Steri-Dot Process Indicator

K210866 · Propper Manufacturing Co., Inc. · JOJ · Jun 21, 2021 · General Hospital

Device Facts

• Record ID: K210866
• Device Name: Steri-Dot Process Indicator
• Applicant: Propper Manufacturing Co., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jun 21, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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: 1. 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

Device Story

Single-use chemical indicator; substrate paper circle with adhesive backing; printed with reactive EO indicator ink. Used by healthcare providers to monitor EO gas sterilization; distinguishes processed from unprocessed items. Input: EO gas sterilization cycle parameters (time, temperature, humidity, gas concentration). Operation: chemical reaction of ink upon exposure to EO gas; color change from purple-red to green indicates processing. Output: visual color change on indicator dot. Benefits: provides visual confirmation of exposure to sterilization conditions; ensures processed items are identifiable. Used in clinical settings; no electronic or software components.

Clinical Evidence

Bench testing only. Conformance to ANSI/AAMI/ISO 11140-1:2014 for Type 1 indicators verified. Testing confirmed color change from purple-red to green across six specified EO sterilization cycles. Biocompatibility and ink transfer testing passed. Adhesive performance verified to remain on packaging materials through sterilization process. Shelf-life stability confirmed via real-time methods.

Technological Characteristics

Single-use paper substrate (3/4" or 1" diameter) with adhesive backing. Reactive chemical indicator ink. Type 1 process indicator per ANSI/AAMI/ISO 11140-1:2014. No energy source, connectivity, or software. Sterilization method: Ethylene Oxide gas.

Indications for Use

Indicated for use by healthcare providers to distinguish between processed and unprocessed units or loads in EO gas sterilization cycles. Applicable to various EO sterilization parameters (37°C-55°C, 45 min-4 hours exposure).

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• EO Gas Sterilization Process Indicator Tapes (K002861)

Reference Devices

• Proper BI-OK® EO Gas Biological Test Pack (K972747)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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:

- 1. 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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# 510(k) Summarv For K210866

| Submitted by: | Propper Manufacturing Company, Inc. |
|-----------------|------------------------------------------------------------|
| Address: | 36-04 Skillman Avenue,<br>Long Island City, New York 11101 |
| Contact Name: | Andrew Sharavara, Ph.D., Chief Technical Officer |
| Telephone: | [phone] x149 |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| 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.

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The Steri-Dot process indicator can be used in the following EO sterilization cycles:

- 1. 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
- 4. 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
- 5. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure
- 6. 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<br>Process Indicator Tapes,<br>K002861 | Similar. Both<br>devices have<br>"process<br>indicator" in the<br>names according<br>to Intended use. | Device purposes | 1.Designed to work as process<br>indicators to distinguish between<br>unprocessed and processed items<br>after EO Gas exposure. | g/m2 paper, with a natural<br>rubber, C-5 tackifier,<br>antioxidant adhesive on the<br>back.<br>1.Designed to work as<br>process indicators to<br>distinguish between<br>unprocessed and processed<br>items after EO Gas<br>exposure.<br>2. The purpose includes use<br>as a tape to wrap a<br>sterilizable article together<br>as a pack. | are different.<br>1. Identical.<br>2. Significant<br>difference. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Product generic<br>name | A physical/chemical sterilization<br>process indicator | A physical/chemical<br>sterilization process<br>indicator | Identical | Back side of<br>indicators | Adhesive | Adhesive | Identical |
| Product code | JOJ | JOJ | Identical | | | | |
| Sterilization<br>method | Ethylene Oxide gas sterilization | Ethylene Oxide gas<br>sterilization | Identical | Initial color | Purple-red | Brown | Similar |
| Intended use | Sterilization process indicator | Sterilization process<br>indicator | Identical | End point color | Green | Green | Identical |
| Sterilization<br>method | Ethylene Oxide Gas sterilization. | Ethylene Oxide Gas<br>sterilization | Identical | FDA indicator | Process indicator | Process indicator | Identical |
| Sterilization<br>cycles | 37°C, 736 mg/l EO, ≥35% RH, 3 hrs<br>37°C, 759 mg/l EO, ≥35% RH, 3 hrs<br>54°C, 600 mg/l EO, 40-60% RH, 45<br>min or longer<br>54°C, 736 mg/l EO, ≥35% RH, 1 hour<br>55°C, 759 mg/l EO, ≥35% RH, 1 hour<br>55°C, 600 mg/l EO, 40-60% RH, 4 hrs | 54°C(130°F), 600 mg/l EO,<br>40-60% RH, 45 min or<br>longer | Similar. Steri-<br>Dot process<br>indicator can be<br>used in several<br>additional<br>cycles. | ISO Indicator type | Type 1, process indicator | Type 1, process indicator | Identical |
| Device design | Paper dots with adhesive backing<br>printed with indicator ink | Cured crepe paper printed<br>with indicator ink lines.<br>The tape is manufactured<br>from a creped, printed,<br>saturated and backsized 42 | Similar design –<br>substrate paper<br>with printed<br>indicator.<br>Substrate papers | Single use | Yes | Yes | Identical |
| Shelf life | 42 months | 36 months | Similar | | | | |
| Indications for<br>use | The Steri-Dot® process indicator for<br>EO gas sterilization is designed for<br>use by a health care provider to<br>demonstrate that the unit or load has<br>been exposed to an EO gas<br>sterilization process, and to<br>distinguish between processed and<br>unprocessed units or loads. The<br>indicator dots turn from purple-red to<br>green when exposed to EO gas<br>sterilization conditions, thus<br>providing an indication of processed<br>items.<br>The Steri-Dot process indicator can<br>be used in the following EO<br>sterilization cycles:<br>37°C, 736 mg/l EO, ≥35% RH, 3 hrs<br>37°C, 759 mg/l EO, ≥35% RH, 3 hrs<br>54°C, 600 mg/l EO, 40-60% RH, 45<br>min or longer<br>54°C, 736 mg/l EO, ≥35% RH, 1 hr<br>55°C, 759 mg/l EO, ≥35% RH, 1 hr<br>55°C, 600 mg/l EO, 40-60% RH, 4<br>hrs | The EO Sterilization<br>Indicator Tape is for use in<br>ethylene oxide sterilizers<br>operating at 600 mg/l EO<br>gas, 40-60% relative<br>humidity, 130°F, for 45<br>minutes or longer. The<br>word "gas" turns green<br>after exposure to a EO gas<br>sterilization process, thus<br>providing identification of<br>processed items. | Similar. Steri-<br>Dot process<br>indicator can be<br>used in several<br>additional<br>cycles. | | | | |

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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

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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<br>11140-1:2014 testing<br>for Type 1 indicator. | To demonstrate<br>conformance of Steri-Dot<br>indicator to the<br>requirements specified in<br>ISO 11140-1:2014 for<br>process indicators. | 37°C, RH 60%, EO 600mg/l, 3 min: no color<br>change or color markedly different compared<br>to green<br>37°C, RH 60%, EO 600mg/l, 25 min: green color<br>54°C, RH 60%, EO 600mg/l, 2 min: no color<br>change or color markedly different compared<br>to green<br>54°C, RH 60%, EO 600mg/l, 20 min: green color<br>60°C, RH ≥85%, EO - none, 90 min: no change | Passed |
| Testing in EO<br>cycles with<br>parameters used in<br>healthcare<br>sterilization. | To demonstrate that<br>Steri-Dot Process<br>indicator achieves<br>specified end color in<br>typical cycles. | Color change from purple-red to green | Passed |
| Biocompatibility<br>study and ink<br>transfer test | To demonstrate that the<br>indicator does not create<br>biocompatibility issues to<br>health care professionals<br>and patients.<br><br>The exposure to health<br>care professional is<br>minimal and well below<br>any identified toxic<br>thresholds for the<br>compounds. | Evaluation of individual components for<br>biocompatibility and indicators with similar<br>formulation with long history of on the<br>market.<br><br>Testing according to ISO 11140-1:2014.<br>Requirement: 6.2.2. No ink transfer should<br>be observed on unprocessed and EO<br>processed samples. | Passed |
| End point stability<br>and shelf- life study | To confirm that Steri-<br>Dot process indicator<br>has acceptable stability<br>after processing when<br>achieved and not<br>achieved end point color<br>( | | |
| | parameters when tested<br>using real-time shelf-life<br>exposure method. | | |
| Adhesive test –<br>healthcare<br>applications | The purpose of the test is<br>to evaluate if the adhesive<br>is suitable for its function<br>and does not deteriorate<br>during sterilization<br>process. | The test is considered a pass if at least 95% of<br>the indicators at different stages of shelf life<br>remain on surfaces of sterilization packaging<br>materials before and after Steri processing. | Passed |

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# 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.