(71 days)
Not Found
No
The device is a chemical indicator tape that changes color based on exposure to specific sterilization parameters. There is no mention of any computational analysis, learning, or decision-making processes that would involve AI or ML.
No.
The device is an indicator tape used to confirm exposure to an EO gas sterilization process, not to treat or diagnose a medical condition.
No.
The device is an indicator tape used to confirm exposure to an EO gas sterilization process, distinguishing between processed and unprocessed packs. It does not diagnose medical conditions.
No
The device is a physical indicator tape that changes color based on exposure to Ethylene Oxide gas sterilization conditions. It is a hardware device, 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 secure wrapped packs for sterilization and to indicate whether a pack has been exposed to an EO gas sterilization process. This is a quality control and process monitoring function for sterilization, not a diagnostic test performed on a biological sample.
- Device Description: The device is a tape with a chemical indicator that changes color based on exposure to sterilization conditions. It does not interact with or analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for the diagnosis, treatment, or prevention of disease
- Measuring analytes or biomarkers
- Using reagents or assays for biological reactions
The device is clearly a sterilization process indicator, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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 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:
- 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
- 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure
- 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer
- 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure
- 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure
Product codes
JOJ
Device Description
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.
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)
Performance testing in BIER vessel: ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 Indicator.
Purpose: To demonstrate conformance of EO Chex indicator tape 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 orange-brown
37°C, RH 60%, EO 600mg/L, 25 min: orange-brown
54°C, RH 60%, EO 600mg/L, 2 min: no color change or color markedly different compared to orange-brown
54°C, RH 60%, EO 600mg/L, 20 min: orange-brown
60°C, RH >=85%, EO - none, 90 min: no change
Result: Passed
Testing in EO cycles with parameters typical for use in healthcare.
Purpose: To demonstrate that EO Chex indicator tape achieves specified end color in typical cycles.
Acceptance Criteria: Color change from pink to orange-brown
Result: Passed
Biocompatibility study and ink transfer test
Purpose: To demonstrate that the indicator does not create biocompatibility issues for 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
End point stability and shelf-life study
Purpose: To confirm that EO Chex indicator tape has acceptable stability after processing when achieved and not achieved end point color ("Pass" and "Fail" conditions). To demonstrate that EO Chex indicator tape meet the performance parameters when tested using real-time shelf-life exposure method.
Acceptance Criteria: EO Chex indicator tape processed in Pass and Fail cycles at various time points after production and at the end of shelf-life should demonstrate stable color for 180 days. Met specifications after 24 months of real time shelf-life exposure.
Result: Passed
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 EO processing.
Result: 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 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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Enclosure
3
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:
- 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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4
K240910 510(k) Summary
| 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: | 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.
5
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:
-
- 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
-
- 38°C, 759 mg/L EO, 40-80% RH, 4.5 hours exposure
-
- 54℃, 600 mg/L EO, 40-60% RH, 45 min or longer
-
- 55°C, 736 mg/L EO, 40-80% RH, 1 hour exposure
-
- 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 | |
| Indicator Tapes | Similar. Both | ||
| devices are "EO | |||
| Indicator Tapes" | |||
| Product Generic | |||
| Name | A physical/chemical sterilization | ||
| process indicator | A physical/chemical | ||
| sterilization process indicator | Identical | ||
| Product Code | JOJ | JOJ | Identical |
| Sterilization | |||
| Method | Ethylene Oxide Gas Sterilization | Ethylene Oxide | |
| 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 | ||
| 38°C,759 mg/L EO,40-80% RH, 4.5 hrs | |||
| 54°C,600 mg/L EO, 40-60% RH, 45 | |||
| min or longer | |||
| 55°C, 736 mg/L EO, 40-80% RH, 1 hr | |||
| 55°C, 759 mg/L EO, 40-80% RH, 1 hr | 54°C(130°F), 600 mg/l EO, | ||
| 40-60% RH, 45 min or longer | Similar. EO-Chex | ||
| indicator tape can | |||
| be used in several | |||
| additional cycles. | |||
| Device Design | Cured crepe paper printed with | ||
| indicator ink lines. The tape is | |||
| manufactured from a creped, printed, | |||
| saturated paper, with a natural rubber | |||
| and hydrocarbon resin adhesive on the | |||
| back. | Cured crepe paper printed | ||
| with indicator ink lines. The | |||
| tape is manufactured from a | |||
| creped, printed, saturated | |||
| paper with a natural rubber | |||
| adhesive on the back. | Similar design - | ||
| substrate paper | |||
| with adhesive and | |||
| printed indicator. | |||
| Device Purposes | 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. | 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. | 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. | ||
| The EO Chex indicator tape can be used in the following cycles: |
- 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
- 38°C, 759 mg/L EO, 40-80% RH, 4.5 hours exposure
- 54°C, 600 mg/L EO, 40-60% RH, 45 min or longer
- 55°C, 736 mg/L EO, 40-80% RH, 1 hour exposure
- 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. |
6
7
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 | |||
| testing in BIER | |||
| vessel: | |||
| ANSI/AAMI/ | |||
| ISO 11140- | |||
| 1:2014 testing | |||
| for Type 1 | |||
| Indicator. | To demonstrate conformance | ||
| of EO Chex indicator tape 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 | |||
| orange-brown | |||
| 37°C, RH 60%, EO 600mg/L, 25 min: orange-brown | |||
| 54°C, RH 60%, EO 600mg/L, 2 min: no color change | |||
| or color markedly different compared to orange- | |||
| brown | |||
| 54°C, RH 60%, EO 600mg/L, 20 min: orange-brown | |||
| 60°C, RH ≥85%, EO - none, 90 min: no change | Passed | ||
| Testing in EO | |||
| cycles with | |||
| parameters | |||
| typical for use | |||
| in healthcare. | To demonstrate that EO Chex | ||
| indicator tape achieves | |||
| specified end color in typical | |||
| cycles. | Color change from pink to orange-brown | Passed | |
| Biocompatibili | |||
| ty study and | |||
| ink transfer | |||
| test | To demonstrate that the | ||
| indicator does not create | |||
| biocompatibility issues for | |||
| 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 EO Chex | ||
| indicator tape has acceptable | |||
| stability after processing | |||
| when achieved and not | |||
| achieved end point color | |||
| ("Pass" and "Fail" | |||
| conditions). | |||
| To demonstrate that EO Chex | |||
| indicator tape meet the | |||
| performance parameters when | |||
| tested using real-time shelf- | |||
| life exposure method. | EO Chex indicator tape processed in Pass and Fail | ||
| cycles at various time points after production and at | |||
| the end of shelf-life should demonstrate stable color | |||
| for 180 days. | |||
| Met specifications after 24 months of real time shelf- | |||
| life exposure. | Passed | ||
| 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 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.