Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical sterilization package/reel with chemical indicators. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.

Therapeutic

No

Explanation: The device is a sterilization package used to maintain the sterility of other medical devices. It does not directly treat or diagnose a medical condition in a patient.

Diagnostic

No

The device is a sterilization package/reel used to enclose medical devices for sterilization and maintain their sterility. Its external chemical indicators show successful exposure to sterilization processes (steam or EO) but do not diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization package/reel made of materials like paper and film, designed to enclose medical devices for sterilization and maintain their sterility. It includes physical components like seals and chemical ink indicators. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. It is not used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical properties of the packaging, the sterilization process, and the chemical indicators that show exposure to sterilization agents. It does not describe any components or functions related to analyzing biological samples.
Performance Studies: The performance studies evaluate the effectiveness of the sterilization process, the integrity of the packaging, and the functionality of the chemical indicators. They do not involve testing or analyzing human specimens.

IVD devices are specifically designed to be used in vitro (outside the body) to test samples like blood, urine, or tissue to provide medical information. This device's function is related to the sterilization and storage of other medical devices, not the analysis of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes. · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃(140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel. The following table (Table 1) lists the model numbers of the Sterilization Package/Reel by type, model, dimensions, and content/max. load (lbs.):

Product codes (comma separated list FDA assigned to the subject device)

FRG, JOJ

Device Description

The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains the sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post Steam or EO gas sterilization. The Self-seal Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization. The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas. The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

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 workers

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)

Summary of non-clinical and performance testing bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The test results demonstrated the subject device is confirmed to be safe and effective for the intended use.

Test Item: Sterilization Process Validation

Test Methodology: ISO 11135:2014; ISO 17665-1:2006; ISO TS 17665-2:2009
Acceptance Criteria or End Point: Ethylene oxide: 60 minutes at 55 °C; relative humidity between 50%- 80%; ethylene oxide concentration is 735 mg/L, 8 hours aeration time at 60°C (140°F). SAL=10-6. Steam; 4 minutes at 132°C; 30 minutes dry time. SAL=10-6.
Test Results: SAL=10-6 Pass

Test Item: EO/ECH Residuals

Test Methodology: ISO 10993-7:2008
Acceptance Criteria or End Point: EO 3.2 Kpa or No Burst
Test Results: Pass
Test Methodology: ASTM F1929-15
Acceptance Criteria or End Point: The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration)
Test Results: No Infiltration Pass
Test Methodology: ASTM F88/F88M-21
Acceptance Criteria or End Point: Seal strength > 2.5 (N/15mm)
Test Results: Pass
Test Methodology: ISO 1924-2:2008
Acceptance Criteria or End Point: Tensile strength: CD ≥ 2.2KN/m, MD ≥ 4.4KN/m
Test Results: Pass
Test Methodology: ASTM F2096-11
Acceptance Criteria or End Point: No Leakage
Test Results: No Leakage Pass
Test Methodology: DIN 58953-6
Acceptance Criteria or End Point: CFU = 0
Test Results: CFU = 0 Pass
Test Methodology: ISO 5636-3
Acceptance Criteria or End Point: 10-50 mL/min·m²
Test Results: 20-30 mL/min·m² Pass

Test Item: Chemical Indicator Efficacy Testing

Test Methodology: ISO 11140-1:2014
Acceptance Criteria or End Point: 1. Remain stable before use based on its shelf life. 2. Maintain the endpoint stability of the color change after being in the presence of the sterilant. Steam: The color of CI changes from blue to black, when exposed to Steam; EO: The color of CI changes from pink to yellow, when exposed to EO gas.
Test Results: The real time aging test was carried out that demonstrates: the test device which exposed to Steam maintain the color of black, the test group which exposed to EO maintain the color of yellow, and the real time aging test was carried out on the empty Sterilization Package/Reel that demonstrates the test device maintain the original color within the stated validity period of 2 years.

Test Item: Shelf-Life Validation

Test Methodology: /
Acceptance Criteria or End Point: Shelf Life: 2 Years; Shelf Life after Sterilized: 6 months
Test Results: Pass

Biocompatibility Testing

Test Methodology: ISO 10993-5:2009
Acceptance Criteria or End Point: Non-cytotoxic
Test Results: Under conditions of the study, did not show potential toxicity to L-929 cells. Pass
Test Methodology: ISO 10993-23:2021
Acceptance Criteria or End Point: Non-irritating
Test Results: Under the conditions of the study, not an irritant. Pass
Test Methodology: ISO 10993-10:2021
Acceptance Criteria or End Point: Non-sensitizing
Test Results: Under conditions of the study, not a sensitizer. Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K212338

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The logo is simple and professional, and it is easily recognizable.

February 24, 2025

Anqing Clean Dental Instrument Technology Co., Ltd. % Wang Boyle General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai. 200120 China

Re: K241565

Trade/Device Name: Sterilization Package/Reel Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: January 20, 2025 Received: January 24, 2025

Dear Wang Boyle:

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

2

Sincerely,

Stephen A. Anisko -S

Digitally signed by Stephen A. Anisko -S Date: 2025.02.24 20:03:28 -05'00'

for: Christopher K. Dugard, M.S. 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) K241565

Device Name Sterilization Package/Reel

Indications for Use (Describe)

The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes.

· Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃(140°F).

Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process.

The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.

The following table (Table 1) lists the model numbers of the Sterilization Package/Reel by type, model, dimensions, and content/max. load (lbs.):

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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4

		Specification Size (WXL)		Content/Max Load(lbs)
Product Name	Item	Inch	Dimension	Metal	Plastic	Gauze/Linen
s
	KLDT-90165	3.5"x6.5"	90mmx165mm	0.12	0.11	0.1
	KLDT-305430	12"x17"	305mmx430mm	1.10	1.09	0.66
	KLDT-70230	2.75"x9"	70mm×230mm	0.09	0.08	0.07
	KLDT-135280	3⅛"x11"	135mmx280mm	0.50	0.47	0.46
	KLDT-90135	3.5"x5.25	90mmx135mm	0.10	0.09	0.08
Self
Sealing
Sterilization
Pouch	KLDT-70260	2.75"x10"	70mm×260mm	0.10	0.09	0.08
	KLDT-90260	3.5"x10"	90mmx260mm	0.15	0.14	0.12
	KLDT-135260	3⅛"x10"	135mmx260mm	0.48	0.46	0.45
	KLDT-250370	10"x14.5"	250mmx370mm	1.06	1.05	0.62
	KLDT-190360	7.5"x14"	190mmx360mm	0.60	0.58	0.55
	KLDT-57130	2.25"x5"	57mm×130mm	0.04	0.03	0.005
	KLDT-57100	2.25"x4"	57mm×100mm	0.03	0.02	0.004
	KLDT-135330	3⅛"x13"	135mmx330mm	0.55	0.53	0.50
	KLDT-90230	3.5"x9"	90mmx230mm	0.14	0.13	0.11
Flat
Sterilization
Reel	KLDT-200200	8"	200mm×200m	0.60	0.58	0.55
	KLDT-300200	12"	300mm×200m	1.04	1.03	0.60
	KLDT-75200	3"	75mm×200m	0.09	0.05	0.004
	KLDT-100200	4"	100mm×200m	0.14	0.13	0.11
	KLDT-50200	2"	50mm×200m	0.02	0.01	0.003
	KLDT-400200	16"	400mm×200m	1.08	1.07	0.64
	KLDT-250200	10"	250mm×200m	0.80	0.78	0.58
	KLDT-350200	14"	350mm×200m	1.06	1.05	0.62
	KLDT-55200	2.25"	55mm×200m	0.03	0.02	0.003
	KLDT-150200	6"	150mm×200m	0.55	0.53	0.50
Gusseted
Sterilization
Reel	KLDT-75100	3"	75mm×30mm×100m	0.09	0.05	0.004
	KLDT-350100	14"	350mm×80mm×100m	1.06	1.05	0.62
	KLDT-150100	6"	150mm×50mm×100m	0.55	0.53	0.50
	KLDT-400100	16"	400mm×80mm×100m	1.08	1.07	0.64
	KLDT-250100	10"	250mm×65mm×100m	0.80	0.78	0.58
	KLDT-300100	12"	300mm×75mm×100m	1.04	1.03	0.60
	KLDT-200100	8"	200mm×55mm×100m	0.60	0.58	0.55

Table 1. The model numbers of Sterilization Package/Reel (Type, Model and Dimension and Content/Max. Load)

5

| KLDT-100100 | A 11 | 100mm×50mm×100m | CALI | 0 40
V. IV | Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara
Vill |
|-------------|------|-----------------|------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

6

510(k) Summary K241565

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's Information

Name:	Anqing Clean Dental Instrument Technology Co.,LTD.
Address:	Floor 2, D4-A,Jiabao Industrial Park.Yangtze River Bridge
Economic Development Zone ,246000 Anqing City, Anhui
Province,China
Tel:		0086-556-5577869
Contact:		Wu Yiming

Designated Submission Correspondent

Contact:	Mr. Boyle Wang
Name:	Shanghai Truthful Information Technology Co., Ltd.
Address:	Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai
200120 China
Tel:	+86-21-50313932
Email:	Info@truthful.com.cn

Date Submitted: Jan.20,2025

2.0 Device Information

Trade/Device name:	Sterilization Package/Reel
Common name:	Sterilization Package/Reel
Classification name:	Sterilization Wrap;
Classification Product Code:	FRG,JOJ
Regulation number:	21 CFR880.6850
Classification:	Class II
Panel:	General Hospital

3.0 Predicate Device Information

Predicate Device:

Manufacturer:	Sterileright Packaging Mfg., Inc.
Trade/Device Name:	SterileRight Sterilization Pouch and Roll

7

510(k) number: K212338

4.0 Device Description

The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains the sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post Steam or EO gas sterilization.

The Self-seal Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization.

The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas.

The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

5.0 Indication for Use Statement

The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

· Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes.

• Ethylene Oxide (EO) with a concentration of 735 mg/L at 55° C (131° F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C(140°F).

Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process.

The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.

The following table (Table 1) lists the model numbers of the Sterilization Package/Reel by type, model, dimensions, and content/max. load (Ibs.):

8

Product Name	Item	Specification Size (WXL)		Content/Max Load(lbs)
		Inch	Dimension	Metal	Plastic	Gauze/Linen
s
	KLDT-90165	3.5"x6.5"	90mmx165mm	0.12	0.11	0.1
	KLDT-305430	12"x17"	305mmx430mm	1.10	1.09	0.66
	KLDT-70230	2.75"x9"	70mm×230mm	0.09	0.08	0.07
	KLDT-135280	3⅛"x11"	135mmx280mm	0.50	0.47	0.46
	KLDT-90135	3.5"x5.25
"	90mmx135mm	0.10	0.09	0.08
Self
Sealing
Sterilization
Pouch	KLDT-70260	2.75"x10"	70mm×260mm	0.10	0.09	0.08
	KLDT-90260	3.5"x10"	90mmx260mm	0.15	0.14	0.12
	KLDT-135260	3⅛"×10"	135mmx260mm	0.48	0.46	0.45
	KLDT-250370	10"x14.5"	250mmx370mm	1.06	1.05	0.62
	KLDT-190360	7.5"x14"	190mmx360mm	0.60	0.58	0.55
	KLDT-57130	2.25"x5"	57mm×130mm	0.04	0.03	0.005
	KLDT-57100	2.25"x4"	57mm×100mm	0.03	0.02	0.004
	KLDT-135330	3⅛"×13"	135mmx330mm	0.55	0.53	0.50
	KLDT-90230	3.5"x9"	90mmx230mm	0.14	0.13	0.11
	KLDT-200200	8"	200mm×200m	0.60	0.58	0.55
	KLDT-300200	12"	300mm×200m	1.04	1.03	0.60
	KLDT-75200	3"	75mm×200m	0.09	0.05	0.004
	KLDT-100200	4"	100mm×200m	0.14	0.13	0.11
Flat
Sterilization
Reel	KLDT-50200	2"	50mm×200m	0.02	0.01	0.003
	KLDT-400200	16"	400mm×200m	1.08	1.07	0.64
	KLDT-250200	10"	250mm×200m	0.80	0.78	0.58
	KLDT-350200	14"	350mm×200m	1.06	1.05	0.62
	KLDT-55200	2.25"	55mm×200m	0.03	0.02	0.003
	KLDT-150200	6"	150mm×200m	0.55	0.53	0.50
Gusseted
Sterilization
Reel	KLDT-75100	3"	75mm×30mm×100m	0.09	0.05	0.004
	KLDT-350100	14"	350mm×80mm×100m	1.06	1.05	0.62
	KLDT-150100	6"	150mm×50mm×100m	0.55	0.53	0.50
	KLDT-400100	16"	400mm×80mm×100m	1.08	1.07	0.64
	KLDT-250100	10"	250mm×65mm×100m	0.80	0.78	0.58
	KLDT-300100	12"	300mm×75mm×100m	1.04	1.03	0.60
	KLDT-200100	8"	200mm×55mm×100m	0.60	0.58	0.55
KLDT-100100	4"	100mmx50mmx100m	0.14	0.13	0.11

Table 1. The model numbers of Sterilization Package/Reel (Type, Model and Dimension and Content/Max. Load)

9

6.0 Summary of Non-Clinical Testing

Summary of non-clinical and performance testing bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The test results demonstrated the subject device is confirmed to be safe and effective for the intended use.

Test Item	Test Methodology	Acceptance Criteria or End Point	Test Results
Sterilization
Process Validation	ISO 11135:2014	Ethylene oxide: 60 minutes at 55 °C; relative
humidity between 50%- 80%;
ethylene oxide concentration
is 735 mg/L, 8 hours aeration
time at 60°C (140°F).
SAL=10-6	SAL=10-6
Pass
	ISO 17665-1:2006;
ISO TS 17665-2:2009	Steam; 4 minutes at 132°C;
30 minutes dry time.
SAL=10-6	SAL=10-6
Pass
EO/ECH Residuals	ISO 10993-7:2008	EO 3.2 Kpa or No Burst	Pass
	ASTM F1929-15	The dye solution is no any
leakage across the seal width
of sterile barrier system.
(No Infiltration)	No Infiltration
Pass
	ASTM F88/F88M-21	Seal strength > 2.5 (N/15mm)	Pass
	ISO 1924-2:2008	Tensile strength:
CD $\ge$ 2.2KN/m,MD $\ge$ 4.4KN/m	Pass
	ASTM F2096-11	No Leakage	No Leakage
Pass
	DIN 58953-6	CFU = 0	CFU = 0
Pass
	ISO 5636-3	10-50 mL/min·m²	20-30 mL/min·m²
Pass

Table 2: Performance testing summary – Bench

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| Chemical Indicator

Efficacy Testing	ISO 11140-1:2014	Steam:	The real time aging test
	1. Remain stable
before use based on
its shelf life.

Maintain the
endpoint stability of the
color change after
being in the presence
of the sterilant. | The color of CI changes from
blue to black, when exposed
to Steam;

EO:
The color of CI changes from
pink to yellow, when exposed
to EO gas. | was carried out that
demonstrates: the test
device which exposed to
Steam maintain the color
of black, the test group
which exposed to EO
maintain the color of
yellow, and the real time
aging test was carried out
on the empty Sterilization
Package/Reel that
demonstrates the test
device maintain the
original color within the
stated validity period of 2
years. |
| Shelf-Life
Validation | / | Shelf Life:2 Years;
Shelf Life after Sterilized:
6 months | Pass |

Biocompatibility Testing

The biocompatibility evaluation for the Sterilization Package/Reel was conducted in accordance with the FDA's Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"

Table 3 Summary test of Biocompatibility Testing

| Biocompatibility
testing | ISO 10993-5:2009 | Non-cytotoxic | Under conditions of the study, did not
show potential toxicity to L-929 cells.
Pass |
|-----------------------------|-------------------|-----------------|-------------------------------------------------------------------------------------------|
| | ISO 10993-23:2021 | Non-irritating | Under the conditions of the study, not an
irritant.
Pass |
| | ISO 10993-10:2021 | Non-sensitizing | Under conditions of the study, not a
sensitizer.
Pass |

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7.0 Technological Characteristic Comparison Table

| Item | Subject Device
K241565 | Predicate Device
K212338 | Comparison
Analysis |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Sterilization Package/Reel | SterileRight sterilization pouch and roll | ---- |
| Product Code | FRG,JOJ | FRG,JOJ | Same |
| Regulation No. | 21 CFR 880.6850 | 21 CFR 880.6850
21 CFR 880.2800 | Same |
| Class | II | II | Same |
| Indication for
Use | The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes. Ethylene Oxide (EO) with a concentration of 735 mg/L at 55° C (131 ° F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. | The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). The SterileRight provide sterilization pouch and roll made with Paper/Film or Tyvek® /Film. The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of | Similar |
| | | | |
| | The Sterilization Package/Reel is
offered 3 types in the following:
Self -Seal Sterilization Pouch;
Flat Sterilization Reel;
Gusseted Sterilization Reel. | manufacture. The pouch's
external chemical ink indicators
are designed to indicate to the
user that the pouch has
undergone either a steam or EO
sterilization process.
The SterileRight sterilization
pouch and roll which are made
with Tyvek® is for EO gas | |
| | | sterilization only. It also maintains
the sterility of the enclosed
devices for up to 6 months
post EO gas sterilization, and | |
| | | before sterilization has
a
maximum shelf life of 3 years
from the date of manufacture. | |
| Material
Composition | Composed of medical dialysis
paper and transparent colored
PET/CPP composite film , EO and
Steam Process Indicator, Print Ink,
adhesive | Medical Grade Paper, CPP, PET,
adhesive,EO and Steam Process
Indicator, Print Ink.
Tyvek®, PET, PE, adhesive. | Similar |
| Sterilization
Cycles | • Steam Sterilization at 132°C
(270°F) for 4 minutes; Drying time
of 30 minutes.
• Ethylene Oxide (EO) with a
concentration of 735 mg/L at 55°
C (131 ° F) and 50% to 80%
relative humidity for 60 minutes.
Aeration time of 8 hours at 60°C
(140°F). | • Gravity steam at 121°C (250°F)
for 30 minutes; Drying time of 25
minutes.
• Pre-vacuum steam at 132°C
(270°F) for4 minutes; Drying time
of 20 minutes.
• Ethylene Oxide (EO) with a
concentration of 735 mg/L at
55°C (131°F) and 50% to 80%
relative humidity for 60 minutes.
Aeration time of 8hours at 60°C
(140°F). | Similar |
| Configuration/
Dimension | Various Size, Heat Sealing and
Self Sealing | Various Size, Heat Sealing and
Self Sealing | Same |
| Sterilant
Penetration
Efficacy | The test meet the requirement of
SAL 10-6 | The test meet the requirement of
SAL 10-6 | Same |
| Chemical
Indicator
(CI)
Functionality
and Endpoint | The sterilant penetrated through
the pouch configuration and
affected the CI color change to
the endpoint color | The sterilant penetrated through
the pouch configuration and
affected the CI color change to the
endpoint color | Same |
| Device Design
of Steam Cl | The color of Chemical Indicator
changes from Blue to | The color of Chemical Indicator
changes from Pink to | Similar |
| | Black, when exposed to Steam | Brown/Black, when exposed to Steam | |
| Device Design of EO gas CI | The color of Chemical Indicator changes from Pink to Yellow, when exposed to Steam | The color changes from Blue to Yellow/Brown, when exposed to EO gas | Similar |
| Thickness Variations (mm) ASTM F 2251 | Passed | Passed | Same |
| Tensile strength ISO 1924-2 | Passed | Passed | Same |
| Burst Strength (kPa) ASTM F1140 | Passed | Passed | Same |
| Bubble Leak Test ASTM D 3078 or ASTM-F 2096 | Passed | Passed | Same |
| Seal Peel Test (N/15mm) ASTM F88/F88M ; ISO 11607-1 | Passed | Passed | Same |
| Dye penetration Test ASTM F1929 | Passed | Passed | Same |
| Microbial Barrier Test DIN 58953-6 | Passed | Passed | Same |
| Air permeance testing ISO 5636-3 | Passed | Passed | Same |
| End point stability testing results | The color of chemical indicator for EO sterilization indicator ink is Pink, and the color of chemical indicator for steam sterilization indicator ink is Blue after 2 year shelf life before sterilization.
The color of chemical indicator for EO sterilization indicator ink is Yellow, and the color of chemical indicator for steam sterilization | The color of chemical indicator for EO sterilization indicator ink is Blue, and the color of chemical indicator for steam sterilization indicator ink is Pink after 2 year shelf life before sterilization.
The color of chemical indicator for EO sterilization indicator ink is Yellow/Brown , and the color of chemical indicator for steam | Similar |
| | | | |
| | indicator ink is Blue after EO sterilized and 6 months shelf life. | sterilization indicator ink is Pink after EO sterilized and 6 months shelf life | |
| | The color of chemical indicator for EO sterilization indicator ink is Pink, and the color of chemical indicator for steam sterilization indicator ink is Black after steam sterilized and 6 months shelf life. | The color of chemical indicator for EO sterilization indicator ink is Bue, and the color of chemical indicator for steam sterilization indicator ink is Brown/Black after steam sterilized and 6 months shelf life. | Similar |
| Maintenance of Sterility | 6 months | 6 months | Same |
| Shelf Life | 2 years from date of manufacture for EO and Steam Indicators | 3 years from date of manufacture for EO and Steam Indicators | Different |
| Biocompatibility | Conform with ISO10993-1 (ISO10993-5, ISO10993-10) | Conform with ANSI/AAMI/ISO 10993-10 | Same |

Table 4- Comparison of Technology Characteristics

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The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device.

The comparison between the subject and predicate devices is based on the following:

Same intended use
· Same indications for use
· Similar material types that meet ISO 10993 biocompatibility requirements
· Same sterilization methods (EO and Steam sterilization process)
Same fundamental technology/principal of operation/user interface

The sterilization parameters of the subject device are little different with those of the predicate device, but the EO sterilization validation results demonstrate the subject device fully meet the requirements of ISO 11135 and the steam sterilization validation results fully meet the requirements of ISO 17665-1.

8.0 Summary of Clinical Testing

No clinical study is included in this submission.

9.0 Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K212338.