Autoclave Indicator Tape; EO Indicator Tape

K241036 · Jiangmen New Era External Use Drug Co., Ltd. · JOJ · Dec 17, 2024 · General Hospital

Device Facts

• Record ID: K241036
• Device Name: Autoclave Indicator Tape; EO Indicator Tape
• Applicant: Jiangmen New Era External Use Drug Co., Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Dec 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile. The Autoclave Indicator Tape can be used in the following steam sterilization cycles: 1. Gravity: 121°C, 30 minutes 2. Vacuum assisted (pre-vacuum): 134°C, 4 minutes EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile. The EO Indicator Tape can be used in the following EO sterilization cycle: 55°C, 762mg/l EO, 40~80%RH, 4 hours exposure

Device Story

Single-use, disposable chemical indicator tapes; crepe paper substrate with indicator ink lines. Autoclave tape: yellow-to-black color change; EO tape: orange-to-green color change. Used by healthcare providers to visually confirm sterilization exposure of medical units/loads. Tapes applied to items before sterilization; color change indicates exposure to specific sterilization conditions. Prevents use of non-processed items; helps distinguish processed loads. Non-sterile; non-toxic; non-irritant; non-sensitizing.

Clinical Evidence

No clinical data. Bench testing only. Performance verified per ISO 11140-1:2014 for Type 1 indicators, including color change stability, shelf-life, adhesion, and biocompatibility (ISO 10993-5, -10, -23).

Technological Characteristics

Crepe paper substrate with chemical indicator ink; adhesive backing. Type 1 chemical indicator per ISO 11140-1:2014. Non-sterile, single-use. Adhesion strength ≥3.8 N/19mm. No electronic components or software.

Indications for Use

Indicated for healthcare providers to verify exposure of units/loads to steam or EO gas sterilization processes and distinguish processed from unprocessed items. Autoclave tape: steam cycles (121°C/30min gravity; 134°C/4min pre-vacuum). EO tape: EO gas cycle (55°C, 762mg/l EO, 40-80% RH, 4 hours).

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

• Steam-Dot Process Indicator (K210553)
• Steri-Dot® Process Indicator (K210866)

Submission Summary (Full Text)

{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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 17, 2024

Jiangmen New Era External Use Drug Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K241036

Trade/Device Name: Autoclave Indicator Tape; EO Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: JOJ Dated: November 15, 2024 Received: November 15, 2024

Dear Ivy Wang:

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"

{1}------------------------------------------------

(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).

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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

{2}------------------------------------------------

Sincerely,

Stephen A. Anisko -S

Digitally signed by Stephen A. Anisko -S Date: 2024.12.17 08:16:57 -05'00'

for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

### Indications for Use

510(k) Number (if known) K241036

Device Name Autoclave Indicator Tape EO Indicator Tape

#### Indications for Use (Describe)

Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.

The Autoclave Indicator Tape can be used in the following steam sterilization cycles:

1. Gravity: 121°C, 30 minutes

2. Vacuum assisted (pre-vacuum): 134°C, 4 minutes

EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile.

The EO Indicator Tape can be used in the following EO sterilization cycle:

55°C, 762mg/l EO, 40~80%RH, 4 hours exposure

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(K) Summary

# K241036

Prepared date: 2024-12-10 A. Applicant: Jiangmen New Era External Use Drug Co., Ltd Address: No 8 Beiyuan RD., Jianghai Dist., Jiangmen City Guangdong China Contact: Mr. Yingxuan Mu Tel: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo 14th Floor, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

| B. Device: | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Model |
| Autoclave Indicator Tape | 19mm x 50m, 25mm x 50m, 18mm x 50m, 24mm x 50m, 12mm x 50m, 12.5mm x 50m, 19mm x 30m, 25mm x 30m, 12mm x 30m, 19mm x 55m, 25mm x 55m, 18mm x 55m, 24mm x 55m, 12mm x 55m, 12.5mm x 55m, 19mm x 45yards, 25mm x 45yards, 12mm x 45yards, 20mm x 45yards |
| EO Indicator Tape | 19mm x 50m, 25mm x 50m, 18mm x 50m, 24mm x 50m, 12mm x 50m, 12.5mm x 50m, 19mm x 30m, 25mm x 30m, 12mm x 30m, 19mm x 55m, 25mm x 55m, 18mm x 55m, 24mm x 55m, 12mm x 55m, 12.5mm x 55m, 19mm x 45yards, 25mm x 45yards, 12mm x 45yards, 20mm x 45yards |

## R Device:

Common name: Sterilization Indicator

Classification Name: Physical/Chemical Sterilization Process Indicator

Regulation Number: 880.2800

Product Code: JOJ

Device Class: Class II

{5}------------------------------------------------

### C. Predicate device:

| 510(k) Number | Trade Name | Manufacturer |
|---------------|------------------------------|-------------------------------------|
| K210553 | Steam-Dot Process Indicator | Propper Manufacturing Company, Inc. |
| K210866 | Steri-Dot® Process Indicator | Propper Manufacturing Company, Inc. |

#### D. Indications for use of the device:

Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.

The Autoclave Indicator Tape can be used in the following steam sterilization cycles:

- 1. Gravity: 121℃, 30 minutes
- 2. Vacuum assisted (pre-vacuum):

134℃, 4 minutes

EO Indicator Tape 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 chemical indicator lines turn from orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile. The EO Indicator Tape can be used in the following EO sterilization cycle: 55°C, 762mg/l EO, 40~80%RH, 4 hours exposure

#### E. Device Description:

Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.

EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.

### F. Technological Characteristics Comparison Table

| Device | Subject Device | Predicate Device | Result |
|-------------|----------------|------------------|--------|
| 510K number | K241036 | K210553 | - |

{6}------------------------------------------------

| Product name | Autoclave Indicator Tape | Steam-Dot™ Process Indicator | - |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Same |
| Regulation | 880.2800 | 880.2800 | Same |
| Product code | JOJ | JOJ | Same |
| Indications<br>for<br>use | Autoclave Indicator Tape is<br>designed for use by a health care<br>provider to demonstrate that the<br>unit or load has been exposed to a<br>steam sterilization process and to<br>distinguish between processed and<br>unprocessed units or loads. After<br>steam sterilization, the chemical<br>indicator lines will show a visual<br>color change from yellow to<br>Black. This is a single use,<br>disposable device(s), and provided<br>non-sterile.<br>The Autoclave Indicator Tape can<br>be used in the following steam<br>sterilization cycles:<br>1. Gravity: 121°C, 30 minutes<br>2. Vacuum assisted (pre-vacuum):<br>134°C, 4 minutes | The Steam-Dot process indicator<br>for steam sterilization is designed<br>for use by a health care provider<br>to demonstrate that the unit or<br>load has been exposed to a steam<br>sterilization process, and to<br>distinguish between processed<br>and unprocessed units or loads.<br>The indicator dots turn from<br>white to dark brown/black when<br>exposed to steam sterilization<br>conditions, thus providing an<br>indication of processed items.<br>The Steam-Dot process indicator<br>can be used in the following<br>steam sterilization cycles:<br>Gravity: 121°C/250°F - 30 min<br>Pre-vacuum: 132°C/270°F -3min<br>Pre-vacuum: 132°C/270°F -4min<br>Pre-vacuum: 134°C/273°F -3 min<br>Pre-vacuum: 134°C/273°F -4 min<br>Pre-vacuum: 135°C/275°F -3 min | Similar<br>The subject<br>device has<br>less steam<br>sterilization<br>cycle than<br>predicate<br>device. |
| Intended use | sterilization process indicator | sterilization process indicator | Same |
| Sterilization<br>method | Steam sterilization | Steam sterilization | Same |
| Type of<br>sterilization<br>cycles | Gravity and pre-vacuum | Gravity and pre-vacuum | Same |
| Sterilization<br>cycles | Gravity: 121°C, 30 minutes<br>Vacuum assisted (pre-vacuum):<br>134°C, 4 minutes | 121°C-30 min gravity<br>132°C-3 min pre-vacuum<br>132°C-4 min pre-vacuum<br>134°C-3 min pre-vacuum<br>134°C-4 min pre-vacuum<br>135°C-3 min pre-vacuum | Similar<br>The subject<br>device has<br>less steam<br>sterilization<br>cycle than<br>predicate<br>device. |
| Endpoint<br>specification | Change to Black color | Change to Black, dark brown<br>color | Similar |
| Initial color | Yellow | White | Similar |
| Device design | Crepe paper printed with<br>indicator ink lines | Paper dots printed with indicator<br>ink | Similar |
| Back<br>side<br>of<br>indicators | Adhesive | Adhesive | Same |
| Performance | ISO 11140-1:2014 | ANSI/AAMI/ISO 11140-1:2014 | Same |
| ISO<br>Indicator<br>type | Type 1 | Type 1 | Same |
| Single use | Yes | Yes | Same |
| Shelf life | 2 years | 4 years | Similar |

{7}------------------------------------------------

| Device | Subject Device | Predicate Device | Result |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 510K number | K241036 | K210866 | - |
| Product name | EO Indicator Tape | Steri-Dot Process Indicator | - |
| Classification | Class II | Class II | Same |
| Regulation | 880.2800 | 880.2800 | Same |
| Product code | JOJ | JOJ | Same |
| Indications<br>for<br>use | EO Indicator Tape is designed for<br>use by a health care provider to<br>demonstrate that the unit or load<br>has been exposed to an EO gas<br>sterilization process and<br>to<br>distinguish between processed and<br>unprocessed units or loads. The<br>chemical indicator lines turn from<br>orange to Green when exposed to<br>EO gas sterilization conditions.<br>This is a single use, disposable<br>device(s), and provided<br>non-sterile.<br>The EO Indicator Tape can be<br>used in the following EO<br>sterilization cycle: | The Steri-Dot® process indicator<br>for EO gas sterilization is<br>designed for use by a health care<br>provider to demonstrate that the<br>unit or load has been exposed to<br>an EO gas sterilization process,<br>and to distinguish between<br>processed and unprocessed units<br>or loads. The indicator dots turn<br>from purple-red to green when<br>exposed to EO gas sterilization<br>conditions, thus providing an<br>indication of processed items.<br>The Steri-Dot process indicator<br>can be used in the following EO | Similar<br>The subject<br>device has<br>less<br>sterilization<br>cycle than<br>predicate<br>device. |
| | 55°C, 762mg/l EO, 40~80%RH, 4 | sterilization cycles:<br>1. 37° C, 736 mg/l EO, ≥35% | |
| | hours exposure | RH, 3 hours exposure<br>2. 37° C, 759 mg/l EO, ≥35%<br>RH, 3 hours exposure<br>3. 54°C, 600 mg/l EO, 40-60%<br>RH, 45 min or longer<br>4. 54° C, 736 mg/l EO, ≥35%<br>RH, 1 hour exposure<br>5. 55° C, 759 mg/l EO, ≥35%<br>RH, 1 hour exposure<br>6. 55°C, 600 mg/l EO, 40-60%<br>RH, 4 hours exposure | |
| Intended use | sterilization process indicator | sterilization process indicator | Same |
| Sterilization<br>method | Ethylene Oxide gas sterilization | Ethylene Oxide gas sterilization | Same |
| Sterilization<br>cycles | 55°C, 762mg/1 EO, 40~80%RH, 4<br>hours exposure | 37° C, 736 mg/l EO, ≥35% RH, 3<br>hrs<br>37° C, 759 mg/l EO, ≥35% RH, 3<br>hrs<br>54°C, 600 mg/1 EO, 40-60% RH, 45<br>min or longer<br>54° C, 736 mg/l EO, ≥35% RH, 1<br>hour<br>55° C, 759 mg/l EO, ≥35% RH, 1<br>hour<br>55°C, 600 mg/l EO, 40-60% RH, 4<br>hrs | Similar.<br>The subject<br>device has<br>less<br>sterilization<br>cycle than<br>predicate<br>device. |
| Endpoint<br>specification | Change to Green color | Change to green color | Similar |
| Initial color | Orange | Purple-red | Similar |
| Device design | Crepe paper printed with<br>indicator ink lines. | Paper dots printed with adhesive<br>backing printed with indicator<br>ink | Similar |
| Back side of<br>indicators | Adhesive | Adhesive | Same |
| ISO Indicator<br>type | Type 1 | Type 1 | Same |
| Single use | Yes | Yes | Same |
| Shelf life | 18 months | 42 months | Similar |

K241036

{8}------------------------------------------------

{9}------------------------------------------------

### G. 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.

| Autoclave Indicator Tape | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Test | Purpose | Acceptance Criteria | Result |
| Steam process<br>indicator<br>performance test<br>according to<br>ISO 11140-<br>1:2014 testing<br>for Type 1<br>indicator and<br>FDA guidance | To demonstrate conformance<br>of Autoclave indicator tape<br>to the requirements specified<br>in ISO 11140-1:2014 and<br>FDA guidance for industry<br>and FDA staff, "Premarket<br>Notification [510(k)]<br>Submissions for Chemical<br>Indicators". | 121°C for 10 minutes: black<br>121°C for 2 minutes: no color<br>change or color markedly<br>different compared to black<br>134°C for 2 minutes: black<br>134°C for 0.3 minutes: no color<br>change or color markedly<br>different compared to black<br>140°C for 30 minutes Dry heat:<br>no color change | PASS |
| Hospital steam<br>sterilizer testing | To demonstrate that<br>Autoclave indicator tape<br>achieves specified end color<br>in typical cycles in hospital<br>sterilizers. | Color change from yellow to<br>black | PASS |
| Biocompatibility<br>and ink transfer<br>test | To demonstrate that the<br>indicator does not create<br>biocompatibility issues to<br>health care professionals and<br>patients. | Individual components should not<br>create biocompatibility issues.<br>Testing according to ISO<br>11140-1:2014.<br>Requirement: 6.2.2. No ink<br>transfer should be observed on<br>unprocessed and steam processed<br>indicators.<br>Testing according to ISO<br>10993-5, ISO 10993-10 and ISO<br>10993-23. The subject device is<br>non-toxic, non-irritant or<br>non-sensitizing. | PASS |
| End point<br>stability and<br>shelf life study | Determine the length of time<br>that an exposed Autoclave<br>Indicator Tape retains its | 9 month | PASS |

{10}------------------------------------------------

| | postexposure signal color.<br>To demonstrate that<br>Autoclave Indicator Tape<br>meets the performance<br>parameters when tested using<br>real-time shelf-life exposure<br>method. | Meet specifications after<br>real-time 24 months shelf-life<br>exposure. | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Offset/<br>transference | Demonstrate the Autoclave<br>indicator tape do not bleed or<br>offset to substrate which it's<br>applied according to ISO<br>11140-1: 2014. | The Autoclave indicator tapes<br>shall not offset or bleed, penetrate<br>the substrate to which it is<br>applied, or materials in which it is<br>in contact before, during or after<br>the steam sterilization cycles for<br>which it is designed. | PASS |
| Adhesion test | To evaluate if the peel<br>adhesion of the autoclave<br>indicator tape. | ≥3.8 N/19mm | PASS |

# EO Indicator Tape

| Test | Purpose | Acceptance Criteria | Result |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ISO 11140-<br>1:2014 testing<br>for Type 1<br>indicator | To demonstrate conformance<br>of EO indicator tape to the<br>requirements specified in<br>ISO 11140-1:2014 for<br>process indicators and the<br>FDA guidance for industry<br>and FDA staff, "Premarket<br>Notification [510(k)]<br>Submissions for Chemical<br>Indicators". | 54°C, RH 60%, EO 600mg/l, 2<br>min: no color change or color<br>markedly different compared to<br>green<br>54°C, RH 60%, EO 600mg/l, 20<br>min: green color<br>60°C, RH ≥85%, EO - none, 90<br>min: no change | PASS |
| Hospital EO<br>sterilizer<br>testing | To demonstrate that EO<br>indicator tape achieves<br>specified end color in typical<br>cycles in hospital sterilizers. | Color change from orange to<br>green. | PASS |
| Biocompatibility<br>and ink transfer<br>test | To demonstrate that the<br>indicator does not create<br>biocompatibility issues to<br>health care professionals and<br>patients. | Individual components should not<br>create biocompatibility issues.<br>Testing according to ISO<br>11140-1:2014.<br>Requirement: 6.2.2. No ink<br>transfer should be observed on<br>unprocessed and EO processed<br>indicators. | PASS |

{11}------------------------------------------------

| | | Testing according to ISO 10993-5, ISO 10993-10 and ISO 1099-23. The subject device is non-toxic, non-irritant or non-sensitizing. | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| End point stability and shelf-life study | Determine the length of time that an exposed EO Indicator Tape retains its postexposure signal color.<br>To demonstrate that Autoclave Indicator Tape meets the performance parameters when tested using real-time shelf-life exposure method. | 9 month<br>Meet specifications after real-time 18 months shelf-life exposure. | PASS |
| Offset/transference | Demonstrate the EO indicator tape do not bleed or offset to substrate which it's applied according to ISO 11140-1: 2014. | The EO indicator tapes shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the EO sterilization cycles for which it is designed. | PASS |
| Adhesion test | To evaluate if the peel adhesion of the EO indicator tape. | ≥3.8 N/19mm | PASS |

### H. Clinical Test Conclusion

No clinical study is included in this submission.

# I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K210553 and K210866.