The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 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 indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)

Device Description

The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:

Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.

AI/ML Overview

Based on the provided text, the device in question is "Sterilization Pouches and Reels" (K242898), which is a medical device intended for enclosing other medical devices for sterilization. There is no mention of "AI" or "human readers" in the context of this device. The document describes a traditional 510(k) submission, primarily focusing on non-clinical performance testing and comparison to a predicate device.

Therefore, many of the requested points in your prompt that relate to AI/algorithm performance, human readers, ground truth establishment for complex data, and MRMC studies are not applicable to the information provided.

However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical performance testing described.

Table of Acceptance Criteria and Reported Device Performance

The document details various performance tests conducted to demonstrate the safety and effectiveness of the Sterilization Pouches and Reels. The acceptance criteria are implicitly met if the "Pass" status is achieved for each test, indicating conformity to the referenced ISO or ASTM standards.

Acceptance Criteria (Measured Performance Aspect)	Standard (Acceptance Threshold/Method)	Reported Device Performance
Sterilant Penetration Efficiency	SAL10-6 (Specific threshold for sterility assurance level - not explicitly defined in text but implied by standard)	Meets the requirement of SAL10-6
EO, ECH (Ethylene Oxide, Ethylene Chlorohydrin) Residue	ISO 10993-7:2008 (EO < 4mg, ECH < 9mg)	EO < 4mg, ECH < 9mg (Pass)
Chemical Indicator (CI) Functionality and Endpoint	Sterilant penetrated through pouch, CI color changed to endpoint color (Steam: Pink to Cocoa; EO: Blue to Golden Brown)	Sterilant penetrated, CI color changed (Pass)
Thickness Variations	ASTM F 2251-13 (Acceptance threshold not explicitly defined, but implies compliance with standard specifications)	Pass
Tensile Strength	ISO 1924-2:2008 (Acceptance threshold not explicitly defined, but implies compliance with standard specifications)	Pass
Burst Strength	ASTM F1140 (≥ 0.45 Psig (3.1Kpa))	≥ 0.45 Psig (3.1Kpa) (Pass)
Bubble Leak Test	ASTM F 2096-2011 (2019) (No Leakage)	No Leakage (Pass)
Seal Peel Test	ASTM F88/F88M-2023 (Min value= 1.89 N/15mm)	Min value= 1.89 N/15mm (Pass)
Dye Penetration Test	ASTM F1929-15 (No Infiltration)	No Infiltration (Pass)
Microbial Barrier Test	DIN 58953-6-2016 (CFU = 0)	CFU = 0 (Pass)
End Point Stability Testing (CI color pre/post-sterilization, at various time points)	Color holds as expected (e.g., EO CI: Blue -> Golden Brown after EO sterilized and 24 months shelf life; Steam CI: Pink -> Cocoa after steam sterilized and 24 months shelf life)	All specified color changes and stabilities met (Pass/Similar to predicate)
Maintenance of Sterility	Not explicitly stated as a test, but claimed as "12 months"	12 months (validated for effectiveness)
Shelf Life	Not explicitly stated as a test, but claimed as "5 years from date of manufacture"	5 years from date of manufacture (same as predicate)
Biocompatibility	ISO 10993-1, -5, -7, -10, -12 (Non-cytotoxic, non-irritative, non-sensitive to skin)	Non-cytotoxic, non-irritative, and non-sensitive to skin (Pass)

Information Not Applicable or Not Found in the Provided Text:

Sample size used for the test set and the data provenance: The document does not specify the sample sizes (number of pouches/reels) used for the non-clinical performance and biocompatibility tests. It also does not specify the provenance (country of origin, retrospective/prospective) of any "data" beyond general testing. The tests are laboratory-based performance tests of the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this device, is adherence to established engineering and material science standards (e.g., ISO, ASTM), rather than expert consensus on medical image interpretation.
Adjudication method: Not applicable, as there's no expert interpretation involved in the performance testing described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
The type of ground truth used: For this device, the "ground truth" is adherence to established physical, chemical, and biological performance standards (e.g., seal strength, sterility barrier, chemical indicator color change, biocompatibility). It is determined by the results of specific standardized laboratory tests, not by expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics.
The sample size for the training set: Not applicable. There is no AI/machine learning component, so no training set is used.
How the ground truth for the training set was established: Not applicable. There is no AI/machine learning component, so no training set or its ground truth establishment is mentioned.

Summary of Applicable Information:

The study proving the device meets its acceptance criteria is primarily based on non-clinical performance testing as outlined by various international and national standards (ASTM, ISO, DIN). The document explicitly states: "Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards..."

The core method of verification is demonstrating "Pass" for each of the listed tests according to the requirements of the specified standards. This type of device relies on engineering and material science validation rather than clinical trials involving human subjects or AI performance metrics.

Summary

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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 21, 2025

Shanghai Jianzhong Medical Packaging Co., Ltd. Xinhua Wei Medical Device Regulatory Affairs Specialist Bldg 16, 789# Puxing Road, Minhang District Shanghai. 201114 China

Re: K242898

Trade/Device Name: Sterilization Pouches and Reels Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: September 24, 2024 Received: January 24, 2025

Dear Xinhua Wei:

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,

Digitally signed by Stephen A. Stephen A. Anisko -S Date: 2025.02.21 Anisko -S 15:53:10 -05'00'

for: Christopher K. Dugard, M.S. Division 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) K242898

Device Name Sterilization Pouches and Reels

Indications for Use (Describe)

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

b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).

The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 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 indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)

The following tables (Table 1~5) identifies the size of subject device and its Maximum validated load. Table 1:Sterilization Pouches, self seal

Size of device		Content/Max Load (Ibs.)
Inch	Metric	Metal	Plastic	Gauze/Linens
2.25"×4"	57× (100+30) mm	0.004	0.0088	0.005
2.25"×2.75"	57× (70+30) mm	0.004	0.0088	0.004
2.75"×9"	70× (230+30) mm	0.020	0.04	0.02
3.5"×6.5"	90× (135+30) mm	0.016	0.032	0.016
3.5"×9"	90× (230+30) mm	0.024	0.12	0.024
3.5"×10.5"	90× (270+30) mm	0.032	0.15	0.032
3.5"×22"	90× (560+30) mm	0.072	0.32	0.072
5"×15"	127× (380+30) mm	0.062	0.30	0.062
5.25"×10"	135× (254+29) mm	0.045	0.22	0.045
5.25"×10"	135× (255+30) mm	0.045	0.22	0.045
5.25"×12"	135× (305+30) mm	0.052	0.26	0.05
5.25"×13"	140× (330+30) mm	0.072	0.36	0.07
6"×9"	150× (230+30) mm	0.055	0.27	0.05
7.5"×13"	190× (330+30) mm	0.102	0.48	0.10
8"×12.5"	200× (320+30) mm	0.12	0.53	0.10
10"×14.5"	250× (370+30) mm	0.21	0.65	0.19
10.6"×17"	270× (400+30) mm	0.38	0.78	0.22
10.5"×17"	270× (430+30) mm	0.42	0.82	0.24
12"×15"	300× (380+30) mm	0.52	0.90	0.23
12"×16.5"	300× (420+30) mm	0.58	1.02	0.25
12"×18"	300× (460+30) mm	0.68	1.10	0.28
14"×19"	355× (480+30) mm	0.92	1.10	0.34

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15"×25"	380× (635+30) mm	1.30	1.10	0.50
20"×22"	500× (560+40) mm	1.87	1.10	0.60

Table 2 Sterilization Pouches, flat, heat seal

Size of device
Inch	Metric
3.5"×22"	90×560mm
4"×12"	100×300mm
5"×15"	127×380mm
6"×10"	150×254mm
6"×22"	150×560mm
7.5"×13"	190×330mm
8"×20"	200×500mm
12"×15"	300×380mm
12"×18"	300×460mm
16.5"×22.5"	420×570mm

Table 3 Sterilization Pouches, gusseted, heat seal

Size of device
Inch	Metric
4"×12"	100×50×300mm
4"×14"	100×50×360mm
6"×16"	150×50×400mm
6"×18"	150×50×460mm
8"×20"	200×55×500mm
8"×16"	200×55×400mm
8"×19"	250×65×480mm
12"×22"	300×80×550mm
16.5"×22.5"	420×100×570mm

Table 4 Sterilization Reels, flat, heat seal

	Size of device
--	----------------

Inch	Metric
3"	75mm×30.5m
4"	100mm×30.5m
6"	150mm×30.5m
8"	200mm×30.5m
10"	250mm×30.5m
2"	50mm × 200m
2.15"	55mm × 200m
3"	75mm × 200m
4"	100mm × 200m
4.7"	120mm × 200m
6"	150mm × 200m
8"	200mm × 200m
10"	250mm×200m
12"	300mm × 200m
14"	350mm × 200m
16"	400mm × 200m
18"	450mm × 200m
20"	500mm × 200m

	Table 5 Sterilization Reels, gusseted, heat seal
--	--------------------------------------------------	--	--	--	--

Metal	Plastic	Gauze/Linens
0.005	0.01	0.020
0.004	0.0088	0.0176
0.07	0.20	0.055
0.06	0.19	0.05
0.12	0.32	0.10
0.10	0.25	0.09
0.12	0.53	0.10
0.44	0.54	0.38
0.58	0.74	0.52
1.87	1.10	0.60

Content/Max Load (Ibs.)
Metal	Plastic	Gauze/Linens
0.004	0.0088	0.0176
0.02	0.04	0.025
0.05	0.12	0.04
0.06	0.18	0.06
0.12	0.53	0.10
0.12	0.48	0.10
0.30	0.74	0.26
1.15	0.98	0.40
1.87	1.10	0.60

Content/Max Load (Ibs.)
Metal	Plastic	Gauze/Linens
0.02	0.04	0.02
0.025	0.15	0.032
0.06	0.27	0.07
0.10	0.53	0.10
0.12	0.53	0.10
0.004	0.0088	0.004
0.004	0.0088	0.005
0.02	0.04	0.002
0.025	0.08	0.035
0.04	0.10	0.04
0.06	0.20	0.06
0.12	0.38	0.08
0.12	0.53	0.10
0.52	0.53	0.25
0.92	1.05	0.34
1.08	1.07	0.52
1.30	1.10	0.58
1.87	1.10	0.60

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Size of device		Content/Max Load (Ibs.)
Inch	Metric	Metal	Plastic	Gauze/Linens
4.15"	55mm × 100m	0.004	0.0088	0.004
3"	75mm × 100m	0.02	0.04	0.04
4"	100mm × 100m	0.05	0.15	0.08
6"	150mm × 100m	0.07	0.20	0.10
8"	200mm x 100m	0.12	0.53	0.10
10"	250mm x 100m	0.12	0.53	0.10
12"	300mm × 100m	1.15	0.98	0.40
14"	350mm x 100m	1.35	1.0	0.50
16"	400mm × 100m	1.65	1.03	0.58
18"	450mm x 100m	1.87	1.10	0.60
20"	500mm x 100m	1.87	1.10	0.60

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.The

assigned 510(k) Number: K242898

1. Date of Preparation: February 20, 2025
1. Sponsor Identification

Shanghai Jianzhong Medical Packaging Co., Ltd.

Bldg 16, 789# Puxing Road, Minhang District, Shanghai 201114, P.R. China Registration Number: 3005030944. Contact Person: Xinhua Wei Position: Medical Device Regulatory Affairs Specialist Tel: +86-21-54315666-5201 Fax: +86-21-54315801 Email: weixinhua@mpackchina.com

1. Identification of Proposed Device
  Trade Name: Sterilization Pouches and Reels

Common Name: Sterilization Pouches and Reels

Regulatory Information

Classification Name: Wrap, Sterilization

Classification: II;

Product Code: FRG;

Subsequent Product Code: JOJ;

Regulation Number: 21 CFR 880.6850

Review Panel: General Hospital;

1. Identification of Predicate Device 510(k) Number: K221875 Product Name: Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II

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Product Code: FRG, Subsequent Product Code: JOJ Dated: January 17, 2023 Received: January 17, 2023

5. Device Description

Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).

The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.

The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.

1. Indication for Use Statement
  The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:

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

b) Ethylene Oxide (EQ) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20°C (68 °F).

The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 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 indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization process. Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of

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Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)

Item	Size of Device		Content/Max Load(Ibs)
	Inch	Metric	Metal	Plastic	Gauze/Linens
SterilizationPouches,self-seal	2.25"x4"	57x(100+30)mm	0.004	0.0088	0.005
	2.25"x2.75"	57x(70+30)mm	0.004	0.0088	0.004
	2.75"x9"	70x(230+30)mm	0.020	0.04	0.02
	3.5"x6.5"	90x(135+30)mm	0.016	0.032	0.016
	3.5"x9"	90x(230+30)mm	0.024	0.12	0.024
	3.5"x10.5"	90x(270+30)mm	0.032	0.15	0.032
	3.5"x22"	90x(560+30)mm	0.072	0.32	0.072
	5"x15"	127x(380+30)mm	0.062	0.30	0.062
	5.25"x10"	135x(254+29)mm	0.045	0.22	0.045
	5.25"x10"	135x(255+30)mm	0.045	0.22	0.045
	5.25"x12"	135x(305+30)mm	0.052	0.26	0.05
	5.25"x13"	140x(330+30)mm	0.072	0.36	0.07
es,self-seal	6"x9"	150x(230+30)mm	0.055	0.27	0.05
	7.5"x13"	190x(330+30)mm	0.102	0.48	0.10
	8"x12.5"	200x(320+30)mm	0.12	0.53	0.10
	10"x14.5"	250x(370+30)mm	0.21	0.65	0.19
	10.6"x17"	270x(400+30)mm	0.38	0.78	0.22
	10.5"x17"	270x(430+30)mm	0.42	0.82	0.24
	12"x15"	300x(380+30)mm	0.52	0.90	0.23
	12"x16.5"	300x(420+30)mm	0.58	1.02	0.25
	12"x18"	300x(460+30)mm	0.68	1.10	0.28
	14"x19"	355x(480+30)mm	0.92	1.10	0.34
	15"x25"	380x(635+30)mm	1.30	1.10	0.50
	20"x22"	500x(560+40)mm	1.87	1.10	0.60
SterilizationPouches,flat,heatseal	3.5"x22"	90x560mm	0.005	0.01	0.020
	4"x12"	100x300mm	0.004	0.0088	0.0176
	5"x15"	127x380mm	0.07	0.20	0.055
	6"x10"	150x254mm	0.06	0.19	0.05
	6"x22"	150x560mm	0.12	0.32	0.10
	7.5"x13"	190x330mm	0.10	0.25	0.09
	8"x20"	200x500mm	0.12	0.53	0.10
	12"x15"	300x380mm	0.44	0.54	0.38
	12"x18"	300x460mm	0.58	0.74	0.52
	16.5"x22.5"	420x570mm	1.87	1.10	0.60
	4"x12"	100x50x300mm	0.004	0.0088	0.0176
	4"x14"	100x50x360mm	0.02	0.04	0.025
SterilizationPouches,gusseted,heatseal	6"x16"	150x50x400mm	0.05	0.12	0.04
	6"x18"	150x50x460mm	0.06	0.18	0.06
	8"x20"	200x55x500mm	0.12	0.53	0.10
	8"x16"	200x55x400mm	0.12	0.48	0.10
	8"x19"	250x65x480mm	0.30	0.74	0.26
	12"x22"	300x80x550mm	1.15	0.98	0.40
	16.5"x22.5"	420x100x570mm	1.87	1.10	0.60
	3"	75mmx30.5m	0.02	0.04	0.02
	4"	100mmx30.5m	0.025	0.15	0.032
	6"	150mmx30.5m	0.06	0.27	0.07
	8"	200mmx30.5m	0.10	0.53	0.10
	10"	250mmx30.5m	0.12	0.53	0.10
	2"	50mm x 200m	0.004	0.0088	0.004
	2.15"	55mm x 200m	0.004	0.0088	0.005
SterilizationReels,flat,heatseal	3"	75mm x 200m	0.02	0.04	0.002
	4"	100mm x 200m	0.025	0.08	0.035
	4.7"	120mm x 200m	0.04	0.10	0.04
	6"	150mm x 200m	0.06	0.20	0.06
	8"	200mm x 200m	0.12	0.38	0.08
	10"	250mmx200m	0.12	0.53	0.10
	12"	300mm x 200m	0.52	0.53	0.25
	14"	350mm x 200m	0.92	1.05	0.34
	16"	400mm x 200m	1.08	1.07	0.52
	18"	450mm x 200m	1.30	1.10	0.58
	20"	500mm x 200m	1.87	1.10	0.60
	4.15"	55mm x 100m	0.004	0.0088	0.004
SterilizationReels,gusseted,	3"	75mm x 100m	0.02	0.04	0.04
	4"	100mm x 100m	0.05	0.15	0.08
	6"	150mm x 100m	0.07	0.20	0.10
	8"	200mm x 100m	0.12	0.53	0.10
heatseal	10"	250mm x 100m	0.12	0.53	0.10
	12"	300mm x 100m	1.15	0.98	0.40
	14"	350mm x 100m	1.35	1.0	0.50
	16"	400mm x 100m	1.65	1.03	0.58
	18"	450mm x 100m	1.87	1.10	0.60
	20"	500mm x 100m	1.87	1.10	0.60

(Model and Dimension and Content/Max. Load)

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7. Non-Clinical Test Conclusion

Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards (included but not fully described):

ASTM F88/F88M-2015, Standard Test Method for Seal Strength of Flexible Barrier Materials.(Sterility)
ASTM F1929-2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F 2096-2011 (2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
A ISO 1924-2:2008 Paper and board -- Determination of tensile properties.
A ASTM F 2251-13 Standard Test Method for Thickness Measurement of Flexible Packaging Material
ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General requirements
ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
ISO 10993-12: Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
DIN58953-6-2010 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized.
ISO17665-1:2006 Sterilization of health care products-Moist heat-Part1: requirements for the development, validation and routine control of a sterilization process for medical devices.

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8. Technological Characteristic Comparison Table

ITEM	Subject Device	Predicate Device K221875	Comparisonanalysis
Product Code	FRG, JOJ	FRG, JOJ	same
Regulation No.	21 CFR 880.6850	21 CFR 880.6850	same
Class	II	II	same
Indication for Use	The Sterilization Pouches and Reels is intended to providehealth care workers with an effective method to encloseddevices in a single or double pouch configuration by steam orethylene oxide sterilization. The recommended sterilizationcycle parameters are as follows:a) Steam sterilization at 132°C (270°F) for 4 minutes;Drying time of 20 minutes.b) Ethylene Oxide (EO) with a concentration of 800 mg/Lat 55 °C (131 °F) and 40%-80% relative humidity for 6hours. Aeration time of 7 days at 20℃ (68 °F).The Sterilization Pouches and Reels is composed of medicalgrade paper and medical compound film, maintains the sterilityof the enclosed devices for up to 12 months post Steam or EOgas sterilization, and before sterilization has a maximum shelflife of 5 years from the date of manufacture.The pouch's external chemical indicators are designed toindicate to the user that the pouch has undergone either a steamor EO Sterilization process. Sterilization indicators will changecolor according to the sterilization method (Steam, Ethyleneoxide). The color of steam sterilization indicator changes fromPink before sterilization to Cocoa after sterilization. The colorof Ethylene oxide sterilization indicator changes from Bluebefore sterilization to Golden Brown after sterilization.The maximum validated pouch load is 1.87 lbs. (850g); Themaximum validated reel load is 1.87 lbs. (850 g)	The Sterilization Pouch and Roll are intended to provide healthcare workers with an effective method to enclose devicesintended 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 at55°C (131 °F) and 40% to 90% relative humidity for 6 hours.Aeration time of 7 days at 20℃).The sterilization pouch and roll are made with medical gradepaper and medical compound film. The sterilization pouch androll maintains the sterility of the enclosed devices for up to 24months post Steam or EO gas sterilization, and beforesterilization has a maximum shelf life of 5 years from the dateof manufacture. The pouch's external chemical ink indicatorsare designed to indicate to the user that the pouch hasundergone either a steam or EO sterilization process.Sterilization indicator will change color according to thesterilization method (ethylene oxide, steam). Ethylene oxidesterilization indicator color change from Pink beforesterilization to Yellow after sterilization. The steamsterilization indicator color change from Blue beforesterilization to Dark Grey after sterilization.	Same
			K242898
Material Composition	Composed of medical grade paper and medical compound filmand printed with a chemical indicator bar that changed fromPink to Cocoa (Steam) or Blue to Golden Brown (EO) whenexposed to Steam vapor or EO gas during process."Sterilization Pouches, flat, self seal" type contains tape.	Composed of medical grade paper, medical compound film,EO and Steam Process Indicator.	Similar. ThePouches with tapewere validated fortheir effectivenessand safety. The testresults show thatthe pouches are aseffective and safeas predicate device.
SterilizationCycles	Steam sterilization at 132°C (270°F) for 4 minutes; Drying timeof 20 minutes.Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C(131 °F) and 40%-80% relative humidity for 6 hours. Aerationtime of 7 days at 20°C (68 °F).	Steam Sterilization at 132°C (270°F) for 4 minutes; Drying timeof 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 hours. Aerationtime of 7 days at 20°C.	same
Dimensions	Length of Pouches ranges from 2.75" to 25";Width of Pouches ranges from 2.25" to 20";Length of Reels ranges from 30.5m (=1200.78") to 200m(=7874.01");Width of Reels ranges from 2" to 20";There are 72 sizes in total.Please refer to table of Comparison of Dimension for detailedinformation.	Length of Pouches ranges from 3.5" to 17";Width of Pouches ranges from 2.25" to 12";Length of Reels (or Rolls) ranges from 100m (=3937") to200m (=7874.01");Width of Reels ranges from 2" to 17.7"There are 32 sizes in total.Please refer to table of Comparison of Dimension for detailedinformation.	Similar
Sterilant Penetration Efficiency	It meets the requirement of SAL10-6	It meets the requirement of SAL10-6	same
EO、ECH residue	Referring to ISO 10993-7:2008, EO<4mg, ECH<9mg	Referring to ISO 10993-7:2008, EO<4mg, ECH<9mg	same
	Performance Testing
Chemical Indicator (CI)Functionality and Endpoint	The sterilant penetrated through the pouch configuration andrendered the CI color the endpoint color.	The sterilant penetrated through the pouch configuration andrendered the CI color the endpoint color.	same
Device Design of Steam CI	It changes from Pink to Cocoa when exposed to Steam vapor.	The color of Chemical Indicatorchanges from Blue to dark grey, when exposed to Steam.	different
Device Design of EO gas CI	It changes from Blue to Golden Brown when exposed to EOgas during process.	The color of Chemical Indicatorchanges from Pink to Yellow,when exposed to Steam	different
Thickness Variations (mm)ASTM F 2251-13	Pass	Pass	same
Tensile strengthISO 1924-2:2008	Pass	Pass	same

Burst Strength (kPa)ASTM F1140	$\geq$ 0.45 Psig (3.1Kpa)Pass	> 3.0 KpaPass	same
Bubble Leak TestASTM F 2096-2011 (2019)	No LeakagePass	No LeakagePass	same
Seal Peel Test (N/15mm)ASTM F88/F88M-2023	Min value= 1.89Pass	Min value= 2.10Pass	same
Dye penetration Test ASTMF1929-15	No InfiltrationPass	No InfiltrationPass	same
MicrobialBarrier TestDIN 58953-6-2016	CFU = 0Pass	CFU = 0Pass	same
EO、ECH residue	Referring to ISO 10993-7:2008, EO<4mg, ECH<9mg	Referring to ISO 10993-7:2008, EO<4mg, ECH<9mg	same
End point stability testing results	The color of chemical indicator for EO sterilization indicatorink is blue, and the color of chemical indicator for steamsterilization indicator ink is pink after 5 years shelf life beforesterilization.The color of chemical indicator for EO sterilization indicatorink is Golden Brown, and the color of chemical indicator forsteam sterilization indicator ink is Pink after EO sterilized and24 months shelf life.The color of chemical indicator for EO sterilization indicatorink is Blue, and the color of chemical indicator for steamsterilization indicator ink is Cocoa after steam sterilized and 24months shelf life.	The color of chemical indicator for EO sterilization indicatorink is Pink, and the color of chemical indicator for steamsterilization indicator ink is Blue after 5 years shelf life beforesterilization.The color of chemical indicator for EO sterilization indicatorink is Yellow, and the color of chemical indicator for steamsterilization indicator ink is Blue after EO sterilized and 24months shelf life.The color of chemical indicator for EO sterilization indicatorink is Pink, and the color of chemical indicator for steamsterilization indicator ink is Dark Grey after steam sterilized and24 months shelf life.	sameSimilarSimilar
Maintenance of Sterility	12 months	24months	Different butvalidated for itseffectiveness
Shelf Life	5 years from date of manufacture	5 years from date of manufacture for EO and SteamIndicators	same
Biocompatibility	non-cytotoxic, non-irritative and non-sensitive to skin andconforming with ISO10993-1, ISO10993-5, ISO10993-7,ISO10993-10, ISO10993-12	non-cytotoxic, non-irritative and non-sensitive to skin andconforming with ISO10993-1,ISO10993-5, ISO10993-10,ISO10993-11	same. Tests resultshowed that thesubject device isnon-cytotoxic, non-irritative and non-sensitive to skin

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K242898

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Comparison of Dimension
Subject device			Predicate device
Model	Item	Specification Size(W×L)		Model	Item	Specification Size(W×L)
	No.	Inch	Metric		No.	Inch	Metricmm×mm
	2001	2.25"×4"	57× (100+30) mm		P-001	2.25"×3.5"	57×90
	2031	2.25"×2.75"	57× (70+30) mm		P-002	2.25"×4"	57×100
	2002	2.75"×9"	70× (230+30) mm		P-003	2.25"×5"	57×130
	2003	3.5"×6.5"	90× (135+30) mm		P-004	2.75"×10"	70×260
	2004	3.5"×9"	90× (230+30) mm		P-005	3.5"×5.25"	90×135
	2005	3.5"×10.5"	90× (270+30) mm	PLANE-01SterilizationPouch	P-006	3.5"×6.5"	90×165
	2032	3.5"×22"	90× (560+30) mm		P-007	3.5"×10"	90×260
	2033	5"×15"	127× (380+30) mm		P-008	5.31"×10"	135×260
	2006	5.25"×10"	135× (254+29) mm		P-009	5.31"×11"	135×280
	2034	5.25"×10"	135× (255+30) mm		P-010	5.31"×13"	135×330
	2035	5.25"×12"	135× (305+30) mm		P-011	7.5"×14"	190×360
Sterilization Pouches,self-seal	2036	5.25"×13"	140× (330+30) mm		P-012	10"×14.5"	250×370
	2009	6"×9"	150× (230+30) mm		P-013	10.25"×16"	260×410
	2008	7.5"×13"	190× (330+30) mm		P-014	12"×17.7"	300×450
	2037	8"×12.5"	200× (320+30) mm			R-101	2"
	2009	10"×14.5"	250× (370+30) mm			R-102	3"
	2010	10.6"×17"	270× (400+30) mm			R-103	4"
	2038	10.5"×17"	270× (430+30) mm			R-104	6"
	2039	12"×15"	300× (380+30) mm	Roll-01SterilizationRoll	R-105	8"	200mm×200m
	2012	12"×16.5"	300× (420+30) mm		R-106	10"	250mm×200m
	2011	12"×18"	300× (460+30) mm		R-107	12"	300mm×200m
	2040	14"×19"	355x (480+30) mm	Roll	R-108	14"	350mm×200m
	2041	15"×25"	380× (635+30) mm		R-109	16"	400mm×200m
	2042	20"×22"	500× (560+40) mm		R-110	17.7"	450mm×200m
	2161	3.5"×22"	90×560mm	Roll-01	R-111	20"	500mm×200m
	2107	4"×12"	100×300mm		GR-201	3"	75mm×100m
	2162	5"×15"	127×380mm		GR-202	4"	100mm×100m
Sterilization Pouches,flat, heat seal	2163	6"×10"	150×254mm	Sterilization	GR-203	6"	150mm×100m
	2164	6"×22"	150×560mm	Roll	GR-204	8"	200mm×100m
	2165	7.5"×13"	190×330mm		GR-205	10"	250mm×100m
	2166	8"×20"	200×500mm		GR-206	12"	300mm×100m

	2167	12"x15"	300×380mm	GR-207	14"	350mm×100m
	2168	12"x18"	300×460mm	GR-208	16"	400mm×100m
	2169	16.5"×22.5"	420×570mm
Sterilization Pouches,gusseted, heat seal	2406	4"x12"	100×50×300mm
	2401	4"x14"	100×50×360mm
	2402	6"x16"	150×50×400mm
	2403	6"x18"	150×50×460mm
	2404	8"×20"	200×55×500mm
	2407	8"x16"	200×55×400mm
	2408	8"×19"	250×65×480mm
	2405	12"x22"	300×80×550mm
	2409	16.5"×22.5"	420×100×570mm
	2229	3"	75mm×30.5m
	2230	4"	100mm×30.5m
	2231	6"	150mm×30.5m
Sterilization Reels, flat,heat seal	2232	8"	200mm×30.5m
	2233	10"	250mm×30.5m
	2201	2"	50mm × 200m
	2211	2.15"	55mm x 200m
	2202	3"	75mm×200m
	2203	4"	100mm×200m
	2210	4.7"	120mm×200m
	2204	6"	150mm×200m
	2205	8"	200mm × 200m
	2206	10"	250mm×200m
	2207	12"	300mm×200m
	2208	14"	350mm×200m
	2209	16"	400mm×200m
	2212	18"	450mm×200m
	2213	20"	500mm×200m
Sterilization Reels,gusseted, heat seal	2314	4.15"	55mm×100m
	2301	3"	75mm×100m
	2302	4"	100mm×100m
	2303	6"	150mm×100m
	2304	8"	200mm×100m
	2305	10"	250mm×100m
	2306	12"	300mm×100m
	2307	14"	350mm×100m
	2308	16"	400mm×100m
	2315	18"	450mm×100m
	2309	20"	500mm×100m

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9. Clinical Test Conclusion

No clinical study is included in this submission.

10. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K242898, the Sterilization Pouches and Reels, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared in K221875.

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).