Cardinal Health Sterilization Wrap

K151788 · Cardinal Health200, LLC · FRG · Oct 30, 2015 · General Hospital

Device Facts

• Record ID: K151788
• Device Name: Cardinal Health Sterilization Wrap
• Applicant: Cardinal Health200, LLC
• Product Code: FRG · General Hospital
• Decision Date: Oct 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using: Gravity steam at 250°F/121°C for 30 minutes Pre-vacuum steam at 270°F/132°C for 4 minutes 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes Advanced Sterilization Products (ASP) STERRAD® 100S System Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced Cycles Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and DUO cycles Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus and STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed devices until it is used.

Device Story

Cardinal Health™ Sterilization Wrap consists of 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Provided in six basis weights and various dimensions; used by healthcare providers to enclose medical devices prior to sterilization. The wrap allows for sequential or simultaneous double-wrapping techniques. Following sterilization, the wrap maintains the sterility of the enclosed contents until the package is opened aseptically. The device is single-use and available over-the-counter. It is compatible with multiple sterilization modalities, including gravity steam, pre-vacuum steam, ethylene oxide, and various low-temperature hydrogen peroxide gas plasma systems. The wrap's physical integrity remains stable post-sterilization, ensuring the microbial barrier is maintained.

Clinical Evidence

Bench testing only. Testing included sterilization efficacy, microbial barrier properties (aerosol challenge), physical properties, and biocompatibility (ISO 10993-5, ISO 10993-10). Results demonstrated successful sterilization and maintenance of sterility for 30 days (gravity steam) and 365 days (other methods).

Technological Characteristics

Material: 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Form factor: Six basis weight models in various dimensions. Sterilization compatibility: Gravity steam, pre-vacuum steam, EO, and low-temperature hydrogen peroxide gas plasma (STERRAD, STERIS V-PRO). Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating per ISO 10993.

Indications for Use

Indicated for healthcare providers to enclose medical devices for sterilization via gravity steam, pre-vacuum steam, 100% ethylene oxide, and specific low-temperature sterilization systems (STERRAD, STERIS V-PRO). Intended to maintain 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

• DuraBlue™ Sterilization Wrap (K132060)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the image of the faces.

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

October 30, 2015

Cardinal Health 200, LLC Ms. Megan Middaugh Regulatory Affairs Manager 1500 Waukegan Road Waukegan, IL 60085

Re: K151788

Trade/Device Name: Cardinal Health™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: October 8, 2015 Received: October 9, 2015

Dear Ms. Middaugh:

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. Iisting 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.

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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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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

Erin I. Keith, M.S. 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)

#### K151788

Device Name Cardinal HealthTM Sterilization Wrap

Indications for Use (Describe)

Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using:

·Gravity steam at 250°F/121°C for 30 minutes

·Pre-vacuum steam at 270°F/132°C for 4 minutes

· 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes

· Advanced Sterilization Products (ASP) STERRAD® 100S System

· Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced Cycles

· Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and DUO cycles

• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus and STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems

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

For gravity steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600, CH500 and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55 °C. Models CH400, CH500 and CH600 have been validated for EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less.

All models of Cardinal Health™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® cycles in Table 2. Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® sterilization cycles.

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#### Table 1 - Validated Advanced Sterilization Products STERRAD® NX® and STERRAD® 100NX® Sterilization Cycles and Intended Loads

| Advanced<br>Sterilization<br>Products (ASP)<br>STERRAD®<br>System | Maximum<br>Recommended<br>Chamber Load | Intended Load |
|-------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASP<br>STERRAD® NX®<br>Standard Cycle | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to 10<br>lumens of the following lumen dimensions per chamber load:<br>• an inside diameter of 1 mm or larger and a length of 150 mm or<br>shorter of single-channel stainless steel lumens<br>• an inside diameter of 2 mm or larger and a length of 400 mm or<br>shorter of single-channel stainless steel lumens |
| ASP<br>STERRAD® NX®<br>Advanced Cycle | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to 10<br>lumens of the following lumen dimensions per chamber load:<br>• an inside diameter of 1 mm or larger and a length of 500 mm or<br>shorter of single-channel stainless steel lumens<br>OR<br>One single-channel Flexible Endoscope with or without a silicone mat<br>and no additional load. The flexible endoscope may contain:<br>• a single-channel Teflon®/Polyethylene lumen with an inside<br>diameter of 1 mm or larger and a length of 850 mm or shorter |
| ASP<br>STERRAD®<br>100NX®<br>Standard Cycle | 21.4 lbs. | Reusable metal and non-metal medical devices, including up to 10<br>lumens of the following lumen dimensions per chamber load:<br>• an inside diameter of 0.7 mm or larger and a length of 500 mm or<br>shorter of single-channel stainless steel lumens (A maximum of<br>five lumens per tray per sterilization cycle) |
| ASP<br>STERRAD®<br>100NX® Flex<br>Cycle | 12.2 lbs. | One or two single-channel Flexible Endoscope with or without a<br>silicone mat and no additional load. The flexible endoscope may<br>contain:<br>• a single-channel Teflon®/Polyethylene lumen with an inside<br>diameter of 1 mm or larger and a length of 850 mm or shorter (A<br>maximum of two flexible endoscopes, one per tray per<br>sterilization cycle) |
| ASP<br>STERRAD®<br>100NX® Express<br>Cycle | 10.7 lbs. | Non-lumened reusable metal and non-metal medical devices<br>requiring surface sterilization, or sterilization of mated stainless steel<br>and titanium surfaces, and rigid or semi-rigid endoscopes without<br>lumens |
| ASP<br>STERRAD®<br>100NX® Duo<br>Cycle | 13.2 lbs. | One or two single-channel Flexible Endoscope with or without a<br>silicone mat and no additional load. The flexible endoscope may<br>contain:<br>• a single-channel Teflon®/Polyethylene lumen with an inside<br>diameter of 1 mm or larger and a length of 875 mm or shorter |
| STERIS<br>V-PRO® Cycle | Maximum Recommended<br>Chamber Load | Intended Load |
| Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical devices, including up to 20<br>lumens of the following dimensions per chamber load:<br>an inside diameter of 1 mm or larger and a length of<br>125 mm or shorter an inside diameter of 2 mm or larger and a length of<br>250 mm or shorter an inside diameter of 3 mm or larger and a length of<br>400 mm or shorter |
| Non Lumen<br>Cycle | 19.65 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | 24 lbs | Single or dual lumen surgical flexible endoscopes and<br>bronchoscopes in either of two load configurations:<br>Two trays, each containing a flexible endoscope with a light<br>cord (if not integral to endoscope) and mat with no additional<br>load One tray containing a flexible endoscope with a light cord (if<br>not integral to endoscope) and mat and an additional tray<br>containing non-lumened medical devices The flexible endoscope(s) may contain either: a single lumen with an inside diameter of 1 mm or<br>larger and a length of 1050 mm or shorter two lumens, with one lumen having an inside diameter<br>of 1 mm or larger and a length of 998 mm or shorter<br>and the other lumen having an inside diameter of 1<br>mm or larger and a length of 850 mm or shorter |

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# Table 2: Validated STERIS V-PRO® Cycles and Intended Loads

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# Table 3: Wrap Model Recommendations1

| Sterilization<br>Wrap Model | | Maximum Recommended Wrapped Package Content<br>Weights2 | | | |
|-----------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|------------------|
| | Intended Load | Pre-Vacuum,<br>Gravity Steam,<br>and EO | Advanced<br>Sterilization<br>Products<br>(ASP)<br>STERRAD®<br>100S | Advanced<br>Sterilization<br>Products<br>(ASP)<br>STERRAD® NX®<br>and 100NX® | STERIS<br>V-PRO® |
| CH100 | Very light weight package<br>(for example: towel packs or<br>batteries). | 3 lbs. | 3 lbs. | 10.7 lbs. | 3 lbs. |
| CH200 | Light weight package<br>(for example: telescope with<br>light cord). | 6 lbs. | 6 lbs. | 10.7 lbs. | 6.5 lbs. |
| CH300 | Light to moderate weight<br>package<br>(for example: general use<br>medical instruments). | 9 lbs. | 9.7 lbs. | 10.7 lbs. | 9 lbs. |
| CH400 | Moderate to heavy weight<br>package<br>(for example: general use<br>medical instruments). | 13 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |
| CH500 | Heavy weight package<br>(for example: general use<br>medical instruments). | 17 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |
| CH600 | Very heavy weight package<br>(for example: general use<br>medical instruments). | 25 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |

The following loads were used in the Gravity Steam Sterility Validation Studies:

- CH100: 1 tray liner (23 in. x 19.5 in.), 1 lb of metal mass in a 13 in. x 9.2 in. x 3.2 in. tray.
- · CH200: 1 tray liner (23 in. x 19.5 in.), 3 lbs of metal mass in a 13 in. x 9.2 in. x 3.2 in. tray.
- CH300: 1 tray liner (23 in. x 19.5 in.), 6 lbs of metal mass in a 22 in. x 10.6 in. x 2.4 in. tray.
- · CH400: 1 tray liner (23 in. x 19.5 in.), 10 lbs of metal mass in a 22 in. x 10.6 in. x 2.4 in. tray.
- · CH500: 1 tray liner (23 in. x 19.5 in.), 12 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
- CH600: 1 tray liner (23 in. x 19.5 in.), 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

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The following loads were used in the pre-vacuum steam Sterility Validation Studies:

- CH100: 16 huck towels (17 in. x 29 in.).
- · CH200: 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.).
- · CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 lbs of metal mass.
- · CH400: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 8 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
- · CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 12 1bs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
- · CH600: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

The following loads were used in the EO Sterility Validation Studies:

- CH100: 16 huck towels (17 in. x 29 in.).
- · CH200: 2 huck towels (17 in. x 29 in.), 2 fluid-resistant drapes (108 in. x 88 in.), 2.5 lbs of metal mass.
- · CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 lbs of metal mass.

· CH400: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 7.5 bs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

· CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 11.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. trav.

· CH600: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 19.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:

· CH100: Metal instruments.

· CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® NX® and STERRAD® 100NX® Sterility Validation Studies:

· CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.

The following loads were used in the STERIS V-PRO® Sterility Validation Studies:

- · CH100: Metal instruments.
· CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3.

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put 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. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the Cardinal Health™ Sterilization Wraps.

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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1500 Waukegan Road Waukegan, IL 60085 www.cardinalhealth.com

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health™ Sterilization Wrap

| Manufacturer: | Cardinal Health 200, LLC<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Megan Middaugh<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date summary Prepared: | October 26, 2015 |
| Trade Name: | Cardinal Health™ Sterilization Wrap |
| Classification: | Class II per 21 CFR § 880.6850 |
| Classification Name: | Sterilization Wrap |
| Common Name: | Sterilization Wrap |
| Product Code: | FRG |
| Predicate Device: | K132060 - DuraBlue™ Sterilization Wrap for use with Pre-<br>Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO),<br>Advanced Sterilization Products (ASP) STERRAD® 100S,<br>STERRAD® 100NX, and STERRAD® NX Systems, and<br>STERIS Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus, and<br>Amsco® V-PRO® maX Low Temperature Sterilization System |

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#### Description:

Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. This product is a single-use device and for over-the-counter use only.

They are intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

- Gravity steam at 250°F/121°C for 30 minutes .
- Pre-vacuum steam at 270°F/132°C for 4 minutes ●
- 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and ● 40%-80% relative humidity for 60 minutes
- Advanced Sterilization Products (ASP) STERRAD® 100S System
- Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and ● Advanced Cycles
- . Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and DUO cycles
- Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-. PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems

Extensive performance testing has been completed on Cardinal Health™ Sterilization Wrap in this submission of the new indication for use with gravity steam sterilization. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices. Physical properties testing included in this submission also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated sterilization processes and storage because the polypropylene material is inert and very stable.

The trade name of Cardinal Health DuraBlue™ Sterilization Wrap has been changed to Cardinal Health™ Sterilization Wrap. This name change has no impact on the safety and efficacy of the product.

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#### Indications for Use

Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using:

- Gravity steam at 250°F/121°C for 30 minutes ●
- Pre-vacuum steam at 270°F/132°C for 4 minutes ●
- 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and ● 40%-80% relative humidity for 60 minutes
- Advanced Sterilization Products (ASP) STERRAD® 100S System ●
- Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced Cycles
- Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, . Express, and DUO cycles
- Lumen, Non Lumen, and Flexible Cycles in the STERISV-PRO® 1, STERIS V-● PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems

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

For gravity steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55 ℃. Models CH400, CH500 and CH600 have been validated for EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less.

All models of Cardinal Health™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles with the intended loads as described in Table 1.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® cycles with the intended loads as described in Table 2. Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® sterilization cycles.

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### Table 1 – Validated Advanced Sterilization Products STERRAD® NX® and STERRAD® 100NX® Sterilization Cycles and Intended Loads

| Advanced<br>Sterilization<br>Products (ASP)<br>STERRAD®<br>System | Maximum<br>Recommended<br>Chamber Load | Intended Load |
|-------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASP<br>STERRAD® NX®<br>Standard Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10<br>lumens of the following lumen dimensions per chamber load:<br>• an inside diameter of 1 mm or larger and a length of 150 mm or<br>shorter of single-channel stainless steel lumens<br>• an inside diameter of 2 mm or larger and a length of 400 mm or<br>shorter of single-channel stainless steel lumens |
| ASP<br>STERRAD® NX®<br>Advanced Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10<br>lumens of the following lumen dimensions per chamber load:<br>• an inside diameter of 1 mm or larger and a length of 500 mm or<br>shorter of single-channel stainless steel lumens<br>OR<br>One single-channel Flexible Endoscope with or without a silicone mat<br>and no additional load. The flexible endoscope may contain:<br>• a single-channel Teflon®/Polyethylene lumen with an inside<br>diameter of 1 mm or larger and a length of 850 mm or shorter |
| ASP<br>STERRAD®<br>100NX®<br>Standard Cycle | 21.4 lbs | Reusable metal and non-metal medical devices, including up to 10<br>lumens of the following lumen dimensions per chamber load:<br>• an inside diameter of 0.7 mm or larger and a length of 500 mm or<br>shorter of single-channel stainless steel lumens (A maximum of<br>five lumens per tray per sterilization cycle) |
| ASP<br>STERRAD®<br>100NX® Flex<br>Cycle | 12.2 lbs | One or two single-channel Flexible Endoscope with or without a<br>silicone mat and no additional load. The flexible endoscope may<br>contain:<br>• a single-channel Teflon®/Polyethylene lumen with an inside<br>diameter of 1 mm or larger and a length of 850 mm or shorter (A<br>maximum of two flexible endoscopes, one per tray per<br>sterilization cycle) |
| ASP<br>STERRAD®<br>100NX® Express<br>Cycle | 10.7 lbs | Non-lumened reusable metal and non-metal medical devices<br>requiring surface sterilization, or sterilization of mated stainless steel<br>and titanium surfaces, and rigid or semi-rigid endoscopes without<br>lumens |
| ASP<br>STERRAD®<br>100NX® Duo<br>Cycle | 13.2 lbs | One or two single-channel Flexible Endoscope with or without a<br>silicone mat and no additional load. The flexible endoscope may<br>contain:<br>• a single-channel Teflon®/Polyethylene lumen with an inside<br>diameter of 1 mm or larger and a length of 875 mm or shorter |

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| | | | Table 2: Validated STERIS Amsco® V-PRO® Cycles and Intended Loads | |
|--|--|--|-------------------------------------------------------------------|--|
| | | | | |

| STERIS V-PRO®<br>Cycle | Maximum<br>Recommended<br>Chamber Load | Intended Load |
|------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical devices, including up to 20<br>lumens of the following dimensions per chamber load:<br>• an inside diameter of 1 mm or larger and a length of<br>125 mm or shorter<br>• an inside diameter of 2 mm or larger and a length of<br>250 mm or shorter<br>• an inside diameter of 3 mm or larger and a length of<br>400 mm or shorter |
| Non Lumen<br>Cycle | 19.65 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | 24 lbs | Single or dual lumen surgical flexible endoscopes and<br>bronchoscopes in either of two load configurations:<br>1. Two trays, each containing a flexible endoscope with a light<br>cord (if not integral to endoscope) and mat with no additional<br>load<br>2. One tray containing a flexible endoscope with a light cord (if<br>not integral to endoscope) and mat and an additional tray<br>containing non-lumened medical devices<br>The flexible endoscope(s) may contain either:<br>• a single lumen with an inside diameter of 1 mm or<br>larger and a length of 1050 mm or shorter<br>• two lumens, with one lumen having an inside diameter<br>of 1 mm or larger and a length of 998 mm or shorter<br>and the other lumen having an inside diameter of 1<br>mm or larger and a length of 850 mm or shorter |

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#### Table 3: Wrap Model Recommendations1

| | | Maximum Recommended Wrapped Package Content<br>Weights" | | | | |
|-----------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|------------------|--|
| Sterilization<br>Wrap Model | Intended Load | Pre-Vacuum,<br>Gravity Steam,<br>and EO | Advanced<br>Sterilization<br>Products<br>(ASP)<br>STERRAD®<br>100S | Advanced<br>Sterilization<br>Products<br>(ASP)<br>STERRAD® NX®<br>and 100NX® | STERIS<br>V-PRO® | |
| CH100 | Very light weight package<br>(for example: towel packs or<br>batteries). | 3 Ibs | 3 Ibs | 10.7 lbs | 3 Ibs | |
| CH200 | Light weight package<br>(for example: telescope with<br>light cord). | 6 Ibs | 6 Ibs | 10.7 lbs | 6.5 lbs | |
| CH300 | Light to moderate weight<br>package<br>(for example: general use<br>medical instruments). | g Ibs | 9.7 lbs | 10.7 lbs | 9 lbs | |
| CH400 | Moderate to heavy weight<br>package<br>(for example: general use<br>medical instruments). | 13 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | |
| CH500 | Heavy weight package<br>(for example: general use<br>medical instruments). | 17 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | |
| CH600 | Very heavy weight package<br>(for example: general use<br>medical instruments). | 25 Ibs | 9.7 lbs | 10.7 lbs | 9.1 lbs | |

The following loads were used in the gravity steam Sterility Validation Studies:

- CH100: 1 tray liner (23 in. x 19.5 in.), 1 lb of metal mass in a 13 in. x 9.2 in. x 3.2 in. tray.
- · CH200: 1 tray liner (23 in. x 19.5 in.), 3 lbs of metal mass in a 13 in. x 9.2 in. x 3.2 in. tray.
- CH300: 1 tray liner (23 in. x 19.5 in.), 6 lbs of metal mass in a 22 in. x 10.6 in. x 2.4 in. tray.
- CH400: 1 tray liner (23 in. x 19.5 in.), 10 lbs of metal mass in a 22 in. x 10.6 in. x 2.4 in. tray.
- CH500: 1 tray liner (23 in. x 19.5 in.), 12 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
- · CH600: 1 tray liner (23 in. x 19.5 in.), 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

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The following loads were used in the pre-vacuum sterility Validation Studies:

• CH100: 16 huck towels (17 in. x 29 in.).

- CH200: 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.).
• CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 lbs of metal mass.

• CH400: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 8 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

• CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 12 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

• CH600: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

The following loads were used in the EO Sterility Validation Studies:

• CH100: 16 huck towels (17 in. x 29 in.).

· CH200: 2 huck towels (17 in. x 29 in.), 2 fluid-resistant drapes (108 in. x 88 in.), 2.5 lbs of metal mass.

· CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 lbs of metal mass.

• CH400: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 7.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

• CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 11.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

• CH600: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm ID x 400 mm) and 19.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:

- CH100: Metal instruments.
- · CH200 CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.

The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® NX® and STERRAD® 100NX® Sterility Validation Studies:

• CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.

The following loads were used in the STERIS V-PRO® Sterility Validation Studies:

- CH100: Metal instruments.
- · CH200 CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3.

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'Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put 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. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the Cardinal Health™ Sterilization Wraps.

#### Substantial Equivalence

The proposed Cardinal Health™ Sterilization Wrap is substantially equivalent to the predicate devices. Both devices:

- Have the same intended use
- Have the same material composition .
- Have the same physical and chemical properties ●
- Have the same dimensions ●
- Demonstrate maintenance of package sterility ●
- . Performance and safety attributes are substantially equivalent to the predicate. The physical properties of all wrap models have been characterized both before and after exposure to gravity steam sterilization. The resulting data supports the conclusion that Cardinal Health™ Sterilization Wrap sterilized with gravity steam is substantially equivalent to Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the prevacuum steam. The data demonstrates that the Cardinal Health™ Sterilization Wrap is compatible with the gravity steam sterilization.

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| | | | | | Table 4: Overall Comparison to Predicate Device | |
|--|--|--|--|--|-------------------------------------------------|--|
|--|--|--|--|--|-------------------------------------------------|--|

| Element of<br>Comparison | PREDICATE<br>Cardinal Health DuraBlueTM<br>Sterilization Wrap (K132060) | PROPOSED<br>Cardinal HealthTM Sterilization<br>Wrap | Comparison<br>to Predicate |
|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer | Cardinal Health Inc. | Same | Substantially<br>Equivalent |
| Regulation/<br>Product Code | Sterilization Wrap: 880.6850 /<br>FRG | Same | Substantially<br>Equivalent |
| Trade Name | Cardinal Health DuraBlueTM<br>Sterilization Wrap | Cardinal HealthTM Sterilization Wrap | Substantially<br>Equivalent |
| Intended Use | DuraBlueTM Sterilization Wrap is<br>intended to enclose another<br>medical device that is to be<br>sterilized by a health care<br>provider using:<br>• Pre-vacuum steam at<br>270°F/132°C for 4 minutes<br>• 100% ethylene oxide (EO) with<br>a concentration of 725-735<br>mg/L at 131°F/55°C and<br>40%-80% relative humidity for<br>60 minutes<br>• Advanced Sterilization Products<br>(ASP) STERRAD® 100S<br>System<br>• Advanced Sterilization Products<br>(ASP) STERRAD® NX®<br>System, Standard and<br>Advanced Cycles<br>• Advanced Sterilization Products<br>(ASP) STERRAD® 100NX®,<br>Standard, Flex, Express, and<br>DUO cycles<br>• Lumen, Non Lumen, and<br>Flexible Cycles by the<br>STERIS V-PROTM1, V-<br>PROTM1 Plus and V-<br>PROTMMAX Low<br>Temperature Sterilization<br>Systems<br><br>The wrap is intended to allow<br>sterilization of the enclosed<br>medical device(s) and to maintain<br>sterility of the enclosed device(s)<br>until used. | Cardinal HealthTM Sterilization Wrap<br>is intended to enclose another<br>medical device that is to be<br>sterilized by a health care provider<br>using:<br>• Gravity steam at 250°F/121°C for<br>30 minutes<br>• Pre-vacuum steam at<br>270°F/132°C for 4 minutes<br>• 100% ethylene oxide (EO) with a<br>concentration of 725-735 mg/L<br>at 131°F/55°C and 40%-80%<br>relative humidity for 60 minutes<br>• Advanced Sterilization Products<br>(ASP) STERRAD® 100S<br>System<br>• Advanced Sterilization Products<br>(ASP) STERRAD® NX®<br>System, Standard and<br>Advanced Cycles<br>• Advanced Sterilization Products<br>(ASP) STERRAD® 100NX®,<br>Standard, Flex, Express, and<br>DUO cycles<br>• Lumen, Non Lumen, and Flexible<br>Cycles by the STERIS V-<br>PROTM1, V-PROTM1 Plus and<br>V-PROTMMAX Low<br>Temperature Sterilization<br>Systems<br><br>The wrap is intended to allow<br>sterilization of the enclosed medical<br>device(s) and to maintain sterility of<br>the enclosed device(s) until used. | Substantially<br>Equivalent |
| Element of<br>Comparison | PREDICATE<br>Cardinal Health DuraBlue™<br>Sterilization Wrap (K132060) | PROPOSED<br>Cardinal Health™ Sterilization<br>Wrap | Comparison<br>to Predicate |
| Material<br>Composition | Polypropylene fabric using SMS<br>(spunbond-meltblown-spunbond)<br>production process | Same | Substantially<br>Equivalent |
| Physical<br>Properties | Dual Layer, fold-over: Double-<br>layer wrap comprised of a single<br>sheet of blue pigmented SMS<br>fabric that has been folded over in<br>half and ultrasonically sealed to<br>itself on the three non-folded<br>edges | Dual Layer, fold-over: Double-<br>layer wrap comprised of a single<br>sheet of blue pigmented SMS fabric<br>that has been folded over in half<br>and ultrasonically sealed to itself on<br>the three non-folded edges<br><br>Dual Layer: Double-layer wrap<br>comprised of two separate sheets<br>of blue pigmented SMS fabric that<br>have been ultrasonically sealed on<br>two opposing edges<br><br>Two Color: Double-layer wrap<br>comprised of one sheet of blue<br>pigmented SMS fabric and one<br>sheet of green pigmented SMS<br>fabric that have been ultrasonically<br>sealed on two opposing edges ( )<br><br>Single Layer: Single-layer wrap<br>comprised of a single sheet of blue<br>pigmented SMS fabric | Substantially<br>Equivalent |
| Chemical<br>Properties | Polypropylene with blue pigment<br>and antistatic treatment | Polypropylene with blue pigment<br>and antistatic treatment<br><br>Polypropylene with green pigment<br>and antistatic treatment | Substantially<br>Equivalent |
| Element of Comparison | PREDICATE<br>Cardinal Health DuraBlue™<br>Sterilization Wrap (K132060) | PROPOSED<br>Cardinal Health™ Sterilization<br>Wrap | Comparison to Predicate |
| Sterilization<br>Parameters | Pre-vacuum steam at 270°F/132°C<br>for 4 minutes | Gravity steam at 250°F/121°C for<br>30 minutes | Substantially<br>Equivalent |
| | 100% ethylene oxide (EO) with a<br>concentration of 725-735 mg/L at<br>131°F/55°Cand 40%-80% relative<br>humidity for 60 minutes | Pre-vacuum steam at 270°F/132°C<br>for 4 minutes…