The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization.

Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 F/55°C and 40%-80% relative humidity for 60 minutes.

b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar

c) Aeration time: 12 hours

d) Aeration temperature: 55℃

e) Aeration pressure : 841 mBar to 864 mBar

Device Description

Sterilization Wrap is single use, non-sterile provide. It is divided into single and double layers, with double layer edges closed by ultrasonic suture. The sterilization Wrap is made from 100% polypropylene spunbond- meltblown - spunbond (SMS), not made with natural rubber latex.

AI/ML Overview

The provided text describes the regulatory clearance of a "Sterilization Wrap" device (K222151) and its comparison to a predicate device (K181174). The information focuses on the physical, chemical, and sterilization properties of the wrap. The document does not contain information related to a study involving an AI-powered medical device or human readers for image interpretation. Therefore, I cannot provide details on the sample size for a test set, expert qualifications, or MRMC studies, as these concepts are not applicable to the provided document.

However, I can extract the acceptance criteria and performance data for the Sterilization Wrap based on the provided text, as it relates to the device's functional and safety aspects.

Here's the analysis based on the provided text:

Analysis of Sterilization Wrap Acceptance Criteria and Performance

The "Sterilization Wrap" device (K222151) has undergone non-clinical testing to demonstrate its performance and establish substantial equivalence to a predicate device (K181174). The acceptance criteria and reported device performance are generally based on meeting recognized industry standards for medical device sterilization wraps.

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria	Proposed Device Performance	Predicate Device (K181174) Performance	Remark (from document)
Sterilant Penetration and Sterilization Efficacy	Achieving a 10⁻⁶ sterility assurance level (e.g., negative for growth)	Negative for growth	Negative for growth	SAME
Maintenance of package sterility	Maintain sterility for up to 365 Days	Negative for growth (tested for 365 days)	Negative for growth (tested for 365 days)	SAME
Residuals (Ethylene Oxide)	Meet ISO 10993-7	Meet ISO 10993-7 (None detected)	Meet ISO 10993-7	SAME
Biocompatibility (Cytotoxicity)	Non-cytotoxic (ISO 10993-5)	Non-cytotoxic	Non-cytotoxic	Pass
Biocompatibility (Irritation)	Non-irritant (ISO 10993-10)	Non-irritant	Non-irritant	Pass
Biocompatibility (Sensitization)	Non-sensitizer (ISO 10993-10)	Non-sensitizer	Non-sensitizer	Pass
Material Compatibility (EO sterilization process)	Compatible to EO sterilization process	Compatible	Compatible	SAME
Tensile Strength	Complies with selected physical properties (ASTM D 5034 -09)	Passed (before and after EO sterilization)	(Not explicitly stated but implied by "SAME" for material properties)	Pass
Bursting Strength	Complies with selected physical properties (ASTM D3786/D3786M-18)	Passed (before and after EO sterilization)	(Not explicitly stated but implied by "SAME" for material properties)	Pass
Water Resistance Hydrostatic Pressure Test	Complies with selected physical properties (AATC127-18)	Passed (before and after EO sterilization)	(Not explicitly stated but implied by "SAME" for material properties)	Pass
Air Permeability	Complies with selected physical properties (ASTM D737-18)	Passed (before and after EO sterilization)	(Not explicitly stated but implied by "SAME" for material properties)	Pass
Mass per Unit Area	Complies with selected physical properties (ASTMD37776/D3776M-20)	Passed (before and after EO sterilization)	(Not explicitly stated but implied by "SAME" for material properties)	Pass
Tearing Strength	Complies with selected physical properties (ASTM D5587-15)	Passed (before and after EO sterilization)	(Not explicitly stated but implied by "SAME" for material properties)	Pass
Dimension	Meet ISO 11607:2019	Passed (before and after EO sterilization)	(Not explicitly stated but implied by "SAME" for material properties)	Pass
Lint Generation Testing	Coefficient of linting log₁₀ ≤ 4.0 (EN 13795-1:2019)	≤4.0 (before and after EO sterilization)	(Not explicitly stated)	Pass
Microbial Barrier Test	Product has good anti-bacterial permeability of the packaging material	Negative for growth	(Not explicitly stated but implied by "Maintenance of package sterility")	Pass
Shelf Life	Shelf Life 1 year	After 1 year accelerated aging, meets requirements and no significant change from 0 year's test results.	Not obtained (for predicate)	Passed

2. Sample size used for the test set and the data provenance

The document refers to various standard tests (e.g., ASTM, ISO standards) for physical properties, sterilization validation, and biocompatibility. The specific sample sizes for each of these non-clinical tests are not provided in the document.

The data provenance is from non-clinical tests conducted by the manufacturer of the proposed device, Kenpax International Limited. The country of origin of the data is not explicitly stated beyond the manufacturer's address in Hong Kong and the contact person's address in Beijing, China. The studies are prospective in nature, as they involve testing the device to verify its performance against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for this device is established through quantitative measurements and adherence to international testing standards (e.g., sterility assurance level, physical property thresholds) rather than expert consensus on interpretation, as might be the case for an AI diagnostic device.

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 are typically used in studies involving human interpretation or subjective assessments, not for non-clinical, objective performance testing of a physical product like a sterilization wrap.

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. The device is a sterilization wrap, not an AI-powered diagnostic tool, and therefore, an MRMC study with human readers is irrelevant.

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, not an algorithm.

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

The "ground truth" for this device is based on pre-defined, quantitative performance metrics and established international standards. For example:

Sterility: Achieved a 10⁻⁶ sterility assurance level (objective microbial growth testing).
Physical Properties: Meeting specific tensile strength, bursting strength, water resistance, air permeability, mass per unit area, tearing strength, and dimension parameters (objective physical measurements).
Biocompatibility: Absence of cytotoxicity, irritation, and sensitization (objective biological tests against ISO standards).
Residuals: Levels of ethylene oxide residuals below specified thresholds (objective chemical analysis).

8. The sample size for the training set

This question is not applicable. The device is a physical product, and there is no "training set" in the context of machine learning or AI models. Its design and manufacturing process would involve internal validation and quality control, but not a "training set" for an algorithm.

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

This question is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.

Summary

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March 23, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Kenpax International Limited % Ray Wang General Manager Beijing Believe-Med Technology Service Co.,Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District, BeiJing, 102401 China

Re: K222151

Trade/Device Name: Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 17, 2023 Received: February 21, 2023

Dear Ray 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Image /page/1/Picture/6 description: The image shows the name "Eileen Cadel -S" in large font on the left side of the image. On the right side of the image, there is a digital signature that states "Digitally signed by Eileen Cadel -S" followed by the date "Date: 2023.03.23" and the time "12:49:17-04'00'".

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

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Indications for Use

Device Name Sterilization Wrap

Indications for Use (Describe)

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization.

Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 F/55°C and 40%-80% relative humidity for 60 minutes.

b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar

c) Aeration time: 12 hours

d) Aeration temperature: 55℃

e) Aeration pressure : 841 mBar to 864 mBar

Suggestions for the packaging content are given in table , A single layer of wrapping needs to be packaged in two sheets. Table : Wrap Model Recommendations

Series(productfamily)	ProductCode	Size: Length xWidth (Inch)	Layersofsheet	Color	BasicWeight(g/m2)	Enclosed Medical Device	MaximumRecommendedWrapped PackageContent Weights(lb)
BW1000	BW1015	15*15	Dual	White + Blue	34g + 34g	Very light weight package (For example:Huck towels)	0.78
	BW1024	24*24	Dual	White + Blue			2.96
BL1000	BL1012	12*12	Single	Blue	34g	Very light weight package (For example:Huck towels)	0.37
	BL1015	15*15	Single	Blue			0.78
	BL1018	18*18	Single	Blue			1.11
	BL1020	20*20	Single	Blue			2.32
	BL1024	24*24	Single	Blue			2.98
BW3000	BW3024	24*24	Dual	White + Blue	65g + 65g	Light to moderate weight package (forexample: Huck towels, Fluid-resistanttable cover, General use medicalinstruments)	7.5
	BW3036	36*36	Dual	White + Blue			9

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BL4000	BL4018	18*18	Single	Blue	70g	Moderate to heavy weight package (forexample: Tray liners, Lumens, Generaluse medical instruments).Maximum two lumens in one pack, eachwith minimum inner diameter of 3 mm IDand maximum length of 400mm.	3.5
BW5000	BW5024	24*24	Dual	White +Blue	70g + 70g	Heavy weight package (for example: Trayliners, Lumens, General use medicalinstruments)	6
	BW5036	36*36	Dual	White +Blue			9.5
	BW5048	48*48	Dual	White +Blue			17
BW6000	BW6036	36*36	Dual	White +Blue	88g + 88g	Very heavy weight package (for example:Tray liners, Lumens, General use medicalinstruments).	10
	BW6045	45*45	Dual	White +Blue			23
	BW6048	48*48	Dual	White +Blue		Maximum two lumens in one pack, eachwith minimum inner diameter of 3 mm IDand maximum length of 400mm.	25

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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The assigned 510(k) Number: _ K222151

510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

Date of Preparation: 23/03/2023 1.
1. Sponsor Identification

KENPAX INTERNATIONAL LIMITED

Flat 5, 5/F, Wing On Plaza, 62 Mody Road Tsim Sha Tsui, KowLoon, Hong Kong

Contact Person: Jerome Ren Position: QRA director Tel: 852-2-2722935 Email: JeromeRen@kenpax.cn

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com

1. Identification of Proposed Device
  Trade Name: Sterilization Wrap Common Name: Sterilization Wrap

Regulatory Information Classification Name: Sterilization Wrap Classification: 2 Product Code: FRG Regulation Number: 21 CFR 880.6850 Review Panel: General Hospital

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Indication For Use Statement:

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization.

Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 °F/55°C and 40%-80% relative humidity for 60 minutes.

b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar
c) Aeration time: 12 hours
d) Aeration temperature: 55°C
e) Aeration pressure: 841 mBar to 864 mBar

Suggestions for the packaging content are given in table 1, A single layer of wrapping needs to be packaged in two sheets.

			Table 1: Wrap Model Recommendations
--	--	--	-------------------------------------	--

Series(productfamily)	ProductCode	Size: Length xWidth (Inch)	Layersof sheet	Color	BasicWeight(g/m2)	Enclosed Medical Device	MaximumRecommendedWrappedPackageContentWeights (lb)
BW1000	BW1015	15*15	Dual	White +Blue	34g + 34g	Very light weight package (Forexample: Huck towels)	0.78
	BW1024	24*24	Dual	White +Blue	34g + 34g		2.96
BL1000	BL1012	12*12	Single	Blue	34g	Very light weight package (Forexample: Huck towels)	0.37
	BL1015	15*15	Single	Blue	34g	Very light weight package (Forexample: Huck towels)	0.78
	BL1018	18*18	Single	Blue	34g		1.11
	BL1020	20*20	Single	Blue	34g		2.32
	BL1024	24*24	Single	Blue	34g		2.98
BW3000	BW3024	24*24	Dual	White +Blue	65g + 65g	Light to moderate weight package(for example: Huck towels,Fluid-resistant table cover,General use medical instruments)	7.5
	BW3036	36*36	Dual	White +Blue	65g + 65g		9
BL4000	BL4018	18*18	Single	Blue	70g	Moderate to heavy weight package(for example: Tray liners, Lumens,General use medical instruments).Maximum two lumens in one pack,each with minimum inner diameterof 3 mm ID andmaximum length of 400mm.	3.5

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BW5000	BW5024	24*24	Dual	White +Blue	70g + 70g	Heavy weight package (for example:Tray liners, Lumens, General usemedical instruments) Maximum twolumens in one pack, each withminimum inner diameter of 3 mm IDand maximum length of 400mm.	6
	BW5036	36*36	Dual	White +Blue			9.5
	BW5048	48*48	Dual	White +Blue			17
BW6000	BW6036	36*36	Dual	White +Blue	88g + 88g	Very heavy weight package (forexample: Tray liners, Lumens,General use medical instruments).Maximum two lumens in one pack,each with minimum inner diameter of3 mm ID andmaximum length of 400mm.	10
	BW6045	45*45	Dual	White +Blue			23
	BW6048	48*48	Dual	White +Blue			25

న్. Device Description

The Model/Specifications as below:

Model /Specifications (in)	BW1000	BW3000	BW5000	BW6000	BL1000	BL4000
12*12					BL1012
15*15	BW1015				BL1015
18*18					BL1018	BL4018
20*20					BL1020
24*24	BW1024	BW3024	BW5024		BL1024
36*36		BW3036	BW5036	BW6036
45*45				BW6045
48*48			BW5048	BW6048
Basic weight (g/m²)	34g+34g	65g + 65g	70g + 70g	88g + 88g	34g	70g
Color	Blue + White				Blue
Layer	Dual layers				Single layer

Note:

a) BW series is double layer, Double Layer wrap comprised of one sheet of blue pigmented SMS fabric and one sheet of white pigmented SMS fabric that have been ultrasonically sealed on two opposing edges, BL series is single layer, Single Layer wrap comprised of a single sheet of blue pigmented SMS fabric.
b) The specific model under the product series is expressed as series number and size, such as: 24*24inch under the BW1000 series, the model is expressed as: BW1024.

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Identification of Predicate Device(s) 6.

Primary Predicate Device 510(k) Number: K181174 Product Name: Cardinal Health ™ Sterilization Wrap Manufacturer: Cardinal Health 200 LLC Classification: 2 Product Code: FRG Regulation Number: 21 CFR 880.6850

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1. Technological Characteristics

Table 1 General Comparison

ITEM	ProposedDevice	Predicate Device (K181174)	Remark
Intended Use	The wrap is intended to allow sterilization of theenclosed medical device(s) and to maintainsterility of the enclosed device(s) until used upto 365 days post sterilization.Sterilization wrap is intended to be used toenclose another medical device that is to besterilized by a health care provider using:a) 100% ethylene oxide (EO) with aconcentration of 725 - 735 mg/l at 131°F/55°Cand 40%-80% relative humidity for 60 minutes.b) Exhausting the EO gas vacuum depth: 157mBar to 160 mBarc) Aeration time: 12 hoursd) Aeration temperature: 55°Ce) Aeration pressure: 841 mBar to 864 mBar	Cardinal Health™ Sterilization Wrap is intended to enclose anothermedical device that is to be sterilized by a health care provider using:• Pre-vacuum steam at 270°F/132°C for 4 minutes• Gravity steam at 250°F/121°C for 30 minutes• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at131°F/55°C and 40%-80% relative humidity for 60 minutes• Advanced Sterilization Products (ASP) STERRAD® 100S System• Advanced Sterilization Products (ASP) STERRAD® 200 System• Advanced Sterilization Products (ASP) STERRAD® NX System, Standardand Advanced Cycles• Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard,Flex, Express, and DUO cycles• Lumen, Non Lumen, and Flexible Cycles by the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 Low Temperature SterilizationSystems• TSO3 STERIZONE® VP4 System Cycle 1The wrap is intended to allow sterilization of the enclosed medicaldevice(s) and to maintain sterility of the enclosed device(s) until used.	Analyze 1
Product Code	FRG	FRG	SAME
Regulation Number	880.6850	880.6850	SAME
Prescription vs. OTC	OTC	OTC	SAME
Single Use Only vs.Reusable	Single Use only	Single Use only	SAME
Materials	Polypropylene fabric using SMS(spunboundmeltdown-spunbound)production process	Polypropylene fabric using SMS (spunboundmeltdown-spunbound)production process	SAME
Chemical Properties	Polypropylene antistatic treatment	Polypropylene antistatic treatment	SAME
Device Design	Double Layer: Double Layer wrap comprised ofone sheet of blue pigmented SMS fabric and onesheet of white pigmented SMS fabric that havebeen ultrasonically sealed on two opposingedgesSingle Layer: Single Layer wrap comprised ofa single sheet of blue pigmented SMS fabric	Dual layer, fold-over: Double layer wrap comprised of a single sheet ofblue pigmented SMS fabric that has been folded over in half andultrasonically sealed to itself on the three nonfolded edgesDual Layer: Double layer wrap comprised of two separate sheets ofblue pigmented SMS fabric that have been ultrasonically sealed on twoopposing edgesSingle Layer: Single layer wrap comprised of a single sheet of bluepigmented SMS fabricTwo Color: Double layer wrap comprised of one sheet of bluepigmented SMS fabric and one sheet of green pigmented SMS fabricthat have been ultrasonically sealed on two opposing edges	Analyze 2
Color	Dual Layer: Blue + WhiteSingle Layer: Blue	Dual Layer: Blue + greenSingle Layer: Blue	Analyze 3
Sterilization
	100% ethylene oxide (EO) with a concentrationof 725- 735 mg/L at 131°F/55°Cand 40%- 80%relative humidity for 60 minutes	Pre-vacuum steam at 270°F/132°C for 4 minutes Gravity steam at250°F/121°C for 30 minutes100% ethylene oxide (EO) with a concentration of 725- 735 mg/L at131°F/55°Cand 40%- 80% relative humidityfor 60 minutesAdvanced Sterilization Products (ASP) STERRAD® 100S System AdvancedSterilization Products (ASP) STERRAD® 200 SystemAdvanced Sterilization Products (ASP) STERRAD® NX System, Standard andAdvanced CyclesAdvanced Sterilization Products (ASP) STERRAD® 100NX, Standard,Flex, Express, and DUO cyclesLumen, Non-Lumen, and Flexible Cycles in the STERISV-PRO® 1, V-PRO® 1 Plus, VPRO® maX and VPRO® 60 LowTemperature Sterilization SystemsTSO3 STERIZONE® VP4 System Cycle 1	Analyze 4
Maximum Wrapped	EO: up to 25 pounds	Pre-vacuum Steam: 3 to 25 pounds	SAME
Package ContentWeights		Gravity Steam: 3 to 25 pounds
		EO: 3 to 25 pounds
		STERRAD® 100S: 3 to 9.7 pounds
		STERRAD® 200: 9.12 pounds
		STERRAD® NX: 10.7 pounds STERRAD®100NX: 10.7 pounds
		STERIS V-PRO® 1, VPRO® 1 Plus and VPRO® maX: 3 to9.1 pounds
		STERIS V-PRO® 60: 3 to 12 pounds
		STERIZONE® VP4: 3 to 25 pounds
Models/ Dimensions	12 in×12 in, 15 in×15 in, 18 in×18 in, 20 in×20in, 24 in×24 in, 36 in×36 in, 45 in×45 in ,48in×48 in	12 in×12 in, 15 in×15 in, 18 in×18 in, 20 in×20 in, 24 in×24in, 30 in×30 in, 36 in×36 in, 40 in×40 in, 45 in×45 in, 48 in×48 in,54 in×54 in,60 in×60 in, 54 in×72 in, 54 in×90 in	Analyze 5
Product Shelf life	I year	Not obtained	Analyze 6
Maintenance ofSterility	365 days	365 days	SAME

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Analyze 1

Proposed Device (Sterilization Wrap) is intended to enclose another medical device that is to be sterilized by a health care providerusing:

100% ethylene oxide (EO) with a concentration of 725 - 735mg/l at 131°F/55°C and 40%-80% relative humidity for 60 minutes.

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The Predicate Device allow more sterilize method of the Predicate Device includes the sterlize method of Proposed Device. And they are all intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed device(s) until used.

In addition, the proposed Device has been validated for sterilant Penetration Efficacy in accordance with ANSI AAMI ISO 11135:2014, The result show Negative for growth, Maintenance of package sterility meet requirement.

So, it could be considered as the proposed device has same intend use with equivalent device.

Analyze 2

The product design are similar, the structure is divide layer wrap, the material are all SMS fabric .Double Layer wap have been ultrasonically sealed on two opposing edges. The Predicate Device. The difference is that the color of the Dual Laver swap is different.

Proposed Device was tested for package integrity and after sterlization, and the test results net the requirements, the safety and performance of the product can be ensured. so the color difference does not affect the safety and effectiveness of the device.

Analyze 3:

The dual Layer color of proposed device is different. Proposed Device was tested for package integrity and biocompatibility before and after sterlization, and the test results met the safety and performance of the product can be ensured. So the color difference does not affect the safety and effectiveness of the device.

Analyze 4

There are more sterilization methods for Predication nethods including the sterlization method of Proposed Device -EO sterlization, Proposed Device has been validated for sterilization Effication Efficacy in accordance with ANSI AAMI ISO 11135:2014, The results show Negative for growth. Maintenance of package sterility meet requirement the product an be ensured. So the difference does not affect the safety and effectiveness of the device.

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Analyze 5

The Dimensions of Proposed Device are include Device Dimensions. Dimensions meet ISO 11607:2019, therefore, will not aftect the substantially equivalency.

Analyze 6

The Shelf life 1 year of proposed device has been verth ASTM F 1980. After 1 year of accelerated aging, the proposed device performance meets the requirements and has no significant change from 0 year's test results, the safety and performance of the can be ensured.

Conclusion:

According to the above analysis, our device has mine predicate device, but the difference does not affect the safety and effectiveness of the device. So, the proposed device is determined to be substantially equivalency with predicate device.

ITEM	Acceptance criteria	Proposed Device	Predicate Device (K181174)	Remark
Sterilant Penetration andSterilization Efficacy	Achieving a 10-6 sterilityassurance level	Negative for growth	Negative for growth	SAME
Maintenance ofpackage sterility	Maintain sterility for upto 365 Days	Negative for growth	Negative for growth	SAME
Residuals	Meet ISO 10993-7,	Meet ISO 10993-7	Meet ISO 10993-7	SAME
Biocompatibility	Meet ISO 10993	Meet ISO 10993	Meet ISO 10993	SAME

Table 2 Performance Comparison

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Material Compatibility, ASTM	Compatible to EO	Compatible	Compatible	SAME
F2101-19, Bacterial FiltrationEfficiencyASTM D5034-09 (2017), TensileStrengthASTM D3786/ D3786M -18,Bursting Strength AATCC 127-2018, WaterResistance: Hydrostatic Pressure TestASTM D737-18, Air Permeability ASTMD3776/ D3776M-20, Massper Unit AreaASTM D5587-15 (2019), TearingStrength,DIN 58953-6: 2016, MicrobialBarrier Test	sterilization process

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Performance data 8.

8.1 Physical properties testing

Item	Standards	Acceptancecriteria	Before EOsterilization result	After EOsterilization result	Results summary
-Tensile Strength	ASTM D 5034 -09 (2017)	Complies with theselected physicalproperties	Passed	Passed	The physical propertiestesting of before and afterEO sterilization meet theacceptance criteria anddemonstrated passingresults.
-Bursting Strength	ASTM D3786/D3786M-18		Passed	Passed
-Water Resistance HydrostaticPressure Test	AATC127-18		Passed	Passed
- Air permeability	ASTM D737-18		Passed	Passed
-Mass per Unit Area	ASTMD37776/D3776M-20		Passed	Passed
- Tearing strength	ASTM D5587-15		Passed	Passed
-Dimension	ISO 11607:2019		Passed	Passed
- lint generation testing	EN 13795-1:2019	Coefficient oflinting log $log_{10}$ $≤$ 4.0	≤4.0	≤4.0

8.2 Sterilization Validation

Item	Standards	Acceptance criteria	Test Result	Results summary
EO Sterilization Validation	ANSI AAMI ISO 11135:2014	Achieving a 10-6 sterility assurance level	Negative for growth	Pass
Residuals	ISO 10993-7:2008	Meet ISO 10993-7:2008	None detected	Pass

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365 Days Maintenance ofSterility Validation -EOSterilization	AATCC 127-18ASTM F 2101-19ASTM D 5034 -09 (2017)ASTM D3786/D3786M-18AATC127-18ASTM D737-18ASTMD37776/D3776M-20	Maintain sterility for up to 365 Days	Negative for growth,Sterilization Wrap wascapable of maintenanceof sterility for 365 days.	Pass
	ASTM D5587-15ISO 11607:2019
Microbial barrier test	ISO 11607:2019	Product has good anti-bacterialpermeability of the packaging materialin the microbial barrier test.	Negative for growth	Pass

8.3 Shelf Life Testing

Item	Standards	Acceptance criteria	Test Result	Results summary
Shelf Life Testing	ASTM F 2101-19ASTM D 5034 -09 (2017)ASTM D3786/D3786M-18AATC127-18ASTM D737-18ASTMD37776/D3776M-20ASTM D5587-15ISO 11607:2019	Shelf Life 1 year.	After 1 year of accelerated aging, the proposed device performance meets the requirements and has no significant change from 0 year's test results.	Passed

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8.4 Biocompatibility Testing

Item	Standards	Acceptance criteria	Before EO sterilization result	After EO sterilization result	Results summary
Cytotoxicity	ISO 10993-5: 2009	Non-cytotoxic	Non-cytotoxic	Non-cytotoxic	Pass
Irritation	ISO 10993-10:2010	Non-irritant	Non-irritant	Non-irritant	Pass
Sensitization	ISO 10993-10:2010	Non-sensitizer	Non-sensitizer	Non-sensitizer	Pass

9. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A ANSI AAMI ISO 11135:2014 Sterlization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
A ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
AATCC 127-18 Test Method for Water Resisitance: Hydrostatic Pressure A
A ISO 11607:2019 Packaging for terminally sterilized medical devices
A ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) A
A ASTM D737-18 Standard test method for air permeability
A ASTM D3776/D3776M Standard test method for mass per unit area (weight) of fabric
A ASTM D3786/D3786M-18 Standard test method for Bursting Strength of Textile Fabrics-Diaphragm Bursing Strength Tester Wethod
A ASTM F2101-19 Standard Test Method the Bacteral Filtration Efficiency (BFE) of Medical Pace Mask Materials, Using a Biological Aerooo of Staphylococcus aureus
A United States Pharmacopeia < 71 >
EN 13795-1:2019 Surgical clothing and drapes- Requirements and test methods. Part 1:Surgical drapes and gowns

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10. Clinical Test Conclusion

No clinical study is included in this submission.

11. Conclusion

Based on the nonclinical tests performed, the sufective, and performs as well as or better than the legally marketed predicate device, Cardinal Health TM Sterilization Wrap cleared under K181174.

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).