(139 days)
Not Found
No
The device is a simple chemical indicator that changes color based on physical parameters (time, temperature, steam). There is no mention of any computational processing, algorithms, or learning capabilities.
No
The device is a chemical indicator used to monitor the efficacy of steam sterilization processes, not to diagnose, treat, or prevent disease in humans.
No
Explanation: This device is a chemical indicator used to monitor the efficacy of a steam sterilization process. It indicates whether the conditions for sterilization have been met, but it does not diagnose a medical condition or disease in a patient.
No
The device is a physical chemical indicator strip that changes color based on exposure to steam sterilization parameters. It is not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the efficacy of a steam sterilization process. This process is applied to medical devices or other items to render them sterile, not to diagnose a condition in a patient.
- Mechanism: The device is a chemical indicator that changes color based on exposure to specific sterilization parameters (time, temperature, steam). It does not analyze biological samples (blood, urine, tissue, etc.) from a patient.
- Lack of Patient Interaction: The device is placed within sterilization packs and does not come into direct contact with a patient for diagnostic purposes.
- Performance Studies: The performance studies focus on the indicator's response to sterilization parameters and correlation with biological indicators, not on diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV related to a patient's health.
IVDs are defined as devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that definition. It is a process indicator used in the sterilization of medical devices.
N/A
Intended Use / Indications for Use
The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterilization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
*Gravity: 121 C/250 F - 30 minutes
- Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes
- Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes
- Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes
- Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes
- Vacuum assisted (prevacuum): 135 C/275 F 3 minutes
The OK Plus indicator has the following Stated Values determined in Resistometer: - 121 C/250 F - 15 minutes
- 132 C/270 F - 4 minutes
- 134 C/273 F - 3 minutes
- 135 C/275 F - 2.9 minutes
Product codes
JOJ
Device Description
The OK Plus indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. OK Plus indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from off-white to black. If the parameters do not achieve the required level, the indicator color will be light brown or brown.
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 performance of the OK Plus indicator was verified using half-cycle criterion.
The indicator also meets several requirements of ANSI/AAMI/ISO 11140-1:2014 for chemical indicators and the requirements of FDA Guidance for Industry and FDA Staff: Pre-market Notification [510(k)] Submissions for Chemical Indicators, 2003. It includes conformance with general requirements on the design, verification of sensitivity to steam - dry heat testing, ink transfer, shelf life and stability, as well as ink color change in large chamber hospital type and small chamber table-top sterilizers.
Summary of non-clinical testing:
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Performance testing in Steam BIER vessel | Demonstrate conformance of OK Plus Indicator with the half-cycle requirements. The indicator should demonstrate end-point color when bacteria/spores are deactivated. | Color changes - end-point colors: 121°C - 15 min 00 s - black; 132°C - 4 min 00 s - black; 134°C - 3 min 00 s - black; 135°C - 2 min 54 s - black | Passed |
| Testing in Dry Heat oven | Confirm that OK Plus indicator does not change color in absence of Stam. | When tested in cycles at 140°C+/-2°C and time 30+/1 min as per ANSI/AAMI/ISO 11140-1:2014 the OK Plus indicator should not achieve end color. Also, OK Plus indicator should not demonstrate color change to the end point in 180°C - 60 min dry heat typical cycle which it sufficient to kill biological indicator spores. | Passed |
| Testing against biological indicator | Establish correlation between performance of OK Plus indicator and Steam Biological indicator | The OK Plus indicator should not achieve end-point color before the biological indicator is inactivated. | Passed |
| Single parameter variation testing | Confirm that OK Plus indicator is sensitive to critical sterilization parameters. | Variation of one parameter while other ones are maintained steady. OK Plus indicator should not reach specified end-point black color. | Passed |
| Testing in cycles with parameters typical for healthcare | Demonstrate OK Plus indicator achieves specified end color in typical cycles in hospital-size and table-top sterilizers. | Color change from off-white to black. | Passed |
| Bio-compatibility study and ink transfer test | Demonstrate that the indicator does not create biocompatibility issues to health care professionals and patients. | Evaluation of individual components for biocompatibility and review of biocompatibility of indicators with similar formulation with history on the market. Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and Steam processed samples. | Passed |
| End-point stability and shelf- life study | Confirm that OK Plus indicator has acceptable stability after processing when achieved and not achieved end point color ("Pass" and "Fail" conditions). Demonstrate that OK Plus indicator maintains its performance when tested using real-time shelf-life exposure method | OK Plus indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for at least 6 months. Meet specifications after real-time 48 months shelf-life exposure. | Passed |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 5, 2022
Propper Manufacturing Co., Inc. Andrew Sharavara Chief Technical Officer 36-04 Skillman Avenue Long Island City, New York 11101
Re: K222137
Trade/Device Name: OK Plus Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, Dated: October 24, 2022 Received: October 27, 2022
Dear Andrew Sharavara:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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 -2
for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222137
Device Name OK Plus Indicator
Indications for Use (Describe)
The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterlization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
*Gravity: 121 C/250 F - 30 minutes
-
Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes
-
Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes
-
Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes
-
Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes
- *Vacuum assisted (prevacuum): 135 C/275 F 3 minutes
The OK Plus indicator has the following Stated Values determined in Resistometer:
-
121 C/250 F - 15 minutes
-
132 C/270 F - 4 minutes
-
134 C/273 F - 3 minutes
-
135 C/275 F - 2.9 minutes
| 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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3
K222137 510(k) Summary
| Submitted by:
Address: | Propper Manufacturing Company, Inc.
36-04 Skillman Avenue,
Long Island City, New York 11101 |
|-------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Name: | Andrew Sharavara, Ph.D., Chief Technical Officer |
| Telephone:
Fax:
E-mail: | (800) 832-4300 x149
(718) 482-8909
as@proppermfg.com |
| Date Submitted: | July 15, 2022 |
Device information:
| Device Trade Name: | OK Plus TM indicator |
|---|---|
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Common Name: | Steam Sterilization Indicator |
| Product Code: | JOJ |
| Classification: | Class II (21 C.F.R. 880.2800) |
Description of the Device
The OK Plus indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. OK Plus indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from off-white to black. If the parameters do not achieve the required level, the indicator color will be light brown or brown.
Indications for Use
The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterilization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
4
*Gravity: 121° C/250° F - 30 minutes * Vacuum assisted (prevacuum): 132° C/270° F - 4 minutes * Vacuum assisted (prevacuum): 132° C/270° F - 10 minutes * Vacuum assisted (prevacuum): 134° C/273° F - 3.5 minutes * Vacuum assisted (prevacuum): 134° C/273° F - 4 minutes * Vacuum assisted (prevacuum): 135° C/275° F - 3 minutes
The OK Plus indicator has the following Stated Values determined in Resistometer:
-
- 121° C/250° F 15 minutes
-
- 132° C/270° F 4 minutes
-
- 134° C/273° F 3 minutes
-
- 135° C/275° F 2.9 minutes
Performance
The performance of the OK Plus indicator was verified using half-cycle criterion.
The indicator also meets several requirements of ANSI/AAMI/ISO 11140-1:2014 for chemical indicators and the requirements of FDA Guidance for Industry and FDA Staff: Pre-market Notification [510(k)] Submissions for Chemical Indicators, 2003. It includes conformance with general requirements on the design, verification of sensitivity to steam - dry heat testing, ink transfer, shelf life and stability, as well as ink color change in large chamber hospital type and small chamber table-top sterilizers.
Comparison to Legally Marketed Predicate Device
Comparison of the subject device (OK Plus indicator. Propper Manufacturing Co., Inc) to Predicate device (Chemdye CD29 indicator, K191021, Terragene S.A.).
| Subject device | Predicate device | Comparison | |
|---|---|---|---|
| Product name | OK Plus indicator | Chemdye CD29 indicator, | |
| K191021 | Identical | ||
| Product | |||
| generic | |||
| name | A physical/chemical sterilization | ||
| process indicator | A physical/chemical | ||
| sterilization process | |||
| indicator | Identical | ||
| Product | |||
| code | JOJ | JOJ | Identical |
| Sterilization | |||
| method | Steam sterilization | Steam sterilization | Identical |
| Intended use | Sterilization process indicator | Sterilization process | |
| indicator | Identical | ||
| Types of | Gravity and pre-vacuum. | Gravity and Dynamic air | Identical |
| sterilization | removal (pre-vacuum) | ||
| cycles | |||
| Sterilization | |||
| cycles | 121°C-30 min gravity | ||
| 132°C-4 min pre-vacuum | |||
| 132°C-10 min pre-vacuum | |||
| 134°C-3.5 min pre-vacuum | |||
| 134°C-4 min pre-vacuum | |||
| 135°C-3 min pre-vacuum | 121°C-30 min gravity | ||
| 132°C-15 min gravity | |||
| 132°C-25 min gravity | |||
| 135°C-10 min gravity | |||
| 132°C-4 min pre-vacuum | |||
| 135°C-3 min pre-vacuum | Similar. | ||
| End-point | |||
| specification | 121°C-15 min | ||
| 132°C-4min | |||
| 134°C-3min | |||
| 135°C-2.9 min | 121°C-15 min | ||
| 134°C-3.5 min | Similar | ||
| Device | |||
| design | Paper strip printed with indicator | ||
| ink | Paper strip printed with | ||
| indicator ink | Identical | ||
| Operational | |||
| principle | Color change chemistry | Color change chemistry | Identical |
| Initial color | Off-white | Light yellow | Similar |
| End point | |||
| color | Black | Black | Identical |
| Indicator | |||
| type | Internal indicator | Internal Indicator | Identical |
| Single use | Yes | Yes | Identical |
| Shelf life | 4 years | 5 years | Similar |
| Indications | |||
| for use | The OK Plus indicator is a | ||
| chemical indicator designed for | |||
| monitoring the efficacy of steam | |||
| sterilization process. The | |||
| indicator responds to all critical | |||
| sterilization parameters. The OK | |||
| Plus indicator changes color | |||
| from off-white to black to | |||
| indicate that the conditions of the | |||
| cycle have been met. The | |||
| indicator is intended to be placed | |||
| in each pack, pouch, tray or | |||
| other containment device to | |||
| function as an independent | |||
| monitor of critical parameters for | |||
| the following sterilization cycles: |
121°C-30 min gravity
132°C-4 min pre-vacuum
132°C-10 min pre-vacuum
134°C-3.5 min pre-vacuum
134°C-4 min pre-vacuum | Terragene Chemdye® CD29 is
a chemical process indicator
intended for monitoring the
efficacy of steam sterilization
processes. The chemical
indicator changes from yellow
to dark brown/black to indicate
that the conditions of the cycle
have been met.
121°C-30 min gravity
132°C-15 min gravity
132°C-25 min gravity
135°C-10 min gravity
121°C-30 min gravity
132°C-4 min pre-vacuum
135°C-3 min pre-vacuum | Similar.
The difference is
in the sterilization
cycles |
5
6
| The OK Plus indicator has the |
|---|
| following Stated Values |
| determined in Resistometer: |
| 121°C/250°F - 15 min |
| 132°C/270°F - 4 min |
| 134°C/273°F - 3 min |
| 135°C/275°F -2.9 min |
Summary of non-clinical testing
Provided below is the summary of non-clinical testing that was performed to demonstrate that the subject device met the acceptance criteria for each standard or test method.
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Performance | |||
| testing in Steam | |||
| BIER vessel | Demonstrate conformance of | ||
| OK Plus Indicator with the half- | |||
| cycle requirements. | |||
| The indicator should | |||
| demonstrate end-point color | |||
| when bacteria/spores are | |||
| deactivated. | Color changes - end-point colors: |
121°C - 15 min 00 s - black
132°C - 4 min 00 s - black
134°C - 3 min 00 s - black
135°C - 2 min 54 s - black | Passed |
| Testing in Dry
Heat oven | Confirm that OK Plus indicator
does not change color in
absence of Stam. | When tested in cycles at 140°C+/-2°C and time
30+/1 min as per ANSI/AAMI/ISO 11140-
1:2014 the OK Plus indicator should not
achieve end color.
Also, OK Plus indicator should not
demonstrate color change to the end point in
180°C - 60 min dry heat typical cycle which it
sufficient to kill biological indicator spores. | Passed |
| Testing against
biological
indicator | Establish correlation between
performance of OK Plus
indicator and Steam Biological
indicator | The OK Plus indicator should not achieve
end-point color before the biological indicator
is inactivated. | Passed |
| Single parameter
variation testing | Confirm that OK Plus indicator
is sensitive to critical
sterilization parameters. | Variation of one parameter while other ones
are maintained steady. OK Plus indicator
should not reach specified end-point black
color. | Passed |
| Testing in cycles
with parameters
typical for
healthcare | Demonstrate OK Plus indicator
achieves specified end color in
typical cycles in hospital-size
and table-top sterilizers. | Color change from off-white to black. | Passed |
7
| Bio-compatibility
study and ink
transfer test | Demonstrate that the indicator
does not create biocompatibility
issues to health care
professionals and patients. | Evaluation of individual components for
biocompatibility and review of
biocompatibility of indicators with similar
formulation with history on the market.
Testing according to ISO 11140-1:2014.
Requirement: 6.2.2. No ink transfer should be
observed on unprocessed and Steam processed
samples. | Passed |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| End-point
stability and
shelf- life study | Confirm that OK Plus indicator
has acceptable stability after
processing when achieved and
not achieved end point color
("Pass" and "Fail" conditions).
Demonstrate that OK Plus
indicator maintains its
performance when tested using
real-time shelf-life exposure
method | OK Plus indicators processed in Pass and Fail
cycles at various time points after production
and at the end of shelf life should demonstrate
stable color for at least 6 months.
Meet specifications after real-time 48 months
shelf-life exposure. | Passed |
Conclusion
The OK Plus indicator for steam sterilization is substantially equivalent to the predicate device. OK Plus indicator is as safe, as effective, and performs as well as or better than the legally marketed device K191021.