(90 days)
No
The device is a chemical indicator that changes color based on exposure to specific sterilization parameters. There is no mention of any computational or learning-based processes.
No.
This device is an indicator to demonstrate exposure to a sterilization process, not a device used for therapy or treatment.
No
Explanation: A diagnostic device is used to identify a disease, condition, or medical problem. This device is an indicator used to verify the effectiveness of a sterilization process, not to diagnose a medical condition.
No
The device is a physical chemical indicator (ink on paper with adhesive) that changes color based on exposure to EO gas sterilization conditions. It is 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 demonstrate that a unit or load has been exposed to an EO gas sterilization process and to distinguish between processed and unprocessed items. This is a quality control and process monitoring function for sterilization, not a diagnostic test performed on a biological sample to determine a patient's health status or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to EO gas sterilization conditions. It does not interact with biological samples or provide information about a patient's health.
- Lack of Biological Sample Interaction: IVDs are designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or screening purposes. This device does not use or analyze biological samples.
- Performance Studies: The performance studies focus on the indicator's ability to accurately reflect exposure to sterilization conditions, not on diagnostic accuracy metrics like sensitivity, specificity, etc., which are typical for IVDs.
- Predicate and Reference Devices: The predicate and reference devices are also related to sterilization monitoring (process indicator tapes and biological test packs), not IVD devices.
In summary, the Steri-Dot Process Indicator is a device used to monitor the effectiveness of a sterilization process, which is a quality control measure for medical devices or other items. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
The Steri-Dot process indicator can be used in the following EO sterilization cycles:
-
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
-
- 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
-
- 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure
-
- 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
-
- 55°C, 759 mg/l EO, ≥35% RH, l hour exposure
-
- 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Steri-Dot Process Indicator is a single use chemical indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a substrate paper circle, 3/4" or 1" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.
The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from purple-red to green. If the parameters do not achieve the required level, the indicator color will be brown or red.
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
health care provider
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 Steri-Dot process indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators.
Non-clinical testing was performed as follows:
-
Test: ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 indicator. Purpose: To demonstrate conformance of Steri-Dot indicator to the requirements specified in ISO 11140-1:2014 for process indicators. Acceptance Criteria: 37°C, RH 60%, EO 600mg/l, 3 min: no color change or color markedly different compared to green; 37°C, RH 60%, EO 600mg/l, 25 min: green color; 54°C, RH 60%, EO 600mg/l, 2 min: no color change or color markedly different compared to green; 54°C, RH 60%, EO 600mg/l, 20 min: green color; 60°C, RH ≥85%, EO - none, 90 min: no change. Result: Passed.
-
Test: Testing in EO cycles with parameters used in healthcare sterilization. Purpose: To demonstrate that Steri-Dot Process indicator achieves specified end color in typical cycles. Acceptance Criteria: Color change from purple-red to green. Result: Passed.
-
Test: Biocompatibility study and ink transfer test. Purpose: To demonstrate that the indicator does not create biocompatibility issues to health care professionals and patients. The exposure to health care professional is minimal and well below any identified toxic thresholds for the compounds. Acceptance Criteria: Evaluation of individual components for biocompatibility and indicators with similar formulation with long history of on the market. Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed samples. Result: Passed.
-
Test: End point stability and shelf- life study. Purpose: To confirm that Steri-Dot process indicator has acceptable stability after processing when achieved and not achieved end point color (parameters when tested using real-time shelf-life exposure method). Result: Not explicitly stated, but "Passed" can be inferred from the overall conclusion.
-
Test: Adhesive test – healthcare applications. Purpose: The purpose of the test is to evaluate if the adhesive is suitable for its function and does not deteriorate during sterilization process. Acceptance Criteria: The test is considered a pass if at least 95% of the indicators at different stages of shelf life remain on surfaces of sterilization packaging materials before and after Steri processing. Result: Passed.
Key results: The Steri-Dot process indicator is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
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.
EO Gas Sterilization Process Indicator Tapes, SteriTec Products, Inc., K002861
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.
Proper BI-OK® EO Gas Biological Test Pack, K972747
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2021
Propper Manufacturing Co., Inc. Andrew Sharavara Chief Technical Officer 36-04 Skillman Avenue Long Island City, New York 11101
Re: K210866
Trade/Device Name: Steri-Dot Process Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: March 19, 2021 Received: March 23, 2021
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
1
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) 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 (OS) 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 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,
Clarence W. Murray, III, PhD 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) K210866
Device Name Steri-Dot Process Indicator
Indications for Use (Describe)
The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
The Steri-Dot process indicator can be used in the following EO sterilization cycles:
-
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure 4. 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure 5. 55°C, 759 mg/l EO, ≥35% RH, l hour exposure 6. 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summarv For K210866
| Submitted by: | Propper Manufacturing Company, Inc. |
|---|---|
| Address: | 36-04 Skillman Avenue, |
| Long Island City, New York 11101 | |
| Contact Name: | Andrew Sharavara, Ph.D., Chief Technical Officer |
| Telephone: | (800) 832-4300 x149 |
| Fax: | (718) 482-8909 |
| E-mail: | as@proppermfg.com |
| Date Submitted: | June 21, 2021 |
Device information:
| Device Trade Name: | Steri-Dot® Process Indicator |
|---|---|
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Common Name: | Ethylene Oxide Gas Sterilization Indicator |
| Product Code: | JOJ |
| Classification: | Class II (21 C.F.R. 880.2800) |
Description of the Device
The Steri-Dot Process Indicator is a single use chemical indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a substrate paper circle, 3/4" or 1" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.
The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from purple-red to green. If the parameters do not achieve the required level, the indicator color will be brown or red.
Indications for Use
The Steri-Dot® process indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
4
The Steri-Dot process indicator can be used in the following EO sterilization cycles:
-
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
-
- 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
-
- 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer
-
- 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
-
- 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure
-
- 55°C, 600 mg/1 EO, 40-60% RH, 4 hours exposure
Performance
The performance of the Steri-Dot process indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators.
Technological Characteristic Comparison Table
Comparison of the subject device (Steri-Dot process indicator, Propper Manufacturing Co., Inc) to Predicate device (EO Gas Sterilization Process Indicator Tapes, SteriTec Products, Inc., K002861).
| Product name | Steri-Dot Process Indicator | EO Gas Sterilization
Process Indicator Tapes,
K002861 | Similar. Both
devices have
"process
indicator" in the
names according
to Intended use. | Device purposes | 1.Designed to work as process
indicators to distinguish between
unprocessed and processed items
after EO Gas exposure. | g/m2 paper, with a natural
rubber, C-5 tackifier,
antioxidant adhesive on the
back.
1.Designed to work as
process indicators to
distinguish between
unprocessed and processed
items after EO Gas
exposure.
2. The purpose includes use
as a tape to wrap a
sterilizable article together
as a pack. | are different.
- Identical.
- Significant
difference. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Product generic
name | A physical/chemical sterilization
process indicator | A physical/chemical
sterilization process
indicator | Identical | Back side of
indicators | Adhesive | Adhesive | Identical |
| Product code | JOJ | JOJ | Identical | | | | |
| Sterilization
method | Ethylene Oxide gas sterilization | Ethylene Oxide gas
sterilization | Identical | Initial color | Purple-red | Brown | Similar |
| Intended use | Sterilization process indicator | Sterilization process
indicator | Identical | End point color | Green | Green | Identical |
| Sterilization
method | Ethylene Oxide Gas sterilization. | Ethylene Oxide Gas
sterilization | Identical | FDA indicator | Process indicator | Process indicator | Identical |
| Sterilization
cycles | 37°C, 736 mg/l EO, ≥35% RH, 3 hrs
37°C, 759 mg/l EO, ≥35% RH, 3 hrs
54°C, 600 mg/l EO, 40-60% RH, 45
min or longer
54°C, 736 mg/l EO, ≥35% RH, 1 hour
55°C, 759 mg/l EO, ≥35% RH, 1 hour
55°C, 600 mg/l EO, 40-60% RH, 4 hrs | 54°C(130°F), 600 mg/l EO,
40-60% RH, 45 min or
longer | Similar. Steri-
Dot process
indicator can be
used in several
additional
cycles. | ISO Indicator type | Type 1, process indicator | Type 1, process indicator | Identical |
| Device design | Paper dots with adhesive backing
printed with indicator ink | Cured crepe paper printed
with indicator ink lines.
The tape is manufactured
from a creped, printed,
saturated and backsized 42 | Similar design –
substrate paper
with printed
indicator.
Substrate papers | Single use | Yes | Yes | Identical |
| Shelf life | 42 months | 36 months | Similar | | | | |
| Indications for
use | The Steri-Dot® process indicator for
EO gas sterilization is designed for
use by a health care provider to
demonstrate that the unit or load has
been exposed to an EO gas
sterilization process, and to
distinguish between processed and
unprocessed units or loads. The
indicator dots turn from purple-red to
green when exposed to EO gas
sterilization conditions, thus
providing an indication of processed
items.
The Steri-Dot process indicator can
be used in the following EO
sterilization cycles:
37°C, 736 mg/l EO, ≥35% RH, 3 hrs
37°C, 759 mg/l EO, ≥35% RH, 3 hrs
54°C, 600 mg/l EO, 40-60% RH, 45
min or longer
54°C, 736 mg/l EO, ≥35% RH, 1 hr
55°C, 759 mg/l EO, ≥35% RH, 1 hr
55°C, 600 mg/l EO, 40-60% RH, 4
hrs | The EO Sterilization
Indicator Tape is for use in
ethylene oxide sterilizers
operating at 600 mg/l EO
gas, 40-60% relative
humidity, 130°F, for 45
minutes or longer. The
word "gas" turns green
after exposure to a EO gas
sterilization process, thus
providing identification of
processed items. | Similar. Steri-
Dot process
indicator can be
used in several
additional
cycles. | | | | |
5
Proper BI-OK® EO Gas Biological Test Pack, K972747, was used as a reference device
for stability and shelf-life review because the reference device includes EO sterilization
6
record card – a paper sheet printed with EO indicator ink similar to the ink of Steri-Dot process indicator.
Summary of Non-clinical Testing
Provided below is the 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 |
|---|---|---|---|
| ANSI/AAMI/ISO | |||
| 11140-1:2014 testing | |||
| for Type 1 indicator. | To demonstrate | ||
| conformance of Steri-Dot | |||
| indicator to the | |||
| requirements specified in | |||
| ISO 11140-1:2014 for | |||
| process indicators. | 37°C, RH 60%, EO 600mg/l, 3 min: no color | ||
| change or color markedly different compared | |||
| to green | |||
| 37°C, RH 60%, EO 600mg/l, 25 min: green color | |||
| 54°C, RH 60%, EO 600mg/l, 2 min: no color | |||
| change or color markedly different compared | |||
| to green | |||
| 54°C, RH 60%, EO 600mg/l, 20 min: green color | |||
| 60°C, RH ≥85%, EO - none, 90 min: no change | Passed | ||
| Testing in EO | |||
| cycles with | |||
| parameters used in | |||
| healthcare | |||
| sterilization. | To demonstrate that | ||
| Steri-Dot Process | |||
| indicator achieves | |||
| specified end color in | |||
| typical cycles. | Color change from purple-red to green | Passed | |
| Biocompatibility | |||
| study and ink | |||
| transfer test | To demonstrate that the | ||
| indicator does not create | |||
| biocompatibility issues to | |||
| health care professionals | |||
| and patients. |
The exposure to health
care professional is
minimal and well below
any identified toxic
thresholds for the
compounds. | Evaluation of individual components for
biocompatibility and indicators with similar
formulation with long history of on the
market.
Testing according to ISO 11140-1:2014.
Requirement: 6.2.2. No ink transfer should
be observed on unprocessed and EO
processed samples. | Passed |
| End point stability
and shelf- life study | To confirm that Steri-
Dot process indicator
has acceptable stability
after processing when
achieved and not
achieved end point color
( | | |
| | parameters when tested
using real-time shelf-life
exposure method. | | |
| Adhesive test –
healthcare
applications | The purpose of the test is
to evaluate if the adhesive
is suitable for its function
and does not deteriorate
during sterilization
process. | The test is considered a pass if at least 95% of
the indicators at different stages of shelf life
remain on surfaces of sterilization packaging
materials before and after Steri processing. | Passed |
7
Conclusion
The conclusion drawn from the nonclinical test demonstrate that the Steri-Dot process indicator is as safe, as effective, and performs as well as or better that the legally marketed predicate device.