Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are solely focused on the physical properties and function of sterilization wraps, with no mention of AI or ML capabilities.

Therapeutic

No.
The Reliance® Fusion Sterilization Wraps are intended to enclose other medical devices for sterilization, not to treat a condition or disease.

Diagnostic

No
The Reliance® Fusion Sterilization Wraps are intended to enclose other medical devices for sterilization, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization wrap made of nonwoven materials, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Reliance® Fusion Sterilization Wraps are used to enclose medical devices for sterilization. Their purpose is to maintain sterility after the sterilization process and allow for aseptic opening.
Intended Use: The intended use clearly states they are used to "enclose another medical device that is to be sterilized." This is a function related to the sterilization and handling of medical devices, not the analysis of biological samples.
Device Description: The description details the materials and construction of the wraps, which are designed for packaging and sterilization, not for performing diagnostic tests.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.

Therefore, the Reliance® Fusion Sterilization Wraps fall under the category of medical devices used in the sterilization process, not as in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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
- 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 55ºC
- Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less.

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

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

Wrap Code: Reliance® Fusion Heavy
Material Type: Outer SMS / Inner Absorbent Wetlaid Layer
Intended Load: Very Heavy Weight Package (e.g. general use medical instruments)
12" x 12": 1.8 lb
15" x 15": 2.6 lb
18" x 18": 3.7 lb
24" x 24": 6.4 lb
30" x 30": 9.9 lb
36" x 36": 14.2 lb
40" x 40": 17.5 lb
48" x 48": 25 lb
54" x 54": 25 lb
54" x 72": 25 lb

Product codes (comma separated list FDA assigned to the subject device)

FRG

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare provider

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

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Test Performed: Sterilization Penetration / Efficacy
Standards: Sterilization Efficacy Validation, half-cycle, Pre-Vacuum Steam and Ethylene Oxide ANSI/AAMI ST79:2017 (Proposed Device) ANSI/AAMI/ISO 14937:2009/(R)2013
Acceptance Criteria: All Test Samples and BIs negative for growth following minimum incubation period; Integrators/indicators demonstrate sterilant penetration
Proposed Device: Pass
Comments: Similar

Test Performed: Dry Time Validation Study
Standards: Dry Time Validation Study, Pre-Vacuum Steam (4 min. @ 132C) ANSI/AAMI ST79:2017 (Proposed Device)
Acceptance Criteria: Average pre- and post-sterilization weight difference of less than 0.2% within 5 min of cycle completion; Tray, contents and sterilization wrap free of visible moisture following cooling period
Proposed Device: Pass
Comments: Similar

Test Performed: Maintenance of Package Sterility
Standards: 180 Day Event Related Shelf Life Study, Pre-Vacuum Steam and Ethylene Oxide ANSI/AAMI ST79:2017 (Proposed Device) ANSI/AAMI/ISO 14937:2009/(R)2013
Acceptance Criteria: Negative for growth
Proposed Device: Pass
Comments: Same

Test Performed: Microbial Barrier
Standards: Microbial Aerosol Challenge Test, Pre-Vacuum Steam and Ethylene Oxide
Acceptance Criteria: Gauze fallout samples ≥400 CFU/cm²
Proposed Device: Pass
Comments: Same

Test Performed: Biocompatibility
Standards: ISO 10993-5:2009 Tests for in vitro cytotoxicity
Acceptance Criteria: Less than or equal to mild cellular reactivity
Proposed Device: Pass
Comments: Same

Test Performed: Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) Residual Analysis
Standards: ISO 10993-7:2008/(R)2012
Acceptance Criteria: EO residuals ≤ 4mg of EO/ADD ECH residuals ≤ 9 mg of ECH/ADD All EO Tolerable Contact Limits (TCL) ≤10µg/cm² of EO/ADD All ECH Tolerable Contact Limits (TCL) ≤ 5 mg/cm² of ECH/ADD
Proposed Device: Pass
Comments: Same

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Air Permeability ASTM D737-04
Acceptance Criteria: Meets physical property specifications, Non-Sterile and after Pre-vacuum Steam or Ethylene Oxide Sterilization Processes
Proposed Device: Pass
Comments: Different, See note 1B

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Basis Weight ASTM D3776-96
Proposed Device: Pass
Comments: Not specified

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Bursting Strength WSP 30.1.R3 (12)
Proposed Device: Pass
Comments: Not specified

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Grab Tensile CD ASTM D5034-95
Proposed Device: Pass
Comments: Not specified

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Trapezoid Tear MD ISO 9073-4
Proposed Device: Pass
Comments: Not specified

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Hydrohead WSP.080.6.R4 (12)
Proposed Device: Pass
Comments: Not specified

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Bacterial Filtration Efficiency ASTM F2101-19 and ASTM F2101-23 (Subject Device)
Proposed Device: Pass
Comments: Not specified

Test Performed: Material Compatibility: Physical Property Testing Non-Sterile & Sterile
Standards: Gelbo Linting ISO 9073-10:2003
Proposed Device: Pass
Comments: Not specified

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K171533

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

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

Summary

0

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).

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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®
Fusion Light	Outer SMS / Inner
Absorbent
Wetlaid Layer	Light to Moderate
Weight Package
(e.g. general use
medical
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®
Fusion Heavy	Outer SMS / Inner
Absorbent
Wetlaid Layer	Very Heavy
Weight Package
(e.g. general use
medical
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).

3

Table 2: Fusion Wrap Models, sheet color

| Reliance®
Fusion
Models | Wrap Layer | Individual
Sheet
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)

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

l. SUBMITTER

AHLSTROM NONWOVENS LLC 2 Elm Street Windsor Locks, CT 06096 Phone: (860) 654-8556

Contact Person: Gary Jackson Regulatory Affairs gary.jackson@ahlstrom.com 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
Classification Name | Device Class and
Product Code |
|---------|---------------------------------------------------------------------------|----------------------------------------------|----------------------------------|
| K171533 | Reliance® Solo Sterilization Wrap,
Reliance® Tandem Sterilization Wrap | 21 CFR 880.6850
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.

5

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
Type | Intended
Load | 12" x
12" | 15" x
15" | 18" x
18" | 24" x
24" | 30" x
30" | 36" x
36" | 40" x
40" | 48" x
48" | 54" x
54" | 54" x
72" |
|---------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|
| Reliance®
Fusion Light | Outer SMS / Inner
Absorbent
Wetlaid Layer | Light to Moderate
Weight Package
(e.g. general use
medical
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®
Fusion Heavy | Outer SMS / Inner
Absorbent
Wetlaid Layer | Very Heavy
Weight Package
(e.g. general use
medical
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).

6

Table 2: Fusion Wrap Models, sheet color

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

VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

| Element of
Comparison | PREDICATE:
RELIANCE® Solo and Tandem
Sterilization Wrap | SUBJECT (Modified Device):
RELIANCE® Fusion
Sterilization Wrap | Comparison
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
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:

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. x Validated
for dry time of 30 minutes for
Models T400/S400, T500/S500,
T600/S600. All models of Reliance®
Tandem and Solo validated for pre-
vacuum steam sterilization with
stainless steel lumens as part of
the load with a maximum weight
of 25lbs dependent on the model | Ahlstrom 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
Reliance® Fusion Light
-Dry time of 20 minutes for
Fusion Heavy
-Pre-vacuum steam sterilization
using two stainless steel lumens
3 mm in diameter or larger and
400 mm in length or less. | Similar
See note 1A |
| | 100% Ethylene Oxide (EO) with a
concentration of 725-735 mg/L @
131°F/55°C and 40% - 80% relative
humidity for 60 minutes
Validated for aeration time of 8 | 100% Ethylene Oxide (EO) with a
concentration of 725-759 mg/L
@ 131°F/55°C and 40% - 70%
relative humidity for 60 minutes: | |
| | hours at 55°C. All models of
Reliance® Tandem and Solo
validated for ethylene oxide
sterilization with stainless steel
lumens as part of the load with a
maximum weight of 25lbs
dependent on the model. | -Aeration time of 8 hours at 55°C
-Two stainless steel lumens 3
mm in diameter or larger and
400 mm in length or less. | |
| | The wrap is intended to allow
sterilization of the enclosed
medical device(s) and maintain
sterility of the enclosed device(s)
until used. | The wrap is intended to allow
sterilization of the enclosed
medical device(s) and maintain
sterility of the enclosed device(s)
until used. | |
| | | See also the Indications for Use
statement in Section V for
Tables 1 & 2. | |
| Indications for Use | -Gravity Steam 250°F/121°C for 30
minutes | Not to be Used | Different
See note 5A |
| | -Advanced Sterilization Products
(ASP) STERRAD® 100S
-Advanced Sterilization Products
(ASP) STERRAD® 100NX (Standard,
Express and Flex cycles)
-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) | | |
| | Advanced Sterilization Products
(ASP) STERRAD® 100S
Sterilization: All models of
Reliance® Tandem and Solo
validated with ASP STERRAD® 100S
sterilization with stainless steel
lumens as part of the load with a
maximum weight of 10.7lbs
dependent on the model. | | |
| | Advanced Sterilization Products
(ASP) STERRAD® 100NX
Sterilization: All models of
Reliance® Tandem and Solo
validated with ASP STERRAD®
100NX sterilization cycles | | |

7

8

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

9

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

10

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.

11

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

Summary of Non-Clinical Testing

12

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.

13

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.