EO Chex Indicator Tape

K240910 · Propper Manufacturing Co., Inc. · JOJ · Jun 12, 2024 · General Hospital

Device Facts

• Record ID: K240910
• Device Name: EO Chex Indicator Tape
• Applicant: Propper Manufacturing Co., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jun 12, 2024
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The EO Chex indicator tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items. The EO Chex indicator tape can be used in the following EO sterilization cycles: 1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure 2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure 3. 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer 4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure 5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure

Device Story

Single-use, pressure-sensitive adhesive tape; creped, saturated paper substrate; pink indicator ink stripes. Used by healthcare providers to secure sterilization packaging. During EO gas sterilization, indicator ink reacts to critical parameters (time, temperature, relative humidity, EO concentration); color shifts from pink to orange-brown. Provides visual confirmation of exposure to sterilization conditions. Used in clinical settings; compatible with standard tape dispensers. Benefits patient by ensuring clear identification of processed vs. unprocessed surgical/medical packs, reducing risk of using non-sterile items.

Clinical Evidence

Bench testing only. Performance validated per ANSI/AAMI/ISO 11140-1:2014 for Type 1 indicators. Testing confirmed color change (pink to orange-brown) under specified EO cycle parameters, adhesive integrity, and shelf-life stability (24 months). Biocompatibility and ink transfer testing confirmed safety for healthcare professional and patient contact.

Technological Characteristics

Creped, saturated paper substrate; natural rubber and hydrocarbon resin adhesive. Type 1 chemical process indicator (ISO 11140-1:2014). Dimensions: 3/4 inch and 1 inch widths, 55-60 yards long. 3-inch core diameter. No electronic components or software.

Indications for Use

Indicated for use by healthcare providers to secure wrapped packs during Ethylene Oxide (EO) gas sterilization and to visually distinguish between processed and unprocessed packs.

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)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 12, 2024

Propper Manufacturing Co., Inc. Andrew Sharavara Chief Technical Officer 36-04 Skillman Avenue Long Island City, New York 11101

Re: K240910

Trade/Device Name: EO Chex™ Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: April 2, 2024 Received: April 4, 2024

## 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 (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" (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).

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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 QS 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows a digitally signed document by Stephen A. Anisko -S, dated 2024.06.12 at 15:51:31 -04'00'. The document indicates that it is for Christopher Dugard, who is the Assistant Director. It also mentions DHT4B: Division of Infection Control.

and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

Center for Devices and Radiological Health

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Enclosure

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# Indications for Use

510(k) Number (if known) K240910

Device Name EO Chex Indicator Tape

#### Indications for Use (Describe)

The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterlization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The EO Chex indicator tape can be used in the following EO sterilization cycles:

1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure 2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure 3. 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer 4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure 5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure

#### Performance

The performance of the EO Chex indicator tape meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators.

Stated Values

Temperature: 37°C, RH: 60%, Time: 25min, EO: 600mg/L Temperature: 54°C, RH: 60%, Time: 20min, EO: 600mg/L

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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# K240910 510(k) Summary

| 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: | April 2, 2024 |

#### Device information:

| Device Trade Name: | EO Chex™ Indicator Tape |
|----------------------|---------------------------------------------------|
| 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 EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization.

The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown.

The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser.

The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity, and concentration of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming an orange-brown compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve the required level, the indicator ink chemistry changes color from pink to orange-brown. If the parameters do not achieve the required level, the indicator color remains as any shade of pink.

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## EO Chex™ Indicator Tape - Indications for Use

The EO Chex indicator tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The EO Chex indicator tape can be used in the following EO sterilization cycles:

- 1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
- 2. 38°C, 759 mg/L EO, 40-80% RH, 4.5 hours exposure
- 3. 54℃, 600 mg/L EO, 40-60% RH, 45 min or longer
- 4. 55°C, 736 mg/L EO, 40-80% RH, 1 hour exposure
- 5. 55°C, 759 mg/L EO, 40-80% RH, 1 hour exposure

### Performance

The performance of the EO Chex indicator tape meets the requirements of ANSVAAMI/ISO 11140-1:2014 for Type 1 process indicators.

### Stated Values:

Temperature: 37°C, RH: 60%, Time: 25min, EO: 600mg/L Temperature: 54°C, RH: 60%, Time: 20min, EO: 600mg/L

## Technological Characteristic Comparison Table

Comparison of the subject device (EO Chex™ Indicator Tape, Propper Manufacturing Co., Inc.) to Predicate device EO Gas Sterilization Process Indicator Tapes, SteriTec Products, Inc., K002861.

| Parameter | Subject Device | Predicate Device, K002861 | Comparison |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Product Name | EO Chex Indicator Tape | EO Gas Sterilization Process<br>Indicator Tapes | Similar. Both<br>devices are "EO<br>Indicator Tapes" |
| Product Generic<br>Name | A physical/chemical sterilization<br>process indicator | A physical/chemical<br>sterilization process indicator | Identical |
| Product Code | JOJ | JOJ | Identical |
| Sterilization<br>Method | Ethylene Oxide Gas Sterilization | Ethylene Oxide<br>Gas Sterilization | Identical |
| Intended Use | Sterilization process indicator | Sterilization process indicator | Identical |
| Sterilization Cycles | 38°C,736 mg/L EO,40-80% RH, 4.5 hrs<br>38°C,759 mg/L EO,40-80% RH, 4.5 hrs<br>54°C,600 mg/L EO, 40-60% RH, 45<br>min or longer<br>55°C, 736 mg/L EO, 40-80% RH, 1 hr<br>55°C, 759 mg/L EO, 40-80% RH, 1 hr | 54°C(130°F), 600 mg/l EO,<br>40-60% RH, 45 min or longer | Similar. EO-Chex<br>indicator tape can<br>be used in several<br>additional cycles. |
| Device Design | Cured crepe paper printed with<br>indicator ink lines. The tape is<br>manufactured from a creped, printed,<br>saturated paper, with a natural rubber<br>and hydrocarbon resin adhesive on the<br>back. | Cured crepe paper printed<br>with indicator ink lines. The<br>tape is manufactured from a<br>creped, printed, saturated<br>paper with a natural rubber<br>adhesive on the back. | Similar design -<br>substrate paper<br>with adhesive and<br>printed indicator. |
| Device Purposes | 1.Designed to work as process indicators to distinguish between unprocessed and processed items after EO Gas exposure.<br>2.The purpose includes use as a tape to wrap a sterilizable article together as a pack. | 1.Designed to work as process indicators to distinguish between unprocessed and processed items after EO Gas exposure.<br>2.The purpose includes use as a tape to wrap a sterilizable article together as a pack. | Identical. |
| Back Side of the Tapes | Adhesive | Adhesive | Identical |
| Initial Color | Pink | Brown | Different |
| End Point Color | Orange-brown | Green | Different |
| FDA Indicator | EO Process indicator | EO Process indicator | Identical |
| ISO Indicator Type | Type 1, process indicator | Type 1, process indicator | Identical |
| Single Use | Yes | Yes | Identical |
| Shelf Life | 24 months | 36 months | Similar |
| Indications for Use | The EO Chex indicator tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.<br>The EO Chex indicator tape can be used in the following cycles:<br>1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure<br>2. 38°C, 759 mg/L EO, 40-80% RH, 4.5 hours exposure<br>3. 54°C, 600 mg/L EO, 40-60% RH, 45 min or longer<br>4. 55°C, 736 mg/L EO, 40-80% RH, 1 hour exposure<br>5. 55°C, 759 mg/L EO, 40-80% RH, 1 hour exposure | 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. EO Chex indicator tape can be used in several additional cycles. |

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## 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 |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Performance<br>testing in BIER<br>vessel:<br>ANSI/AAMI/<br>ISO 11140-<br>1:2014 testing<br>for Type 1<br>Indicator. | To demonstrate conformance<br>of EO Chex indicator tape to<br>the 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 to<br>orange-brown<br>37°C, RH 60%, EO 600mg/L, 25 min: orange-brown<br>54°C, RH 60%, EO 600mg/L, 2 min: no color change<br>or color markedly different compared to orange-<br>brown<br>54°C, RH 60%, EO 600mg/L, 20 min: orange-brown<br>60°C, RH ≥85%, EO - none, 90 min: no change | Passed |
| Testing in EO<br>cycles with<br>parameters<br>typical for use<br>in healthcare. | To demonstrate that EO Chex<br>indicator tape achieves<br>specified end color in typical<br>cycles. | Color change from pink to orange-brown | Passed |
| Biocompatibili<br>ty study and<br>ink transfer<br>test | To demonstrate that the<br>indicator does not create<br>biocompatibility issues for<br>health care professionals and<br>patients.<br>The exposure to health care<br>professional is minimal and<br>well below any identified<br>toxic thresholds for the<br>compounds. | Evaluation of individual components for<br>biocompatibility and indicators with similar<br>formulation with long history of on the market.<br>Testing according to ISO 11140-1:2014.<br>Requirement: 6.2.2. No ink transfer should be<br>observed on unprocessed and EO processed samples. | Passed |
| End point<br>stability and<br>shelf-life study | To confirm that EO Chex<br>indicator tape has acceptable<br>stability after processing<br>when achieved and not<br>achieved end point color<br>("Pass" and "Fail"<br>conditions).<br>To demonstrate that EO Chex<br>indicator tape meet the<br>performance parameters when<br>tested using real-time shelf-<br>life exposure method. | EO Chex indicator tape processed in Pass and Fail<br>cycles at various time points after production and at<br>the end of shelf-life should demonstrate stable color<br>for 180 days.<br>Met specifications after 24 months of real time shelf-<br>life exposure. | Passed |
| Adhesive test<br>healthcare<br>applications | The purpose of the test is to<br>evaluate if the adhesive is<br>suitable for its function and<br>does not deteriorate during<br>sterilization process. | The test is considered a pass if at least 95% of the<br>indicators at different stages of shelf life remain on<br>surfaces of sterilization packaging materials before<br>and after EO processing. | Passed |

### Conclusion

The conclusion drawn from the non-clinical test demonstrates that the EO Chex™ indicator tape is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K002861.