Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a biological indicator that changes color based on sterilization effectiveness, a purely chemical/biological process. There is no mention of any computational analysis or learning algorithms.

Therapeutic

No
The device is a biological indicator used to monitor the effectiveness of sterilizers for medical devices, not to treat a medical condition or disease.

Diagnostic

No

This device is a biological indicator used to monitor the effectiveness of sterilizers, not to diagnose a medical condition in a patient. It indicates whether the sterilization process was successful based on the growth or non-growth of microorganisms.

SaMD (Software as a Medical Device)

No

The device is a physical biological indicator used to monitor sterilization cycles, involving a vial, growth media, and activation hardware. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the VERIFY® V24 Self-Contained Biological Indicator is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to monitor the effectiveness of sterilization cycles in specific sterilizers (V-PRO and STERRAD systems). It is used to determine if the sterilization process successfully killed microorganisms.
Device Description: The device contains biological spores and growth media. Its function is to indicate the presence or absence of viable spores after a sterilization cycle, which reflects the efficacy of the sterilization process.
Mechanism: The device works by incubating the spores in growth media. A color change or turbidity indicates that spores survived the sterilization process and grew. This is a test of the sterilization equipment's performance, not a test performed on a human specimen to diagnose a condition.
Lack of IVD Characteristics: The description does not mention analyzing human specimens (blood, urine, tissue, etc.) or providing information for the diagnosis, treatment, or prevention of disease in an individual.

Therefore, the VERIFY® V24 Self-Contained Biological Indicator is a device used to monitor the performance of sterilization equipment, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

Lumen, Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
Default Cycle of the STERRAD 100S Sterilizer ●
Default Cycle of the STERRAD 200 Sterilizer .
Standard and Advanced Cycles of the STERRAD NX Sterilizer .
Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

Product codes

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 and the STERRAD® 100S, STERRAD 200, STERRAD NX and STERRAD 100NX (Express, Standard and Flex Scope Cycles) Sterilizers. 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 or STERRAD Sterilizer 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.

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)

Table 5-1. Summary of Nonclinical Tests:
SCBI Half Cycle Performance Evaluation in the STERRAD Sterilizer Cycles: Pass - SCBIs were sterile in half-cycle testing.
SCBI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles: Pass - There was no growth inhibition and no effect of the sterilization process on the media.
SCBI Simulated Use in the STERRAD Sterilizer Cycles: Pass - Simulated use performance has been successfully demonstrated.

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 .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K073244, K090514

Reference Device(s)

K083097, K102330

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/15 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a large, sans-serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal wavy lines stacked on top of each other.

JUN | 6 2014

510(k) Summary for VERIFY® V24 Self-Contained Biological Indicator

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459

Manufacturing Facility

STERIS Corporation 9325 Pinecone Mentor, OH 44060

Contact:

Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: (440) 392-7690 (440) 357-9198 Fax No: e-mail: William brodbeck@steris.com

Submission Date:

March 20, 2014

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

!

5-1

1

1. Device Name

Trade Name:	VERIFY® V24 Self-Contained Biological Indicator
Common/usual Name:	Biological Indicator (BI)
Classification Name:	Indicator, Biological Sterilization Process
(21 CFR 880.2800, FRC), Class II

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 and the STERRAD® 100S, STERRAD 200, STERRAD NX and STERRAD 100NX (Express, Standard and Flex Scope Cycles) Sterilizers. 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 or STERRAD Sterilizer 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 following sterilizer cycles:

Lumen. Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
Default Cycle of the STERRAD 100S Sterilizer .
Default Cycle of the STERRAD 200 Sterilizer .

2

Standard and Advanced Cycles of the STERRAD NX Sterilizer .
Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

5. Description of Safety and Substantial Equivalence

The VERIFY V24 Self-Contained Biological Indicator has the identical accessories, viable population, resistance characteristics, culture conditions, primary and secondary packaging, and storage conditions as compared to its predicate device, the Verify Self-Contained Biological Indicator (SCBI) for Vaporized (VH2O2) Sterilization Processes (name changed in K090514). Testing submitted (Table 5-1) focused on qualification of the subject device for its proposed new indications for use in STERRAD Sterilizers as all other characteristics remain identical to the predicate device.

Table 5-1. Summary of Nonclinical Tests:

Fall Test &	and Result :
SCBI Half Cycle Performance
Evaluation in the STERRAD Sterilizer
Cycles	Pass
SCBIs were sterile in half-cycle testing.
SCBI Growth Inhibition Following
Exposure to STERRAD Sterilizer Cycles	Pass
There was no growth inhibition and no
effect of the sterilization process on the
media.
SCBI Simulated Use in the STERRAD
Sterilizer Cycles	Pass
Simulated use performance has been
successfully demonstrated.

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 .

Technological Characteristics 6.

Table 5-2 compares technological characteristics and specifications to the predicate device. The proposed biological indicator is identical in composition and has the same performance specifications as the predicate.

3

STERIS Traditional 510(k) PREMARKET NOTIFICATION

VERIFY® V24 Self-Contained Biological Indicator

| 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
following sterilizers and
cycles:
• Lumen, Non Lumen
and Flexible Cycles of
the V-PRO® Low
Temperature
Sterilization Systems
• Default Cycle of the
STERRAD 100S
Sterilizer
• Default Cycle of the
STERRAD 200
Sterilizer
•Standard and Advanced
Cycles of the
STERRAD NX
Sterilizer
• Express, Standard and
Flex Scope Cycles of
the STERRAD 100NX
Sterilizer | 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
listed ASP STERRAD
Sterilization system
cycles to the claims. |
| 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
except that the
instructions for use of
the proposed device
include the listed
STERRAD Sterilizer
cycles. |
| Organism: Species
& Strain | Geobacillus
stearothermophilus ATCC
7953 spores | Geobacillus
stearothermophilus ATCC
7953 spores | Same |
| Accessories | • VERIFY Incubator
(Optional)
• VERIFY Activator
(Optional)
• Throughput Process
Indicator | • VERIFY Incubator
(Optional)
• VERIFY Activator
(Optional)
• Throughput Process
Indicator | Same |
| Viable Spore
Population | The specification range for viable spore population is identical for the proposed
device and predicate | | |
| 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 | The specification range for D-value, survival time and kill time are identical for the
proposed device and predicate. | | |
| Culture Conditions | • V24 SCBI Growth
Media
• Incubation Temp: 55-
60°C
• Incubation Time: ≥24
hours | • V24 SCBI Growth
Media
• Incubation Temp: 55-
60°C
• Incubation Time: ≥24
hours | Same
Please note that the
reduced incubation
time of 24 hours was
cleared under
K090514. |
| Carrier Materials | Polypropylene Vial | Polypropylene Vial | Same |
| Packaging:
• Primary Pack
• Secondary
Pack | • Polypropylene Vial
• 50 Indicators Supplied
in a Cardboard Box | • Polypropylene Vial
• 50 Indicators Supplied
in a Cardboard Box | Same |
| Storage Conditions | 16 - 25°C,
30 - 60% RH | 16 - 25°C,
30 - 60% RH | Same |
| Shelf-life | The labeled shelf life is identical for the proposed device and predicate. | | |

Table 5-2. VERIFY V24 Self-Contained Biological Indicator

·

4

STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY® V24 Self-Contained Biological Indicator

7. Conclusion

The VERIFY V24 Self-Contained Biological Indicator is identical in composition and has the same performance specifications as the predicate, therefore, it is substantially equivalent to the claimed predicate device since it is identical in design and performance characteristics and has been qualified for routine monitoring of the STERRAD 100S default cycle, STERRAD 200 default cycle, STERRAD NX Standard and Advanced cycles and STERRAD 100NX Express, Standard and Flex Scope cycles.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

June 16, 2014

STERIS Corporation William Brodbeck. Ph.D Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K140708

Trade/Device Name: VERIFY® V24 Self Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Biological Sterilization Process Regulatory Class: II Product Code: FRC Dated: March 20, 2014 Received: March 21, 2014

Dear Dr. 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 conninered phorte with the provisions of the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costhetic rior (110) that to nevice, subject to the general controls provisions of the Act. The I va may, alorely manns of the Act include requirements for annual registration, listing of general controls provisions of 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.

6

Page 2 - William Brodbeck, Ph.D

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 clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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 vours. Teiashri Puro

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

7

Indications for Use

K140708 510(k) Number (if known):

Device Name:

VERIFY® V24 Self-Contained Biological Indicator

Indications For Use:

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

Lumen, Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
Default Cycle of the STERRAD 100S Sterilizer ●
Default Cycle of the STERRAD 200 Sterilizer .
Standard and Advanced Cycles of the STERRAD NX Sterilizer .
Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth
Gutala -S

Digitally signed by Sreekanth Gutala -S DN: c=US, o-U.S. Government, ou=HHS ou=FDA, ou=People, 0,9.2342.19200300.100.1.1=200054049 cn=Sreekanth Gutala -5 Date: 2014.06.16 11:31:27 -04'00'