Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

K171533 · Ahlstrom Nonwovens, LLC · FRG · Jun 29, 2017 · General Hospital

Device Facts

• Record ID: K171533
• Device Name: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
• Applicant: Ahlstrom Nonwovens, LLC
• Product Code: FRG · General Hospital
• Decision Date: Jun 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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 - Gravity Steam 250°F/121°C for 30 minutes - 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes - 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) The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

Device Story

Reliance® Tandem and Solo Sterilization Wraps are nonwoven polypropylene sheets (SMS construction) used to wrap medical devices prior to sterilization. Tandem uses two separate sheets for sequential wrapping; Solo uses two sheets ultrasonically bonded at edges for simultaneous wrapping. Wraps allow sterilant penetration while maintaining a microbial barrier. Used in healthcare facilities by sterile processing staff. Output is a sterile-wrapped package; sterility maintained for up to 180 days. Benefits include aseptic presentation of instruments and protection of sterile contents.

Clinical Evidence

Bench testing only. Testing included microbial barrier properties, material compatibility, and biocompatibility. Validated for sterility maintenance up to 180 days. Conformance demonstrated with AAMI/ANSI ST79 and ASTM F2101-14 standards.

Technological Characteristics

Three-layer spunbond-meltblown-spunbond (SMS) polypropylene fabric with blue/green pigment and anti-static treatment. Dimensions vary by model. Sterilization via steam, EO, or low-temperature plasma/vapor systems. Microbial barrier properties validated per AAMI/ANSI ST79 and ASTM F2101-14.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam, gravity steam, 100% ethylene oxide, or specific low-temperature sterilization systems (STERRAD, V-PRO). Maintains sterility of enclosed devices until use.

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® Tandem and Reliance® Solo Sterilization Wrap (K160755)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 29, 2017

Ahlstrom Nonwovens LLC % Lauren Chrapowitzky Consultant AJW Technology Consultants. Inc 445 Apollo Beach Blvd Apollo Beach, Florida 33572

Re: K171533

Trade/Device Name: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wran Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: May 5, 2017 Received: May 30, 2017

Dear Lauren Chrapowitzky:

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. 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

{1}------------------------------------------------

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

James P.
Bertram -S

for

Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K171533

### Device Name

Reliance® Tandem and Reliance® Solo Sterilization Wrap

### Indications for Use (Describe)

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
- Gravity Steam 250°F/121°C for 30 minutes
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes
- 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)

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

# Pre-Vacuum Steam Sterilization:

- 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. .
- 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 251bs dependent on the model.

# Gravity Steam Sterilization:

- Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300. ●
- Validated for dry times of 30 minutes for Models T400/S400. .
- Models T100/S100, T200/S200, T400/S400 of Reliance® Tandem and Solo validated for gravity steam sterilization with stainless steel lumens as part of the load with a maximum weight of 251bs dependent on the model.
- o Models T500/S500 and T600/S600 are not validated for use for gravity steam sterilization.

# Ethylene Oxide Sterilization:

- Validated for aeration time of 8 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.

# 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 detailed ● in Table 1.

{3}------------------------------------------------

| Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Advanced Sterilization Products (ASP)<br>STERRAD® System and Cycle | Intended Load |
| 100NX Standard Cycle | Reusable metal and non-metal medical devices,<br>including up to 10 lumens of the following<br>dimensions per chamber load:<br>• An inside diameter of 0.7mm or larger and<br>a length of 500mm or shorter of single-<br>channel stainless steel lumens. |
| 100NX Flex Cycle | One or two single-channel flexible endoscopes with<br>or without a silicone mat. Flexible endoscope may<br>contain:<br>• A single channel Teflon/PE/PTFE lumen<br>with an inside diameter of 1 mm or larger<br>and a length of 850mm or shorter. (A<br>maximum of two flexible endoscopes, one<br>per tray per sterilization cycle) |
| 100NX Express Cycle | Non-lumened reusable metal and non-metal<br>medical devices requiring surface sterilization, or<br>sterilization of mated stainless steel and titanium<br>surfaces, and rigid or semi-rigid endoscopes<br>without lumens. |

Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles

# 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 V-● PRO® cycles detailed in Table 2.
- Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles.

| STERIS Amsco® V-PRO Cycle | Intended Load |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Cycle | Reusable metal and non-metal medical devices,<br>including up to 20 stainless steel lumens with<br>dimensions of 3.0mm diameter or larger and a<br>length of 400mm or shorter. |
| Non Lumen Cycle | Non lumened reusable metal and non-metal<br>medical devices. |
| Flexible Cycle | Single lumen surgical flexible endoscopes and<br>bronchoscopes in the following load configuration:<br>1.) One tray containing a flexible endoscope with a<br>light cord (if not integral to endoscope) and mat.<br>The flexible endoscope having an inside diameter<br>of 1 mm or larger and a length of 850 mm or<br>shorter.<br>2.) An additional tray containing non-lumened<br>medical devices. |

# Table 2: Validated STERIS Amsco® V-PRO Cycles

{4}------------------------------------------------

# 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 OMBnumber."

FORM FDA 3881 (8/14)

PSC Publishing Services [phone] EF

{5}------------------------------------------------

# 510(k) SUMMARY (as required by 807.92) K171533

#### I. SUBMITTER

Ahlstrom Nonwovens LLC 2 Elm Street Windsor Locks, CT 06096

Contact Person: Gary Jackson Date Prepared: 31 January 2017

### REGULATORY CORRESPONDENT

AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572

Phone: [phone] Fax: [phone]

Contact Person: Lauren Chrapowitzky Email: [e-mail]

#### II. DEVICE

Name of Device: Reliance® Tandem and Reliance® Solo Sterilization Wrap Common or Usual Name: Sterilization Wrap Classification Name: Sterilization Wrap Device Panel: General Hospital Regulatory Class: Il Product Code: FRG Regulation Number: 880.6850

#### III. PREDICATE DEVICE

The Ahlstrom Nonwovens LLC Reliance® Tandem and Reliance® Solo Sterilization Wrap, cleared under K160755, is the predicate device for this submission.

#### IV. DEVICE DESCRIPTION

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® Tandem: Consists of single sheets 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.

{6}------------------------------------------------

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.

The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.

| Table 1: Dimensional Specifications of Reliance® Tandem and Reliance® Solo Wrap Models | | | |
|----------------------------------------------------------------------------------------|--|--|--|
|----------------------------------------------------------------------------------------|--|--|--|

| Dimensions | T100/S100 | T200/S200 | T300/S300 | T400/S400 | T500/S500 | T600/S600 |
|-----------------|-----------|-----------|-----------|-----------|-----------|-----------|
| 9 in. x 9 in. | × | | | | | |
| 12 in. x 12 in. | × | × | | | | |
| 15 in. x 15 in. | × | × | | | | |
| 18 in. x 18 in. | × | × | × | × | × | |
| 20 in. x 20 in. | × | | | | | |
| 24 in. x 24 in. | × | × | × | × | × | |
| 30 in. x 30 in. | × | × | × | × | × | |
| 36 in. x 36 in. | × | × | × | × | × | × |
| 40 in. x 40 in. | × | × | × | × | × | × |
| 45 in. x 45 in. | × | | × | × | × | × |
| 48 in. x 48 in. | × | × | × | × | × | × |
| 54 in. x 54 in. | × | × | × | × | × | × |
| 60 in. x 60 in. | | | | | × | |
| 54 in. x 72 in. | × | × | × | × | × | × |
| 54 in. x 90 in. | | | | | × | |

### Wrap Model Recommendations

Table 2 provides the recommended wrapped package content weights by model and sterilization modality for the Reliance® Tandem and Solo products.

Table 2: Wrap Model Recommendations 1

{7}------------------------------------------------

| | | Maximum Recommended Wrapped Package Content Weights2 | | | | |
|---------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| Sterilization<br>Wrap<br>Models | Intended Load | Pre-Vacuum<br>and Gravity*<br>Steam and<br>EO | Advanced<br>Sterilization<br>Products (ASP)<br>Sterrad®<br>100S | Advanced<br>Sterilization<br>Products<br>(ASP)<br>Sterrad®<br>100NX | Steris<br>Amsco®<br>V-PRO<br>Lumen and<br>Non Lumen<br>Cycle | Steris<br>Amsco®<br>V-PRO<br>Flex<br>Cycle |
| T100<br>and<br>S100 | Very Light Weight<br>Package (for example:<br>gauze or towel packs or<br>batteries) | 3 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 3 lbs |
| T200<br>and<br>S200 | Light Weight Package<br>(for example: standard<br>linen packs or<br>telescope with light<br>cord) | 6 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 6.5 lbs |
| T300<br>and<br>S300 | Light to Moderate<br>Weight<br>Package (for example:<br>general use medical<br>instruments) | 9 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T400<br>and<br>S400 | Moderate to Heavy<br>Weight Package (for<br>example: general use<br>medical instruments) | 13 lbs* | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| T500<br>and<br>S500 | Heavy Weight Package<br>(for example: general<br>use medical | 17 lbs | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| S500 | instruments) | | | | | |
| T600<br>and<br>S600 | Very Heavy Weight<br>Package (for example:<br>general use medical<br>instruments) | 25 lbs | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |

{8}------------------------------------------------

*Gravity Steam Sterilization is validated for models T100/S200, T300/S300, T400/S400 only. T500/S500 and T600/S600 models are not validated for gravity steam.

¹ Individual results may differ due to factors such as variations in wrapping techniques, handling practices and folding methods. Results may also differ due to the use of irregularly shaped contents that may result in added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

² 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 Ahlstrom Nonwovens Sterilization Wraps (i.e. wrapped contents).

#### V. 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
- Gravity Steam 250°F/121°C for 30 minutes ●
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and ● 40% - 80% relative humidity for 60 minutes
- 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)

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

# Pre-Vacuum Steam Sterilization:

- 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. .
- 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.

# Gravity Steam Sterilization:

- Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300. ●
- Validated for dry times of 30 minutes for Models T400/S400. .
- Models T100/S100, T200/S200, T300/S300, T400/S400 of Reliance® Tandem and . Solo validated for gravity steam sterilization with stainless steel lumens as part of the load with a maximum weight of 25lbs dependent on the model.

{9}------------------------------------------------

- Models T500/S500 and T600/S600 are not validated for use for gravity steam sterilization.
# Ethylene Oxide Sterilization:

- Validated for aeration time of 8 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.

# 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 detailed in Table 1.

| Advanced Sterilization Products (ASP) | Intended Load |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STERRAD® System and Cycle | |
| 100NX Standard Cycle | Reusable metal and non-metal medical<br>devices, including up to 10 lumens of the<br>following dimensions per chamber load:<br>An inside diameter of 0.7mm or larger<br>● |
| | and a length of 500mm or shorter of<br>single-channel stainless steel lumens. |
| 100NX Flex Cycle | One or two single-channel flexible endoscopes<br>with or without a silicone mat. Flexible<br>endoscope may contain:<br>A single channel Teflon/PE/PTFE lumen<br>●<br>with an inside diameter of 1 mm or<br>larger and a length of 850mm or<br>shorter. (A maximum of two flexible<br>endoscopes, one per tray per<br>sterilization cycle) |
| 100NX Express Cycle | Non-lumened reusable metal and non-metal<br>medical devices requiring surface sterilization,<br>or sterilization of mated stainless steel and<br>titanium surfaces, and rigid or semi-rigid<br>endoscopes without lumens. |

### Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles

# 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 V-PRO® cycles detailed in Table 2.

{10}------------------------------------------------

- Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively . aerated during the pre-programmed STERIS Amsco V-PRO® Sterilization Cycles.

| STERIS Amsco® V-PRO Cycle | Intended Load |
|---------------------------|--------------------------------------------------|
| Lumen Cycle | Reusable metal and non-metal medical |
| | devices, including up to 20 stainless steel |
| | lumens with 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. |

Table 2: Validated STERIS Amsco® V-PRO Cycles

#### VI. COMPARISON OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Manufacturer | Ahlstrom Nonwovens, LLC | Comparison of subject device<br>with the predicate device |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Device Name | RELIANCE® Tandem and Solo<br>Sterilization Wrap | RELIANCE® Tandem and Solo<br>Sterilization Wrap |
| Intended use | Reliance® Tandem and Solo<br>Sterilization Wrap is intended to<br>be used to enclose another<br>medical device that is to be<br>sterilized by a health care<br>provider | same |
| Material Composition | Polypropylene spunbond-<br>meltblown-spunbond (SMS)<br>fabric | same |
| Configurations/<br>Dimensions | Various | same |
| Sterilant Penetration | Pass per ANSI/AAMI ST79:2010 &<br>A1:2010 and ANSI/AAMI/ISO<br>14937:2009 | same |
| Validated for use in<br>Sterilization System | Pre-vacuum Steam 270°F/132°C<br>for 4 minutes<br>Gravity Steam 250°F/121°C for 30 | same |

{11}------------------------------------------------

| | minutes | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | 100% Ethylene Oxide (EO) with a<br>concentration of 725-735 mg/L<br>@ 131°F/55°C and 40% - 80%<br>relative humidity for 60 minutes | same |
| | (ASP) STERRAD® 100S, and 100NX<br>(STANDARD, EXPRESS and Flex<br>cycles) | same |
| | STERIS Amsco® V-PRO 1 & V-PRO<br>1 Plus (Non-Lumen and Lumen<br>cycles) and V-PRO maX cycle | same |
| Microbial Barrier<br>Properties (Packaging<br>Integrity) | Pass | Pass |
| Material Compatibility | Pass | Pass |
| Toxicological Properties<br>(Biocompatibility) | Pass | Pass |
| Maintenance of Sterility | 90 days | 180 days |
| Dry Time | Reliance® Tandem and Solo<br>Models T100/S100, T200/S200,<br>T300/S300: 20 minutes<br><br>Reliance® Tandem and Solo<br>Models T400/S400, T500/S500,<br>T600/S600: 30 minutes | Same |

#### VII. PERFORMANCE DATA

# Summary of Testing:

Performance data for the Reliance® Tandem and Reliance® Solo Sterilization wrap was included under K160755. This submission includes data to demonstrate continued conformance with the microbial barrier properties recommended in Premarket Notification {510(k)} Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Reliance® Tandem and Solo Sterilization Wraps have been tested for the ability to maintain sterility of pack contents after sterilization for up to 180 days under standard conditions. All results of testing met acceptance criteria.

Standards Utilized

- AAMI / ANSI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities.
- . ASTM F2101-14, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. (General Plastic Surgery/General Hospital)

{12}------------------------------------------------

#### VIII. CONCLUSIONS

In conclusion, results from nonclinical testing demonstrate that Reliance® Tandem and Reliance® Solo Sterilization Wrap is as safe, as effective, and performs as well as the predicate device (K160755).