(76 days)
Not Found
No
The device description and performance studies focus on a biological indicator that changes color based on bacterial viability after sterilization, detected by an optical reader. There is no mention of AI or ML in the document.
No.
This device is a biological indicator used to monitor the effectiveness of sterilization cycles for medical devices, not to treat a medical condition or ailment.
No
This device is a biological indicator used to monitor the effectiveness of sterilization cycles in healthcare facilities. It assesses whether the sterilization process has successfully killed microorganisms, not to diagnose a medical condition in a patient.
No
The device description clearly states the product consists of physical components (spores, nutrient media, plastic vial) and interacts with a physical incubator and activator. It is a biological indicator, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of sterilization cycles for medical devices. It is not used to diagnose a disease or condition in a human being.
- Device Description: The device contains spores and nutrient media to assess the killing power of a sterilization process. It does not analyze a sample taken from a human body.
- Lack of IVD Characteristics: The description does not mention analyzing blood, urine, tissue, or any other human specimen. The output is a change in the media indicating whether the sterilization was successful, not a diagnostic result related to a patient's health.
Therefore, the VERIFY® V24 Self-Contained Biological Indicator and the Celerity 20 HP Biological Indicator 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 sterilizer cycles:
· Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
· STERRAD® 100S Sterilizer (Default Cycle)
· STERRAD® 200 Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with ALLClear® Technology
· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.
The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
· STERRAD® 100S Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology
· Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology
When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
Celerity 20 HP Biological Indicator: The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indication for use. It produces an optical change in signal that is detected by the STERIS proprietary reader, Celerity 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
VERIFY V24 Self-Contained Biological Indicator: The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilities 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 SCBI into the V-PRO® 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℃ 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
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)
Celerity 20 HP Biological Indicator:
Study type: Non-clinical Tests
Sample Size: Not Specified
Key Results:
- Verification of Celerity HP BI Performance after V-PRO Specialty Cycle Extended Aeration: Celerity BIs exposed to the Specialty Cycle demonstrate essentially equivalent or not significantly different resistance as compared to SCBIs exposed to the 136L V-PRO Sterilizer Fast Non Lumen Cycle - Pass
- Final Process Qualification of the VPRO maX2 Sterilizer Specialty Cycle: The V-PRO maX 2 Sterilizer Specialty Cycle final process qualification was successful. - Pass
VERIFY V24 Self-Contained Biological Indicator:
Study type: Non-clinical Tests
Sample Size: Not Specified
Key Results:
- Verification of V24 SCBI Performance after V-PRO Specialty Cycle Extended Aeration: SCBIs exposed to the Specialty Cycle demonstrate essentially equivalent or not significantly different resistance as compared to SCBIs exposed to the 136L V-PRO Sterilizer Fast Non Lumen Cycle - Pass
- Final Process Qualification of the VPRO maX2 Sterilizer Specialty Cycle: The V-PRO maX 2 Sterilizer Specialty Cycle final process qualification was successful. - Pass
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 7, 2023
STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060
Re: K231490
Trade/Device Name: Celerity 20 HP Biological Indicator; V24 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: Mav 22, 2023 Received: May 23, 2023
Dear Gregory Land:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231490
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 sterilizer cycles:
· Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
· STERRAD® 100S Sterilizer (Default Cycle)
· STERRAD® 200 Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with ALLClear® Technology
· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.
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) K231490
Device Name Celerity 20 HP Biological Indicator
Indications for Use (Describe)
The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
· STERRAD® 100S Sterilizer (Default Cycle)
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology
· Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology
When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
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
Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a bold, sans-serif font at the top of the image. Below the word is a graphic of several horizontal, curved lines that resemble waves. The lines are blue, and the background is white.
510(K) Summary For K231490 Celerity 20 HP Biological Indicator
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax: (440)357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax:
Contact
Gregory Land Lead Regulatory Affairs Specialist Phone: (440) 352-7424 Fax: (440) 357-9198 Email: greg land(@steris.com
Submission Date:
May 22, 2023
5
Device Name 1
Trade Name: CELERITY 20 HP Biological Indicator Common/usual Name: Biological Indicator Device Classification: Class II Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC]
2 Predicate Device
Proprietary Name Common/usual Name Classification Name: 510(k) Submitter/Holder 510(k) Number:
Celerity 20 HP Biological Indicator Biological indicator Indicator, Biological Sterilization Process STERIS Corporation K183294
3 Description of Device
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indication for use. It produces an optical change in signal that is detected by the STERIS proprietary reader, Celerity 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
ব Intended Use/Indications for Use
The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles:
- Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 ● Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
- STERRAD® 100S Sterilizer (Default Cycle)
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® . Technology
- Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or ● without ALLClear® Technology
When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes.
5 Summary of Technical Characteristics
- 5.1
| Feature | CELRITY 20 HP Biological
Indicator
(proposed) | Celerity 20 HP Biological
Indicator (K183294) | Comparison |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Celerity 20 HP Biological
Indicator is intended for | The Celerity 20 HP Biological
Indicator is intended for | The proposed and
predicate devices are
identical. The |
| Feature | CELRITY 20 HP Biological
Indicator
(proposed) | Celerity 20 HP Biological
Indicator (K183294) | Comparison |
| | routine monitoring of the
following sterilizer cycles:
• Lumen, Non Lumen, Fast
Non Lumen, Fast, Flexible
and Specialty Cycles of the
V-PRO 1, 1 Plus, maX, maX
2, 60 and s2 Low
Temperature Sterilization
Systems.
• STERRAD® 100S Sterilizer
(Default Cycle)
• Standard and Advanced
Cycles of the STERRAD®
| routine monitoring of the
following sterilizer cycles:
• Lumen, Non Lumen, Fast
Non Lumen, Fast and
Flexible Cycles of the V-
PRO: 1, 1 Plus, maX, maX2
and s2 Low Temperature
Sterilization Systems.
• STERRAD® 100S Sterilizer
(Default Cycle)
• Standard and Advanced
Cycles of the STERRAD®
NX Sterilizer with or
without ALLClear
• Standard, Flex Scope,
Express and DUO Cycles of
the STERRAD® 100NX
Sterilizer with or without
ALLClear
When used in conjunction
with the Celerity HP
Incubator, the Celerity 20 HP
BI provides a fluorescent
result within 20 minutes. | Specialty Cycle is a
new cycle in the V-
PRO maX 2 Low
Temperature
Sterilizer, which has
been submitted in this
premarket notification. |
| Indicator
organism | Geobacillus
stearothermophilus | Geobacillus
stearothermophilus | Same |
| Mechanism of
action | An enzyme, which is produced
by the organism, reacts with a
fluorogenic substrate within
the defined nutrient media to
produce a fluorescent moiety. | An enzyme, which is
produced by the organism,
reacts with a fluorogenic
substrate within the defined
nutrient media to produce a
fluorescent moiety. | Same |
| Accessories | Automated incubator / reader | Automated incubator / reader | Same |
| Viable spore
population | 1.0 – 4.0 x 106 spore/BI | 1.0 - 4.0 x 106 spore/BI | Same |
| Resistance | Resistance @ 9.1 mg/L H2O2:
• D-value > 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 7 min | Resistance @ 9.1 mg/L H2O2:
• D-value > 6 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 7 min | Same |
| Feature | CELRITY 20 HP Biological
Indicator
(proposed) | Celerity 20 HP Biological
Indicator (K183294) | Comparison |
| Culture
Conditions | 55-59°C, media included in
BI, 20-minute incubation time. | 55-59°C, media included in
BI, 20-minute incubation time. | Same |
| Primary
Packaging | Direct inoculum on plastic
vial, cap with recovery media. | Direct inoculum on plastic
vial, cap 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 | 10 months | 10 months | Same |
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator
7
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Celerity 20 HP Biological Indicator
6 Summary of Non-clinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Verification of Celerity HP BI | ||
| Performance after V-PRO Specialty | ||
| Cycle Extended Aeration | Celerity BIs exposed to the Specialty | |
| Cycle demonstrate essentially | ||
| equivalent or not significantly | ||
| different resistance as compared to | ||
| SCBIs exposed to the 136L V-PRO | ||
| Sterilizer Fast Non Lumen Cycle | Pass | |
| Final Process Qualification of the | ||
| VPRO maX2 Sterilizer Specialty | ||
| Cycle | The V-PRO maX 2 Sterilizer | |
| Specialty Cycle final process | ||
| qualification was successful. | Pass |
Table 5-3. Summary of Non-clinical Testing
7 Conclusion
Based on the intended use, technological characteristics and the non-clinical tests performed, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the Celerity 20 HP Biological Indicator, K183294 Class II [21 CFR 880.2800(a)], product code FRC.
8
Image /page/8/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.
510(K) Summary For K231490 VERIFY V24 Self-Contained Biological Indicator
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax: (440)357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax: (440) 392-7896
Contact
Gregory Land Lead Regulatory Affairs Specialist Phone: (440) 352-7424 Fax: (440) 357-9198 Email: greg land(@steris.com
Submission Date:
May 22, 2023
9
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY V24 Self-Contained Biological Indicator
Device Name 8
| Trade Name: | VERIFY V24 Self-Contained Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process [21 CFR 880.2800(a), FRC] |
の Predicate Device
Proprietary Name: VERIFY V24 Self-Contained Biological Indicator Common/usual Name Biological indicator Classification Name: Indicator, Biological Sterilization Process 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K183300
10 Description of Device
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilities 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 SCBI into the V-PRO® 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℃ 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.
11 Intended Use/Indications for Use
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
- Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, ● 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
- STERRAD® 100S Sterilizer (Default Cycle)
- STERRAD® 200 Sterilizer (Default Cycle) ●
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer to include sterilizers with . ALLClear® Technology
- . Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology
12 Summary of Technical Characteristics
10
| Feature | VERIFY V24 SCBI
(proposed) | VERIFY V24 SCBI Predicate
(K183300) | Comparison |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY® V24 Self-
Contained Biological
Indicator is intended for
routine monitoring of the
following sterilizer cycles:
• Lumen, Non Lumen,
• Flexible, Fast, Fast Non
Lumen and Specialty
Cycles of the V-PRO® 1,
• 1 Plus, maX, maX 2, 60
and s2 Sterilizers
• STERRAD® 100S
Sterilizer (Default Cycle)
• STERRAD® 200
Sterilizer (Default Cycle)
• Standard and Advanced
Cycles of the
STERRAD® NX
Sterilizer to include
sterilizers with
ALLClear® Technology
• Express, Flex Scope and
Standard Cycles of the
STERRAD® 100NX
Sterilizer to include
sterilizers with
ALLClear® technology. | The VERIFY® V24 Self-
Contained Biological Indicator
is intended for routine
monitoring of the following
sterilizer cycles:
• Lumen, Non Lumen,
• Flexible, Fast and Fast Non
Lumen Cycles of the V-
PRO® 1, 1 Plus, maX, maX
2, 60 and s2 Sterilizers
• STERRAD® 100S
Sterilizer (Default Cycle)
• STERRAD® 200 Sterilizer
(Default Cycle)
• Standard and Advanced
Cycles of the STERRAD®
NX Sterilizer to include
sterilizers with ALLClear®
Technology
• Express, Flex Scope and
Standard Cycles of the
STERRAD® 100NX
Sterilizer to include
sterilizers with ALLClear®
technology. | The proposed and
predicate devices are
identical. The Specialty
Cycle is a new cycle in
the V-PRO maX 2 Low
Temperature Sterilizer,
which has been
submitted in this
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 surviving
indicator organisms. | Visual detection of growth
based on media color change
in the presence of surviving
indicator organisms. | Same |
| 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 |
| 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 |
| Culture
Conditions | 55- 60°C, media included in
SCBI, 24 hour incubation
time. | 55- 60°C, media included in
SCBI, 24 hour incubation
time. | Same |
| Primary
Packaging | Direct inoculum on plastic
vial, glass ampoule with
recovery media. | Direct inoculum on plastic
vial, glass ampoule with
recovery media. | Same |
| Process indicator | VERIFY V24 Self-Contained
Biological Indicator Vial | VERIFY V24 Self-Contained
Biological Indicator Vial | Same |
| Feature | VERIFY V24 SCBI
(proposed) | VERIFY V24 SCBI Predicate
(K183300) | Comparison |
| | Label; magenta to
orange/yellow color change. | Label; magenta to
orange/yellow color change. | |
| Shelf-life | 15 Months | 15 Months | Same |
12.1 YERIFY V24 Self-Contained Biological Indicator
11
13 Summary of Non-clinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.
| Test | Acceptance Criteria | Conclusion | ||
|---|---|---|---|---|
| Verification of V24 SCBI | ||||
| Performance after V-PRO Specialty | ||||
| Cycle Extended Aeration | SCBIs exposed to the Specialty Cycle | |||
| demonstrate essentially equivalent or | ||||
| not significantly different resistance | ||||
| as compared to SCBIs exposed to the | ||||
| 136L V-PRO Sterilizer Fast Non | ||||
| Lumen Cycle | Pass | |||
| Final Process Qualification of the | ||||
| VPRO maX2 Sterilizer Specialty | ||||
| Cycle | The V-PRO maX 2 Sterilizer | |||
| Specialty Cycle final process | ||||
| qualification was successful. | Pass |
Table 5-3. Summary of Non-clinical Testing
14 Conclusion
Based on the intended use, technological characteristics and the non-clinical tests performed, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device, the VERIFY V24 Self-Contained Biological Indicator, K183300 Class II [21 CFR 880.2800(a)], product code FRC.