Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

K160755 · Ahlstrom Nonwovens, LLC · FRG · Jul 27, 2016 · General Hospital

Device Facts

• Record ID: K160755
• Device Name: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
• Applicant: Ahlstrom Nonwovens, LLC
• Product Code: FRG · General Hospital
• Decision Date: Jul 27, 2016
• 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® Solo and Tandem are nonwoven sterilization wraps used to enclose medical devices for sterilization. Solo consists of two ultrasonically bonded sheets; Tandem consists of two separate sheets for sequential wrapping. Used in healthcare facilities to maintain sterility of instruments post-sterilization. Wraps are permeable to sterilants (steam, EO, vaporized hydrogen peroxide) but act as a microbial barrier. Healthcare staff wrap instruments, process them through validated sterilization cycles, and store them until needed. The wrap allows aseptic opening of the package. Benefits include protection of sterile contents and maintenance of sterility for up to 90 days.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (ISO 10993), sterilant penetration, dry time, physical integrity (ASTM D737, D3776, D5034, ISO 9073-4), bacterial filtration efficiency (ASTM F2101), and shelf-life (90 days). All results met acceptance criteria.

Technological Characteristics

Three-layer polypropylene spunbond-meltblown-spunbond (SMS) nonwoven fabric. Includes blue/green pigment and anti-static treatment. Dimensions vary by model. Validated for steam, EO, and low-temperature hydrogen peroxide gas plasma sterilization. Standards: AAMI/ANSI ST79, ASTM D737, D3776, D5034, F2101, BS EN 868-2, ISO 9073-4, ISO 10993-5/7, ISO 14937.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam, gravity steam, 100% ethylene oxide, ASP STERRAD (100S, 100NX), and STERIS Amsco V-PRO systems. 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

• Kimberly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps (K082177)
• K082554
• K091685
• K141071
• K092167
• K112805
• K113806
• K141612

Submission Summary (Full Text)

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

July 27, 2016

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

Re: K160755

Trade/Device Name: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: June 22, 2016 Received: June 24, 2016

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 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

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the quality systems (OS) 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 yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160755

### Device Name

Reliance® Solo Sterilization Wrap, Reliance® Tandem 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. o
- 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 (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.

## 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 (3 mm in diameteror larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
- 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 (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 251bs 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 (2 mm inside diameter or larger and a length of 250mm or less) 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.

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| Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Advanced Sterilization Products (ASP) STERRAD® System and Cycle | Intended Load |
| 100NX Standard Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:<br>• 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:<br>• 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. |

#### T-1 1000 1000 1000V

## 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 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:<br>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.<br>2.) An additional tray containing non-lumened medical devices. |

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

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

__ Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

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

#### I. SUBMITTER

Ahlstrom Nonwovens LLC 2 Elm Street Windsor Locks, CT 06096

Contact Person: Gary Jackson Date Prepared: 25 July 2016

#### REGULATORY CORRESPONDENT

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

Phone: [phone] x100 Fax: [phone]

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

#### II. DEVICE

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

#### III. PREDICATE DEVICE

The Kimberly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps, cleared under K082177 is the primary predicate device utilized in this submission.

The following 510(k) numbers, also referencing the Kimberly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission:

- . K082554, K091685, K141071, K092167, K112805, K113806, K141612
These predicate devices have not been subject to a design-related recall. No reference devices were used in this submission.

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#### 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.

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.

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

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

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| 54 in. x 90 in. | | | | | x | |
|-----------------|--|--|--|--|---|--|
|-----------------|--|--|--|--|---|--|

### 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 Recommendations¹

| Sterilization<br>Wrap<br>Models | Intended Load | Pre-Vacuum<br>and Gravity*<br>Steam and<br>EO | Maximum Recommended Wrapped Package Content Weights2<br>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<br>instruments) | 17 lbs | 10.7 lbs | 10.7 lbs | 10.7 lbs | 9 lbs |
| 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 |

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*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.

4 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.

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- All models of Reliance® Tandem and Solo validated for pre-vacuum steam sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
### 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 (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
- Models T500/S500 and T600/S600 are not validated for use for gravity steam ASSAC 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 (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.

### Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization

- All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100S . sterilization with stainless steel lumens (2 mm inside diameter or larger and a length of 250mm or less) 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)<br>STERRAD® System and Cycle | Intended Load |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 100NX Standard Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:<br>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:<br>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) |

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

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| 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. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## 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 pre-programmed STERIS Amsco V-PRO® Sterilization Cycles.

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

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

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

| Manufacturer | Ahlstrom Nonwovens, LLC | Kimberly-Clark |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | RELIANCE® Tandem and Solo Sterilization Wrap | Kimguard® and Kimguard® ONE-STEP® Sterilization wraps |
| 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 | Kimguard® Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider |
| Material Composition | Polypropylene spunbond-meltblown-spunbond (SMS) fabric | Polypropylene spunbond-meltblown-spunbond (SMS) fabric |
| Configurations/<br>Dimensions | Various | Various |
| Sterilant Penetration | Pass per ANSI/AAMI ST79:2010 &<br>A1:2010 and ANSI/AAMI/ISO<br>14937:2009 | Substantially Equivalent |
| Validated for use in<br>Sterilization System | Pre-vacuum Steam 270°F/132°C<br>for 4 minutes | Substantially Equivalent |
| | Gravity Steam 250°F/121°C for 30<br>minutes | Same, Plus<br>KC500/KC600 |
| | 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 | Substantially Equivalent |
| | (ASP) STERRAD® 100S, and 100NX<br>(STANDARD, EXPRESS and Flex<br>cycles) | Same, Plus<br>STERRAD® 50<br>STERRAD® 200<br>STERRAD® NX (Standard and<br>Advanced Cycles)<br>STERRAD® 100NX DUO cycle |
| | STERIS Amsco® V-PRO 1 & V-PRO<br>1 Plus (Non-Lumen and Lumen<br>cycles) and V-PRO maX cycle | Substantially Equivalent |
| Microbial Barrier<br>Properties (Packaging<br>Integrity) | Pass | Pass |
| Material Compatibility | Pass | Pass |
| Toxicological Properties<br>(Biocompatibility) | Pass | Pass |
| Maintenance of Sterility | 90 days | 30 days (KC100, KC200, KC300,<br>KC400, KC500, KC600)<br>180 days (KC300, KC400, KC500,<br>and KC600)<br>365 days (KC300, KC400, KC500,<br>and KC600) |
| Dry 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 | Kimguard® Models<br>KC100, KC200, KC300: 20<br>minutes<br>Kimguard® Models<br>KC400, KC500, KC600: 30<br>minutes<br>Kimguard® ONE-STEP® Models<br>KC100, KC200: 20 minutes<br>Kimguard® ONE-STEP® Models<br>KC300, KC400, KC500, KC600:<br>30 minutes |

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#### VII. PERFORMANCE DATA

### Summary of Testing:

The Reliance® Tandem and Reliance® Solo Sterilization wrap performance has been tested in accordance with the applicable requirements 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). Testing included: biocompatibility (i.e., cytotoxicity) in compliance with the methods of ISO 10993, sterilant penetration, dry time, and physical integrity. The Sterilization wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 90 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 D737 - 04(2008): Standard Test Method for Air Permeability of Textile Fabrics
- ASTM D3776 - 96 (2002): Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
- . ASTM D5034 - 95(2001): Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- . 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)
- . BS EN 868-2:2009 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
- . ISO 9073-4:1997; Textiles -- Test methods for nonwovens -- Part 4: Determination of tear resistance
- . AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices --Part 5: Tests For In Vitro Cytotoxicity
- . AAMI / ANSI / ISO 10993-7:2008(R)2012, Biological Evaluation Of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals
- ISO 14937 Second Edition 2009-10-15, Sterilization Of Health Care Products - General Requirements For Characterization Of A Sterilizing Agent And The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices

#### VIII. CONCLUSIONS

In conclusion, the Reliance® Tandem and Solo Sterilization wraps are substantially equivalent to the Kimberly-Clark Kimguard® and Kimguard® ONE-STEP® in terms of general intended use, material composition, and configuration. Based on the results of the sterilization validation, shelf-life and physical performance testing, Ahlstrom Reliance® Tandem and Solo sterilization wraps are as safe and as effective, and perform as well as the predicate device, Kimberly-Clark Kimguard® and Kimguard® ONE-STEP®, for their intended use.