(150 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/ML. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
This device is a chemical indicator used to verify sterilization processes, not to treat or diagnose a medical condition in a patient.
No.
This device is a chemical indicator used to verify the sterilization process, not to diagnose a medical condition in a patient.
No
The device is a chemical indicator, which is a physical product that changes color based on exposure to a sterilization process. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vaporized hydrogen peroxide sterilization process indicator." Its purpose is to indicate whether a sterilization cycle has occurred by changing color. It is used within or on packs to be sterilized.
- Device Description: The description reinforces that it's a "process indicator" used in sterilization cycles.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with human samples or provide diagnostic information about a patient.
The device is a sterilization process indicator, which is a different category of medical device used to monitor the effectiveness of a sterilization process.
N/A
Intended Use / Indications for Use
The VERIFY® HPU Chemical Indicator is a Type 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System. The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen, Non Lumen, Flexible, or Fast Non Lumen Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, or V-PRO maX 2 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 1C: VERIFY® HPU Chemical Indicator
- Version 2C: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
The Version 1C: VERIFY® HPU Chemical Indicator is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.
The Version 2C: VERIFY® Vaporized H2O2 Process Indicator Adhesive Label is a Type 1 process indicator in accordance with ISO 11140-1:2014 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. Additional testing was completed to simulate typical in-use applications.
Verification activities were performed for "Type 1 Performance Testing" and "V-PRO maX 2 Simulated Use Testing in Lumen, Non Lumen and Flexible Cycles".
The study result for both tests was "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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acceptance Criteria for both Type 1 Performance Testing and V-PRO maX 2 Simulated Use Testing in Lumen, Non Lumen and Flexible Cycles were 100% (FAIL) and >= 90% (PASS).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
February 9, 2018
STERIS Corporation Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K172746
Trade/Device Name: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH202 Process Indicator Adhesive Label Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 9, 2018 Received: January 10, 2018
Dear Bill 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.
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 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);
1
1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K172746
Device Name VERIFY® HPU Chemical Indicator
Indications for Use (Describe)
The VERIFY® HPU Chemical Indicator is a Type 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.
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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 Druq 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."
3
Indications for Use
510(k) Number (if known) K172746
Device Name
VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
Indications for Use (Describe)
The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.
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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 Druq 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."
4
Image /page/4/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is an image of several horizontal wavy lines that are light blue in color.
510(k) Summary For VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
K172746
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: January 23, 2018
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Device Name
| Trade Name: | VERIFY® HPU Chemical Indicator and
VERIFY® Vaporized VH2O2 Process Indicator Adhesive
Label |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models: | Version 1C: VERIFY® HPU Chemical Indicator
Version 2C: VERIFY® Vaporized VH2O2 Process Indicator
Adhesive Label
(Collectively referenced as the VERIFY® V-PRO Chemical
Indicator) |
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR
880.2800, Product Code JOJ) |
| Class: | II |
2. Predicate Device
VERIFY® V-PRO Chemical Indicator (K140515)
3. Device Description
The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen, Non Lumen, Flexible, or Fast Non Lumen Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, or V-PRO maX 2 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 1C: VERIFY® HPU Chemical Indicator ●
- Version 2C: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label ●
The Version 1C: VERIFY® HPU Chemical Indicator is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.
The Version 2C: VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of
6
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 Type 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 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, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.
ട്. Technological Characteristics
The proposed and predicate devices are Type 1 single use process indicators in accordance with ISO 11140-1:2014 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 1B and 2B.
7
| Proposed | K140515 | Comparison | |
|---|---|---|---|
| Feature | VERIFY® V-PRO Chemical | ||
| Indicator - V1C, V2C | VERIFY® V-PRO Chemical | ||
| Indicator - V1B, V2B | |||
| Intended use | The VERIFY® HPU Chemical | ||
| Indicator is a Type 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, Flexible or Fast | |||
| Non Lumen sterilization cycle | |||
| of a V-PRO® Low | |||
| Temperature Sterilization | |||
| System. | |||
| The VERIFY® Vaporized | |||
| VH2O2 Process Indicator | |||
| Adhesive Label is a Type 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, Flexible or Fast | |||
| Non Lumen sterilization cycle | |||
| of a V-PRO® Low | |||
| Temperature Sterilization | |||
| System. | 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 Intended Use | ||
| has been modified in | |||
| the proposed device | |||
| in order to include | |||
| the Fast Non Lumen | |||
| Cycle of the V-PRO | |||
| maX 2 device. | |||
| Also, the indicator | |||
| reference has | |||
| changed from Class | |||
| 1 to Type 1 based | |||
| upon updates to the | |||
| guiding standard | |||
| (ANSI/AAMI/ISO | |||
| 11140-2014). | |||
| Device | |||
| design - | |||
| components | Indicator Ink printed onto spun- | ||
| bonded polyolefin (Version 1C) | |||
| and spun-bonded polyolefin | |||
| with an adhesive and a glassine | |||
| backing (Version 2C). | Indicator Ink printed onto spun- | ||
| bonded polyolefin (Version 1B) | |||
| and spun-bonded polyolefin | |||
| with an adhesive and a glassine | |||
| backing (Version 2B). | The proposed device | ||
| contains the same | |||
| components for | |||
| versions 1C and 2C | |||
| as versions 1B and | |||
| 2B of the predicate | |||
| device, respectively. | |||
| Indicator | |||
| agent | Proprietary formulation | Proprietary formulation | The indicator agent |
| is identical to the | |||
| predicate. | |||
| Proposed | K140515 | Comparison | |
| Feature | VERIFY® V-PRO Chemical | VERIFY® V-PRO Chemical | |
| Indicator - V1C, V2C | Indicator - V1B, V2B | ||
| Sterilization | |||
| method and | |||
| cycles | Vaporized Hydrogen Peroxide | ||
| in the V-PRO 1, V-PRO 1 | |||
| Plus, V-PRO maX, V-PRO 60 | |||
| and V-PRO maX 2 Low | |||
| Temperature Sterilizers | Vaporized Hydrogen Peroxide | ||
| in the V-PRO 1 and V-PRO 1 | |||
| Plus, V-PRO maX and V-PRO | |||
| 60 Low Temperature | |||
| Sterilizers | The sterilization | ||
| cycles for the V- | |||
| PRO maX 2 are | |||
| being added for the | |||
| proposed device. | |||
| Mechanism | |||
| of action | Proprietary | Proprietary | Mechanism of |
| action is identical to | |||
| predicate | |||
| Endpoint | |||
| specifications | No Endpoint Specifications | ||
| (Type 1 Process Indicator) | No Endpoint Specifications | ||
| (Type 1 Process Indicator) | Same | ||
| Side by side | |||
| testing with | |||
| biological | |||
| indicators? | No | No | Same |
| Specification | Conforms to | ||
| ANSI/AAMI/ISO 11140- | |||
| 1:2014 requirements for a | |||
| Type 1 Hydrogen Peroxide | |||
| Chemical Indicator | Conforms to | ||
| ANSI/AAMI/ISO 11140- | |||
| 1:2005 requirements for a | |||
| Class 1 Hydrogen Peroxide | |||
| Chemical Indicator | Proposed device | ||
| conforms to the | |||
| most recent | |||
| standard. |
Table 5-1. Device Comparison Table
8
K172746/S001 STERIS Response to 11/9/17 Request for Additional Information VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
Performance Testing 6.
Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. 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 1C and Version 2C 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, V-PRO 60 and V-PRO maX 2 Low Temperature Sterilization Systems.
9
| Test of 6 Lots | Acceptance Criteria | | Study
Result |
|------------------------------------------------------------------------------------|---------------------|------------|-----------------|
| | FAIL | PASS | |
| Type 1
Performance Testing | 100% | $\geq$ 90% | Pass |
| V-PRO maX 2 Simulated
Use Testing in Lumen,
Non Lumen and Flexible
Cycles | 100% | $\geq$ 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.
7. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as well as the legally marketed predicate device (K140515, Class II (21 CFR 880.2800), product code JOJ.