The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EtO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 90 Davs post 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 EtO sterilization process.

Device Description

The U&U Sterilization Pouch and Roll are manufactured from paper and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The paper conforms to recognized material standards and can be sterilized by steam and Eto. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as the predicate device. Substantial equivalent to the predicate device was established by physical testing of the sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, and dye migration).

AI/ML Overview

This document is a 510(k) summary for the U&U Sterilization Pouch and Roll, and it focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML studies (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, the document does contain performance testing results for the sterilization pouch and roll, which can be presented as acceptance criteria and reported device performance.

Here's an attempt to answer your questions based only on the provided document, adapting where necessary to the context of a non-AI/ML medical device submission:

1. A table of acceptance criteria and the reported device performance

The document lists "Performance Tests" and the results for the U&U Sterilization Pouch and Roll. The "acceptance criteria" are implied by the "PASSED" result, meaning the device met the requirements of the standards or internal thresholds for each test. For elements where direct comparison with the predicate device implies the "acceptance criteria", those are noted.

Element (Acceptance Criteria Implicitly Met)	Reported Device Performance
Sterilant Penetration	PASSED
Package Integrity	PASSED
Maintenance of Package Integrity	PASSED
Material Compatibility	PASSED
Shelf-Life	PASSED
Biocompatibility	PASSED
Labeling	PASSED
Configurations /Dimensions	PASSED
Air permeance	PASSED
Maintenance of Sterility	PASSED (90 Days)
Endpoint stability of process indicator	PASSED (90 Days)
Shelf Life of Process Indicator	PASSED (18 months)
Chemical Indicator Efficacy	PASSED (Changed color: EtO- YELLOW to COCOA; Steam- GREEN to PURPLE)
Seal strength	PASSED
Peel-open characteristic	PASSED
Seal width	PASSED
Self seal strength	PASSED
Visual inspection	PASSED
Ethylene oxide residuals	PASSED
Specific Comparison with Predicate (Implied Acceptance Criteria)
Air permeance (Max. equivalent pore size diameter)	Not exceed 50um (Reported: Not specified, but implied to meet)
Sterilant Penetration (Pore size diameter)	Determined using EN 868-2:1999 Annex C. Reported: 40 to 44 um (Predicate: 38 to 43 um). "The difference can be accepted."
Microbial Barrier Properties (LRV)	Using ASTM 1608 method, LRV > 3.5 (Predicate: LRV 3.3). "The data is a little higher than the predicated device, The difference can be accepted."
Microbial Barrier Properties (Inspection)	Using ASTM 1929 method, inspection result is PASS (Predicate: PASS)
Maintenance of Sterility (Duration)	90 Days (Predicate: 2 years)
Endpoint stability of process indicator (Duration)	90 Days (Predicate: 2 years)
Shelf Life of Process Indicator (Duration)	18 months (Predicate: 2 years)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: The document does not specify the exact sample sizes used for each performance test. It only states that "Performance testing was conducted" and refers to validation of "Two types of sterilization loads."
Data provenance: The document is a submission from U&U Medical Technology Co., Ltd, located in China. The testing was conducted to support their 510(k) submission to the US FDA. No specific country of origin for the raw test data is explicitly stated, nor is it specified if the studies were retrospective or prospective, though performance testing for regulatory submission is typically prospective for the device being submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the provided document. The device is a sterilization pouch and roll, not an AI/ML-powered diagnostic or predictive device that relies on expert interpretation to establish ground truth for testing. The "ground truth" for this device's performance is based on established engineering and microbiological test methods (e.g., AAMI/ANSI, ISO, ASTM standards) and physical/chemical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus processes for establishing ground truth in image analysis or similar diagnostic contexts, which is not relevant for this device. The performance tests rely on objective laboratory measurements and standardized methods.

5. 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

This question is not applicable. MRMC studies are designed for assessing the impact of AI on human reader performance, which is not relevant for a sterilization pouch and roll.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical product (a sterilization pouch and roll), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" (or basis for evaluation) for this device's performance is derived from:

Compliance with recognized material and performance standards (e.g., AAMI/ANSI ST77, AAMI TIR22, AAMI/ANS//ISO 11140-1).
Results from standardized physical and chemical tests (e.g., EN 868-2:1999 Annex C, ASTM 1608, ASTM 1929, ISO10993 for biocompatibility).
Observed changes in chemical indicators (color change).
Comparison with the performance characteristics of a legally marketed predicate device (SIGMA Sterilization Pouch and Roll - K102158).

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

This question is not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 9, 2015

U&U Medical Technology Co., Ltd Mr. Garfield Wang General Manager Dongzhou Village, Hengshanqiao RM EE1092 1/F Building 1, No 1755 Hongmei Road Changzhou, Jiangsu China

Re: K143637

Trade/Device Name: U&U Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG, JOJ Dated: August 2, 2015 Received: August 5, 2015

Dear Mr. 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. 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.

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Page 2 - Mr. Wang

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143637

Device Name U&U Sterilization Pouch and Roll

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

The U&U sterilization pouch and roll are intended to provide with an effective method to enclose devices intended for sterlization in steam and Ethylene Oxide (EtO). The recommended g r a vi t y steam sterilization vole parameters at 121°C. The recommended EiO sterlization cycle is 4 hours at 5°C with a relative humidity between 50%-55% and a sterilant of 600 mgL. Furthernon, the sterlization pouch and roll maintains the enclosed devices up until 90Days post sterial chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.

STERILIZATION CYCLE:

The recommended g r a v i t y steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes.

Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55℃ (130 °F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85% RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C

Sterilization load claim:

Two types of sterilization loads were validated. Load A: Metal medical instruments and Hand-control pen, the total weight is 24lbs. Load B: Tubing (Silicone) and Surgical Towels. The total weight is 181bs.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov

"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."

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Load Types:

The following matrix is the types of medical instruments used for steam and EtO sterilization.

Medical Device	Steam	EtO Gas
Reusable surgical instruments such as clamps, scissors, retractors, pliers	X	X
Endoscopes (thermostable)	X	X
Endoscopes(thermolabile)	-	X
Reusable containers	X	-
Elastic Products such as Rubber or latex (also combined), siliconelastomer, plastics, closed hollow bodies	X	X
HF-cable and handpieces	X	X
Powertools	X	X
Textile Material such as surgical towels	X	X

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U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Sterilization Pouch]

Rev 1.00 09/09/15

Sec 005_510(K) Summary

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

Date Prepared: 2015-09-09 Submission Numbers for Pre-Submission: K143637

1. Submitter Name and Address:

Name:	U&U Medical Technology Co., Ltd
Address:	Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,ChinaRM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China
Contactor Name:	Garfield Wang
TEL:	+86-13902471751
E-mail:	Wangxuebo_11@hotmail.com

US Agent:

Name:	CARELIFE (USA) INC.
Address:	1580 Boggs Rd, Suite 500/600 Duluth GA 30096
TEL:	404 6612228
Contact person :	Ms. LI QIAN liqian@shanghaicarelife.com

2. Submission Devices Information:

Trade/Proprietary Name: U&U Sterilization Pouch and Roll Common Name: Sterilization Pouch Classification name: 1) Sterilization wrap 2) Indicator, Physical/Chemical Sterilization Process 21 CFR 880.6850 & 21 CFR 880.2800 Class: Il FDA review panel code: General Hospital Product code: 1) FRG 2) JOJ

3. Predicate Devices Information:

Trade Name:	SIGMA Sterilization Pouch and Roll
510(K) Number:	K102158
Manufacturer:	SIGMA Medical Supplies Corp.

4. Devices Description:

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Rev 1.00 09/09/15

5. Model numbers of the pouches:

RefNumber	ModelNumber	Description	Size
UUPP0001	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	3" X 8"
UUPP0002	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	4" X 10.25"
UUPP0003	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	6" X 12.5"
UUPP0004	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	4" X 14"
UUPP0005	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	8" X 16"
UUPP0006	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	6" X 16.5"
UUPP0007	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	10" X 19"
UUPP0008	UUPP	STERILIZATION Pouch-Heat-Seal and Self-Seal	12.5" X 22"
UUPR0001	UUPR	STERILIZATION Roll-Heat-seal	3" X 228'
UUPR0002	UUPR	STERILIZATION Roll-Heat-seal	4" X 228'
UUPR0003	UUPR	STERILIZATION Roll-Heat-seal	6" X 228'
UUPR0004	UUPR	STERILIZATION Roll-Heat-seal	14" X 228'
UUPR0005	UUPR	STERILIZATION Roll-Heat-seal	16.5" X 228'
UUPR0006	UUPR	STERILIZATION Roll-Heat-seal	20" X 228'

5. Intended Use:

STERILIZATION CYCLE:

The recommended gravity steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes. Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55°C (130 ° F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85%RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C

Sterilization load claim:

Two types of sterilization loads were validated

Load A: Metal medical instruments and Hand-control pen, the total weight are 24lb. The double pouched devices are placed into the baskets. Load B: Tubing (Silicone) and Surgical Towels. The total weight is 18lbs.

ISEC 0051

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Rev 1.00 09/09/15

Load Types:

The following matrix is the types of medical instruments used to the sterilization:

Medical Device	Steam	EtO Gas
Reusable surgical instruments such asclamps, scissors, retractors, pliers	X	X
Reusable containers	X	-
Elastic Products such as Rubber or latex(also combined), siliconelastomer,plastics, closed hollow bodies	X	X
HF-cable and handpieces	X	X
Powertools	X	X
Textile Material such as surgical towels	X	X

6. Technological Characteristics:

All testing followed the following standards.

AAMI/ANSI ST77 Containment devices for reusable medical device sterilization AAMI TIR22 Guidance for ANSI/AAMI/ISO 11607-Packaging for terminally sterilized medical devices-Part 1 and Part 2:2006

AAMI/ANS//ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements

7. Performance Testing:

Performance testing was conducted to show that the U&U Sterilization Pouch and Roll maintain sterility until the seal of the Pouch/Roll is opened. Performance Tests

Element	Results
Sterilant Penetration	PASSED
Package Integrity	PASSED
Maintenance of Package Integrity	PASSED
Material Compatibility	PASSED
Shelf-Life	PASSED
Biocompatibility	PASSED
Labeling	PASSED
Configurations /Dimensions	PASSED
Air permeance	PASSED
Maintenance of Sterility	PASSED
Endpoint stability of process indicator	PASSED
Shelf Life of Process Indicator	PASSED
Chemical Indicator Efficacy	PASSED
Seal strength	PASSED
Peel-open characteristic	PASSED
Seal width	PASSED
Self seal strength	PASSED
Visual inspection	PASSED

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U&U ChangZhou Medical Packaging Technology Co., LtdDongzhou Village,Hengshanqiao,Changzhou,Jiangsu,ChinaU&U (Shanghai) Medical Technology Co., LimitedRM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China	510(k) Submission
[Sterilization Pouch]	Rev 1.00	09/09/15
Ethylene oxide residuals	PASSED

8. SUBSTANTIAL EQUIVALENCE DISCUSSION:

Our Sterilization Pouch and the predicate device are same in intended use, components, materials, sterilization, and function.

Side by side testing was conducted on the U&U Sterilization Pouch and Roll and SIGMA Sterilization pouch and roll - K102158 to determine substantial equivalence. Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance were the parameters used to determine substantial equivalence and validate the safety and efficacy of the device.

Element ofComparison	Submission Device	Predicate DeviceK102158
Intended Use	The U&U sterilization pouch and roll areintended to provide health care workerswith an effective method to enclosedevices intended for sterilization insteam and Ethylene Oxide (EtO). Therecommended gravity steam sterilizationcycle parameters are 30 minutes at121 °C. The recommended Etosterilization cycle is 4 hours at 55 °Cwith a relative humidity between 50%-85% and a sterilant concentration of 600mg/L. Furthermore, the sterilizationpouch and roll maintains the encloseddevices up until 90Days post sterilization.Lastly, the pouch's external chemical inkindicators are designed to indicate to theuser that the pouch has undergone eithera steam or Eto sterilization processSTERILIZATION CYCLE:The recommended gravity steam sterilization cycleparametersSteam sterilization temperature: 121°C (250 °F)Steam sterilization time: 30 minutes.Drying time: 25 minutesThe recommended Eto sterilization cycle parametersEto sterilization temperature: 55°C (130 ° F)Eto sterilization time: 4 hourEto sterilization humidity: 50% to 85%RHEto sterilization concentration: 600mg/LAeration time: 8 hours.Aeration Temperature: 60°CSterilization load claim:Two types of sterilization loads were validated.Load A: Metal medical instruments and Hand-control pen,the total weight are 24lb. The double pouched devices areplaced into the baskets.Load B: Tubing (Silicone) and Surgical Towels. The totalweight is 18lbs.	The SIGMA sterilization pouch and rollare intended to provide health careworkers with an effective method toenclose devices intended for sterilizationin steam and Ethylene Oxide (EtO). Therecommended steam sterilization cycleparameters are 30 minutes at 121 °C.The recommended Eto sterilization cycleis 4 hours at 55 °C with a relativehumidity between 50%-85% and asterilant concentration of 600 mg/L.Furthermore, the sterilization pouch androll maintains the enclosed devices upuntil 2 years post sterilization. Lastly, thepouch's external chemical ink indicatorsare designed to indicate to the user thatthe pouch has undergone either a steamor EtO sterilization process

	Medical Device Steam EtO Gas Reusablesurgicalinstrumentssuch as clamps,scissors,retractors, pliers X X Reusablecontainers X -

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U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China (Shanghai) Medical Technology Co., Limited
U&U (Shanghai) Medical Technology Co., Limited
RM EEE0092 1/F Building 1, No 1755, HONGMEl Road, Shanghai, China [Sterilization Pouch]

510(k) Submission

09/09/15 Rev 1.00

	Elastic Productssuch as Rubberor latex (alsocombined).siliconelastomer, plastics,closed hollowbodiesHF-cable and	×	X
	handpieces	×	X
	Powertools	×	X
	Textile Materialsuch as surgicaltowels	×	X
MaterialComposition	Top Web - Medical Porous PaperBottom Web - Medical Plastic film(CPP)Bottom Web - Medical two-sided adhesive tapeEtO gas indicator ink-Process Indicators class 1			Top Web - Medical Porous PaperBottom Web - Medical Plastic film(CPP)Bottom Web -Medical two-sided adhesive tapeEtO gas indicator ink-Process Indicators class 1
	Steam indicator ink-Process Indicators class 1			Steam indicator ink-Process Indicators class 1
SterilizationCycles	The recommended gravity steam sterilization cycleparameters are 30 minutes at 121 ℃. Therecommended EtO sterilization cycle is 4 hours at55 ℃ with a relative humidity between 50%-85% anda sterilant concentration of 600 mg/L.		The recommended steam sterilization cycle parametersare 30 minutes at 121 ℃. The recommended EtOsterilization cycle is 4 hours at 55 ℃ with a relativehumidity between 50%-85% and a sterilantconcentration of 600 mg/L.
Confiqurations/Dimensions	For Pouch:Width: ±0.1"" Length ± 0.2""For Roll:Width: ±0.1"" Length ± 3%			For Pouch:Width: ±0.1"" Length ± 0.2""For Roll:Width: ±0.1"" Length ± 3%
Air permeance	The maximum equivalent pore size diameter shall notexceed 50um.			The maximum equivalent pore size diameter shall notexceed 50um.
SterilantPenetration	Use the EN 868-2:1999 Annex C: Method for thedetermination of the pore size, the pore size diameter is40 to 44 umThe data is a little higher than the predicated device, Thedifference can be accepted.		Use the EN 868-2:1999 Annex C: Method for thedetermination of the pore size, the pore size diameter is38 to 43 um
Microbial BarrierProperties(PackagingIntegrity)	Use ASTM 1608 method, the LRV is more than 3.5Use ASTM 1929 method, the inspection result is PASSThe data is a little higher than the predicated device, Thedifference can be accepted.		Use ASTM 1608 method, the LRV is 3.3Use ASTM 1929 method, the inspection result is PASS
MaterialCompatibility	After sterilization, the materials were not degraded		After sterilization, the materials were not degraded
ToxicologicalProperties(Biocompatibility,includingSterilant ResidueLimits)	Meet ISO10993-4.Haemolysis Test (Direct-contractMethod), ISO10993-10, Test for Irritation (IntractaneousReactivity Test) and ISO10993-10, Test for Skinsensitization (Maximization test)		Meet ISO10993-4,Haemolysis Test (Direct-contractMethod), ISO10993-10, Test for Irritation (IntractaneousReactivity Test) and ISO10993-10, Test for Skinsensitization (Maximization test)
Maintenance ofSterility	90 Days			2 years
Endpoint stabilityof processindicator	90 Days		2 years
Shelf Life ofProcess Indicator	18 months		2 years
Drying time	25 minutes		25 minutes
Aeration time	8 hours at 60°C		8 hours at 60°C
ChemicalIndicator Efficacy	Changed colorEtO- YELLOW to COCOA; Steam- GREEN to PURPLE		Changed color

9. Conclusion:

The performance testing data for the U&U Sterilization Pouch and Roll demonstrates substantial equivalence to the SIGMA Sterilization Pouch and Roll (K102158).

END

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).