Who is the manufacturer of Sterilization Wrap?

Wuhan Zonsen Medical Products Co., Ltd. filed the 510(k) submission for Sterilization Wrap (K223600).

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).

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

K223600 · Wuhan Zonsen Medical Products Co., Ltd. · FRG · Aug 25, 2023 · General Hospital

Device Facts

Record ID	K223600
Device Name	Sterilization Wrap
Applicant	Wuhan Zonsen Medical Products Co., Ltd.
Product Code	FRG · General Hospital
Decision Date	Aug 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Indications for Use

Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time. B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃ The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization.

Device Story

Sterilization wrap consists of square/rectangular three-layer polypropylene SMS (spunbond-meltblown-spunbond) non-woven sheets; two layers are ultrasonically bonded along edges for simultaneous wrapping. Used by healthcare providers in clinical settings to enclose reusable medical instruments prior to sterilization. Protects against physical damage (cuts/tears) and maintains sterility of contents for up to 90 days post-sterilization. Validated for pre-vacuum steam and ethylene oxide sterilization cycles. Output is a sterile-wrapped instrument package; facilitates aseptic presentation of instruments for surgical or clinical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via physical testing (ASTM D3776, ASTM F2101, AATCC 127, ASTM D5034, ASTM D737, ASTM D3786, ASTM D5587, ISO 9073-10), biocompatibility (ISO 10993-5, -10), shelf-life validation, and sterilization process validation (ISO 11135, ISO 17665). All tests passed.

Technological Characteristics

Three-layer polypropylene SMS non-woven fabric. Dimensions: 12x12 to 72x54 inches. Weight: 45gsm or 54gsm. Ultrasonically bonded. Single-use, disposable. Sterilization: Pre-vacuum steam (134°C) or 100% Ethylene Oxide. Standards: ASTM D3776, ASTM F2101, AATCC 127, ASTM D5034, ASTM D737, ASTM D3786, ASTM D5587, ISO 9073-10, ISO 10993, ISO 11135, ISO 17665.

Indications for Use

Indicated for healthcare providers to enclose general purpose non-lumened reusable metal and nonmetal devices, including those with stainless steel diffusion-restricted spaces (e.g., hinged forceps/scissors), for sterilization via pre-vacuum steam or ethylene oxide. Supports loads from 2lbs to 9lbs depending on model size.

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

Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap (K160755)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Wuhan Zonsen Medical Products Co., Ltd. Linna Ye Registration Manager No 8 Jinchao Rd, Zhucheng Street Wuhan, Hubei China ## Re: K223600 Trade/Device Name: Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: July 7, 2023 Received: July 21, 2023 Dear Linna Ye: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for August 25, 2023 {1}------------------------------------------------ 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 medical devices and radiation-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. Digitally signed Eileen by Eileen Cadel -Cadel -S Date: 2023.08.25 13:20:06 -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 510(k) Number (if known) K223600 Device Name Sterilization Wrap #### Indications for Use (Describe) Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healtheare provider via the following: A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time. B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃ Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue (double layers). Size (inches): 12*12, 15*15, 18*18, 20*20, 24*24, 30*30, 36*36, 40*40, 45*45, 48*48, 54*54, 72*54. The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization. Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionr estricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size. For size2*12, 15*15, 18*18, maximum weight is 216, for 20*20, 36*36, 40*40, 45*45, 48*48, maximum weight is 6lb, and for 54*54, 72*54, maximum weight is 9lb. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 510(K) Summary ## 510 (K) Summary This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92 1. Date of Submission: August, 23, 2023. # 2. Submitter / 510(K) Holder ## Wuhan Zonsen Medical Products Co., Ltd. No. 8 Jinchao Road, Zhucheng Avenue, Xinzhou District, Wuhan City, Hubei Province, P.R. China 431400 Contact Person: Ms. Lisa Zhang Position: Registration Manager Email: registration01@zonsenmed.com # 3. Proposed Device Name Trade name: Sterilization Wrap Common name: Sterilization Wrap Classification Name: Wrap, Sterilization/Indicator, Physical/Chemical Sterilization Process Device Class: Class II Classification Panel: General Hospital Product Code: FRG Regulation Number: 21 CFR 880.6850 ## 4. Predicate Devices Primary Predicate Device: K160755 Product Name: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap Submitter: Ahlstrom Nonwovens LLC {4}------------------------------------------------ # 5. Device Description Sterilization Wrap is square or rectangular three-layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown-spunbond (SMS) fabric. Sterilization wrap provides a strong barrier which protects against cuts, tears with particularly device sets. The device is designed to be implemented as an outer sterilization wrap which allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post Pre-Vacuum Steam Sterilization or Ethylene Oxide Sterilization. Sterilization Wrap is two-layer sheet which ultrasonically bonded blue and pink nonwoven sheet together along two edges, thus for convenient simultaneous wrapping. Sterilization Wrap separated into two distinct types depending on different grams of weight of material, for ZSW 1610, it is two 45gsm SMS non-woven sheet ultrasonically bonded together, and for model ZSW 1611, it is two 54gsm SMS sheet. Each model contains series specification, including 12 Sizes (inches): 12*12, 15*15, 18*18, 20*20, 24*24, 30*30, 36*36, 40*40, 45*45, 48*48, 54*54, 72*54. With non-lumened reusable metal and nonmetal devices as part of the load, which with a maximum weight of each type, range from 21bs to 9lbs, which dependent on each model' size (table 1) | Model | Material | Layers | Color | Size | | Maximum Weight(lbs.) | |---------|---------------|--------|--------------------------------|------------------|-------------------|-------------------------| | | | | | Long (inches) | Width (inches) | | | ZSW1610 | 45 gsm SMS | 2 | Pink and Blue double layers | 12 | 12 | 2 | | | | | | 15 | 15 | 2 | | | | | | 18 | 18 | 2 | | | | | | 20 | 20 | 6 | | | | | | 24 | 24 | 6 | | | | | | 30 | 30 | 6 | | | | | | 36 | 36 | 6 | Table 1 Device Specification {5}------------------------------------------------ | K223600 | | | | 510 (k) Summary | | | |---------|-----------|----------|--------------------------------|-----------------|----|---| | | | | | 40 | 40 | 6 | | | | | | 45 | 45 | 6 | | | | | | 48 | 48 | 6 | | | | | | 54 | 54 | 9 | | | | | | 72 | 54 | 9 | | | | | | 12 | 12 | 2 | | | | | | 15 | 15 | 2 | | | | | | 18 | 18 | 2 | | | | | | 20 | 20 | 6 | | | | | | 24 | 24 | 6 | | ZSW1611 | 54 SMS | gsm 2 | Pink and Blue double layers | 30 | 30 | 6 | | | | | | 36 | 36 | 6 | | | | | | 40 | 40 | 6 | | | | | | 45 | 45 | 6 | | | | | | 48 | 48 | 6 | | | | | | 54 | 54 | 9 | | | | | | 72 | 54 | 9 | # 6. Indications for Use Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: A) Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time. B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360~363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 °C. Model: ZSW1610, ZSW 1611. Material (single layer): 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue. Size (inches): 12*12, 15*15, 18*18, 20*20, 24*24, 30*30, 36*36, 40*40, 45*45, 48*48, 54*54, 72*54. {6}------------------------------------------------ The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization. Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusionr estricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each type, range from 21bs to 91bs, which dependent on each model's size. For size: 2*12, 15*15, 18*18, maximum weight is 21b, for 20*20, 24*24, 30*30, 36*36, 40*40. 45*45. 48*48. maximum weight is 6lb. and for 54*54. 72*54. maximum weight is 9lb. # 7. Technological Characteristics Comparison Table The Sterilization Wrap is compared with the predicate device Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap (K160755). The results are shown below in the Technological Characteristics Comparison Table: | Device characteristic | Proposed Device | Predicate Device 510(K) No. K160755 | Comparis on Result | |--------------------------|--------------------------------------------|------------------------------------------------------------------------------------|-----------------------| | Manufacturer | Wuhan Zonsen Medical Products Co., Ltd. | Ahlstrom Nonwovens, LLC | -- | | Product name | Sterilization wrap | Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap | -- | | 510(k) Reference | K223600 | K160755 | -- | Table 2 General Comparison between proposed and predicate device {7}------------------------------------------------ 510 (k) Summary | Class | Class II | Class II | Same | K223600 | | 510 (k) Summary | | |-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Product Code | FRG | FRG | Same | | days post sterilization. | device(s) until used. | | | Regulation Number | 21 CFR PART 880.6850 | 21 CFR PART 880.6850 | Same | Material Composition | Polypropylene spunbondmeltblown- spunbond (SMS) fabric | Polypropylene spunbondmeltblown- spunbond (SMS) fabric | Same | | Intended Use | Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. | Reliance® Tandem and Solo Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care Provider. | Same | Design feature | Zonsen Sterilization Wrap is square or rectangular three- layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown- spunbond (SMS) fabric. The device has two-layer sheet which ultrasonically bonded blue and pink non- woven sheet together along two edges, thus for convenient simultaneous wrapping. | The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular. nonwoven sheets produced using a three- layer SMS (spunbond- meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings: Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices. Reliance® Tandem: Consists of single sheets | Same | | Indication for use | Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time. B) 100% Ethylene Oxide (EO) with a concentration of 360~363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 °C. | Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: A) Pre-vacuum Steam 270°F/132°C for 4 minutes, validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300, Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600 | Similar | | | | | | | B) 100% Ethylene Oxide (EO) with a concentration of 725~735 mg/L @ 131°F/55°C and 40%~80% relative humidity for 60 minutes. C) Gravity Steam 250°F/121°C for 30 minutes D)Advanced Sterilization Products (ASP) STERRAD® 100S E) Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles) F) STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non-Lumen and Flexible Cycles) | | | | | | | | The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 | The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed | Similar | | | | | | {8}------------------------------------------------ {9}------------------------------------------------ # 510 (k) Summary {10}------------------------------------------------ | | | of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical. devices that will be sterilized following standard healthcare practices. | | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Size and color | Pink and blue | Blue and green | Similar | | | Sterilization Wrap separated into two distinct types depending on different grams of weight of material, | Dimensional Specifications of Reliance® Tandem and Reliance® Solo Wrap: six type Models depend on various grams of weight, | | | | Size (inches): 12*12, 15*15, | Size (inches): 9*9, 12*12, | | | | 18*18, 20*20, 24*24, | 15*15, 18*18, 20*20, | | | | 30*30, 36*36, 40*40, | 24*24, 30*30, 36*36, | | | | 45*45, 48*48, 54*54, | 40*40, 45*45, 48*48, | | | | 72*54. | 54*54, 60*60, 72*54. | | | | | | | | Single Use vs. Reusable | Single use | Single use | Same | | Disposable vs. Non-Disposable | Disposable | Disposable | Same | | Maximum Recommended Wrapped Package | Types of medical devices to be sterilized in the Pre- Vacuum Steam Sterilization | All models of Reliance® Tandem and Solo validated for pre-vacuum | Similar | {11}------------------------------------------------ | Content Weights | Ethylene Oxide Sterilization: | steam Sterilization and ethylene oxide | S10 (k) Summary | | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | General purpose non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusion restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each type, range from 2lbs to 9lbs, which dependent on each model's size. | sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model. | | | | Size and Gram weight | ASTM D3776/ D3776M-20 Size: Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m2 the inspection result is PASS | ASTM D3776/ D3776M-20 Size: Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m2 the inspection result is PASS | Same | | | Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 Bacterial Filtration Efficiency (BFE) Using a Biological Aerosol | ASTM F2101-19 Bacterial Filtration Efficiency (BFE) Using a Biological Aerosol | Same | | | | K223600 | | 510 (k) Summary | | | | of Staphylococcus aureus ≥ 90% the inspection result is PASS | Biological Aerosol of Staphylococcus aureus ≥ 90% the inspection result is PASS | | | | Hydrostatic Pressure | AATCC 127-03, Water Resistance: Hydrostatic Pressure ≥ 50 cm H2O the inspection result is PASS | AATCC 127-03, Water Resistance: Hydrostatic Pressure ≥ 50 cm H2O the inspection result is PASS | Same | | | | Tensile Strength | ASTM D5034-09 Standard, Breaking Strength and Elongation of Textile Fabrics (Grab Test) MD≥ 90N; CD≥ 63N the inspection result is PASS | ASTM D5034-09 Standard, Breaking Strength and Elongation of Textile Fabrics (Grab Test) MD≥ 90N; CD≥ 63N the inspection result is PASS | Same | | Air Permeability | | ASTM D737-18Standard, Air Permeability of Textile Fabrics ≥ 30 cfm the inspection result is PASS | ASTM D737-18Standard, Air Permeability of Textile Fabrics ≥ 30 cfm the inspection result is PASS | Same | | | Bursting Strength | ASTM D3786-18 Standard Test Method for Bursting Strength of Textile Fabrics—Diaphragm Bursting Strength Tester Method ≥ 130 kpa (18.86psi) the inspection result is | ASTM D3786-18 Standard Test Method for Bursting Strength of Textile Fabrics— Diaphragm Bursting Strength Tester Method ≥ 130 kpa (18.86psi) the inspection result is | Same | | | | PASS | PASS | | | Tearing Strength | ASTM D5587-15, Tearing Strength of Fabrics, MD≥ 50N, CD≥ 30N. the inspection result is PASS | ASTM D5587-15, Tearing Strength of Fabrics, MD≥ 50N, CD≥ 30N. the inspection result is PASS | Same | | | Lint Generation | ISO9073-10, Textiles Lint, Cofficient of linting ≤4.0 the inspection result is PASS | ISO9073-10, Textiles Lint, Cofficient of linting ≤4.0 the inspection result is PASS | Same | | | Material Compatibility | After Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization, the materials were not degraded. Performance test including Size and Gram weight Bacterial Filtration Efficiency (BFE) Hydrostatic Pressure Tensile Strength Air Permeability Bursting Strength Tearing Strength Lint Generation can meet requirements | After Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization, the materials were not degraded. Performance test including Size and Gram weight Bacterial Filtration Efficiency (BFE) Hydrostatic Pressure Tensile Strength Air Permeability Bursting Strength Tearing Strength Lint Generation can meet requirements | Same | | | Biocompatibility | ISO 10993-5 non-cytotoxic post sterilization | ISO 10993-5, non- cytotoxic post | Same | | | | | sterilization | | | | Maintenance of Sterility | 90days | 90days | Same | | | Shelf Life | 2 years from date of manufacture | unknown | Similar | | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ The design and technological characteristics of the Sterilization wrap is similar to the predicate chosen. There are minor differences between the devices including Indication for use (sterilization parameter). Size and color. Maximum Recommended Wrapped Package Content Weights, ## Note 1 : Indication for use (sterilization parameter) The proposed device and the predicate device have same sterilizaiton method application, including Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization. For those two devices, parameter recommend are different. However, the proposed device has been conducted verification in accordance with ISO11135 and ISO 17665, performance test has been done before and after sterilizaiton, all results can meet standards requirements. Therefore, there are no different questions of safety and effectiveness questions pertaining to performance of the proposed device. ### Note 2: Size and color The proposed device and the predicate device have same dimention, but they are differences in color. However, the proposed device meets the requirements of the standard ISO 10993-5, articles after the steam and EO sterilized were used for the biocompatibility validation testing. Test result shows that the device has non-cytotoxicity. Therefore, the different technological specifications of the proposed device do not raise different questions of safety. ## Note 3 Maximum Recommended Wrapped Package Content Weights Although the maximum recommended wrap package loading are different from the predicate device,the proposed device has been conducted verification in accordance with ISO11135 and ISO 17665, Types of medical devices to be sterilized in the Pre-Vacuum 12/17 {15}------------------------------------------------ Steam Sterilization and Ethylene Oxide Sterilization including general purpose nonlumened reusable metal and nonmetal devices including devices with stainless steel diffusionr estricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. All models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size. Performance test has been done before and after sterilizaiton, all results can meet standards requirements. There are no different questions of safety and effectiveness questions pertaining to performance of the proposed device. ### Note 4 Performance test Both the predicate device and the proposed device has been tested including. Size and Gram weight, Bacterial Filtration Efficiency (BFE), Hydrostatic Pressure, Tensile Strength, Air Permeability, Bursting Strength, Tearing Strength, Lint Generation, Result shows that there are no different questions of safety and effectiveness questions related to performance. Based on above analysis mentioned above, we can conclude that subject device substantial equivalence with the predicate device. ## 8. Performance Data ## Non-Clinical Performance Test Conclusion Non- clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate Sterilization Wraps complies with the following standards: | Test Items | Standard and Acceptance Criteria | Test Result | |-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Size and Gram weight | ASTM D3776M-20: Standard Test Methods for Mass Per Unit Area (Weight) of Fabric Size : Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m² | Pass | | Bacterial | ASTM F 2101- 19 Standard Test Method for Evaluating | Pass | | Filtration Efficiency (BFE) | the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus BFE ≥ 90% | | | Hydrostatic Pressure | AATCC 127-03 Test Method for Water Resistance: Hydrostatic Pressure Hydrostatic Pressure ≥ 50 cm H2O | Pass | | Tensile Strength | ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) MD≥ 90N; CD≥ 63N | Pass | | Air Permeability | ASTM D737-18Standard Test Method for Air Permeability of Textile Fabrics Air Permeability≥ 30 cfm | Pass | | Bursting Strength | ASTM D3786-18 Standard Test Method for Bursting Strength of Textile Fabrics—Diaphragm Bursting Strength Tester Method Bursting Strength≥ 130 kpa (18.86psi) | Pass | | Tearing Strength | ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure MD≥ 50N; CD≥ 30N | Pass | | Lint Generation | ISO9073-10: 2019 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state Coefficient of linting ≤4.0 | Pass | | Skin Irritation AND Skin Sensitization | ISO 10993- 1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices. ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization. Under the conditions of the study, the test article (pouches | Pass | | K223600 | 510 (k) Summary | | | | and chemical indicator) extract did not show no significant evidence of causing skin sensitization in the guinea pig before and after sterilized. | | | Shelf-Life Validation | Shelf Life Validation Test; Conducted the shelf-life testing as real time aging method. After the shelf life indicated as following, Shelf Life: 2 Years; Shelf Life after Sterilized: 90 days; The device performance shall be meet the requirements of the device. SAL=10-6 | Pass | | Sterilization Process Validation for EO | EO Sterilization Process Validation Test. Conducted the EO sterilization process validation as the method/principle of ISO11135: 2014 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Healthcare Product Sterilization - Ethylene Oxide-Medical Device Sterilization Process Development. Validation and Routine Control Requirements). Use the half cycle method to validate the EO sterilization cycle claimed in indication for use is effective. Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 °C The device performance shall be meet the requirements of the device with the worst loading, SAL=10-6 | Pass | | K223600 | 510 (k) Summary | | | Sterilization Process Validation for steam | Steam Sterilization Process Validation Test. Conducted the Steam sterilization process validation as the method/principle of AAMI / ANSI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities and ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 's requirements. Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time. The device performance shall be meet the requirements of the device with the worst loading, SAL=10-6 | Pass | | Material compatibility | After Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization, the materials were not degraded. Performance test including: Size and Gram weight Bacterial Filtration Efficiency (BFE) Hydrostatic Pressure Tensile Strength Air Permeability Bursting Strength Tearing Strength Lint Generation should meet requirements. | Pass | | EO/ECH residue | ISO 10993-7: 2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals $EO≤4mg/d$ , $ECH ≤9mg/d$…

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