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.

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.

AI/ML Overview

This document describes two devices, the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Biological Indicator Challenge Pack. Both submissions are focused on qualifying these devices for use with the new V-PRO 60 Low Temperature Sterilization System, demonstrating substantial equivalence to their respective predicate devices.

VERIFY® V24 Self-Contained Biological Indicator (SCBI)

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
SCBI Half Cycle Performance Evaluation in the V-PRO 60 Sterilizer	SCBIs must be sterile after half-cycle testing.	Pass (SCBIs were sterile)
SCBI Growth Inhibition Following Exposure to V-PRO 60 Cycle	No growth inhibition or effect on media detected.	Pass (No growth inhibition)
SCBI Simulated Use in the V-PRO 60 Sterilizer	Successful demonstration of simulated use performance.	Pass
SCBI Worst Case Location in the V-PRO 60 Sterilizer	The worst-case location for SCBI placement must be determined.	Pass

2. Sample Size Used for the Test Set and Data Provenance:

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 unit," implying prospective testing for this specific sterilizer. The K numbers (K073244, K090514) indicate prior clearances and associated data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided within the document. The "ground truth" for biological indicators is inherently based on the viability of Geobacillus stearothermophilus spores, which is determined by culturing and observing growth or no-growth.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail, or sterile/non-sterile) for biological indicators is typically a direct observation of microbial growth or lack thereof.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This type of study is not applicable as the device is a biological indicator, not an imaging or diagnostic AI tool that involves human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is a standalone performance study. The device, a biological indicator, functions independently without a human in the loop for its direct performance, though human observation is required for interpreting its results (color change, turbidity).

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores. A successful sterilization cycle should kill all spores, resulting in no growth (sterile). If spores survive, they will grow, indicating a sterilization failure. This is effectively a biological assay for sterility.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator. All listed tests are performance evaluations for the device itself rather than training data for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth underpin the ground truth for biological indicators.

VERIFY® V24 Biological Indicator Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Resistance Characterization	Challenge Pack resistance must be equivalent or greater than the biological models used to validate the V-PRO 60 Low Temperature Sterilization System cycles.	Pass
Simulated Use Evaluation	VERIFY HPU Chemical Indicator and VERIFY V24 SCBI must yield passing results under worst-case simulated use conditions.	Pass
Worst Case Location	The worst-case location within the V-PRO 60 Sterilizer Chamber must be identified.	Pass

2. Sample Size Used for the Test Set and Data Provenance:

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 Sterilizer," implying prospective testing for this specific sterilizer. K103331 is cited as the predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided within the document. Similar to the SCBI, the ground truth for the challenge pack relies on the biological viability of Geobacillus stearothermophilus spores and the visual change of the chemical indicator.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail) is based on the biological indicator's growth/no growth and the chemical indicator's color change.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This type of study is not applicable as the device is a biological indicator challenge pack.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is a standalone performance study. The challenge pack, containing a biological indicator and a chemical indicator, functions independently in the sterilizer without a human in the loop for its direct performance. Human observation is required for interpreting the results of both indicators.

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores for the biological indicator component and the color change of the chemical indicator. Both are indicators of effective sterilization.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator challenge pack. All listed tests are performance evaluations for the device itself.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth, along with established chemical indicator responses to sterilization processes, underpin the ground truth.

Summary

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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

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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 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.

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.

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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 DeviceVERIFY V24 Self-Contained BiologicalIndicator	Predicate DeviceVerify Self-ContainedBiological Indicator(SCBI) for VaporizedVH2O2 SterilizationProcesses (K073244)modified underK090514	Comparison
Intended Use:Method of MonitoringSterilizationProcess Parameters	The VERIFY® V24Self-ContainedBiological Indicator isintended for routinemonitoring of theLumen, Non Lumenand Flexible cycles ofV-PRO® LowTemperatureSterilization Systems.	A standard method forfrequent monitoring ofthe V-PRO 1 LowTemperature Sterilizercycle	The device has beenpreviously cleared foruse with the V-PRO 1(K073244), V-PRO 1Plus (K083097) andV-PRO maX(K102330) LowTemperatureSterilization Systems.The proposed device isintended to add thenew V-PRO 60 unit tothe claims and is thefocus of performancetesting in thissubmission.
Labeling	• Vial Label• Certificate ofPerformance• Carton Label• Instructions for Use	• Vial Label• Certificate ofPerformance• Carton LabelInstructions for Use	Proposed andpredicate devices haveidentical labeling.
Organism: Species &Strain	GeobacillusstearothermophilusATCC 7953 spores	GeobacillusstearothermophilusATCC 7953 spores	Proposed andpredicate devicesutilize the identicalorganism species andstrain
Accessories	• VERIFY Incubator(Optional)• VERIFY Activator(Optional)• Throughput ProcessIndicator	• VERIFY Incubator(Optional)• VERIFY Activator(Optional)• Throughput ProcessIndicator	Proposed andpredicate devicesutilize the identicalaccessories
Viable Spore Population	> 106 CFU	> 106 CFU	Proposed andpredicate devicesspecify the sameviable sporepopulation
Feature	Proposed DeviceVERIFY V24 Self-Contained BiologicalIndicator	Predicate DeviceVerify Self-ContainedBiological Indicator"(SCBI) for VaporizedVH2O2 SterilizationProcesses (K073244)modified underK090514	Comparison
Resistancecharacteristics @ 2.7mg/L H2O2:	• D-value• Survival/KillWindow	• D-value• Survival/KillWindow	Proposed andpredicate devices havethe same resistancecharacteristicsspecifications
Culture Conditions	• Trypticase SoyBroth Based Media• Incubation Temp:55-60°C• Incubation Time:≥24 hours	• Trypticase SoyBroth Based Media• Incubation Temp:55-60°C• Incubation Time:≥24 hours	Proposed andpredicate devicesutilize identicalculture conditions.Please note that thereduced incubationtime of 24 hours wascleared underK090514.
Carrier Materials	Polypropylene Vial	Polypropylene Vial	Proposed andpredicate devices haveidentical carriermaterials
Packaging:• Primary Pack• SecondaryPack	• Polypropylene Vial• 50 IndicatorsSupplied in aCardboard Box	• Polypropylene Vial• 50 IndicatorsSupplied in aCardboard Box	Primary andpackaging materialsare identical forpredicate andproposed devices.
Storage Conditions	16-25°C,30 - 60% RH	16-25°C,30 - 60% RH	Proposed andpredicate devicesspecify identicalstorage conditions.
Shelf-life	As indicated onlabeling	As indicated onlabeling	Proposed andpredicate devicesclaim identical shelflife

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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.

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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 PerformanceEvaluation in the V-PRO 60 Sterilizer	PassSCBIs were sterile in half-cycle testing.
SCBI Growth Inhibition FollowingExposure to V-PRO 60 Cycle	PassThere was no growth inhibition and noeffect of the sterilization process on themedia.
SCBI Simulated Use in the V-PRO 60Sterilizer	PassSimulated use performance has beensuccessfully demonstrated.
SCBI Worst Case Location in the V-PRO60 Sterilizer	PassWorst case location for SCBI placementwas 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.

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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

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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 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.

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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 DeviceVERIFY V24 BiologicalIndicator Challenge Pack	Predicate DeviceVerify® Biological IndicatorChallenge Pack for VaporizedVH2O2 SterilizationProcesses, K103331	Comparison
Intended Use	The VERIFY V24 BiologicalIndicator Challenge Pack isintended for qualificationtesting of the Lumen, NonLumen and Flexible Cycles inV-PRO Low TemperatureSterilization Systemsfollowing installation,relocation, malfunctions ormajor repairs.The challenge pack is placedin an otherwise emptysterilizer chamber; a hospital-defined challenge load is notincluded.The challenge pack is notintended for routinemonitoring of V-PROSterilizers. It has been testedand validated solely for use inperiodic testing of theSterilizers.	The Verify Biological IndicatorChallenge Pack for VaporizedVH2O2 Sterilization Processes isintended for qualification testing ofthe Amsco® V-PROTM 1, theAmsco V-PRO 1 Plus (Lumen andNon Lumen Cycles, K092906) andthe V-PROTM maX (Flexible,Lumen and Non Lumen Cycles)Low Temperature SterilizationSystems following installation,relocation, malfunctions or majorrepairs.The challenge pack is placed in anotherwise empty sterilizerchamber; a hospital-definedchallenge load is not included.The challenge pack is not intendedfor routine monitoring of V-PROSterilizers. It has been tested andvalidated solely for use in periodictesting of the V-PRO 1,V-PRO 1 Plus and V-PRO maXSterilizers.	The device has beenpreviously clearedfor use with the V-PRO 1, V-PRO 1Plus and V-PROmaX LowTemperatureSterilizationSystems (K103330).This submission isintended to add thenew V-PRO 60Sterilizer to theclaimed intendeduses of the deviceand is the focus ofperformance testingin this submission.
Feature	Proposed DeviceVERIFY V24 BiologicalIndicator Challenge Pack	Predicate DeviceVerify® Biological IndicatorChallenge Pack for VaporizedVH2O2 SterilizationProcesses, K103331	Comparison
BiologicalIndicator (BI)	VERIFY V24 SCBI (subjectof this submission)	Verify V24 SCBI (K090514)	The biologicalindicator is identicalin materials.
Mechanism toIncrease theResistance ofthe BI	The VERIFY V24 SCBIis packaged with a sheetof polyurethane foamwhich serves as a physicalbarrier to penetration aswell as a reservoir forhydrogen peroxide.	The Verify V24 SCBI ispackaged with a sheet ofpolyurethane foam which servesas a physical barrier topenetration as well as areservoir for hydrogen peroxide.	The mechanismto increase BIresistance isidentical in theproposed andpredicate devices
BI SecondaryPackaging	The SCBI and foam sheetare placed within a Tyvekpouch.	The SCBI and foam sheet areplaced within a Tyvek pouch.	The BI SecondaryPackaging isidentical in theproposed andpredicate devices.
Class 1ChemicalIndicator	The VERIFY HPUChemical Indicator(separate PremarketNotification submission)is placed in the pouch. Athroughput processindicator is also located onthe VERIFY V24 SCBIlabel.	The Verify V-PRO ChemicalIndicator (K091174) is placedin the pouch. A throughputprocess indicator is also locatedon the Verify V24 SCBI label.	The Class 1ChemicalIndicatorintended to be .used in theproposed deviceis similar to thatin the predicatedevice. Aseparate,concurrentPremarketNotification isbeing submittedfor the Class 1Process Indicator
ResistanceCharacteristics	The VERIFY V24Biological IndicatorChallenge Pack is moreresistant to the V-PRO 60Sterilizer cycles than isthe biological modeldeveloped for validationof those sterilizationcycles.	The Verify Biological IndicatorChallenge Pack for VaporizedVH2O2 Sterilization Processesis more resistant to the V-PROmax Sterilizer cycles than isthe biological model developedfor validation of thosesterilization cycles.	Performancetesting providedin thissubmissiondemonstratesthat the VERIFYV24 BiologicalIndicatorChallenge Packis more resistantto the V-PRO 60Sterilizer cyclesthan is thebiological modeldeveloped forvalidation ofthosesterilizationcycles.

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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	PassChallenge Pack resistance is equivalent orgreater than the biological models used tovalidate the V-PRO 60 Low TemperatureSterilization System.
Simulated Use Evaluation	PassThe VERIFY HPU Chemical Indicatorand VERIFY V24 SCBI yielded passingresults when evaluated under worst casesimulated use conditions.
Worst Case Location	PassThe worst case location within the V-PRO60 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.

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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.

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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

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

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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)

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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 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 -SDN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People,0.9.2342.19200300.100.1.1=1300055864, cn=Elizabeth F. Claverie -SDate: 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."

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."

Regulation Number and Section

§ 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).