(100 days)
Not Found
No
The device is a chemical indicator tape that changes color based on exposure to hydrogen peroxide, a purely chemical reaction. There is no mention of any computational analysis, learning, or decision-making processes that would involve AI/ML.
No.
The device is an indicator tape used to distinguish between processed and unprocessed units in sterilization cycles, not to treat or diagnose a disease or condition.
No
The device is a chemical indicator tape used to confirm that items have been processed through a sterilization cycle by changing color. It does not diagnose any medical condition or disease.
No
The device is a physical indicator tape with a chemical indicator, not a software program. The description details its material composition and physical performance characteristics.
Based on the provided information, the VERIFY™ VH2O2 Indicator Tape is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to secure items and indicate whether they have been processed through a hydrogen peroxide sterilization cycle. This is a process monitoring function, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is a chemical indicator tape that changes color based on exposure to hydrogen peroxide. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or predicting disease
- Determining the state of health
- Screening for medical conditions
The device falls under the category of a sterilization process indicator, which is used to confirm that a sterilization process has occurred. This is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter.
The tape may be used in the following sterilization cycles:
- · Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014.
The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The VERIFY VH2O2 Indicator Tape was tested in nonclinical testing. Performance of the chemical indicator, CI, was demonstrated by testing in an ANSI/AAMI/ISO 18472:2006-conforming resistometer according to the vapor-phased hydrogen peroxide, Type 1 chemical indicator requirements in ANSI/AAMI/ISO 11140-1:2014. CI performance was also tested in hydrogen peroxide sterilizers (V-Pro and STERRAD) with loads under simulated use conditions under pass and fail conditions. Endpoint stability was tested by evaluating the color of processed tape at various time points when stored at room temperature. Light stability was demonstrated by evaluating the tape after storage outside its packaging before exposure to peroxide sterilization. Tape adhesion was evaluated using ASTM adhesion standard and under simulated use conditions on wrapped loads processed through the sterilizer. Biocompatibility was demonstrated by testing peroxide residual levels of processed tape samples and Off-set testing per ANSI/AAMI/ISO 11140-1:2014. Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014 and tape adhesion after various times of storage within the labeled storage conditions.
Key Results:
- ANSI/AAMI/ISO 11140-1:2014 Vaporized Hydrogen Peroxide Process Indicator Performance Testing: Pass
- Simulated Use: Pass Performance Testing: Pass
- Simulated Use: Fail Performance Testing: Pass
- Endpoint Stability: Pass
- Light Stability after Removal from Packaging: Pass
- Adhesion Evaluation: Pass
- Shelf Life Evaluation: Pass
- Hydrogen Peroxide Residual Testing: Pass
- Off-set (transference) Performance Testing: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
Steris Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K160485
Trade/Device Name: VERIFY™ VH2O2 Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: April 29, 2016 Received: May 2, 2016
Dear Mr. Piotrkowski:
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.
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 devicerelated 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.
1
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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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
2
Indications for Use
510(k) Number (if known) K160485
Device Name VERIFY™ VH2O2 Indicator Tape
Indications for Use (Describe)
The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter.
The tape may be used in the following sterilization cycles:
- · Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the word "STERIS" in a bold, serif typeface. A registered trademark symbol is located to the upper right of the final "S". The text is black against a white background.
Image /page/3/Picture/2 description: The image shows a logo with a series of horizontal, curved lines stacked on top of each other. The lines are all the same color, a light blue, and they create a wave-like pattern. The logo is simple and abstract, with no text or other elements present.
510(k) Summary for VERIFY™ VH2O2 Indicator Tape
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459
Anthony Piotrkowski Contact: Sr. Manager, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 E-mail: tpiotrko@steris.com
Submission Date: May 28, 2016
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape
Device Name 1.
| Trade Name: | VERIFYTM VH2O2 Indicator Tape |
|---|---|
| Common/Usual Name: | Chemical Sterilization Process Indicator |
| Classification Name: | Sterilization Process Indicator |
| (21 CFR 880.2800, JOJ) |
2. Predicate Device
STERRAD® Sealsure™ Chemical Indicator Tape (K111519)
Description of Device 3.
The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014.
The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.
4. Intended Use/ Indications for Use
The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, vellow or lighter.
The tape may be used in the following sterilization cycles:
- . Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
- Standard Cycle of the STERRAD® 100S Sterilizer ●
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer ●
- Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX ● Sterilizer
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape
| Proposed | Predicate (K111519) STERRAD
SEALSURE Chemical Indicator Tape | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VERIFY VH2O2 Indicator Tape | | |
| The VERIFY VH2O2 Indicator Tape
is intended to secure items wrapped
in synthetic wrap materials until used
and to distinguish between processed
and unprocessed units through a
color change from the start color
(pink) to peach, yellow or lighter.
The tape may be used in the
following sterilization cycles:
• Non Lumen, Flexible and Lumen
Cycles of the V-PRO 1, 1 Plus,
maX and 60 Low Temperature
Sterilizers
• Standard Cycle of the
STERRAD® 100S Sterilizer
• Standard and Advanced Cycles of
the STERRAD® NX Sterilizer
• Express, Flex Scope, Duo and
Standard Cycles of the | STERRAD SEALSURE Chemical
Indicator Tape (PN 14202) is a process
indicator (ISO 11140-1:2205) intended
for use by healthcare providers to secure
non-woven sterilization packs and wraps
to be sterilized in the STERRAD
Sterilization Systems.
• Standard Cycle of STERRAD 100S
• Standard Cycle of STERRAD 50
• Standard Cycle of STERRAD 200
• Standard and Advanced Cycles of
STERRAD NX
• Standard, Flex, DUO and EXPRESS
Cycles of STERRAD 100NX
The color of the STERRAD SEALSURE
Chemical Indicator Tape changes from
red to gold (or lighter) when exposed to
hydrogen peroxide and is intended to
differentiate between processed and
unprocessed loads. | Both devices are
chemical indicator
tapes used to secure
packs for
sterilization in
hydrogen peroxide
sterilizers and to
indicate through a
color change that the
packs have been
exposed to hydrogen
peroxide. Testing is
included in this
submission to
demonstrate safe and
effective
performance of the
proposed device in
the indicated cycles. |
5. Description of Safety and Substantial Equivalence
The VERIFY VH2O2 Indicator Tape has equivalent characteristics as compared to its predicate device, STERRAD® Sealsure™ Chemical Indicator Tape. Table 5.2 compares the proposed device's design to the predicate.
| Characteristic | Proposed | Predicate | Comparison |
|---|---|---|---|
| Substrate | Crepe Paper | Crepe Paper | Same |
| Indicator | Proprietary - conforms | ||
| with ISO 11140-1:2014 | |||
| Type 1 requirements | Proprietary - conforms | ||
| with ISO 11140-1:2005 | |||
| Class 1 requirements | Testing included in this | ||
| submission demonstrating | |||
| performance (See Table | |||
| 5.3). | |||
| Adhesive | Proprietary | Proprietary | Testing included in this |
| submission demonstrating | |||
| performance (See Table | |||
| 5.3). | |||
| Color Change | Pink to Peach/Yellow | Red to Gold | Similar start and endpoint |
| colors | |||
| Detection | hydrogen peroxide dose | hydrogen peroxide dose | Same |
| Shelf-life | 3 months to be | ||
| extended as real time | |||
| data allows to a | |||
| projected 24 months | 22 months | Testing included in this | |
| submission to support | |||
| proposed device's shelf life | |||
| when stored under labeled | |||
| conditions (See Table 5.3). | |||
| Storage | |||
| Conditions | 16 - 24°C, | ||
| 30 - 60% RH | 15 - 30°C, | ||
| Dry Conditions |
Table 5.2 Device Comparison
6
TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape
The VERIFY VH2O2 Indicator Tape was tested in nonclinical testing. Performance of the chemical indicator, CI, was demonstrated by testing in an ANSI/AAMI/ISO 18472:2006-conforming resistometer according to the vapor-phased hydrogen peroxide, Type 1 chemical indicator requirements in ANSI/AAMI/ISO 11140-1:2014. CI performance was also tested in hydrogen peroxide sterilizers (V-Pro and STERRAD) with loads under simulated use conditions under pass and fail conditions. Endpoint stability was tested by evaluating the color of processed tape at various time points when stored at room temperature. Light stability was demonstrated by evaluating the tape after storage outside its packaging before exposure to peroxide sterilization. Tape adhesion was evaluated using ASTM adhesion standard and under simulated use conditions on wrapped loads processed through the sterilizer. Biocompatibility was demonstrated by testing peroxide residual levels of processed tape samples and Off-set testing per ANSI/AAMI/ISO 11140-1:2014. Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014 and tape adhesion after various times of storage within the labeled storage conditions. Table 5.3 summarizes the testing performed to demonstrate substantial equivalence.
| Test | Result |
|---|---|
| ANSI/AAMI/ISO 11140-1:2014 Vaporized Hydrogen Peroxide Process | |
| Indicator Performance Testing | Pass |
| Simulated Use: Pass Performance Testing | Pass |
| Simulated Use: Fail Performance Testing | Pass |
| Endpoint Stability | Pass |
| Light Stability after Removal from Packaging | Pass |
| Adhesion Evaluation | Pass |
| Shelf Life Evaluation | Pass |
| Hydrogen Peroxide Residual Testing | Pass |
| Off-set (transference) Performance Testing | Pass |
| Table 5.3 Summary of Nonclinical Tests: | |||
|---|---|---|---|
| -- | -- | ----------------------------------------- | -- |
6. Conclusion
The VERIFY | VH2O2 Indicator Tape is substantially equivalent to the predicate device, STERRAD® Sealsure™ Chemical Indicator Tape. Based on the performance testing provided in this submission and summarized above, the subject device is as safe and as effective as the legally marketed, claimed predicate device.