka Senior Regulatory Affairs Specialist 5960 Heisley Rd. Mentor, Ohio 44060
Re: K172748
Trade/Device Name: VERIFY @ V24 Self-Contained Biological Indicator VERIFY® V24 Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Biological Sterilization Process Regulatory Class: Class II Product Code: FRC Dated: January 09, 2018 Received: January 10, 2018
Dear Ms. Jennifer Nalepka :
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172748
Device Name
VERIFY V24 Self-Contained Biological Indicator
Indications for Use (Describe)
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:
- · Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
[X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
K172748
Device Name VERIFY V24 Challenge Pack
Indications for Use (Describe)
The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
[X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary For VERIFY® V24 Self-Contained Biological Indicator
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist
Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com
Submission Date: January 9, 2018
Premarket Notification Number: K172748
5
1. Device Name
| Trade Name: | VERIFY® V24 Self-Contained Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR 880.2800, FRC) |
2. Predicate Device
VERIFY® V24 Self-Contained Biological Indicator, K140499
3. Description of Device
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.
The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator 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 VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media.
The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.
6
4. Intended Use/ Indications for Use
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:
- · Non Lumen, Flexible, Lumen and Fast Non Lumen of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer
ട. Summary of Technical Characteristics
A comparison of technical characteristics versus the predicate is summarized in Table 5-1.
| Table 5-1. VERIFY V24 Self-Contained Biological Indicator Physical Description and |
|---|
| Technological Properties vs the Predicate Device |
| Feature | VERIFY V24 Self-
Contained Biological
Indicator
(Proposed, K172748) | VERIFY V24 Self-
Contained Biological
Indicator
(Predicate, K140499) | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY V24 Self-
Contained Biological
Indicator is intended for
routine monitoring of the
following sterilizers and
cycles:
• Non Lumen, Flexible,
Lumen and Fast Non
Lumen Cycles of the V-
PRO 1, 1 Plus, maX, 60
and maX 2 Sterilizers
• Standard Cycle of the
STERRAD 100S
Sterilizer
• Standard and Advanced
Cycles of the
STERRAD NX
Sterilizer
• Express, Flex Scope and
Standard Cycles of the
STERRAD 100 NX
Sterilizer | The VERIFY V24 Self-
Contained Biological
Indicator is intended for
routine monitoring of the
following sterilizers and
cycles:
• Lumen, Non Lumen and
Flexible Cycles of the
V-PRO 1, 1 Plus, maX
and 60 Sterilizers
• Standard Cycle of the
STERRAD 100S
Sterilizer
• Standard and Advanced
Cycles of the
STERRAD NX
Sterilizer
• Express, Flex Scope and
Standard Cycles of the
STERRAD 100 NX
Sterilizer. | The proposed and predicate
devices are identical. The
Fast Non Lumen Cycle is a
new cycle in the V-PRO
maX 2 Low Temperature
Sterilizer, which has been
submitted in a separate
premarket notification. |
| Indicator
organism | Geobacillus
stearothermophilus | Geobacillus
stearothermophilus | Same |
| Mechanism of
action | Visual detection of growth
based on media color
change in the presence of | Visual detection of growth
based on media color
change in the presence of | Same. Resistance testing
and simulated use testing
demonstrate appropriate |
7
| Feature | VERIFY V24 Self-
Contained Biological
Indicator
(Proposed, K172748) | VERIFY V24 Self-
Contained Biological
Indicator
(Predicate, K140499) | Comparison |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | surviving indicator
organisms. | surviving indicator
organisms. | monitoring of indicated
sterilization cycles. |
| Accessories | VERIFY Incubator and
VERIFY SCBI HP
Activator (optional) | VERIFY Incubator and
VERIFY SCBI HP
Activator (optional) | Same |
| Viable spore
population | 2.0 – 3.4 x 106 spore/BI | 2.0 – 3.4 x 106 spore/BI | Same. Both contain greater
than 106 spores/BI. |
| Resistance
characteristics | Resistance @ 2.7 mg/L
H2O2:
• D-value 4.0 – 8.0 sec
• Survival Time 4 - 30 sec
• Kill Time ≤ 16 min | Resistance @ 2.7 mg/L
H2O2:
• D-value 4.0 – 8.0 sec
• Survival Time 4 - 30 sec
• Kill Time ≤ 16 min | Same. Simulated use testing
verifies suitability for use in
claimed cycles. |
| Culture
Conditions | 55- 60°C, media included
in the VERIFY V24 Self-
Contained Biological
Indicator, 24 hour
incubation time. | 55-60°C, media included
in the VERIFY V24 Self-
Contained Biological
Indicator, 24 hour
incubation time. | Same. RIT Testing and ISO
11138-1 media testing
verifies performance |
| Primary
Packaging | Direct inoculum on plastic
vial, glass ampoule with
recovery media. | Direct inoculum on plastic
vial, glass ampule with
recovery media. | Same |
| Process
indicator | VERIFY V-PRO
Chemical Indicator
(K140515); magenta to
yellow color change. | VERIFY V-PRO
Chemical Indicator
(K140515); magenta to
yellow color change. | Same |
| Shelf-life | 9 months: An 18-month
shelf life is established for
the SCBI however the
throughput process
indicator (K140515) has a
shelf life of 9 months so
the maximum labeled
shelf life for the SCBI is 9
months | 9 months: An 18-month
shelf life is established for
the SCBI however the
throughput process
indicator (K140515) has a
shelf life of 9 months so
the maximum labeled
shelf life for the SCBI is 9
months | Same |
Summary of Nonclinical Tests 6.
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| 1/4, 1/2 & 3/4 Cycle | ||
| Performance | The performance of the VERIFY V24 Self- | |
| Contained Biological Indicator in 1/4, 1/2 or 3/4 cycles | ||
| was evaluated. Partial positive results were obtained in | ||
| the 1/4 and 1/2 cycles and all negative results were | ||
| obtained in the 3/4 cycle evaluations. | PASS | |
| Growth Inhibition | Uninoculated VERIFY V24 Self-Contained Biological | |
| Indicators were processed in a Fast Non Lumen Cycle | PASS |
Table 5-2. Summary of Non-clinical Testing
8
| Test | Acceptance Criteria | Conclusion | ||
|---|---|---|---|---|
| and inoculated with low numbers (not | ||||
| intended for routine | ||||
| monitoring of V-PRO | ||||
| Sterilizers. It has been | ||||
| tested and validated solely | ||||
| for use in Sterilizer | ||||
| qualification testing. | The challenge pack is not | |||
| intended for routine | ||||
| monitoring of V-PRO | ||||
| Sterilizers. It has been | ||||
| tested and validated solely | ||||
| for use in Sterilizer | ||||
| qualification testing. |
12
| Feature | VERIFY V24 Challenge
Pack
(proposed K172748) | VERIFY V24 Challenge
Pack
Predicate (K140499) | Comparison |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Biological
Indicator | VERIFY V24 Self-
Contained Biological
Indicator (subject of this
submission) | VERIFY V24 Self-
Contained Biological
Indicator | Same |
| Class 1
Chemical
Indicator | The VERIFY HPU
Chemical Indicator
(subject of a separate
Premarket Notification) is
placed inside the pouch.
A throughput process
indicator is also located on
the VERIFY V24 SCBI
label. | The VERIFY HPU
Chemical Indicator is
placed inside the pouch.
A throughput process
indicator is also located on
the VERIFY V24 SCBI
label. | Same |
| Means to
distinguish
processed
from
unprocessed | Chemical indicator of
proposed device visible
through the pack. | Chemical indicator of
proposed device visible
through the pack. | Same |
13. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Comparitive Dose | ||
| Response to | ||
| Biological Model | The VERIFY V24 Challenge Pack was compared to | |
| the worst case biological model in the Fast Non Lumen | ||
| Cycle. The challenge pack shall demonstrate equal or | ||
| greater resistance as compared to the worst case | ||
| biological model. | PASS | |
| Simulated Use | VERIFY V24 Challenge Pack were processed in the | |
| Fast Non Lumen Cycle under simulated use conditions | ||
| with the following results: | ||
| • All processed SCBIs exhibit negative growth results | ||
| • All processed SCBI Label PIs exhibit a “pass” result | ||
| • All processed CIs exhibit a “pass” result | PASS |
Table 5-2. Summary of Non-clinical Testing
14. Conclusion
Based on the intended use, technological characteristics and nonclinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device, VERIFY V24 Challenge Pack (cleared in K140499), Class II (21 CFR 880.2800), product code FRC.