VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES

Q: Who is the manufacturer of VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES?

STERIS Corporation filed the 510(k) submission for VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES (K140499).

Q: What is the FDA product code for VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES?

FRC. It is classified under 21 CFR 880.2800 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K140499 · STERIS Corporation · FRC · Jul 17, 2014 · General Hospital

Device Facts

Record ID	K140499
Device Name	VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
Applicant	STERIS Corporation
Product Code	FRC · General Hospital
Decision Date	Jul 17, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2800
Device Class	Class 2

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. 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.

Device Story

VERIFY V24 SCBI and Challenge Pack monitor V-PRO Low Temperature Sterilization Systems. SCBI contains Geobacillus stearothermophilus spores; placed in sterilizer with medical devices. Post-cycle, SCBI activated via STERIS VERIFY SCBI HP activator to release growth media; incubated at 55-60°C for ≥24 hours. Pass indicated by orange, non-turbid media; failure by yellow/turbid media. Challenge Pack includes SCBI, polyurethane foam reservoir, and Class 1 Chemical Indicator; used for qualification testing in empty chambers. Healthcare providers use results to verify sterilization efficacy, ensuring patient safety by confirming device sterility before clinical use.

Clinical Evidence

Bench testing only. Studies included viable spore population assay, resistance characteristics, carrier/packaging evaluation, holding time assessment, recovery methods, and shelf-life. Performance in V-PRO 60 sterilizer confirmed via half-cycle testing, growth inhibition studies, and simulated use evaluations. No clinical data.

Technological Characteristics

Biological indicator consists of Geobacillus stearothermophilus spores on a carrier in a polypropylene vial. Challenge pack includes polyurethane foam reservoir and Tyvek pouch. Sensing principle: biological growth/colorimetric change. Incubation: 55-60°C. No electronic components or software algorithms.

Indications for Use

Indicated for healthcare providers to monitor V-PRO Low Temperature Sterilization Systems (Lumen, Non-Lumen, and Flexible cycles). The Challenge Pack is indicated for qualification testing following installation, relocation, malfunction, or major repair.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2) Sterilization Processes (K073244) modified under K090514
Verify Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes (K103331)

Reference Devices

V-PRO 1 Low Temperature Sterilizer (K073244)
V-PRO 1 Plus (K083097)
V-PRO maX (K102330)
Verify V-PRO Chemical Indicator (K091174)

Related Devices

K172748 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack · Steris Corporations · Feb 9, 2018
K140708 — VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR · STERIS Corporation · Jun 16, 2014
K173488 — CELERITY 20 HP Challenge Pack · STERIS Corporation · Mar 1, 2018
K090514 — VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES · STERIS Corporation · Mar 16, 2009
K103331 — VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES · STERIS Corporation · Sep 1, 2011

Submission Summary (Full Text)

{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."

VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES

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VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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