Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization pouch and roll with chemical indicators, which are passive components and do not involve AI or ML.

Therapeutic

No
This device is a sterilization pouch and roll intended to contain other medical devices for sterilization and maintain their sterility, not to treat a patient.

Diagnostic

No

Explanation: The device is a sterilization pouch and roll intended to enclose and maintain the sterility of medical devices after sterilization. While it contains chemical indicators that change color to show exposure to sterilization processes, these indicators only confirm exposure to the sterilant, not the successful sterilization or diagnostic information about a patient or condition.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization pouch and roll made of medical grade paper and film, with integrated chemical indicators. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to enclose devices for sterilization and maintain their sterility. This is a function related to the processing and storage of medical devices, not the diagnosis of disease or other conditions.
Device Description: The description focuses on the physical composition of the pouch/roll and its function in the sterilization process and maintaining sterility. It also describes the chemical indicators, which are process indicators, not diagnostic tools.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.

The device is clearly intended for use in the sterilization and storage of medical devices, which falls under the category of medical device accessories or packaging, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 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: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. · Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C (131°F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃). The sterilization pouch and roll are made with medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization.

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

FRG, JOJ

Device Description

The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is: Steam: 4 minutes at 132°C (270°F); 20 minutes dry time. Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain 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 24 months post sterilization. The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator 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 EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

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 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
Acceptance Criteria or End Point: Ethylene oxide: 6 hours at 55 °C; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7days aeration time at 20°C. SAL=10-6
Results: SAL=10-6 Pass
Test Methodology: ISO 17665-1:2006; ISO TS 17665-2:2009
Acceptance Criteria or End Point: Steam; 8 minutes at 134°C; 8 minutes dry time. SAL=10-6
Results: SAL=10-6 Pass

Test Item: EO/ECH Residuals

Test Methodology: ISO 10993-7:2008
Acceptance Criteria or End Point: EO 3 Kpa or No Burst
Results: Pass Minimum of Burst pressure = 6.4 (kPa) 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)
Results: No Infiltration Pass
Test Methodology: ASTM F88/F88M-15
Acceptance Criteria or End Point: Seal strength > 2.5 (N/15mm)
Results: Minimum of Seal strength = 2.9 Pass
Test Methodology: ISO 1924-2:2008
Acceptance Criteria or End Point: Tensile strength: CD ≥ 2.2KN/m, MD ≥ 4.4KN/m
Results: Pass
Test Methodology: Real time aging
Acceptance Criteria or End Point: 5 years real time aging Incubation 24 months real time aging Incubation for post steam/EO sterilization storage
Results: The test results of all samples are meet the requirements. Pass
Test Methodology: ASTM F2096-11
Acceptance Criteria or End Point: No Leakage
Results: No Leakage Pass
Test Methodology: DIN 58953-6
Acceptance Criteria or End Point: CFU = 0
Results: CFU = 0 Pass

Test Item: Chemical Indicator Efficacy Testing

Test Methodology: ISO 11140-1:2014 Steam: The color of CI changes from Blue to Dark Grey, when exposed to Steam;
Acceptance Criteria or End Point: Steam Change the color: Color of indicator changes from blue to dark grey after Steam sterilization
Results: Color of indicator changes from blue to dark grey under indicated condition and no changed under other condition. Pass
Test Methodology: EO: The color of CI changes from Pink to Yellow, when exposed to EO gas.
Acceptance Criteria or End Point: EO gas Color of indicator changes from pink to yellow after EO sterilization
Results: Color of indicator changes from pink to yellow under indicated condition and no changed under other condition. Pass
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. All performance attributes should maintain the original color: 5 years shelf life
Results: The real-time test was carried out from Jan. 08, 2020 to Jan.20, 2022 that demonstrates: the test device which exposed to Steam maintain the color of Dark Grey, the test group which exposed to EO maintain the color of Yellow, and the real-time test was carried out on the empty pouch that demonstrates the test device maintain the original color from Jan. 08, 2017 to Jan.28, 2022.

No clinical study is included in this submission.

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.

K180661

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 date February 13, 2023. The text is written in a clear, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is black and the background is white.

Image /page/0/Picture/1 description: The image contains 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China

Re: K221875

Trade/Device Name: Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: January 17, 2023 Received: January 17, 2023

Dear Boyle 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 (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 located 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.

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

1

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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Anne D. Talley -S for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K221875

Device Name Sterilization Pouch and Roll

The 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: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.

· Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C (131°F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃).

The sterilization pouch and roll are made with medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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"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."

3

The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).

Model	Item	Specification Size (WXL)		Content/Max Load(lbs)
	NO.	Inch	mm*mm	Metal	Plastic	Gauze/Linens
	P-001	2.25"x3.5"	57x90	0.02	0.01	0.003
	P-002	2.25"x4"	57x100	0.03	0.02	0.004
	P-003	2.25"x5"	57x130	0.04	0.03	0.005
	P-004	2.75"x10"	70x260	0.09	0.08	0.07
	P-005	3.5"x5.25"	90x135	0.10	0.09	0.08
	P-006	3.5"x6.5"	90x165	0.12	0.11	0.1
	P-007	3.5"x10"	90x260	0.14	0.13	0.11
PLANE-01
Sterilization
Pouch	P-008	51/3"x10"	135x260	0.48	0.46	0.45
	P-009	51/3"x11	135x280	0.50	0.47	0.46
	P-010	51/3"x13"	135x330	0.55	0.53	0.50
	P-011	7.5"x14"	190x360	0.60	0.58	0.55
	P-012	10"x14.5"	250x370	1.06	1.05	0.62
	P-013	10.25"x16"	260x410	1.08	1.07	0.64
	P-014	12"x17.7"	300x450	1.10	1.09	0.66
ROLL-01
Sterilization
Roll	R-101	2"	50mm×200m	0.02	0.01	0.003
	R-102	3"	75mm×200m	0.09	0.05	0.004
	R-103	4"	100mm×200m	0.14	0.13	0.11
	R-104	6"	150mm×200m	0.55	0.53	0.50
	R-105	8"	200mm×200m	0.60	0.58	0.55
	R-106	10'	250mm×200m	1.06	1.05	0.62
	R-107	12"	300mm×200m	0.60	0.58	0.55
	R-108	14"	350mm×200m	1.06	1.05	0.62
	R-109	16"	400mm×200m	1.08	1.07	0.64
	R-110	17.7"	450mm×200m	1.10	1.09	0.66
	R-111	20"	500mm×200m	1.10	1.09	0.66
	GR-201	3"	75mm×100m	0.09	0.05	0.004
	GR-202	4"	100mm×100m	0.14	0.13	0.11
	GR-203	6"	150mm×100m	0.55	0.53	0.50
	GR-204	8"	200mm×100m	0.60	0.58	0.55
	GR-205	10"	250mm×100m	1.06	1.05	0.62
	GR-206	12"	300mm×100m	0.60	0.58	0.55
	GR-207	14"	350mm×100m	1.06	1.05	0.62
	GR-208	16"	400mm×100m	1.08	1.07	0.64

(Model and Dimension and Content/Max. Load)

4

510(k) Summary K221875

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:	Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.
Address:	Dongjing Road 23, Yuanlin Office, 433100 Qianjiang,
PEOPLE'S REPUBLIC OF CHINA
Tel:	+86-13349816939
Contact:	Zhao Fusong

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: Feb.11,2023

2.0 Device Information

Trade/Device name:	Sterilization Pouch and Roll
Common name:	Sterilization Pouch and Roll
Regulation Name:	1) Sterilization Wrap;

Sterilization process indicator |
| Classification Product Code: | 1) FRG; |
| Subsequent Product Code: | 2) JOJ |
| Regulation number: | 1) 21 CFR880.6850
21 CFR880.2800 |
| Classification: | Class II |
| Panel: | General Hospital |

3.0 Predicate Device Information

Predicate Device:

5

Manufacturer:	Sterileright Packaging Mfg., Inc
Trade/Device Name:	SterileRight Sterilization Pouch and Roll
510(k) number:	K212338

Reference Device:

Manufacturer:	Sigma Medical Supplies Corp.
Trade/Device Name:	SIGMA Sterilization Pouch and Roll
510(k) number:	K180661

4.0 Device Description

The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:

Steam: 4 minutes at 132°C (270°F); 20 minutes dry time.

Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain 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 24 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator 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 EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

5.0 Indication for Use Statement

The 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:

• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.

• Ethylene Oxide (EO) with a concentration of 800 mg/L at 55° C (131° F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃).

6

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.

The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).

| Model No. | Specification Size (WXL) | |------------------------------------|------ | | | | P-001 | | P-002 | | P-003 | | P-004 | | P-005 | | P-006 | | P-007 | PLANE-01
Sterilization
Pouch | P-008 | 51/3"x10" | | P-009 | | P-010 | | P-011 | | P-012 | | P-013 | | P-014 | | R-101 | | R-102 | | R-103 | | R-104 | ROLL-01
Sterilization
Roll | R-105 | 8" | | R-106 | | R-107 | | R-108 | | R-109 | | R-110 | Item
| Content/Max Load(lbs) | | |
-------|--------------------------|------------|-----------------------|---------|--------------|
| Inch | mm*mm | Metal | Plastic | Gauze/Linens |
| 2.25"x3.5" | 57x90 | 0.02 | 0.01 | 0.003 |
| 2.25"x4" | 57x100 | 0.03 | 0.02 | 0.004 |
| 2.25"x5" | 57x130 | 0.04 | 0.03 | 0.005 |
| 2.75"x10" | 70x260 | 0.09 | 0.08 | 0.07 |
| 3.5"x5.25" | 90x135 | 0.10 | 0.09 | 0.08 |
| 3.5"x6.5" | 90x165 | 0.12 | 0.11 | 0.1 |
| 3.5"x10" | 90x260 | 0.14 | 0.13 | 0.11 |
| 135x260 | 0.48 | 0.46 | 0.45 |
| 51/3"x11 | 135x280 | 0.50 | 0.47 | 0.46 |
| 51/3"x13" | 135x330 | 0.55 | 0.53 | 0.50 |
| 7.5"x14" | 190x360 | 0.60 | 0.58 | 0.55 |
| 10"x14.5" | 250x370 | 1.06 | 1.05 | 0.62 |
| 10.25"x16" | 260x410 | 1.08 | 1.07 | 0.64 |
| 12"x17.7" | 300x450 | 1.10 | 1.09 | 0.66 |
| 2" | 50mm×200m | 0.02 | 0.01 | 0.003 |
| 3" | 75mm×200m | 0.09 | 0.05 | 0.004 |
| 4" | 100mm×200m | 0.14 | 0.13 | 0.11 |
| 6" | 150mm×200m | 0.55 | 0.53 | 0.50 |
| 200mm×200m | 0.60 | 0.58 | 0.55 |
| 10' | 250mm×200m | 1.06 | 1.05 | 0.62 |
| 12" | 300mm×200m | 0.60 | 0.58 | 0.55 |
| 14" | 350mm×200m | 1.06 | 1.05 | 0.62 |
| 16" | 400mm×200m | 1.08 | 1.07 | 0.64 |
| 17.7" | 450mm×200m | 1.10 | 1.09 | 0.66 |

(Model and Dimension and Content/Max. Load)

7

R-111	20"	500mm×200m	1.10	1.09	0.66
GR-201	3"	75mm×100m	0.09	0.05	0.004
GR-202	4"	100mm×100m	0.14	0.13	0.11
GR-203	6"	150mm×100m	0.55	0.53	0.50
GR-204	8"	200mm×100m	0.60	0.58	0.55
GR-205	10"	250mm×100m	1.06	1.05	0.62
GR-206	12"	300mm×100m	0.60	0.58	0.55
GR-207	14"	350mm×100m	1.06	1.05	0.62
GR-208	16"	400mm×100m	1.08	1.07	0.64

6.0 Summary of Non-Clinical Testing

Summary of non-clinical and performance 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	Results
Sterilization
Process Validation	ISO 11135:2014	Ethylene oxide: 6 hours at 55 °C; relative
humidity between 40%- 90%;
ethylene oxide concentration
is 800 mg/L, 7days aeration
time at 20°C.
SAL=10-6	SAL=10-6
Pass
	ISO 17665-1:2006;
ISO TS 17665-2:2009	Steam; 8 minutes at 134°C; 8
minutes dry time.
SAL=10-6	SAL=10-6
Pass
EO/ECH Residuals	ISO 10993-7:2008	EO 3 Kpa or No Burst	Pass
Minimum of Burst pressure = 6.4 (kPa)
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-15	Seal strength > 2.5 (N/15mm)	Minimum of Seal strength = 2.9
Pass
	ISO 1924-2:2008	Tensile strength:
CD $≧$ 2.2KN/m,MD $≧$ 4.4KN/m	Pass
	Real time aging	5 years real time aging
Incubation 24 months real time aging Incubation for post steam/EO sterilization storage	The test results of all samples are meet the requirements.
Pass
	ASTM F2096-11	No Leakage	No Leakage
Pass
	DIN 58953-6	CFU = 0	CFU = 0
Pass
Chemical Indicator
Efficacy Testing	ISO 11140-1:2014 Steam:
The color of CI changes from Blue to Dark Grey, when exposed to Steam;	Steam
Change the color:
Color of indicator changes from blue to dark grey after Steam sterilization	Color of indicator changes from blue to dark grey under indicated condition and no changed under other condition.
Pass
	EO:
The color of CI changes from Pink to Yellow, when exposed to EO gas.	EO gas
Color of indicator changes from pink to yellow after EO sterilization	Color of indicator changes from pink to yellow under indicated condition and no changed under other condition.
Pass
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. | All performance attributes
should maintain the original
color : 5 years shelf life | The real-time test was
carried out from Jan. 08,
2020 to Jan.20, 2022 that
demonstrates: the test
device which exposed to
Steam maintain the color
of Dark Grey, the test
group which exposed to
EO maintain the color of
Yellow, and the real-time
test was carried out on
the empty pouch that
demonstrates the test
device maintain the
original color from Jan.
08, 2017 to Jan.28, 2022. | |

Table 1: Performance testing summary – Bench

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7.0 Technological Characteristic Comparison Table

| Item | Subject Device | Predicate Device | Reference Device | Comparison
Analysis |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Sterilization Pouch and Roll | SterileRight sterilization pouch
and roll | SIGMA Sterilization Pouch and
Roll | ---- |
| 510(k) No. | K221875 | K 212338 | K180661 | ---- |
| Product Code | FRG,JOJ | FRG,JOJ | FRG | Same |
| Regulation No. | 21 CFR 880.6850
21 CFR 880.2800 | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Class | II | II | II | Same |
| Intended Use | The 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:

Steam Sterilization at 132°C
(270°F) for 4 minutes; Drying time
of 30 minutes.
Ethylene Oxide (EO) with a | 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. | The SIGMA sterilization pouch
and roll are intended to provide
health care workers with an
effective method to enclose
devices intended for sterilization
in steam auto claves and via
Ethylene Oxide (EO). The
recommended steam sterilization
cycle parameters are 30 minutes
at 121°C. The recommended EO
sterilization cycle is 4 hours at
55°C with a relative humidity | Similar |

Table 2- Comparison of Technology Characteristics

11

| concentration of 800 mg/L at 55°
C (131 ° F) and 40% to 90%
relative humidity for 6 hour.
Aeration time of 7 days at 20°C).

The sterilization pouch and roll are
made with medical grade paper
and medical compound film.The
sterilization pouch and roll
maintains the sterility of the
enclosed devices for up to 24
months post Steam or EO gas
sterilization, and before
sterilization has a maximum shelf
life of 5 years from the date of
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. Sterilization
indicator will change color
according to the sterilization
method (ethylene oxide, steam).
Ethylene oxide sterilization
indicator color change from Prink | • 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
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. | between 50%-85% and a sterilant
concentration of 600 mg/L.
Furthermore, the sterilization
pouch and roll maintains the
enclosed devices up until 3 years
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 pouch
has undergone either a steam or
EO sterilization process.

The SIGMA sterilization pouch
and roll is offered in the following
5 types:
• Self-sealing sterilization
pouches
• Sterilization pouches, Flat
• Sterilization pouches,
Gusseted
•Sterilization rolls, Flat
•Sterilization rolls, Gusseted |

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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| | before sterilization to Yellow after sterilization. The steam
sterilization indicator color change from Blue before sterilization to
Dark Grey after sterilization. | 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 grade paper
and medical compound film, EO
and Steam Process Indicator | Medical Grade Paper, CPP, PET,
adhesive,EO and Steam Process
Indicator, Print Ink.
Tyvek®, PET, PE, adhesive. | Medical Grade Paper, CPP, PET,
PU adhesive, EO and Steam
Process Indicator
Print Ink | Same |
| Sterilization
Cycles | • Steam Sterilization at 132°C
(270°F) for 4 minutes; Drying time
of 20 minutes.
• Ethylene Oxide (EO) with a
concentration of 800 mg/L at 55°
C (131 ° F) and 40% to 90%
relative humidity for 6 hour.
Aeration time of 7 days at 20°C). | • 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). | • Steam sterilization cycle
parameters are 30 minutes at
121°C.
• EO sterilization cycle is 4
hours at 55 °C with a relative
humidity between 50%-85%
and a sterilant concentration of
600 mg/L | Different |
| Configuration/
Dimension | Various Size, Heat Sealing | Various Size, Heat Sealing and
Self Sealing | Various Size, Heat Sealing | Same |
| Performance Testing | | | | |
| Sterilant
Penetration
Efficacy | The test meet the requirement of
SAL 10-6 | 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 Cl color change to
the endpoint color | 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 Cl color change to the
endpoint color | Same |
| Device Design
of Steam CI | The color of Chemical Indicator
changes from Blue to
dark grey, when exposed to
Steam | The color of Chemical Indicator
changes from Pink to
Brown/Black, when exposed to
Steam | The color of Chemical Indicator
changes from Blue to
Greenish Black, when exposed to
Steam | Similar |
| 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 | The color changes from - Red to
Yellow, when exposed to EO gas | Similar |
| Thickness
Variations (mm)
ASTM F 2251 | Passed | Passed | Passed | Same |
| Tensile strength
ISO 1924-2 | Passed | Passed | Passed | Same |
| Burst Strength
(kPa)
ASTM F1140 : | > 3.0 Kpa
Passed | Passed | Passed | Same |
| ISO 11607-1 | | | | |
| Bubble Leak
Test
ASTM D 3078
or ASTM-F
2096 | No Leakage

Passed | 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 5 year
shelf life before 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
Red, and the color of chemical
indicator for steam sterilization
indicator ink is Blue after 2 year
shelf life before sterilization. | Similar |
| | The color of chemical indicator for | The color of chemical indicator for | The color of chemical indicator for | Similar |
| | EO sterilization indicator ink is
Yellow, and the color of chemical
indicator for steam sterilization
indicator ink is Blue after EO
sterilized and 24 months shelf life. | EO sterilization indicator ink is
Yellow/Brown , and the color of
chemical indicator for steam
sterilization indicator ink is Pink
after EO sterilized and 6 months
shelf life | EO sterilization indicator ink is
yellow, and the color of chemical
indicator for steam sterilization
indicator ink is Blue after EO
sterilized and 3 years 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 Dark Grey after
steam sterilized and 24 months
shelf life. | The color of chemical indicator for
EO sterilization indicator ink is
Blue, and the color of chemical
indicator for steam sterilization
indicator ink is Brown/Black after
steam sterilized and 6 months
shelf life. | The color of chemical indicator for
EO sterilization indicator ink is
Red, and the color of chemical
indicator for steam sterilization
indicator ink is Greenish Black
after steam sterilized and 6
months shelf life. | Similar |
| Maintenance of
Sterility | 24 months | 6 months | 3 years post EO gas sterilization
6 months post Steam sterilization | Different |
| Shelf Life | 5 years from date of manufacture
for EO and Steam Indicators | 3 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
(ISO10993-4, ISO10993-5,
ISO10993-10, ISO10993-11) | Conform with ANSI/AAMI/ISO
10993-10 | Conform with ISO 10993
standards | Same |

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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 is different with those of the predicate device, but the EO sterilization 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. The subject device is confirmed to be substantial equivalence as the predicate device.

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.