(24 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
This device is a chemical indicator used for monitoring peracetic acid concentration in sterilant processing systems, not for treating patients.
No
This device is a chemical indicator used for monitoring the concentration of peracetic acid in sterilization systems, rather than diagnosing a medical condition in a patient.
No
The device is a physical chemical indicator consisting of a polypropylene strip with indicator ink, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the concentration of a chemical sterilant (peracetic acid) in a processing system used for medical devices. It is not intended to diagnose a disease, condition, or state of health in a human being.
- Device Description: The device is a chemical indicator that changes color based on the concentration of a chemical. It does not interact with biological samples (blood, urine, tissue, etc.) from a patient.
- Lack of Biological Sample Interaction: IVD devices are designed to perform tests on biological specimens to provide information about a patient's health. This device does not handle or analyze any biological samples.
The device is a quality control indicator for a sterilization process, not a diagnostic tool for a patient.
N/A
Intended Use / Indications for Use
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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 SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end. 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)
No new testing was performed for this submission. This submission revises the product's name, indications for use and, consequently, labeling to list specific liquid chemical processing systems where the CI can be used, changes that raise no new questions of safety or effectiveness.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
December 8, 2023
Steris Anthony Piotrkowski Director Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060
Re: K233654
Trade/Device Name: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 14, 2023 Received: November 14, 2023
Dear Anthony 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
Indications for Use (Describe)
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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)
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Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines that are blue.
510(k) Summary For VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Tony Piotrkowski Contact: Director, Regulatory Affairs (440) 392-7437 Telephone: Email: tony piotrkowski@steris.com
Submission Date: December 7, 2023
Premarket Notification Number; K233654
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
1. Device Name
| Trade Name: | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM
1® endo Liquid Chemical Sterilant Processing Systems |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Models: | LCC016 |
| 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 (K173428)
3. Device Description
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end. 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/Indications for Use:
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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.
6
ડ. Description of Technological Characteristics
The proposed device and its predicate are physically identical. The more descriptive intended use statement will identify use of the Chemical Indicator in specific STERIS automated liquid chemical sterilant processors that use S40 Sterilant Concentrate. This includes the indicator's intended use in the SYSTEM 1E Liquid Chemical Sterilant Processing System and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System.
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.
| Feature | Proposed VERIFY® Chemical
Indicator for SYSTEM 1E® and
SYSTEM 1® endo Liquid Chemical
Sterilant Processing Systems | Predicate K173428
VERIFY Chemical Indicator for
S40 Sterilant | Comparison |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Intended use | The VERIFY® Chemical Indicator for
SYSTEM 1E® and SYSTEM 1® endo
Liquid Chemical Sterilant Processing
Systems is a peracetic acid concentration
indicator for routine monitoring of SYSTEM
1E® and SYSTEM 1® endo Liquid
Chemical Sterilant Processing Systems that
employ S40 Sterilant Concentrate in a
controlled cycle.
The unprocessed Chemical Indicator for
SYSTEM 1E® and SYSTEM 1® endo
Liquid Chemical Sterilant Processing
Systems 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℃, 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® 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 proposed
rewording
focuses on the
specific
processors
which the CI
is intended to
monitor. |
Table 1. Device Comparison Table for Modified Chemical Indicator and Predicate
7
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
| Feature | Proposed VERIFY® Chemical
Indicator for SYSTEM 1E® and
SYSTEM 1® endo Liquid Chemical
Sterilant Processing Systems | Predicate K173428
VERIFY Chemical Indicator for
S40 Sterilant | 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 |
| Indicator agent | Lissamine green B (active dye) and savinyl
orange (background dye) | Lissamine green B (active dye) and
savinyl orange (background dye) | Identical |
| Mechanism of
action | Bleaching of lissamine green B dye as a
result of oxidation, resulting in blue to
beige/pink color change. | Bleaching of lissamine green B dye as a
result of oxidation, resulting in blue to
beige/pink color change. | Identical |
| Peracetic acid
concentration
for the endpoint
color change | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 2 years | 2 years | Identical |
| Open bottle
shelf life | 6 months | 6 months | Identical |
6. Performance Testing
No new testing was performed for this submission. This submission revises the product's name, indications for use and, consequently, labeling to list specific liquid chemical processing systems where the CI can be used, changes that raise no new questions of safety or effectiveness.
7. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K173428), Class II (CFR 880.2800), product code JOJ.