(139 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to a sterilization process, which is a purely chemical reaction and does not involve AI or ML. The document explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
This device is a chemical indicator used to verify the sterilization process of other medical devices, not to directly treat a patient's condition.
No
Explanation: The device is a chemical indicator used to verify that an item has been exposed to a sterilization process, not to diagnose a condition or disease.
No
The device is a physical chemical indicator that changes color based on exposure to a sterilization process. It is described as consisting of a chemical indicator applied to a substrate, with one version including an adhesive. This clearly indicates a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to indicate whether a sterilization process using vaporized hydrogen peroxide has occurred. It's used to distinguish between processed and unprocessed items within a sterilization cycle.
- Device Description: The device is a chemical indicator that changes color based on exposure to the sterilization agent. It's a physical indicator of a process, not a test performed on a biological sample.
- Lack of Biological Sample Testing: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions. This device does not interact with or analyze any biological samples.
- Focus on Sterilization Process: The entire description revolves around the device's function within a sterilization process for medical devices or other items.
In summary, this device is a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non-Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
Product codes
JOJ
Device Description
The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen. Non-Lumen or Flexible Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, or V-PRO 60 Low Temperature Sterilizer. When exposed to the defined processing conditions, the indicator exhibits a visible color change from magenta to yellow.
The VERIFY® V-PRO Chemical Indicator is provided as two formats:
- Version 1B: VERIFY® HPU Chemical Indicator.
- Version 2B: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
The Version 1B: VERIFY® HPU Chemical Indicator is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.
The Version 2B: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.
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
Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005. Additional testing was completed to simulate typical in-use applications.
Study type: Verification activities
Sample size: 6 lots
Key results:
Class 1 Performance Testing: Pass (100% Fail, >= 90% Pass)
V-PRO 60 Simulated Use Testing in Lumen, Non Lumen and Flexible Cycles: Pass (100% Fail, >= 90% Pass)
V-PRO maX Simulated Use Testing in Lumen, Non-Lumen and Flexible Cycles: Pass (100% Fail, >= 90% Pass)
The results of the VERIFY® V-PRO Chemical Indicator performance testing demonstrate that both formats of the device, VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label, perform as intended and the proposed device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
STERIS®
JUL 1 7 2014
510(k) Summary For VERIFY® V-PRO Chemical Indicator
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Manufacturing Facility
Albert Browne Ltd., a subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
Contact:
Bill Brodbeck Director, Regulatory Affairs
Telephone: (440) 392-7690 Fax No: (440) 357-9198 William brodbeck@steris.com
Submission Date:
July 16, 2014
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
1
1. Device Name
| Trade Name: | VERIFY® HPU Chemical Indicator and
VERIFY® Vaporized VH2O2 Process Indicator Adhesive
Label |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models: | Version 1B: VERIFY® HPU Chemical Indicator
Version 2B: VERIFY® Vaporized VH2O2 Process Indicator
Adhesive Label
(Collectively referenced as the VERIFY® V-PRO Chemical
Indicator) |
| Common Name: | Chemical Indicator |
| Class: | II |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR
880.2800, Product Code JOJ) |
2. Predicate Device
Verify® V-PRO Chemical Indicator - Version 1A and 2A (K091174)
3. Device Description
The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen. Non-Lumen or Flexible Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, or V-PRO 60 Low Temperature Sterilizer. When exposed to the defined processing conditions, the indicator exhibits a visible color change from magenta to yellow.
The VERIFY® V-PRO Chemical Indicator is provided as two formats:
- Version 1B: VERIFY® HPU Chemical Indicator .
- Version 2B: VERIFY® Vaporized VH2O2 Process Indicator Adhesive . Label
The Version 1B: VERIFY® HPU Chemical Indicator is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.
The Version 2B: VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of
2
K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR
the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.
4. Indications for Use:
The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
ડ. Description of Safety and Substantial Equivalence
The proposed and predicate devices are single use process indicators for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The differences between the proposed V-PRO Chemical Indicator - Versions 1B and 2B and the predicate VERIFY® V-PRO Chemical Indicator - Version 1A and 2A device are limited to minor physical differences as well as expanding the indications for use statement to include use in the V-PRO 60 Low Temperature Sterilization System. Testing included in this submission demonstrates that the proposed device performs as intended and is substantially equivalent to the predicate device.
6. Technological Characteristics
The proposed and predicate devices are Class 1 single use process indicators in accordance with ISO 11140-1:2005 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The ink, mechanism of action, and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to yellow.
Table 5-1 contains a comparison of technological characteristics and specifications of the proposed VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label to the predicate Verify® V-PRO Chemical Indicator - Version 1A and 2A.
3
K140515 STERIS ABBREVIATED 510(K) PREMARKET NOTIFICATION
VERIFY® V-PRO CHEMICAL INDICATOR
| Feature | Proposed
VERIFY® V-PRO Chemical
Indicator - V1B, V2B | K091174
Verify® V-PRO Chemical
Indicator - V1A, V2A | Comparison |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The VERIFY® HPU Chemical
Indicator is a Class 1
vaporized hydrogen peroxide
sterilization process indicator.
It is designed to distinguish
between processed and
unprocessed units when placed
within packs to be sterilized to
indicate, through a visible
change from magenta to
yellow, when the device has
been exposed to the Lumen,
Non Lumen or Flexible
sterilization cycle of a V-
PRO® Low Temperature
Sterilization System.
The VERIFY® Vaporized
VH2O2 Process Indicator
Adhesive Label is a Class 1
vaporized hydrogen peroxide
sterilization process indicator.
It is designed to distinguish
between processed and
unprocessed units, when
affixed to packs to be
sterilized, through a visible
color change from magenta to
yellow, when the pack has
been exposed to the Lumen,
Non Lumen or Flexible
sterilization cycle of a V-
PRO® Low Temperature
Sterilization System. | The Verify® V-PRO
Chemical Indicator (Version
1A) and the Verify® V-PRO
Chemical Indicator Adhesive
Label (Version 2A) are Class
1 vaporized hydrogen
peroxide sterilization process
indicators that conform to
ANSI/AAMI/ISO 11140-1:
2005. They are designed to
distinguish between processed
and unprocessed units when
placed within (Version 1A) or
affixed to (Version 2A)
sterilization wraps, trays or
pouches to indicate, through a
visible change from magenta
to yellow, when the device
(Version 1A) or pack (Version
2A) has been exposed to a V-
PRO 1 Low Temperature
sterilization process (Lumen
Cycle) or V-PRO 1 Plus Low
Temperature sterilization
process (Lumen or Non-
Lumen cycle). This product is
designed for use exclusively in
the Amsco V-PRO 1 Low
Temperature Sterilization
System and Amsco V-PRO 1
Plus Low Temperature
Sterilization System at 50 °C
using Vaprox™ HC Sterilant.
The Verify® V-PRO
Chemical Indicator (Version
1A) and the Verify® V-PRO
Chemical Indicator Adhesive
Label (Version 2A) intended
for use in vaporized hydrogen
peroxide sterilization
processes. The Verify® V-
PRO Chemical Indicator
(Version 1A) and the Verify®
V-PRO Chemical Indicator
Adhesive Label (Version 2A)
change color from magenta to
yellow when exposed to the
appropriate cycle conditions of
temperature, sterilant | The intended use
statement has been
rearranged for
simplicity for the
proposed device but
conveys a similar
intended use. The
proposed device is
intended to monitor
Lumen, Non Lumen
and Flexible Cycles
of V-PRO 1, 1 Plus
and maX Low
Temperature
Sterilization
Systems as with the
predicate device
with the addition of
adding the claim of
use in the V-PRO 60
Low Temperature
Sterilization System. |
| Feature | Proposed
VERIFY® V-PRO Chemical
Indicator - V1B, V2B | K091174
Verify® V-PRO Chemical
Indicator - V1A, V2A | Comparison |
| Device
design -
components | Indicator Ink printed onto spun-
bonded polyolefin (Versions 1B
and 2B) | Indicator Ink printed onto
Polypropylene (Version 1A) or
spun-bonded polyolefin
(Version 2A) | The proposed device
contains the same
components for
versions 2A and 2B
as version IB of the
predicate device. |
| Indicator
agent | Proprietary formulation | Proprietary formulation | The indicator agent
is identical to the
predicate. |
| Sterilization
method and
cycles | Vaporized Hydrogen Peroxide
in the V-PRO 1, V-PRO 1
Plus, V-PRO maX and V-PRO
60 Low Temperature
Sterilizers | Vaporized Hydrogen Peroxide
in the Amsco V-PRO 1 and
Amsco V-PRO 1 Plus Low
Temperature Sterilizers | The sterilization
cycles for the V-
PRO maX and V-
PRO 60 are being
added for the
proposed device. |
| Mechanism
of action | Proprietary | Proprietary | Mechanism of
action is identical to
predicate |
| Endpoint
specifications | No Endpoint Specifications
(Class 1 Process Indicator) | No Endpoint Specifications
(Class 1 Process Indicator) | Same |
| Side by side
testing with
biological
indicators? | No | No | Same |
| Specification | Conforms to
ANSI/AAMI/ISO 11140-
1:2005 requirements for a
Class I Hydrogen Peroxide
Chemical Indicator | Conforms to
ANSI/AAMI/ISO 11140-
1:2005 requirements for a
Class I Hydrogen Peroxide
Chemical Indicator | Same |
Table 5-1. Device Comparison Table
4
K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR
7. Performance Testing
Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005. Additional testing was completed to simulate typical in-use applications.
Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the proposed VERIFY® V-PRO Chemical Indicator - Version 1B and Version 2B is safe and effective. These studies confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria and intended uses, and qualify the proposed device for use in the V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems.
5
K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR
| Test of 6 Lots | Acceptance Criteria | Study | |
|---|---|---|---|
| FAIL | PASS | Result | |
| Class 1 | |||
| Performance Testing | 100% | $\u2265$ 90% | Pass |
| V-PRO 60 Simulated Use | |||
| Testing in Lumen, Non | |||
| Lumen and Flexible Cycles | 100% | $\u2265$ 90% | Pass |
| V-PRO maX Simulated | |||
| Use Testing in Lumen, | |||
| Non-Lumen and Flexible | |||
| Cycles | 100% | $\u2265$ 90% | Pass |
Table 5-2. Verification Results Summary
The results of the VERIFY® V-PRO Chemical Indicator performance testing demonstrate that both formats of the device, VERIFY® HPU Chemical Indicator and VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label, perform as intended and the proposed device is substantially equivalent to the predicate device.
8. Conclusion
The proposed device contains the same indicator agent on the same substrate with the minor addition of the adhesive on the VERIFY® Vaporized (VH2O2) Process Indicator Adhesive Label. The indications for use vary only in the addition of claims for a new sterilizer. Testing included in this submission demonstrates that the VERIFY® V-PRO Chemical Indicator performance testing demonstrate that both formats of the device, VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label, perform as intended and the proposed device is substantially equivalent to the predicate device.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
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: K140515
Trade/Device Name: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label Regulation Number: 21 CFR 880.2800 Regulation Name: Process Indicators Regulatory Class: II Product Code: JOJ Dated: June 19, 2014 Received: June 20, 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 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.
7
Page 2 - Dr. 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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/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
8
Indications for Use
510(k) Number (if known): K140515
VERIFY® HPU Chemical Indicator and Device Name: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
Indications For Use:
The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non-Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
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)
Elizabeth F. Claverie -
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 19:14:13 -04'00'
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