(140 days)
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 or diagnose a disease or condition in a patient.
No
This device is a biological indicator used to monitor the effectiveness of sterilization cycles in low-temperature sterilizers. It does not diagnose a medical condition in a patient; rather, it assesses the performance of a medical device (the sterilizer).
No
The device description clearly outlines physical components like a self-contained biological indicator (SCBI) vial, growth media, and a chemical indicator (CI), which are hardware. The device relies on a biological and chemical reaction to indicate sterilization success or failure, not solely on software processing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for monitoring the performance of sterilization systems (V-PRO Low Temperature Sterilization Systems). It assesses whether the sterilization process was successful in killing microorganisms.
- Mechanism: The device contains biological indicators (spores) that are exposed to the sterilization process. The outcome (growth or no growth of the spores) indicates the effectiveness of the sterilization. This is a method for evaluating the sterilization equipment, not for diagnosing a condition in a patient or analyzing a sample from a patient.
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This device does not perform such tests on patient samples.
The device is a biological indicator used to validate and monitor the performance of a sterilization process, which is a quality control measure for medical equipment.
N/A
Intended Use / Indications for Use
- The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems.
- The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen. Non Lumen and Flexible Cycles in V-PRO 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 Sterliizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
- The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers 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 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.
- The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare providers for qualification testing of the V-PRO 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 user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Sterilizer and performs a sterilization cycle. After cvcle 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 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 vellow 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)
- VERIFY® V24 Self-Contained Biological Indicator
- SCBI Half Cycle Performance Evaluation in the V-PRO 60 Sterilizer: SCBIs were sterile in half-cycle testing.
- SCBI Growth Inhibition Following Exposure to V-PRO 60 Cycle: There was no growth inhibition and no effect of the sterilization process on the media.
- SCBI Simulated Use in the V-PRO 60 Sterilizer: Simulated use performance has been successfully demonstrated.
- SCBI Worst Case Location in the V-PRO 60 Sterilizer: Worst case location for SCBI placement was determined.
- All performance studies for the VERIFY V24 Self-Contained Biological Indicator recommended within FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions have been previously completed, submitted and cleared under K073244 and K090514. These studies and the results are summarized in the appropriate sections throughout this submission and include, but are not limited to: Viable Spore Population Assay, Resistance Characteristics, Carrier and Primary Packaging Evaluation, Holding Time Assessment, Recovery Methods, Shelf Life.
- VERIFY® V24 Biological Indicator Challenge Pack
- Resistance Characterization: Challenge Pack resistance is equivalent or greater than the biological models used to validate the V-PRO 60 Low Temperature Sterilization System.
- Simulated Use Evaluation: The VERIFY HPU Chemical Indicator and VERIFY V24 SCBI yielded passing results when evaluated under worst case simulated use conditions.
- Worst Case Location: The worst case location within the V-PRO 60 Sterilizer Chamber was identified.
- The subject device is similar to the claimed predicate and conforms with all performance studies recommended within FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions.
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.
K090514, K083097, K102330, K092906, K091174, K103330
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
JUL 1 7 2014
STERIS®
510(k) Summary for VERIFY® V24 Self-Contained Biological Indicator
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459
Contact:
Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198
Submission Date: July 10, 2014
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
1
1. Device Name
| Trade Name: | VERIFY® V24 Self-Contained Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI) |
| Device Class: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process (21 CFR 880 2800 FRC) |
2. Predicate Device
Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2 Sterilization Processes (K073244) modified under K090514.
3. Description of Device
The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers 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 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.
4. Intended Use
The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lumen. Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems.
2
Description of Safety and Substantial Equivalence 5.
The VERIFY V24 Self-Contained Biological Indicator has the identical characteristics as compared to its predicate device, the Verify Self-Contained Biological Indicator (SCBI) for Vaporized VH2O2 Sterilization Processes (name changed in K090514). A comparison table that outlines the characteristics of the proposed and predicate devices is below.
| Feature | Proposed Device
VERIFY V24 Self-
Contained Biological
Indicator | Predicate Device
Verify Self-Contained
Biological Indicator
(SCBI) for Vaporized
VH2O2 Sterilization
Processes (K073244)
modified under
K090514 | Comparison |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:
Method of Monitoring
Sterilization
Process Parameters | The VERIFY® V24
Self-Contained
Biological Indicator is
intended for routine
monitoring of the
Lumen, Non Lumen
and Flexible cycles of
V-PRO® Low
Temperature
Sterilization Systems. | A standard method for
frequent monitoring of
the V-PRO 1 Low
Temperature Sterilizer
cycle | The device has been
previously cleared for
use with the V-PRO 1
(K073244), V-PRO 1
Plus (K083097) and
V-PRO maX
(K102330) Low
Temperature
Sterilization Systems.
The proposed device is
intended to add the
new V-PRO 60 unit to
the claims and is the
focus of performance
testing in this
submission. |
| Labeling | • Vial Label
• Certificate of
Performance
• Carton Label
• Instructions for Use | • Vial Label
• Certificate of
Performance
• Carton Label
Instructions for Use | Proposed and
predicate devices have
identical labeling. |
| Organism: Species &
Strain | Geobacillus
stearothermophilus
ATCC 7953 spores | Geobacillus
stearothermophilus
ATCC 7953 spores | Proposed and
predicate devices
utilize the identical
organism species and
strain |
| Accessories | • VERIFY Incubator
(Optional)
• VERIFY Activator
(Optional)
• Throughput Process
Indicator | • VERIFY Incubator
(Optional)
• VERIFY Activator
(Optional)
• Throughput Process
Indicator | Proposed and
predicate devices
utilize the identical
accessories |
| Viable Spore Population | > 106 CFU | > 106 CFU | Proposed and
predicate devices
specify the same
viable spore
population |
| Feature | Proposed Device
VERIFY V24 Self-
Contained Biological
Indicator | Predicate Device
Verify Self-Contained
Biological Indicator
"(SCBI) for Vaporized
VH2O2 Sterilization
Processes (K073244)
modified under
K090514 | Comparison |
| Resistance
characteristics @ 2.7
mg/L H2O2: | • D-value
• Survival/Kill
Window | • D-value
• Survival/Kill
Window | Proposed and
predicate devices have
the same resistance
characteristics
specifications |
| Culture Conditions | • Trypticase Soy
Broth Based Media
• Incubation Temp:
55-60°C
• Incubation Time:
≥24 hours | • Trypticase Soy
Broth Based Media
• Incubation Temp:
55-60°C
• Incubation Time:
≥24 hours | Proposed and
predicate devices
utilize identical
culture conditions.
Please note that the
reduced incubation
time of 24 hours was
cleared under
K090514. |
| Carrier Materials | Polypropylene Vial | Polypropylene Vial | Proposed and
predicate devices have
identical carrier
materials |
| Packaging:
• Primary Pack
• Secondary
Pack | • Polypropylene Vial
• 50 Indicators
Supplied in a
Cardboard Box | • Polypropylene Vial
• 50 Indicators
Supplied in a
Cardboard Box | Primary and
packaging materials
are identical for
predicate and
proposed devices. |
| Storage Conditions | 16-25°C,
30 - 60% RH | 16-25°C,
30 - 60% RH | Proposed and
predicate devices
specify identical
storage conditions. |
| Shelf-life | As indicated on
labeling | As indicated on
labeling | Proposed and
predicate devices
claim identical shelf
life |
3
K140499/S001 STERIS Response to 4/28/14 Request for Additional Information VERIFY® V24 Self-Contained Biological Indicator and VERIFY® V24 Biological Indicator Challenge Pack
The proposed and predicate devices are therefore identical in respect to the labeling, organism, accessories, spore population, resistance characteristics, culture conditions, carrier materials, packaging, storage conditions and claimed shelf life. The only difference between the subject and predicate device is the claimed intended use. This submission therefore focuses on testing to qualify the proposed biological indicator for use in the V-PRO 60 Low Temperature Sterilization System to demonstrate substantial equivalence to the claimed predicate.
4
K140499/S001 STERIS Response to 4/28/14 Request for Additional Information VERIFY® V24 Self-Contained Biological Indicator and VERIFY® V24 Biological Indicator Challenge Pack
Summary of Nonclinical Tests:
| Test | Result |
|---|---|
| SCBI Half Cycle Performance | |
| Evaluation in the V-PRO 60 Sterilizer | Pass |
| SCBIs were sterile in half-cycle testing. | |
| SCBI Growth Inhibition Following | |
| Exposure to V-PRO 60 Cycle | Pass |
| There was no growth inhibition and no | |
| effect of the sterilization process on the | |
| media. | |
| SCBI Simulated Use in the V-PRO 60 | |
| Sterilizer | Pass |
| Simulated use performance has been | |
| successfully demonstrated. | |
| SCBI Worst Case Location in the V-PRO | |
| 60 Sterilizer | Pass |
| Worst case location for SCBI placement | |
| was determined. |
All performance studies for the VERIFY V24 Self-Contained Biological Indicator recommended within FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions have been previously completed, submitted and cleared under K073244 and K090514. These studies and the results are summarized in the appropriate sections throughout this submission and include, but are not limited to:
- . Viable Spore Population Assay
- Resistance Characteristics ●
- Carrier and Primary Packaging Evaluation .
- Holding Time Assessment .
- Recovery Methods .
- . Shelf Life
Therefore, the VERIFY V24 Self-Contained Biological Indicator is substantially equivalent to the claimed predicate device since it is identical in design and performance characteristics and has, in addition, been qualified for use in the V-PRO 60 Sterilizer.
5
Image /page/5/Picture/1 description: The image shows the logo for STERIS. 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 is a graphic of several horizontal lines that are curved to resemble waves.
510(k) Summary for VERIFY® V24 Biological Indicator Challenge Pack
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198
Summary Date: July 10, 2014
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
6
Device Name 6.
| Trade Name: | VERIFY® V24 Biological Indicator Challenge Pack |
|---|---|
| Common/usual Name: | Biological Indicator (BI) Process Challenge Device |
| Device Class: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR 880.2800, FRC) |
7. Predicate Device
Verify Biological Indicator Challenge Pack for Vaporized | H2O2 Sterilization Processes, K103331.
8. Description of Device
The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare providers for qualification testing of the V-PRO 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 user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Sterilizer and performs a sterilization cycle. After cvcle 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 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 vellow and/or if the media is turbid.
7
9. Intended Use
The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen, Non Lumen and Flexible Cycles in V-PRO 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 Sterilizer qualification testing.
Description of Safety and Substantial Equivalence 10.
The VERIFY V24 Biological Indicator Challenge Pack has the identical characteristics as compared to its predicate device, the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes, K103331. A comparison table that outlines the characteristics of the proposed and predicate devices is below.
| Feature | Proposed Device
VERIFY V24 Biological
Indicator Challenge Pack | Predicate Device
Verify® Biological Indicator
Challenge Pack for Vaporized
VH2O2 Sterilization
Processes, K103331 | Comparison |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY V24 Biological
Indicator Challenge Pack is
intended for qualification
testing of the Lumen, Non
Lumen and Flexible Cycles in
V-PRO 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
Sterilizers. | The Verify Biological Indicator
Challenge Pack for Vaporized
VH2O2 Sterilization Processes is
intended for qualification testing of
the Amsco® V-PROTM 1, the
Amsco V-PRO 1 Plus (Lumen and
Non Lumen Cycles, K092906) and
the V-PROTM maX (Flexible,
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,
V-PRO 1 Plus and V-PRO maX
Sterilizers. | The device has been
previously cleared
for use with the V-
PRO 1, V-PRO 1
Plus and V-PRO
maX Low
Temperature
Sterilization
Systems (K103330).
This submission is
intended to add the
new V-PRO 60
Sterilizer to the
claimed intended
uses of the device
and is the focus of
performance testing
in this submission. |
| Feature | Proposed Device
VERIFY V24 Biological
Indicator Challenge Pack | Predicate Device
Verify® Biological Indicator
Challenge Pack for Vaporized
VH2O2 Sterilization
Processes, K103331 | Comparison |
| Biological
Indicator (BI) | VERIFY V24 SCBI (subject
of this submission) | Verify V24 SCBI (K090514) | The biological
indicator is identical
in materials. |
| Mechanism to
Increase the
Resistance of
the BI | The VERIFY V24 SCBI
is packaged with a sheet
of polyurethane foam
which serves as a physical
barrier to penetration as
well as a reservoir for
hydrogen peroxide. | The Verify V24 SCBI is
packaged with a sheet of
polyurethane foam which serves
as a physical barrier to
penetration as well as a
reservoir for hydrogen peroxide. | The mechanism
to increase BI
resistance is
identical in the
proposed and
predicate devices |
| BI Secondary
Packaging | The SCBI and foam sheet
are placed within a Tyvek
pouch. | The SCBI and foam sheet are
placed within a Tyvek pouch. | The BI Secondary
Packaging is
identical in the
proposed and
predicate devices. |
| Class 1
Chemical
Indicator | The VERIFY HPU
Chemical Indicator
(separate Premarket
Notification submission)
is placed in the pouch. A
throughput process
indicator is also located on
the VERIFY V24 SCBI
label. | The Verify V-PRO Chemical
Indicator (K091174) is placed
in the pouch. A throughput
process indicator is also located
on the Verify V24 SCBI label. | The Class 1
Chemical
Indicator
intended to be .
used in the
proposed device
is similar to that
in the predicate
device. A
separate,
concurrent
Premarket
Notification is
being submitted
for the Class 1
Process Indicator |
| Resistance
Characteristics | The VERIFY V24
Biological Indicator
Challenge Pack is more
resistant to the V-PRO 60
Sterilizer cycles than is
the biological model
developed for validation
of those sterilization
cycles. | The Verify Biological Indicator
Challenge Pack for Vaporized
VH2O2 Sterilization Processes
is more resistant to the V-PRO
max Sterilizer cycles than is
the biological model developed
for validation of those
sterilization cycles. | Performance
testing provided
in this
submission
demonstrates
that the VERIFY
V24 Biological
Indicator
Challenge Pack
is more resistant
to the V-PRO 60
Sterilizer cycles
than is the
biological model
developed for
validation of
those
sterilization
cycles. |
8
K140499/S001 STERIS Response to 4/28/14 Request for Additional Information
VERIFY® V24 Self-Contained Biological Indicator and VERIFY® V24 Biological Indicator Challenge Pack
9
The proposed and predicate devices are therefore identical except for the claimed intended use and the Class 1 Chemical Indicator, which has been submitted under a separate concurrent Premarket Notification. This submission therefore focuses on testing to qualify the proposed device for use in the V-PRO 60 Low Temperature Sterilization System to demonstrate substantial equivalence to the claimed predicate.
| Test | Result |
|---|---|
| Resistance Characterization | Pass |
| Challenge Pack resistance is equivalent or | |
| greater than the biological models used to | |
| validate the V-PRO 60 Low Temperature | |
| Sterilization System. | |
| Simulated Use Evaluation | Pass |
| The VERIFY HPU Chemical Indicator | |
| and VERIFY V24 SCBI yielded passing | |
| results when evaluated under worst case | |
| simulated use conditions. | |
| Worst Case Location | Pass |
| The worst case location within the V-PRO | |
| 60 Sterilizer Chamber was identified |
Summary of Nonclinical Tests:
The subject device is similar to the claimed predicate and conforms with all performance studies recommended within FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions.
Therefore, the VERIFY V24 Biological Indicator Challenge Pack is substantially equivalent to the claimed predicate device for use in the V-PRO 60 Sterilizer.
10
Image /page/10/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 text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2014
Steris Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060
Re: K140499
Trade/Device Name: Verify® V24 Self-Contained Biological Indicator, Verify® V24 Biological Indicator Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: FRC Regulatory Class: II Product Code: FRC Dated: June 19, 2014 Received: June 24, 2014
Dear Mr. Brodbeck:
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.
11
Page 2 - Mr. Brodbeck
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
DAGRID/ODE/CDRH FOR
Tejashri Purohit-Sheth M.D. Clinical Deputy Director
14
Erin I, Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
12
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140499
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 Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
【不】【得】【下】【,】【EOR FDA USE ONLY 【送】【。】【公】【。】
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/12/Picture/13 description: The image shows the name "Elizabeth F. Claverie" in a simple, sans-serif font. The text is horizontally aligned and appears to be extracted from a document or label. The name is likely that of a person, possibly an author, researcher, or individual associated with the document from which it was extracted.
Digitally signed by Elizabeth F. Claverie -S
DN://tel.js. o=u.s. Government, ou=HHS, ou=FDA, ou=People,
019.2342.19200300.100.1.1=1300055864, cn=Elizabeth F. Claverie -S
Date: 2014.07.15 19:27:40 -04:00'
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
13
Indications for Use
510(k) Number (if known) に140499
Device Name
VERIFY® V24 Biological Indicator Challenge Pack
Indications for Use (Describe)
The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen. Non Lumen and Flexible Cycles in V-PRO 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 Sterliizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
# # # # TFOR FDA USE ONLY . L . 1 For : 参考: 上一 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
| Elizabeth F. Claverie -S |
|---|
| Digitally signed by Elizabeth F. Claverie -S |
| DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, |
| 0.9.2342.19200300.100.1.1=1300055864, cn=Elizabeth F. Claverie -S |
| Date: 2014.07.15 19:29:23 -04'00' |
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."