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:

Gravity: 121°C, 30 minutes
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 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.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Autoclave Indicator Tape

Test	Acceptance Criteria	Reported Device Performance
Steam process indicator performance test (ISO 11140-1:2014 Type 1)	121°C for 10 minutes: black	PASS
	121°C for 2 minutes: no color change or color markedly different compared to black	PASS
	134°C for 2 minutes: black	PASS
	134°C for 0.3 minutes: no color change or color markedly different compared to black	PASS
	140°C for 30 minutes Dry heat: no color change	PASS
Hospital steam sterilizer testing	Color change from yellow to black	PASS
Biocompatibility and ink transfer test (ISO 11140-1:2014, ISO 10993-5, -10, -23)	Individual components should not create biocompatibility issues. No ink transfer observed on unprocessed and steam processed indicators. Subject device is non-toxic, non-irritant, or non-sensitizing.	PASS
End point stability and shelf life study	9 months postexposure signal color retention. Meet specifications after real-time 24 months shelf-life exposure.	PASS
Offset/transference (ISO 11140-1: 2014)	The Autoclave 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 steam sterilization cycles for which it is designed.	PASS
Adhesion test	≥3.8 N/19mm	PASS

EO Indicator Tape

Test	Acceptance Criteria	Reported Device Performance
ISO 11140-1:2014 testing for Type 1 indicator	54°C, RH 60%, EO 600mg/l, 2 min: no color change or color markedly different compared to green	PASS
	54°C, RH 60%, EO 600mg/l, 20 min: green color	PASS
	60°C, RH ≥85%, EO - none, 90 min: no change	PASS
Hospital EO sterilizer testing	Color change from orange to green.	PASS
Biocompatibility and ink transfer test (ISO 11140-1:2014, ISO 10993-5, -10, -23)	Individual components should not create biocompatibility issues. No ink transfer should be observed on unprocessed and EO processed indicators. The subject device is non-toxic, non-irritant, or non-sensitizing.	PASS
End point stability and shelf-life study	9 months postexposure signal color retention. Meet specifications after real-time 18 months shelf-life exposure.	PASS
Offset/transference (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	≥3.8 N/19mm	PASS

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test within the non-clinical testing. However, the tests are performed according to recognized international standards (ISO 11140-1:2014, ISO 10993 series) and FDA guidance, which typically involve specific sample sizes to ensure statistical validity.

The data provenance is not specified beyond "non-clinical testing" conducted by the applicant, Jiangmen New Era External Use Drug Co., Ltd. Given the nature of these tests (e.g., sterilization cycle performance, biocompatibility, adhesion), they are most likely conducted in a controlled laboratory environment. The document does not indicate if the data is retrospective or prospective, but performance testing for regulatory submission is typically prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This section is not applicable. The tests performed are objective chemical and physical performance tests against established international standards and regulatory guidance, rather than subjective evaluations that would require expert human interpretation to establish ground truth.

4. Adjudication Method for the Test Set:

This section is not applicable. The tests performed are objective, with clearly defined pass/fail criteria based on physical and chemical reactions or measurements. There is no indication of an adjudication method being necessary for these types of tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing of the sterilization indicators themselves, not on their use by human readers in a diagnostic capacity or with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was done. The entirety of the "Summary of Non-Clinical Testing" section describes the standalone performance of the Autoclave Indicator Tape and EO Indicator Tape against established standards and criteria for their chemical indicator function. The device itself is the "algorithm" in this context, where it is designed to change color based on exposure to specific sterilization conditions. The tests evaluate this color change and other physical properties directly.

7. Type of Ground Truth Used:

The ground truth used for these studies is based on:

Established International Standards: ISO 11140-1:2014 for chemical indicators for sterilization.
Regulatory Guidance: FDA guidance for industry and FDA staff, "Premarket Notification [510(k)] Submissions for Chemical Indicators."
Defined Physical and Chemical Parameters: Specific temperature, time, and concentration parameters for steam and EO sterilization cycles that should induce a color change, and absence of color change under non-sterilizing conditions or dry heat.
Biocompatibility Standards: ISO 10993-5, ISO 10993-10, and ISO 10993-23 for evaluating biological effects of medical devices.
Material Science Specifications: Criteria for adhesion, offset/transference, and shelf-life.

8. Sample Size for the Training Set:

This information is not provided. The document describes premarket notification (510(k)) testing, which evaluates the final device product against performance criteria. It does not detail any "training set" in the context of machine learning, as these are chemical indicators, not AI/ML-based devices. The "training" for such devices is inherent in the chemical formulation and manufacturing process development.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable as the device is not an AI/ML-based system requiring a training set with established ground truth in that context. The "ground truth" for the development of these chemical indicators would have been established through extensive chemical research, formulation, and iterative testing to achieve the desired color change properties in response to specific sterilization parameters, guided by the ISO standards and regulatory requirements.

Summary

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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 & 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"

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(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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

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Indications for Use

510(k) Number (if known) K241036

Device Name Autoclave Indicator Tape EO Indicator Tape

Indications for Use (Describe)

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

Gravity: 121°C, 30 minutes
Vacuum assisted (pre-vacuum): 134°C, 4 minutes

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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: +86 13119640020 Email: myxuan@kenai-tape.com

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com

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

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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
1. 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:

F. Technological Characteristics Comparison Table

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

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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
Indicationsforuse	Autoclave Indicator Tape isdesigned for use by a health careprovider to demonstrate that theunit or load has been exposed to asteam sterilization process and todistinguish between processed andunprocessed units or loads. Aftersteam sterilization, the chemicalindicator lines will show a visualcolor change from yellow toBlack. This is a single use,disposable device(s), and providednon-sterile.The Autoclave Indicator Tape canbe used in the following steamsterilization cycles:1. Gravity: 121°C, 30 minutes2. Vacuum assisted (pre-vacuum):134°C, 4 minutes	The Steam-Dot process indicatorfor steam sterilization is designedfor use by a health care providerto demonstrate that the unit orload has been exposed to a steamsterilization process, and todistinguish between processedand unprocessed units or loads.The indicator dots turn fromwhite to dark brown/black whenexposed to steam sterilizationconditions, thus providing anindication of processed items.The Steam-Dot process indicatorcan be used in the followingsteam sterilization cycles:Gravity: 121°C/250°F - 30 minPre-vacuum: 132°C/270°F -3minPre-vacuum: 132°C/270°F -4minPre-vacuum: 134°C/273°F -3 minPre-vacuum: 134°C/273°F -4 minPre-vacuum: 135°C/275°F -3 min	SimilarThe subjectdevice hasless steamsterilizationcycle thanpredicatedevice.
Intended use	sterilization process indicator	sterilization process indicator	Same
Sterilizationmethod	Steam sterilization	Steam sterilization	Same
Type ofsterilizationcycles	Gravity and pre-vacuum	Gravity and pre-vacuum	Same
Sterilizationcycles	Gravity: 121°C, 30 minutesVacuum assisted (pre-vacuum):134°C, 4 minutes	121°C-30 min gravity132°C-3 min pre-vacuum132°C-4 min pre-vacuum134°C-3 min pre-vacuum134°C-4 min pre-vacuum135°C-3 min pre-vacuum	SimilarThe subjectdevice hasless steamsterilizationcycle thanpredicatedevice.
Endpointspecification	Change to Black color	Change to Black, dark browncolor	Similar
Initial color	Yellow	White	Similar
Device design	Crepe paper printed withindicator ink lines	Paper dots printed with indicatorink	Similar
Backsideofindicators	Adhesive	Adhesive	Same
Performance	ISO 11140-1:2014	ANSI/AAMI/ISO 11140-1:2014	Same
ISOIndicatortype	Type 1	Type 1	Same
Single use	Yes	Yes	Same
Shelf life	2 years	4 years	Similar

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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
Indicationsforuse	EO Indicator Tape is designed foruse by a health care provider todemonstrate that the unit or loadhas been exposed to an EO gassterilization process andtodistinguish between processed andunprocessed units or loads. Thechemical indicator lines turn fromorange to Green when exposed toEO gas sterilization conditions.This is a single use, disposabledevice(s), and providednon-sterile.The EO Indicator Tape can beused in the following EOsterilization cycle:	The Steri-Dot® process indicatorfor EO gas sterilization isdesigned for use by a health careprovider to demonstrate that theunit or load has been exposed toan EO gas sterilization process,and to distinguish betweenprocessed and unprocessed unitsor loads. The indicator dots turnfrom purple-red to green whenexposed to EO gas sterilizationconditions, thus providing anindication of processed items.The Steri-Dot process indicatorcan be used in the following EO	SimilarThe subjectdevice haslesssterilizationcycle thanpredicatedevice.
	55°C, 762mg/l EO, 40~80%RH, 4	sterilization cycles:1. 37° C, 736 mg/l EO, ≥35%
	hours exposure	RH, 3 hours exposure2. 37° C, 759 mg/l EO, ≥35%RH, 3 hours exposure3. 54°C, 600 mg/l EO, 40-60%RH, 45 min or longer4. 54° C, 736 mg/l EO, ≥35%RH, 1 hour exposure5. 55° C, 759 mg/l EO, ≥35%RH, 1 hour exposure6. 55°C, 600 mg/l EO, 40-60%RH, 4 hours exposure
Intended use	sterilization process indicator	sterilization process indicator	Same
Sterilizationmethod	Ethylene Oxide gas sterilization	Ethylene Oxide gas sterilization	Same
Sterilizationcycles	55°C, 762mg/1 EO, 40~80%RH, 4hours exposure	37° C, 736 mg/l EO, ≥35% RH, 3hrs37° C, 759 mg/l EO, ≥35% RH, 3hrs54°C, 600 mg/1 EO, 40-60% RH, 45min or longer54° C, 736 mg/l EO, ≥35% RH, 1hour55° C, 759 mg/l EO, ≥35% RH, 1hour55°C, 600 mg/l EO, 40-60% RH, 4hrs	Similar.The subjectdevice haslesssterilizationcycle thanpredicatedevice.
Endpointspecification	Change to Green color	Change to green color	Similar
Initial color	Orange	Purple-red	Similar
Device design	Crepe paper printed withindicator ink lines.	Paper dots printed with adhesivebacking printed with indicatorink	Similar
Back side ofindicators	Adhesive	Adhesive	Same
ISO Indicatortype	Type 1	Type 1	Same
Single use	Yes	Yes	Same
Shelf life	18 months	42 months	Similar

K241036

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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 processindicatorperformance testaccording toISO 11140-1:2014 testingfor Type 1indicator andFDA guidance	To demonstrate conformanceof Autoclave indicator tapeto the requirements specifiedin ISO 11140-1:2014 andFDA guidance for industryand FDA staff, "PremarketNotification [510(k)]Submissions for ChemicalIndicators".	121°C for 10 minutes: black121°C for 2 minutes: no colorchange or color markedlydifferent compared to black134°C for 2 minutes: black134°C for 0.3 minutes: no colorchange or color markedlydifferent compared to black140°C for 30 minutes Dry heat:no color change	PASS
Hospital steamsterilizer testing	To demonstrate thatAutoclave indicator tapeachieves specified end colorin typical cycles in hospitalsterilizers.	Color change from yellow toblack	PASS
Biocompatibilityand ink transfertest	To demonstrate that theindicator does not createbiocompatibility issues tohealth care professionals andpatients.	Individual components should notcreate biocompatibility issues.Testing according to ISO11140-1:2014.Requirement: 6.2.2. No inktransfer should be observed onunprocessed and steam processedindicators.Testing according to ISO10993-5, ISO 10993-10 and ISO10993-23. The subject device isnon-toxic, non-irritant ornon-sensitizing.	PASS
End pointstability andshelf life study	Determine the length of timethat an exposed AutoclaveIndicator Tape retains its	9 month	PASS

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	postexposure signal color.To demonstrate thatAutoclave Indicator Tapemeets the performanceparameters when tested usingreal-time shelf-life exposuremethod.	Meet specifications afterreal-time 24 months shelf-lifeexposure.
Offset/transference	Demonstrate the Autoclaveindicator tape do not bleed oroffset to substrate which it'sapplied according to ISO11140-1: 2014.	The Autoclave indicator tapesshall not offset or bleed, penetratethe substrate to which it isapplied, or materials in which it isin contact before, during or afterthe steam sterilization cycles forwhich it is designed.	PASS
Adhesion test	To evaluate if the peeladhesion of the autoclaveindicator tape.	≥3.8 N/19mm	PASS

EO Indicator Tape

Test	Purpose	Acceptance Criteria	Result
ISO 11140-1:2014 testingfor Type 1indicator	To demonstrate conformanceof EO indicator tape to therequirements specified inISO 11140-1:2014 forprocess indicators and theFDA guidance for industryand FDA staff, "PremarketNotification [510(k)]Submissions for ChemicalIndicators".	54°C, RH 60%, EO 600mg/l, 2min: no color change or colormarkedly different compared togreen54°C, RH 60%, EO 600mg/l, 20min: green color60°C, RH ≥85%, EO - none, 90min: no change	PASS
Hospital EOsterilizertesting	To demonstrate that EOindicator tape achievesspecified end color in typicalcycles in hospital sterilizers.	Color change from orange togreen.	PASS
Biocompatibilityand ink transfertest	To demonstrate that theindicator does not createbiocompatibility issues tohealth care professionals andpatients.	Individual components should notcreate biocompatibility issues.Testing according to ISO11140-1:2014.Requirement: 6.2.2. No inktransfer should be observed onunprocessed and EO processedindicators.	PASS

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		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.To demonstrate that Autoclave Indicator Tape meets the performance parameters when tested using real-time shelf-life exposure method.	9 monthMeet 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.

Regulation Number and Section

§ 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).