Who is the manufacturer of Sterilization Wrap?

Kenpax International Limited filed the 510(k) submission for Sterilization Wrap (K222151).

What is the FDA product code for Sterilization Wrap?

FRG. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Sterilization Wrap?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Sterilization Wrap?

Cardinal Health™ Sterilization Wrap (K181174).

Who can help prepare an FDA 510(k) submission like Sterilization Wrap?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sterilization Wrap

K222151 · Kenpax International Limited · FRG · Mar 23, 2023 · General Hospital

Device Facts

Record ID	K222151
Device Name	Sterilization Wrap
Applicant	Kenpax International Limited
Product Code	FRG · General Hospital
Decision Date	Mar 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

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℃ e) Aeration pressure : 841 mBar to 864 mBar

Device Story

Sterilization wrap consists of single or dual layers of 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. Used by healthcare providers to enclose medical devices prior to ethylene oxide (EO) sterilization. Dual-layer models feature ultrasonically sealed edges. The wrap acts as a microbial barrier to maintain device sterility for up to 365 days post-sterilization. It is a single-use, non-sterile device.

Clinical Evidence

No clinical data. Bench testing only. Validation included EO sterilization efficacy (ANSI AAMI ISO 11135:2014), 365-day sterility maintenance, biocompatibility (ISO 10993-5, -7, -10), and physical property testing (tensile, bursting, tearing strength, air permeability, hydrostatic pressure, lint generation) per ASTM/ISO standards.

Technological Characteristics

Material: 100% polypropylene SMS fabric. Design: Single or dual-layer sheets with ultrasonic edge sealing. Dimensions: 12x12 to 48x48 inches. Sterilization: 100% EO. Standards: ISO 11607, ASTM D5034, ASTM D3786, AATCC 127, ASTM D737, ASTM D3776, ASTM D5587, EN 13795-1.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via 100% ethylene oxide (EO) and to maintain sterility for up to 365 days post-sterilization.

Regulatory Classification

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.

Predicate Devices

Cardinal Health™ Sterilization Wrap (K181174)

Related Devices

K181174 — Cardinal Health Sterilization Wrap · Cardinal Health200, LLC · Dec 11, 2018
K161910 — Cardinal Health Sterilization Wrap · Cardinal Health200, LLC · Apr 20, 2017
K223600 — Sterilization Wrap · Wuhan Zonsen Medical Products Co., Ltd. · Aug 25, 2023
K151788 — Cardinal Health Sterilization Wrap · Cardinal Health200, LLC · Oct 30, 2015
K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) · Primed Medical Products, Inc. · Oct 7, 2024

Submission Summary (Full Text)

{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 | 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 (for example: Huck towels, Fluid-resistant table cover, General use medical instruments) | 7.5 | | | BW3036 | 36*36 | Dual | White + Blue | | | 9 | {3}------------------------------------------------ | 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 diameter of 3 mm ID and maximum length of 400mm. | 3.5 | |--------|--------|-------|--------|-----------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | BW5000 | BW5024 | 24*24 | Dual | White + Blue | 70g + 70g | Heavy weight package (for example: Tray liners, Lumens, General use medical instruments) | 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 medical instruments). | 10 | | | BW6045 | 45*45 | 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {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. - 2. 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 - 3. 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 - 4. 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 | Maximum Recommended Wrapped Package Content 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 | 34g + 34g | | 2.96 | | BL1000 | BL1012 | 12*12 | Single | Blue | 34g | Very light weight package (For example: Huck towels) | 0.37 | | | BL1015 | 15*15 | Single | Blue | 34g | Very light weight package (For example: 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 diameter of 3 mm ID and maximum length of 400mm. | 3.5 | {6}------------------------------------------------ | BW5000 | BW5024 | 24*24 | 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 | 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 medical instruments). Maximum two lumens in one pack, each with minimum inner diameter of 3 mm ID and maximum length of 400mm. | 10 | | | BW6045 | 45*45 | Dual | White + Blue | | | 23 | | | BW6048 | 48*48 | 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}------------------------------------------------ - 7. 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 The wrap is intended to allow sterilization of the enclosed medical device(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 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 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 TSO3 STERIZONE® VP4 System Cycle 1 | Analyze 4 | | Maximum Wrapped | EO: up to 25 pounds | Pre-vacuum Steam: 3 to 25 pounds | SAME | | Package Content Weights | | 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 to 9.1 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×20 in, 24 in×24 in, 36 in×36 in, 45 in×45 in ,48 in×48 in | 12 in×12 in, 15 in×15 in, 18 in×18 in, 20 in×20 in, 24 in×24 in, 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 of Sterility | 365 days | 365 days | SAME | {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 | {16}------------------------------------------------ | 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 s…