Reliance® Fusion Sterilization Wraps

K230137 · Ahlstrom-Munksjo Nonwovens, LLC · FRG · Dec 7, 2023 · General Hospital

Device Facts

• Record ID: K230137
• Device Name: Reliance® Fusion Sterilization Wraps
• Applicant: Ahlstrom-Munksjo Nonwovens, LLC
• Product Code: FRG · General Hospital
• Decision Date: Dec 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: - Pre-vacuum Steam 270°F/132°C for 4 minutes - Dry time of 12 minutes for Fusion Light - Dry time of 20 minutes for Fusion Heavy - Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less. - 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% - 70% relative humidity for 60 minutes - Aeration time of 8 hours at 55°C - Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less.

Device Story

Reliance® Fusion Sterilization Wraps are nonwoven sheets used to wrap medical devices for sterilization. The device consists of two ultrasonically bonded layers: an outer spunbond-meltblown-spunbond (SMS) polypropylene layer and an inner absorbent wetlaid layer (wood pulp/synthetic fibers). The wrap is used by healthcare staff to enclose instruments before placing them in pre-vacuum steam or ethylene oxide sterilizers. The wrap maintains the sterility of the enclosed devices until aseptic opening. It provides a microbial barrier and is validated for specific dry times and load weights. The device is supplied non-sterile and is for single use only.

Clinical Evidence

Bench testing only. No clinical data was required. Testing included sterilization efficacy (half-cycle), dry time validation, 180-day shelf-life maintenance of sterility, microbial aerosol challenge, biocompatibility (ISO 10993-5), EO/ECH residual analysis, and physical property testing (air permeability, burst strength, tensile strength, tear resistance, hydrohead, bacterial filtration efficiency, and linting).

Technological Characteristics

Two-layer nonwoven sheet: outer SMS polypropylene; inner absorbent wetlaid (wood pulp/synthetic fibers/acrylic binder). Ultrasonically bonded. Dimensions: 12"x12" to 54"x72". Sterilization: Pre-vacuum steam, 100% EO. Microbial barrier: Microbial Aerosol Challenge. Physical standards: ASTM D737, D3776, D5034; WSP 30.1, 080.6; ISO 9073.

Indications for Use

Indicated for healthcare providers to enclose medical devices for sterilization via pre-vacuum steam or 100% ethylene oxide. Suitable for light to very heavy weight packages (e.g., general medical instruments).

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 and Reliance® Tandem Sterilization Wrap (K171533)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.

December 7, 2023

Ahlstrom-Munksjo Nonwovens LLC % Ryan Burke Quality and Regulatory Consultant AJW Technology Consultants, Inc. 11705 Boyette Road, Suite 503 Riverview. Florida 33569

Re: K230137

Trade/Device Name: Reliance® Fusion Sterilization Wraps Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 8, 2023 Received: November 9, 2023

Dear Ryan Burke:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin
O'neill -S
FDA

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

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## Indications for Use

510(k) Number (if known) K230137

Device Name Reliance® Fusion Sterilization Wraps

### Indications for Use (Describe)

Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

- . Pre-vacuum Steam 270°F/132°C for 4 minutes
- Dry time of 12 minutes for Fusion Light O
- Dry time of 20 minutes for Fusion Heavy O
- Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
- 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% 70% relative ● humidity for 60 minutes
- Aeration time of 8 hours at 55oC O
- Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.

| | | | Wrap Sheet Size, Maximum Recommended Wrapped Package Content | | | | | | | | | |
|---------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------|--------|--------|--------|--------|---------|---------|-------|-------|-------|
| | | | Weight: Pre-Vacuum Steam and Ethylene Oxide¹ | | | | | | | | | |
| Wrap Code | Material | Intended | 12" x | 15" x | 18" x | 24" x | 30" x | 36" x | 40" x | 48" x | 54" x | 54" x |
| | Type | Load | 12" | 15" | 18" | 24" | 30" | 36" | 40" | 48" | 54" | 72" |
| Reliance®<br>Fusion Light | Outer SMS / Inner<br>Absorbent<br>Wetlaid Layer | Light to Moderate<br>Weight Package<br>(e.g. general use<br>medical<br>instruments) | 1.8 lb | 2.0 lb | 2.4 lb | 3.2 lb | 4.3 lb | 5.7 lb | 6.7 lb | 9 lb | 9 lb | 9 lb |
| Reliance®<br>Fusion Heavy | Outer SMS / Inner<br>Absorbent<br>Wetlaid Layer | Very Heavy<br>Weight Package<br>(e.g. general use<br>medical<br>instruments) | 1.8 lb | 2.6 lb | 3.7 lb | 6.4 lb | 9.9 lb | 14.2 lb | 17.5 lb | 25 lb | 25 lb | 25 lb |

Table 1: Reliance® Fusion Models and Load Recommendations

1 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. In addition, it is recommended to not exceed the number, weight, and size of individual content types that were validated for Reliance® Fusion Sterilization Wraps (i.e. wrapped contents).

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Table 2: Fusion Wrap Models, sheet color

| Reliance®<br>Fusion<br>Models | Wrap Layer | Individual<br>Sheet<br>Color |
|-------------------------------|-------------|------------------------------|
| Light | Outer Layer | Light Blue |
| Light | Inner Layer | Green |
| Heavy | Outer Layer | Dark Blue |
| Heavy | Inner Layer | Green |

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

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

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### l. SUBMITTER

AHLSTROM NONWOVENS LLC 2 Elm Street Windsor Locks, CT 06096 Phone: [phone]

Contact Person: Gary Jackson Regulatory Affairs [e-mail] Date Prepared: December 6, 2023

### II. DEVICE

| Name of Device: | Reliance® Fusion Sterilization Wraps |
|-----------------------|--------------------------------------|
| Common or Usual Name: | Sterilization Wrap |
| Classification Name: | Sterilization Wrap (21 CFR 880.6850) |
| Regulatory Class: | 2 |
| Product Code: | FRG |

### PREDICATE DEVICE lll.

Primary Predicate:

Reliance® Solo and Reliance® Tandem Sterilization Wrap, K171533

| 510(k) | Device Name | Regulation Number and<br>Classification Name | Device Class and<br>Product Code |
|---------|---------------------------------------------------------------------------|----------------------------------------------|----------------------------------|
| K171533 | Reliance® Solo Sterilization Wrap,<br>Reliance® Tandem Sterilization Wrap | 21 CFR 880.6850<br>Wrap, Sterilization | Class 2, FRG |

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The Reliance® Fusion Sterilization Wraps are square or rectangular nonwoven sheets consisting of two layers of nonwoven 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. The Fusion wraps consist of two distinct nonwovens for each layer.

Outer Layer: SMS nonwoven layer produced using a spunbond-meltblown-spunbond process and composed of polypropylene with blue pigment and an anti-static treatment.

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Inner Layer: Wetlaid nonwoven, produced using a wood pulp process, composed of natural wood pulp and synthetic fibers bonded with a synthetic binder, containing green pigment and treated to impart hydrophilic properties.

The Reliance® Fusion Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically and are supplied in a variety of sheet sizes ranging from 12 in. x 12 in. The Sterilization Wraps have no intended patient contact and are supplied non-sterile. They are for Single Use Only.

### V. INDICATIONS FOR USE

Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

- Pre-vacuum Steam 270°F/132°C for 4 minutes
- Dry time of 12 minutes for Fusion Light O
- o Dry time of 20 minutes for Fusion Heavy
- Pre-vacuum steam sterilization of two stainless steel lumens о 3 mm in diameter or larger and 400 mm in length or less.
- 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% - 70% relative humidity for 60 minutes
- O Aeration time of 8 hours at 55ºC
- Ethylene oxide sterilization of two stainless steel lumens 3 mm in O diameter or larger and 400 mm in length or less.

| Wrap Code | Material<br>Type | Intended<br>Load | 12" x<br>12" | 15" x<br>15" | 18" x<br>18" | 24" x<br>24" | 30" x<br>30" | 36" x<br>36" | 40" x<br>40" | 48" x<br>48" | 54" x<br>54" | 54" x<br>72" |
|---------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|
| Reliance®<br>Fusion Light | Outer SMS / Inner<br>Absorbent<br>Wetlaid Layer | Light to Moderate<br>Weight Package<br>(e.g. general use<br>medical<br>instruments) | 1.8 lb | 2.0 lb | 2.4 lb | 3.2 lb | 4.3 lb | 5.7 lb | 6.7 lb | 9 lb | 9 lb | 9 lb |
| Reliance®<br>Fusion Heavy | Outer SMS / Inner<br>Absorbent<br>Wetlaid Layer | Very Heavy<br>Weight Package<br>(e.g. general use<br>medical<br>instruments) | 1.8 lb | 2.6 lb | 3.7 lb | 6.4 lb | 9.9 lb | 14.2 lb | 17.5 lb | 25 lb | 25 lb | 25 lb |

Table 1: Reliance® Fusion Models and Load Recommendations

41 is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. In addition, it is recommended to not exceed the number, weight, and size of individual content types that were valiance® Fusion Sterilization Wraps (i.e. wrapped contents).

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Table 2: Fusion Wrap Models, sheet color

| Reliance®<br>Fusion<br>Models | Wrap Layer | Individual<br>Sheet<br>Color |
|-------------------------------|-------------|------------------------------|
| Light | Outer Layer | Light Blue |
| | Inner Layer | Green |
| Heavy | Outer Layer | Dark Blue |
| | Inner Layer | Green |

### VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

| Element of<br>Comparison | PREDICATE:<br>RELIANCE® Solo and Tandem<br>Sterilization Wrap | SUBJECT (Modified Device):<br>RELIANCE® Fusion<br>Sterilization Wrap | Comparison<br>to Predicate |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K171553 | K230137 | NA |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Product Code | FRG | FRG | Same |
| Device Classification | 2 | 2 | Same |
| Classification Name | Wrap, Sterilization | Wrap, Sterilization | Same |
| Indications for Use | Ahlstrom Reliance® Tandem and<br>Solo Sterilization Wraps are<br>intended to be used to enclose<br>another medical device that is to<br>be sterilized by a healthcare<br>provider via the following:<br><br>Pre-vacuum Steam 270°F/132°C<br>for 4 minutes:<br>Validated for dry time of 20<br>minutes for Models T100/S100,<br>T200/S200, T300/S300. x Validated<br>for dry time of 30 minutes for<br>Models T400/S400, T500/S500,<br>T600/S600. All models of Reliance®<br>Tandem and Solo validated for pre-<br>vacuum steam sterilization with<br>stainless steel lumens as part of<br>the load with a maximum weight<br>of 25lbs dependent on the model | Ahlstrom Reliance® Fusion<br>Sterilization Wraps are intended<br>to be used to enclose another<br>medical device that is to be<br>sterilized by a healthcare<br>provider via the<br>following:<br><br>Pre-vacuum Steam 270°F/132°C<br>for 4 minutes:<br>-Dry time of 12 minutes for<br>Reliance® Fusion Light<br>-Dry time of 20 minutes for<br>Fusion Heavy<br>-Pre-vacuum steam sterilization<br>using two stainless steel lumens<br>3 mm in diameter or larger and<br>400 mm in length or less. | Similar<br>See note 1A |
| | 100% Ethylene Oxide (EO) with a<br>concentration of 725-735 mg/L @<br>131°F/55°C and 40% - 80% relative<br>humidity for 60 minutes<br>Validated for aeration time of 8 | 100% Ethylene Oxide (EO) with a<br>concentration of 725-759 mg/L<br>@ 131°F/55°C and 40% - 70%<br>relative humidity for 60 minutes: | |
| | hours at 55°C. All models of<br>Reliance® Tandem and Solo<br>validated for ethylene oxide<br>sterilization with stainless steel<br>lumens as part of the load with a<br>maximum weight of 25lbs<br>dependent on the model. | -Aeration time of 8 hours at 55°C<br>-Two stainless steel lumens 3<br>mm in diameter or larger and<br>400 mm in length or less. | |
| | The wrap is intended to allow<br>sterilization of the enclosed<br>medical device(s) and maintain<br>sterility of the enclosed device(s)<br>until used. | The wrap is intended to allow<br>sterilization of the enclosed<br>medical device(s) and maintain<br>sterility of the enclosed device(s)<br>until used. | |
| | | See also the Indications for Use<br>statement in Section V for<br>Tables 1 & 2. | |
| Indications for Use | -Gravity Steam 250°F/121°C for 30<br>minutes | Not to be Used | Different<br>See note 5A |
| | -Advanced Sterilization Products<br>(ASP) STERRAD® 100S<br>-Advanced Sterilization Products<br>(ASP) STERRAD® 100NX (Standard,<br>Express and Flex cycles)<br>-STERIS Amsco® V-PRO 1, STERIS<br>Amsco® V-PRO 1 Plus, STERIS<br>Amsco® V-PRO maX Low<br>Temperature Sterilization Systems<br>(Lumen, Non Lumen and Flexible<br>Cycles) | | |
| | Advanced Sterilization Products<br>(ASP) STERRAD® 100S<br>Sterilization: All models of<br>Reliance® Tandem and Solo<br>validated with ASP STERRAD® 100S<br>sterilization with stainless steel<br>lumens as part of the load with a<br>maximum weight of 10.7lbs<br>dependent on the model. | | |
| | Advanced Sterilization Products<br>(ASP) STERRAD® 100NX<br>Sterilization: All models of<br>Reliance® Tandem and Solo<br>validated with ASP STERRAD®<br>100NX sterilization cycles | | |

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| Validated Advanced Sterilization | |
|-------------------------------------|--|
| Products (ASP) STERRAD® 100NX | |
| Cycles Advanced Sterilization | |
| Products (ASP) STERRAD® System | |
| and Cycle: | |
| 100NX Standard Cycle: Reusable | |
| metal and non-metal medical | |
| devices, including up to 10 lumens | |
| of the following dimensions per | |
| chamber load: An inside diameter | |
| of 0.7mm or larger and a length of | |
| 500mm or shorter of single | |
| channel stainless steel lumens. | |
| 100NX Flex Cycle: | |
| One or two single-channel flexible | |
| endoscopes with or without a | |
| silicone mat. Flexible endoscope | |
| may contain: A single channel | |
| Teflon/PE/PTFE lumen with an | |
| inside diameter of 1 mm or larger | |
| and a length of 850mm or shorter. | |
| (A maximum of two flexible | |
| endoscopes, one per tray per | |
| sterilization cycle) | |
| 100NX Express Cycle: | |
| Non-lumened reusable metal and | |
| non-metal medical devices | |
| requiring surface sterilization, or | |
| sterilization of mated stainless | |
| steel and titanium surfaces, and | |
| rigid or semi-rigid endoscopes | |
| without lumens. | |
| STERIS Amsco® V-PRO 1, STERIS | |
| Amsco® V-PRO 1 Plus, STERIS | |
| Amsco® V-PRO maX Low | |
| Temperature Sterilization | |
| Systems: All models of Reliance® | |
| Tandem and Solo Sterilization | |
| Wraps have been validated for use | |
| with STERIS VPRO® cycles. | |
| Reliance® Tandem and Solo | |
| Sterilization Wraps were validated | |
| to be effectively aerated during | |
| the preprogrammed STERIS Amsco | |
| V-PRO® Sterilization Cycles. | |
| Validated STERIS Amsco® V-PRO | |
| Cycles STERIS Amsco® V-PRO | |
| Cycle: | |
| Lumen Cycle: | |
| Reusable metal and non-metal | |
| medical devices, including up to 20 | |
| stainless steel lumens with | |

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| | dimensions of 3.0mm diameter or<br>larger and a length of 400mm or<br>shorter.<br>Non Lumen Cycle:<br>Non lumened reusable metal and<br>non-metal medical devices.<br>Flexible Cycle:<br>Single lumen surgical flexible<br>endoscopes and bronchoscopes in<br>the following load configuration:<br>1.) One tray containing a flexible<br>endoscope with a light cord (if not<br>integral to endoscope) and mat.<br>The flexible endoscope having an<br>inside diameter of 1 mm or larger<br>and a length of 850 mm or shorter.<br>2.) An additional tray containing<br>non-lumened medical devices. | | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Manufacturer | Ahlstrom Nonwovens LLC | Ahlstrom Nonwovens LLC | Same |
| Intended Use | Reliance® Tandem and<br>Solo Sterilization Wrap is intended<br>to be used to enclose another<br>medical device that is to be<br>sterilized by a health care provider | Reliance® Fusion Sterilization<br>Wrap is intended to be used to<br>enclose another medical device<br>that is to be sterilized by a health<br>care provider | Similar |
| Product Name | Reliance® Solo S100, Reliance®<br>Solo S200, Reliance® Solo S300,<br>Reliance® Solo S400, Reliance®<br>Solo S500, Reliance® Solo, S600 | Reliance® Fusion Light, Reliance®<br>Fusion Heavy | Different.<br>No product<br>impact. |
| Material<br>Composition | OUTER LAYER: Polypropylene<br>spunbond-meltblown-spunbond<br>(SMS) nonwoven fabric<br>INNER LAYER: Polypropylene<br>spunbond-meltblown-spunbond<br>(SMS) nonwoven fabric | OUTER LAYER: Polypropylene<br>spunbond-meltblown-spunbond<br>(SMS) nonwoven fabric<br>INNER LAYER: Absorbent Wetlaid<br>nonwoven fabric | Different.<br>See note 2A. |
| Drying Time | Reliance® Tandem and Solo<br>Models T100/S100, T200/S200,<br>T300/S300: 20 minutes<br>Reliance® Tandem and Solo<br>Models T400/S400, T500/S500,<br>T600/S600: 30 minutes | Reliance® Fusion Light:<br>12 minutes<br>Reliance® Fusion Heavy:<br>20 minutes | Different.<br>See note 3A |
| Configurations /<br>Dimensions | Sheet sizes:<br>12 inch x 12 inch,<br>15 inch x 15 inch,<br>18 inch x 18 inch,<br>24 inch x 24 inch,<br>30 inch x 30 inch,<br>36 inch x 36 inch,<br>40 inch x 40 inch, | Sheet sizes:<br>12 inch x 12 inch,<br>15 inch x 15 inch,<br>18 inch x 18 inch,<br>24 inch x 24 inch,<br>30 inch x 30 inch,<br>36 inch x 36 inch,<br>40 inch x 40 inch, | Same |
| | 48 inch x 48 inch,<br>54 inch x 54 inch,<br>54 inch x 72 inch | 48 inch x 48 inch,<br>54 inch x 54 inch,<br>54 inch x 72 inch | |
| Sterilant Penetration | Pass per ANSI/AAMI ST79:2010 &<br>A1:2010 and ANSI/AAMI/ISO<br>14937:2009 | Pass per ANSI/AAMI ST79:2017,<br>ANSI/AAMI/ISO<br>14937:2009/(R)2013 | Similar. See<br>note 4A |
| Maintenance of<br>Sterility | 180 days | 180 days | Similar |
| Sterilization<br>Parameters | 100% Ethylene Oxide (EO) with a<br>concentration of 725-735 mg/L @<br>131°F/55°C and 40% - 80% relative<br>humidity for 60 minutes | 100% Ethylene Oxide (EO) with a<br>concentration of 725-759 mg/L<br>@ 131°F/55°C and 40% - 70%<br>relative humidity for 60 minutes | Similar |
| | Pre-vacuum Steam 270ºF/132ºC<br>for 4 minutes | Pre-vacuum Steam 270ºF/132ºC<br>for 4 minutes | Same |
| | Gravity Steam 250°F/121°C for 30<br>minutes | N/A - Not for use with Gravity<br>Steam | Different.<br>See note 5A |
| | (ASP) STERRAD® 100S, and 100NX<br>(STANDARD, EXPRESS and FLEX<br>cycles) | N/A - Not for use with STERRAD<br>Sterilizers | Different.<br>See note 5A |
| | STERIS Amsco® V-PRO 1 & V-pro 1<br>Plus (Non-Lumen and Lumen<br>Cycles) and V-PRO maX cycle | N/A – Not for use with V-PRO<br>Sterilizers | Different.<br>See note 5A |
| Microbial Barrier<br>Properties<br>(Packaging Integrity) | Microbial Aerosol Challenge Test,<br>Pre-Vacuum Steam and Ethylene<br>Oxide<br>Gauze fallout samples ≥400<br>CFU/cm²<br>Pass | Microbial Aerosol Challenge Test,<br>Pre-Vacuum Steam and Ethylene<br>Oxide<br>Gauze fallout samples ≥400<br>CFU/cm²<br>Pass | Same |
| Material<br>Compatibility | Pass | Pass | Same |
| Toxicological<br>Properties<br>(Biocompatibility) | Pass | Pass | Same |
| Pigment Contents | Pigment Blue, Pigment Violet,<br>Pigment Red, Pigment White,<br>Pigment Black, Pigment Green | Pigment Blue, Pigment Violet,<br>Pigment Red, Pigment White,<br>Pigment Black, Pigment Green,<br>Pigment Yellow | Different.<br>See note 6A |
| Composition of<br>Materials | Polypropylene | Polypropylene, Cellulose,<br>Polyester, & Acrylic binder | Different.<br>See Note 7A |
| Shelf Life<br>(Nonsterile) | 5 years | 3 years | Different.<br>See Note 8A |

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Note 1A: Differences for Pre-vacuum Steam: Testing of modified device confirms safety and efficacy for intended use at modified dry time. For Ethylene Oxide, concentration and humidity were similar due to worst case validation sterilization parameters for the modified device studies. For predicate peroxide sterilization: different, due to peroxide sterilization being incompatible with the inner wetlaid layer.

Note 2A: No impact on safety or efficacy for intended use based on biocompatibility and simulated use testing.

Note 3A: Dry Time validations and simulated use testing confirm safety and efficacy for intended use.

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Note 4A: Changes in standard revision did not impact test methodology used.

Note 5A: Differences are outside the scope of the proposed devices intended use and will not affect the safety and efficacy for its intended use.

Note 6A: No impact on safety or efficacy for intended use based on biocompatibility and simulated use testing.

Note 7A: No impact on safety or efficacy for intended use based on results of biocompatibility and validation testing.

Note 8A: No impact on safety or efficacy for intended use within the shelf-life period based on performance testing.

### VII. PERFORMANCE DATA

Performance data for the Reliance Fusion Sterilization Wraps confirm that the device conforms to design specifications. Clinical data was not required for this submission.

| | | | Predicate | Proposed | |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------|---------------------------|
| Test Performed | Standards | Acceptance Criteria | Device | Device | Comments |
| Sterilization<br>Penetration / Efficacy | Sterilization Efficacy<br>Validation, half-cycle,<br>Pre-Vacuum Steam and<br>Ethylene Oxide<br>ANSI/AAMI ST79:2010<br>& A1:2010 (Predicate)<br>ANSI/AAMI ST79:2017<br>(Proposed Device)<br>ANSI/AAMI/ISO<br>14937:2009/(R)2013 | All Test Samples and Bls<br>negative for growth<br>following minimum<br>incubation period;<br>Integrators/indicators<br>demonstrate sterilant<br>penetration | Pass | Pass | Similar |
| Dry Time Validation<br>Study | Dry Time Validation<br>Study,<br>Pre-Vacuum Steam (4<br>min. @ 132C)<br>ANSI/AAMI ST79:2010<br>& A1:2010 (Predicate)<br>ANSI/AAMI ST79:2017<br>(Proposed Device) | Average pre- and post-<br>sterilization weight<br>difference of less than<br>0.2% within 5 min of<br>cycle completion; Tray,<br>contents and<br>sterilization wrap free of<br>visible moisture<br>following cooling period | Pass | Pass | Similar |
| Maintenance of<br>Package Sterility | 180 Day Event Related<br>Shelf Life Study,<br>Pre-Vacuum Steam and<br>Ethylene Oxide<br>ANSI/AAMI ST79:2010<br>& A1:2010 (Predicate)<br>ANSI/AAMI ST79:2017<br>(Proposed Device)<br>ANSI/AAMI/ISO<br>14937:2009/(R)2013 | Negative for growth | Pass | Pass | Same |
| Test Performed | Standards | Acceptance Criteria | Predicate<br>Device | Proposed<br>Device | Comments |
| Microbial Barrier | Microbial Aerosol<br>Challenge Test,<br>Pre-Vacuum Steam and<br>Ethylene Oxide | Gauze fallout samples<br>$≥400 CFU/cm²$ | Pass | Pass | Same |
| Biocompatibility | ISO 10993-5:2009 Tests<br>for in vitro cytotoxicity | Less than or equal to<br>mild cellular reactivity | Pass | Pass | Same |
| Ethylene Oxide (EO)<br>and Ethylene<br>Chlorohydrin (ECH)<br>Residual Analysis | ISO 10993-<br>7:2008/(R)2012 | EO residuals ≤ 4mg of<br>EO/ADD<br>ECH residuals ≤ 9 mg of<br>ECH/ADD<br>All EO Tolerable Contact<br>Limits (TCL) ≤10µg/cm²<br>of EO/ADD<br>All ECH Tolerable<br>Contact Limits (TCL) ≤ 5<br>mg/cm² of ECH/ADD | Pass | Pass | Same |
| Material<br>Compatibility:<br>Physical Property<br>Testing Non-Sterile &<br>Sterile | Air Permeability<br>ASTM D737-04 | Meets physical property<br>specifications, Non-<br>Sterile and after Pre-<br>vacuum Steam or<br>Ethylene Oxide<br>Sterilization Processes | Pass | Pass | Different,<br>See note 1B |
| | Basis Weight ASTM<br>D3776-96 | | Pass | Pass | |
| | Bursting Strength<br>WSP 30.1.R3 (12) | | Pass | Pass | |
| | Grab Tensile CD<br>ASTM D5034-95 | | Pass | Pass | |
| | Trapezoid Tear<br>MD ISO 9073-4 | | Pass | Pass | |
| | Hydrohead<br>WSP.080.6.R4 (12) | | Pass | Pass | |
| | Bacterial Filtration<br>Efficiency | | Pass | Pass | |
| | ASTM F2101-07 /<br>EN14683:2014<br>(Predicate) | | Pass | Pass | |
| | ASTM F2101-19 and<br>ASTM F2101-23 (Subject<br>Device) | | Pass | Pass | |
| | Gelbo Linting<br>ISO 9073-10:2003 | | Pass | Pass | |

### Summary of Non-Clinical Testing

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Note 1B: Differences in test standard revision numbers have no impact on test methodology and therefore no impact on safety or efficacy of the proposed device.

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### NON-CLINCIAL TEST CONCLUSION

In summary, pre-, and post-sterilization physical performance test results of Reliance® Fusion wrap models demonstrate the robustness required of sterilization wraps. The non-clinical tests were selected to evaluate the overall performance criteria needed to ensure safety and efficacy of the proposed device.

#### VIII. CONCLUSIONS

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K171533.