(120 days)
Not Found
No
The device is a simple chemical indicator that changes color based on chemical concentration and temperature, with no mention of AI or ML in the description or performance studies.
No.
The device is a chemical indicator used to monitor the concentration of a sterilant, not to treat a medical condition or disease.
No
This device is a chemical indicator used to monitor the concentration of a sterilant, not to diagnose a medical condition in a patient.
No
The device is a physical chemical indicator consisting of a polypropylene strip with ink, 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 monitor the concentration of a sterilant (peracetic acid) in an automated processing system. This is a quality control measure for the sterilization process itself, not a test performed on a biological sample from a patient to diagnose a condition or provide information about their health.
- Device Description: The device is a chemical indicator that changes color based on the concentration of the sterilant. It does not interact with or analyze biological samples.
- Lack of Biological Sample Interaction: There is no mention of the device being used with blood, urine, tissue, or any other biological material.
- Focus on Sterilization Process: The entire description revolves around monitoring the effectiveness of a sterilization process for medical devices.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The VERIFY Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of automated STERIS liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator changes color from blue through an intermediate beige and then to the endpoint color, pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 sterilant use dilution.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The VERIFY® Chemical Indicator for S40 Sterilant is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end.
The subject device is physically identical to the predicate device.
The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevent the indicator ink from leaching from the substrate. The indicator monitors the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in an automated liquid chemical sterilant processing system that uses S40 Sterilant Concentrate and provides a controlled 6-minute exposure at 45.5 - 60°C during a processing cycle.
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 following table summarizes the non-clinical performance testing of the identical predicate device that has demonstrated that the product is safe and effective. This submission revises the product's name and its indications for use description, changes that raise no new questions of safety or effectiveness.
- Testing: Comparative Sensitivity and Specificity, Results: PASS
- Testing: Color Read Time, Results: PASS
- Testing: Analytic Specificity, Results: PASS
- Testing: Blind Reader, Results: PASS
- Testing: Simulated Use Testing, Results: PASS
- Testing: UV Study, Results: PASS
- Testing: Shelf Life for 24 months, Results: PASS
- Testing: Effects of Aggressive Chemicals, Results: PASS
- Testing: Effects of Contaminants, Results: PASS
- Testing: Open Bottle Stability for 6 months, Results: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Comparative Sensitivity and Specificity: 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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a circular emblem with abstract shapes, and the text is arranged in three lines, with "FDA" in a black square.
May 18, 2018
STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K173428
Trade/Device Name: VERIFY Chemical Indicator for S40 Sterilant Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 31, 2018 Received: February, 2018
Dear Marcia Benedict:
This letter corrects our substantially equivalent letter of March 2, 2018.
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
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
Page 2 - Marcia Benedict
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); manufaceaning product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 medical devices and radiation-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/CDRHLeam). 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,
Tina Kiang
-S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
VERIFY® Chemical Indicator for S40® Sterilant
Indications for Use (Describe)
The VERIFY Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of automated STERIS liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator changes color from blue through an intermediate beige and then to the endpoint color, pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 sterilant use dilution.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and is above a symbol that looks like several horizontal wavy lines stacked on top of each other. The registered trademark symbol is to the right of the word STERIS.
510(k) Summary For VERIFY® Chemical Indicator for S40 Sterilant
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
.
Marcia L. Benedict Senior Director, Regulatory Affairs (440) 392-7063 Telephone: (440) 357-9198 Fax No:
February 6, 2018 Submission Date:
Premarket Notification Number: K173428
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
Device Name 1.
| Trade Name: | VERIFY® Chemical Indicator for S40 Sterilant |
|---|---|
| Models: | N/A |
| Common Name: | Chemical Indicator. |
| Classification Name: | Physical/chemical sterilization process indicator |
| Classification | 21 CFR 880.2800 |
| Product Code | JOJ |
2. Predicate Device
VERIFY® Chemical Indicator for SYSTEM 1E Processor (K102217)
3. Device Description
The VERIFY® Chemical Indicator for S40 Sterilant is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end.
The subject device is physically identical to the predicate device.
The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevent the indicator ink from leaching from the substrate. The indicator monitors the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in an automated liquid chemical sterilant processing system that uses S40 Sterilant Concentrate and provides a controlled 6-minute exposure at 45.5 - 60°C during a processing cycle.
4. Intended Use
The VERIFY® Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of STERIS automated liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator changes color from blue through an intermediate beige and then to the endpoint color, pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 sterilant use dilution.
5
Description of Technological Similarities and Differences ડ.
The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored are identical.
The proposed device, like the predicate, indicates exposure to a targeted effective concentration of peracetic acid by a color change from blue through intermediate beige and then pink endpoint color when exposed for 6 minutes to concentrations of peracetic acid greater than 1820 ppm at 45.5 - 60°C during the liquid chemical sterilant processing system's standard cycle.
The more descriptive intended use statement will enable use of the VERIFY Chemical Indicator for S40 Sterilant in STERIS automated liquid chemical sterilant processors that use S40 Sterilant Concentrate and provide the same specific described and validated liquid chemical sterilant exposure parameters in a controlled automated cycle.
| Feature | K173428 - Proposed
VERIFY® Chemical
Indicator for S40 Sterilant | K102217 - Predicate
VERIFY® Chemical
Indicator for SYSTEM 1E
Processor | Comparison |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The VERIFY Chemical
Indicator for S40 Sterilant is a
peracetic acid concentration
indicator for routine monitoring
of STERIS automated liquid
chemical sterilant processing
systems that employ S40
Sterilant Concentrate in a
controlled cycle.
The unprocessed VERIFY
Chemical Indicator for S40
Sterilant is blue. When exposed
in a STERIS automated liquid
chemical sterilant processor to a
concentration of >1820 ppm
(mg/L) peracetic acid found in
the S40 use dilution during a
controlled 6-minute exposure at
45.5 - 60°C, the indicator
changes color from blue through
an intermediate beige and then to
the endpoint color, pink. The
indicator may become more pink
when exposed to higher
peracetic acid concentrations in
S40 sterilant use dilution. | The VERIFY SYSTEM 1E
Chemical Indicator (SYSTEM
1E Chemical Indicator) is a
peracetic acid concentration
indicator for routine monitoring
of the SYSTEM 1E Liquid
Chemical Sterilant Processing
System employing S40 Sterilant
Concentrate.
The unprocessed Verify
SYSTEM 1E Chemical Indicator
is blue. When exposed to a
concentration of >1820 ppm
(mg/L) peracetic acid found in
the S40 use dilution, the
indicator changes color from
blue through an intermediate
beige and then to the endpoint
color pink. The indicator may
become more pink when
exposed to higher peracetic acid
concentrations in S40 use
dilution. | The proposed
descriptive
wording
focuses on the
S40 sterilant
and the liquid
chemical
sterilization
cycle exposure
parameters
monitored
rather than on
a specific
processing
system name. |
Table 1. Device Comparison Table
6
K173428/S001 STERIS Response to 12/29/17 Request for Additional Information VERIFY Chemical Indicator for S40 Sterilant
| Feature | K173428 - Proposed
VERIFY® Chemical
Indicator for S40 Sterilant | K102217 - Predicate
VERIFY® Chemical
Indicator for SYSTEM 1E
Processor | Comparison |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device
design -
components | Printed indicator ink printed onto
polypropylene overlaid with a
clear, permeable laminate | Printed indicator ink printed onto
polypropylene overlaid with a
clear, permeable laminate | Identical |
| Sterilization
method and
cycles | Used in a liquid chemical
sterilant processing system
employing S40 Sterilant
Concentrate to form a use
dilution concentration of ≥1820
ppm (mg/L) peracetic acid and
provide 6 minutes exposure at
45.5 - 60°C. | Used in a liquid chemical
sterilant processing system
employing S40 Sterilant
Concentrate to form a use
dilution concentration of ≥1820
ppm (mg/L) peracetic acid and
provide 6 minutes exposure at
45.5 - 60°C. | Identical |
| Mechanism
of action | Ink ingredients change color as a
result of oxidation, resulting in
blue to beige/pink color change. | Ink ingredients change color as a
result of oxidation, resulting in
blue to beige/pink color change. | Identical |
| Peracetic
acid concen-
tration for
the endpoint
color change | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 15 months;
pending change to 2 years | 15 months;
pending change to 2 years | Identical |
| Open bottle
shelf life | 6 months | 6 months | Identical |
Description of Safety and Substantial Equivalence 6.
The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored by the strip are identical.
The proposed device, like the predicate, indicates exposure to a targeted effective concentration of peracetic acid by a color change from blue through intermediate beige and then pink endpoint color when exposed for 6 minutes to concentrations of peracetic acid greater than 1820 ppm at 45.5 - 60°C during the liquid chemical sterilant processing system's standard cycle.
7. Performance Testing
The following table summarizes the non-clinical performance testing of the identical predicate device that has demonstrated that the product is safe and
7
effective. This submission revises the product's name and its indications for use description, changes that raise no new questions of safety or effectiveness.
| Testing | Results |
|---|---|
| Comparative Sensitivity and Specificity | PASS |
| Color Read Time | PASS |
| Analytic Specificity | PASS |
| Blind Reader | PASS |
| Simulated Use Testing | PASS |
| UV Study | PASS |
| Shelf Life for 24 months | PASS |
| Effects of Aggressive Chemicals | PASS |
| Effects of Contaminants | PASS |
| Open Bottle Stability for 6 months | PASS |
8. Conclusion
The VERIFY Chemical Indicator for S40 Sterilant has met the established performance criteria. Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K102217), Class II (CFR 880.2800), product code JOJ.