Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization wrap, a physical barrier for maintaining sterility. The description focuses on material properties and sterilization process parameters, with no mention of AI/ML or data processing.

Therapeutic

No.
This device is a sterilization wrap intended to maintain sterility of medical devices, not to provide therapy itself.

Diagnostic

No

Explanation: The device is a sterilization wrap, intended to maintain the sterility of enclosed medical devices. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product made from polypropylene spunbond-meltblown-spunbond (SMS) and is used to enclose other medical devices for sterilization. It is a tangible, hardware-based medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the wrap is for sterilizing and maintaining the sterility of other medical devices. It does not mention any use in the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description details the material and construction of the wrap, which is consistent with a packaging material for sterilization, not a diagnostic tool.
Performance Studies: The performance studies focus on the wrap's ability to withstand sterilization processes, maintain sterility, and meet material standards. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics relevant to IVDs.
Lack of IVD-related information: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, this device falls under the category of a medical device used in the sterilization process, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FRG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

8.1 Physical properties testing

Item: Tensile Strength, Bursting Strength, Water Resistance Hydrostatic Pressure Test, Air permeability, Mass per Unit Area, Tearing strength, Dimension, lint generation testing
Standards: ASTM D 5034 -09 (2017), ASTM D3786/D3786M-18, AATC127-18, ASTM D737-18, ASTMD37776/D3776M-20, ASTM D5587-15, ISO 11607:2019, EN 13795-1:2019
Acceptance criteria: Complies with the selected physical properties, Coefficient of linting log $log_{10}$ $≤$ 4.0
Results summary: The physical properties testing of before and after EO sterilization meet the acceptance criteria and demonstrated passing results.

8.2 Sterilization Validation

Item: EO Sterilization Validation, Residuals, 365 Days Maintenance of Sterility Validation -EO Sterilization, Microbial barrier test
Standards: ANSI AAMI ISO 11135:2014, ISO 10993-7:2008, AATCC 127-18, ASTM F 2101-19, ASTM D 5034 -09 (2017), ASTM D3786/D3786M-18, ASTM D737-18, ASTMD37776/D3776M-20, ASTM D5587-15, ISO 11607:2019
Acceptance criteria: Achieving a 10-6 sterility assurance level, Meet ISO 10993-7:2008, Maintain sterility for up to 365 Days, Product has good anti-bacterial permeability of the packaging material in the microbial barrier test.
Test Result: Negative for growth, None detected, Negative for growth, Sterilization Wrap was capable of maintenance of sterility for 365 days, Negative for growth
Results summary: Pass for all tests.

8.3 Shelf Life Testing

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

8.4 Biocompatibility Testing

Item: Cytotoxicity, Irritation, Sensitization
Standards: ISO 10993-5: 2009, ISO 10993-10:2010
Acceptance criteria: Non-cytotoxic, Non-irritant, Non-sensitizer
Results summary: Pass for all tests (Non-cytotoxic, Non-irritant, Non-sensitizer).

Key Metrics

Not Found

Predicate Device(s)

K181174

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

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

Summary

0

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

1

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

2

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
(product
family) | Product
Code | Size: Length x
Width (Inch) | Layers
of
sheet | Color | Basic
Weight
(g/m2) | Enclosed Medical Device | Maximum
Recommended
Wrapped Package
Content Weights
(lb) |
|-------------------------------|-----------------|--------------------------------|-----------------------|--------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| BW1000 | BW1015 | 1515 | Dual | White + Blue | 34g + 34g | Very light weight package (For example:
Huck towels) | 0.78 |
| | BW1024 | 2424 | Dual | White + Blue | | | 2.96 |
| BL1000 | BL1012 | 1212 | Single | Blue | 34g | Very light weight package (For example:
Huck towels) | 0.37 |
| | BL1015 | 1515 | Single | Blue | | | 0.78 |
| | BL1018 | 1818 | Single | Blue | | | 1.11 |
| | BL1020 | 2020 | Single | Blue | | | 2.32 |
| | BL1024 | 2424 | Single | Blue | | | 2.98 |
| BW3000 | BW3024 | 2424 | 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 | | | 9 |

3

| BL4000 | BL4018 | 1818 | 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 diameter of 3 mm ID
and maximum length of 400mm. | 3.5 |
|--------|--------|-------|--------|-----------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| BW5000 | BW5024 | 2424 | Dual | White +
Blue | 70g + 70g | Heavy weight package (for example: Tray
liners, Lumens, General use medical
instruments) | 6 |
| | BW5036 | 3636 | Dual | White +
Blue | | | 9.5 |
| | BW5048 | 4848 | Dual | White +
Blue | | | 17 |
| BW6000 | BW6036 | 3636 | Dual | White +
Blue | 88g + 88g | Very heavy weight package (for example:
Tray liners, Lumens, General use medical
instruments). | 10 |
| | BW6045 | 4545 | Dual | White +
Blue | | | 23 |
| | BW6048 | 48*48 | Dual | White +
Blue | | Maximum two lumens in one pack, each
with minimum inner diameter of 3 mm ID
and 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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4

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

5

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
(product
family) | Product
Code | Size: Length x
Width (Inch) | Layers
of sheet | Color | Basic
Weight
(g/m2) | Enclosed Medical Device Recommended
Wrapped
Package
Content
Weights (lb) |
|-------------------------------|------- | BW1000 | BW1015 Blue | 34g + 34g example: Huck towels) | | BW1024 Blue | 34g + 34g | | BL1000 | BL1012 example: Huck towels) | | BL1015 example: Huck towels) | | BL1018 | | BL1020 | | BL1024 | BW3000 | BW3024 Blue | 65g + 65g (for example: Huck towels,
Fluid-resistant table cover,
General use medical instruments) | | BW3036 Blue | 65g + 65g | | BL4000 | BL4018 (for example: Tray liners, Lumens,
General use medical instruments).
Maximum two lumens in one pack,
each with minimum inner diameter
of 3 mm ID and
maximum length of 400mm. | 3.5 | Maximum
----------|--------------------------------|--------------------|-----------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 1515 | Dual | White +
| Very light weight package (For
| 0.78 |
| 2424 | Dual | White +
| 2.96 |
| 1212 | Single | Blue | 34g | Very light weight package (For
| 0.37 |
| 1515 | Single | Blue | 34g | Very light weight package (For
| 0.78 |
| 1818 | Single | Blue | 34g | | 1.11 |
| 2020 | Single | Blue | 34g | | 2.32 |
| 2424 | Single | Blue | 34g | | 2.98 |
| 2424 | Dual | White +
| Light to moderate weight package
| 7.5 |
| 3636 | Dual | White +
| 9 |
| 1818 | Single | Blue | 70g | Moderate to heavy weight package
|

6

| BW5000 | BW5024 | 2424 | Dual | White +
Blue | 70g + 70g | Heavy weight package (for example:
Tray liners, Lumens, General use
medical instruments) Maximum two
lumens in one pack, each with
minimum inner diameter of 3 mm ID
and maximum length of 400mm. | 6 |
|--------|--------|-------|------|-----------------|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| | BW5036 | 3636 | Dual | White +
Blue | | | 9.5 |
| | BW5048 | 4848 | Dual | White +
Blue | | | 17 |
| BW6000 | BW6036 | 3636 | Dual | White +
Blue | 88g + 88g | Very heavy weight package (for
example: Tray liners, Lumens,
General use medical instruments).
Maximum two lumens in one pack,
each with minimum inner diameter of
3 mm ID and
maximum length of 400mm. | 10 |
| | BW6045 | 4545 | Dual | White +
Blue | | | 23 |
| | BW6048 | 4848 | Dual | White +
Blue | | | 25 |

న్. 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.

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.

7

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

8

1. Technological Characteristics

Table 1 General Comparison

| ITEM | Proposed
Device | Predicate Device (K181174) | Remark |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Intended Use | 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 | Cardinal Health™ Sterilization Wrap is intended to enclose another
medical 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 at
131°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, Standard
and 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 Sterilization
Systems
• TSO3 STERIZONE® VP4 System Cycle 1

Single Layer: Single Layer wrap comprised of
a single sheet of blue pigmented SMS fabric | Dual layer, fold-over: Double layer wrap comprised of a single sheet of
blue pigmented SMS fabric that has been folded over in half and
ultrasonically sealed to itself on the three nonfolded edges

Dual Layer: Double layer wrap comprised of two separate sheets of
blue pigmented SMS fabric that have been ultrasonically sealed on two
opposing edges

Single Layer: Single layer wrap comprised of a single sheet of blue
pigmented SMS fabric

Two Color: Double layer wrap comprised of one sheet of blue
pigmented SMS fabric and one sheet of green pigmented SMS fabric
that have been ultrasonically sealed on two opposing edges | Analyze 2 |
| Color | Dual Layer: Blue + White
Single Layer: Blue | Dual Layer: Blue + green
Single Layer: Blue | Analyze 3 |
| Sterilization | | | |
| | 100% ethylene oxide (EO) with a concentration
of 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 at
250°F/121°C for 30 minutes

100% ethylene oxide (EO) with a concentration of 725- 735 mg/L at
131°F/55°Cand 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, Standard and
Advanced Cycles

Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard,
Flex, Express, and DUO cycles

Lumen, Non-Lumen, and Flexible Cycles in the STERIS
V-PRO® 1, V-PRO® 1 Plus, VPRO® maX and VPRO® 60 Low
Temperature Sterilization Systems

9

10

11

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.

12

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.

13

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 and
Sterilization Efficacy	Achieving a 10-6 sterility
assurance level	Negative for growth	Negative for growth	SAME
Maintenance of
package sterility	Maintain sterility for up
to 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

14

Material Compatibility, ASTM	Compatible to EO	Compatible	Compatible	SAME
F2101-19, Bacterial Filtration
Efficiency
ASTM D5034-09 (2017), Tensile
Strength
ASTM D3786/ D3786M -18,
Bursting Strength AATCC 127-
2018, Water
Resistance: Hydrostatic Pressure Test
ASTM D737-18, Air Permeability ASTM
D3776/ D3776M-20, Mass
per Unit Area
ASTM D5587-15 (2019), Tearing
Strength,
DIN 58953-6: 2016, Microbial
Barrier Test	sterilization process

15

Performance data 8.

8.1 Physical properties testing

| Item | Standards | Acceptance
criteria | Before EO
sterilization result | After EO
sterilization result | Results summary |
|------------------------------------------------|------------------------|------------------------------------------------------|-----------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| -Tensile Strength | ASTM D 5034 -09 (2017) | Complies with the
selected physical
properties | Passed | Passed | The physical properties
testing of before and after
EO sterilization meet the
acceptance criteria and
demonstrated passing
results. |
| -Bursting Strength | ASTM D3786/D3786M-18 | | Passed | Passed | |
| -Water Resistance Hydrostatic
Pressure 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 of
linting 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 of
Sterility Validation -EO
Sterilization | AATCC 127-18
ASTM F 2101-19
ASTM D 5034 -09 (2017)
ASTM D3786/D3786M-18
AATC127-18
ASTM D737-18
ASTMD37776/D3776M-20 | Maintain sterility for up to 365 Days | Negative for growth,
Sterilization Wrap was
capable of maintenance
of sterility for 365 days. | Pass |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------|
| | ASTM D5587-15
ISO 11607:2019 | | | |
| Microbial barrier test | ISO 11607:2019 | Product has good anti-bacterial
permeability of the packaging material
in the microbial barrier test. | Negative for growth | Pass |

8.3 Shelf Life Testing

Item	Standards	Acceptance criteria	Test Result
Shelf Life Testing	ASTM F 2101-19
ASTM D 5034 -09 (2017)
ASTM D3786/D3786M-18
AATC127-18
ASTM D737-18
ASTMD37776/D3776M-20
ASTM D5587-15
ISO 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
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.