Who is the manufacturer of DURABLUE STERILIZATION WRAP?

Cardinal Health-Medical Products and Services filed the 510(k) submission for DURABLUE STERILIZATION WRAP (K132060).

What is the FDA product code for DURABLUE STERILIZATION WRAP?

FRG. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for DURABLUE STERILIZATION WRAP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DURABLUE STERILIZATION WRAP?

DuraBlue™ Sterilization Wrap (K123857); DuraBlue™ Sterilization Wrap (K123289); DuraBlue™ Sterilization Wrap (K120658).

Who can help prepare an FDA 510(k) submission like DURABLUE STERILIZATION WRAP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DURABLUE STERILIZATION WRAP

K132060 · Cardinal Health-Medical Products and Services · FRG · Dec 13, 2013 · General Hospital

Device Facts

Record ID	K132060
Device Name	DURABLUE STERILIZATION WRAP
Applicant	Cardinal Health-Medical Products and Services
Product Code	FRG · General Hospital
Decision Date	Dec 13, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: • 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 by the STERIS Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® 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 device(s) until used.

Device Story

DuraBlue™ Sterilization Wrap consists of 100% polypropylene SMS (spunbond-meltblown-spunbond) trilaminate nonwoven fabric. Designed as a double-layer wrap for simultaneous double-wrapping technique; allows aseptic opening. Used by healthcare providers to enclose medical devices prior to sterilization; maintains sterility of contents for up to 365 days post-sterilization. Available in six models (CH100-CH600) varying by basis weight to accommodate different load weights and types (metal/non-metal instruments, lumens, flexible endoscopes). Validated for specific sterilization cycles including pre-vacuum steam, EO, and various low-temperature hydrogen peroxide gas plasma/vapor systems. Healthcare providers select appropriate wrap model based on package weight and content type. Benefits include protection of sterilized instruments from contamination during storage and transport.

Clinical Evidence

Bench testing only. Studies validated sterilization efficacy and sterility maintenance for 365 days across all indicated sterilization modalities (steam, EO, STERRAD, Amsco V-PRO). Testing included microbial barrier (aerosol challenge), physical property integrity, and biocompatibility (non-irritating). No clinical data presented.

Technological Characteristics

Material: 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Form factor: Double-layer wrap (single sheet folded and sealed). Sterilization compatibility: Pre-vacuum steam, 100% EO, hydrogen peroxide gas plasma (STERRAD), and vaporized hydrogen peroxide (Amsco V-PRO). Six models (CH100-CH600) with varying basis weights.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam, 100% EO, or specific low-temperature systems (STERRAD 100S, NX, 100NX; Amsco V-PRO 1, 1 Plus, MAX). 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

DuraBlue™ Sterilization Wrap (K123857)
DuraBlue™ Sterilization Wrap (K123289)
DuraBlue™ Sterilization Wrap (K120658)

Related Devices

K112283 — DURA BLUE STERILIZATION WRAP · Cardinal Health200, LLC · Oct 20, 2011
K122507 — DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION · Cardinal Health200, LLC · Sep 26, 2012
K123289 — DURABLUE STERILIZATION WRAP · Cardinal Health-Medical Products and Services · Feb 28, 2013
K112211 — DURA BLUE STERILIZATION WRAP · Cardinal Health200, LLC · Oct 20, 2011
K130927 — DURABLUE STERILIZATION WRAP · Cardinal Health200, LLC · Jun 18, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K132060 DEC 13 2013 Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that resemble abstract wings or feathers. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter of each word capitalized. 1430 Waukegan Road Waukegan, IL 60085 www.cardinalhealth.com ### 510(k) SUMMARY DuraBlue™ Sterilization Wrap Manufacturer: . Cardinal Health 200, LLC 1430 Waukegan Road Waukegan, IL 60085 1430 Waukegan Road Waukegan, IL 60085 Lavenia Ford (847) 887-3323 (847) 887-2461 November 15, 2013 Sterilization Wrap FRG Regulatory Affairs Contact: Telephone Number: Fax Number: Trade Name: Classification: Date summary Prepared: DuraBlue™ Sterilization Wrap Class II per 21 CFR § 880.6850 Classification Name: Sterilization Wrap Common Name: Product Code: Predicate Device: K123857 – DuraBlue™ Sterilization Wrap – Johnson & Johnson STERRAD® NX and STERRAD® 100NX K123289 - DuraBlue™ Sterilization Wrap - Pre-Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO) K120658 - DuraBlue™ Sterilization Wrap - STERRAD® 100S and Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus, and Amsco® V-PRO® MAX Low Temperature Sterilization Systems {1}------------------------------------------------ #### Description: DuraBlue™ Sterlization Wraps are made from 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Each double-layer wrap is comprised of a single sheet of SMS fabric that has been folded in half and sealed to itself on the three non-folded edges. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. This product is 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: - 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 by the STERIS Amsco® V-PRO® 1, Amsco® V-. PRO® 1 Plus and Amsco® V-PRO® MAX Low Temperature Sterilization Systems The modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use labeling and involves extending the real-time aging data from 180 days to 365 days. This change is being made in order to comply with 21CFR880.6850 which states "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 sterlized 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." Additionally, maintenance of package sterility was validated with realtime testing for a duration of 365 days for each indicated sterilization process. Extensive performance testing has also been completed on DuraBlue™ Sterlization Wrap. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterlization 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. This submission covers six different models of DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology. #### Indications for Use DuraBlue ™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: - . 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. . {2}------------------------------------------------ - . Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles - . Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles - . Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® 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 device(s) until used. 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 DuraBlue™ Sterilization Wrap have been validated for Advanced Sterlization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less. All models of DuraBlue™ 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 DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles. {3}------------------------------------------------ ## Table 1 ~ Validated Advanced Sterilization Products STERRAD® NX and STERRAD® 100NX Sterilization Cycles | Advanced Sterilization Products (ASP) STERRAD® System and Cycle | Maximum Recommended Chamber Load | Intended Load | |-----------------------------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ASP STERRAD® NX Standard Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: • an inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens • an inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens | | ASP STERRAD® NX Advanced Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: • an inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens OR One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: • a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter | | ASP STERRAD® 100NX Standard Cycle | 21.4 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: • an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens (A maximum of five lumens per tray per sterilization cycle) | | ASP STERRAD® 100NX Flex Cycle | 12.2 lbs | One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: • a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (A maximum of two flexible endoscopes, one per tray per sterilization cycle) | | ASP STERRAD® 100NX Express Cycle | 10.7 lbs | 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 | | ASP STERRAD® 100NX Duo Cycle | 13.2 lbs | One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: • a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 875 mm or shorter | . ' {4}------------------------------------------------ ## Table 2 – Validated STERIS Amsco® V-PRO® cycles | Amsco® V-PRO® Cycle | Maximum Recommended Chamber Load | Intended Load | |---------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load: an inside diameter of 1 mm or larger and a length of 125 mm or shorter an inside diameter of 2 mm or larger and a length of 250 mm or shorter an inside diameter of 3 mm or larger and a length of 400 mm or shorter | | Non Lumen 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 bronchoscopes in either of two load configurations: 1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load 2. One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devices The flexible endoscope(s) may contain either: a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter two lumens, with one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter | · {5}------------------------------------------------ | Table 3 - Wrap Model Recommendations' | | |---------------------------------------|--| |---------------------------------------|--| | | | Maximum Recommended Wrapped Package Content Weight2 | | | | |-----------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------| | Sterilization Wrap Model | Intended Load | Pre-Vacuum Steam and EO | Advanced Sterilization Products (ASP) STERRAD® 100S | Advanced Sterilization Products (ASP) STERRAD® NX and 100NX | STERIS Amsco® V-PRO® | | CH100 | Very light weight package (for example: towel packs or batteries) | 3 lbs | 3 lbs | 10.7 lbs | 3 lbs | | CH200 | Light weight package (for example: telescope with light cord) | 6 lbs | 6 lbs | 10.7 lbs | 6.5 lbs | | CH300 | Light to moderate weight package (for example: general use medical instruments) | 9 lbs | 9.7 lbs | 10.7 lbs | 9 lbs | | CH400 | Moderate to heavy weight package (for example: general use medical instruments) | 13 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | | CH500 | Heavy weight package (for example: general use medical instruments) | 17 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | | CH600 | Very heavy weight package (for example: general use medical instruments) | 25 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | 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 I. D 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 I. D x 400 mm), and 12 Ibs 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 I. D x 400 mm), and 20 ibs of metal mass in a 23 in. x 11 in. x 3.5 in. tray. {6}------------------------------------------------ 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 I. D 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 I. D x 400 mm), and 11.5 Ibs 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 I. D x 400 mm), and 19.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. trav. The following loads were used in the Advanced Sterlization 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 Amsco® V-PR® sterility Validation Study: - · CH100: Metal Instruments - · CH200 CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments Note: The loads used in the 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 DuraBlue" Sterilization Wraps. #### Substantial Equivalence The proposed DuraBlue" Sterlization 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 configurations/dimensions - . Demonstrate maintenance of package sterility - Are indicated for the same sterilization parameters . - Are indicated for the same Maximum Wrapped Package Content Weights ● - Demonstrate maintenance of package sterility within the period of time for which performance . data demonstrating maintenance of sterility has been provided {7}------------------------------------------------ # Table 4: Overall Comparison to Predicate Devices 。 | | PREDICATE | PROPOSED | Comparison to Predicate | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Element of Comparison | DuraBlue™ Sterilization Wrap (K123857, K123289, and K120658) | DuraBlue™ Sterilization Wrap | | | Intended Use | K123857: Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using the following modalities: • Johnson & Johnson STERRAD 100NX system, Standard, Flex, Express, and DUO Cycles. • Johnson & Johnson STERRAD NX system, Standard, and Advanced Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality. All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Johnson & Johnson STERRAD® 100NX and STERRAD® NX cycles in Table 1 and 2. | DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider using: • 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 by the STERIS Amsco® V-PRO™1, Amsco® V-PRO™1 Plus and Amsco® 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 device(s) until used. For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 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°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 DuraBlue™ 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 | Substantially Equivalent | | | Johnson & Johnson STERRAD® 100NX Standard cycle (Max Chamber Load 21.4 lbs) • Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: • an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens • an inside diameter of 1 mm or larger and a length of 1000 mm or shorter of single-channel Teflon®/Polyethylene lumens | | | | | Johnson & Johnson STERRAD® 100NX Flex cycle (Max Chamber Load 21.4 lbs) • One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: | | | {8}------------------------------------------------ a single-channel 0 Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter # Johnson & Johnson STERRAD® 100NX Express cycle (Max Chamber Load 10.7 lbs) - 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, including da Vinci 3-D scopes ## Johnson & Johnson STERRAD® 100NX DUO cycle (Max Chamber Load 13.2 lbs) - . One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: - a single-channel o Teflon®/Polvethviene tumen with an inside diameter of 1 mm or larger and a length of 875 mm or shorter Johnson & Johnson STERRAD® NX Standard cycle (Max Chamber Load 10.7 lbs) - Reusable metal and non-metal . medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: - an inside diameter of 1 mm or o larger and a length of 150 mm or shorter of single-channel stainless steel lumens - o an inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens Johnson & Johnson STERRAD® NX Advanced cycle (Max Chamber Load 10.7 lbs) All models of DuraBlue™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cvcles in Table 1. #### ASP STERRAD® 100NX Standard cycle (Max Chamber Load 21.4 Ibs) - · Reusable metal and non-metal medical - devices, including up to 10 lumens of the following lumen dimensions per chamber load: - o an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens - o · an inside diameter of 1 mm or larger and a length of 1000 mm or shorter of single-channel Teflon®/Polyethylene lumens #### ASP STERRAD® 100NX Flex cycle (Max Chamber Load 21.4 Ibs) - · One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: - o a single-channel - Teflon®/Polvethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter #### ASP STERRAD® 100NX Express cycle (Max Chamber Load 10.7 ibs) - · 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-naid endoscopes without lumens, including da Vinci 3-D scopes ### ASP STERRAD® 100NX DUO cvcle (Max Chamber Load 13.2 Ibs) - · One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: - o a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 875 mm or shorter {9}------------------------------------------------ | Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: an inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens OR One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter K123289: Cardinal Health DuraBlue™ Sterilization Wrap is intended to allow sterilization of the enclosed medical device that is to be sterilized by a health care provider using the following modalities: 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 and maintain sterility of the enclosed device(s) for 180 days. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality. For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 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. | ASP STERRAD® NX Standard cycle (Max Chamber Load 10.7 lbs) Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: an inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens an inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens ASP STERRAD® NX Advanced cycle (Max Chamber Load 10.7 lbs) Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: an inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens OR One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter All models of DuraBlue™ Sterilization Wrap have been validated for use with the Amsco® V-PRO™cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed Amsco® V-PRO™sterilization cycles. | Lumen Cycle: (Max Chamber Load 19.65lbs) Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load: an inside diameter of 1 mm or larger and a length of 125 mm or shorter an inside diameter of 2 mm or larger and a length of 250 mm or shorter an inside diameter of 3 mm or larger and a length of 400 mm or shorter | 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. K120658: Cardinal Health DuraBlueTM Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider in the following modalities Pre-vacuum steam at 270°F/132°C for 4 minutes STERRAD 100S System Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus, and Amsco® V-PRO® MAX Low Temperature Sterilization Systems The Wrap is intended to allow sterilization of the enclosed medical devices(s) and to maintain sterility of the enclosed devices(s). Maintenance of package sterility was validated with real-time testing for the following durations: 180 days following sterilization by STERRAD 100S and Amsco V-PRO (Lumen, Non Lumen, and Flexible Cycles). 30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less. | Non Lumen Cycle: (Max Chamber Load 19.65 lbs) Non-lumened reusable metal and non-metal medical devices Flexible Cycle: (Max Chamber Load 24 lbs) Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations: Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devices The flexible endoscope(s) may contain either: a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter two lumens, with one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter | 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: , . : : - . · {10}------------------------------------------------ : . , : : . . {11}------------------------------------------------ All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco® V-PRO™cycles: Lumen Cycle: (Max Chamber Load 19.65lbs) - . Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load: - an inside diameter of 1 mm or o larger and a length of 125 mm or shorter - an inside diameter of 2 mm or o larger and a length of 250 mm or shorter - an inside diameter of 3 mm or o larger and a length of 400 mm or shorter Non Lumen Cycle: (Max Chamber Load 19.65 Ibs) - · Non-lumened reusable metal and non-metal medical devices Flexible Cycle: (Max Chamber Load 24 lbs) - · Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations: - 1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load - 2. One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devices The flexible endoscope(s) may contain either: - a single lumen with an inside . diameter of 1 mm or larger and a length of 1050 mm or shorter - . two lumens, with one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter {12}------------------------------------------------ | Element of Comparison | PREDICATE DuraBlue™ Sterilization Wrap (K123857, K123289, and K120658) | PROPOSED DuraBlue™ Sterilization Wrap | Comparison to Predicate | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------| | Material Composition | Polypropylene fabric using SMS (spunbond- meltblown-spunbond) production process | Same | Substantially Equivalent | | Sterilization Parameters | 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 Amsco® V-PRO®: Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® MAX Low Temperature Sterilization Systems | Same | Substantially Equivalent | | Configurations/ Dimensions | Six basis weights Fourteen sizes | Same | Substantially Equivalent | | Maximum Wrapped Package Content. Weights | Pre-vacuum Steam: 3 to 25 pounds EO: 3 to 25 pounds STERRAD® 100S: 3 to 9.7 pounds STERRAD® NX: 10.7 pounds STERRAD® 100NX: 10.7 pounds Amsco® V-PRO®: 3 to 9.1 pounds | Same | Substantially Equivalent | | Sterilization Performance | Pass | Same | Substantially Equivalent | | Physical Performance | Pass | Same | Substantially Equivalent | | Biocompatibility | Non-cytotoxic, Non-sensitizing, Non-irritating | Same | Substantially Equivalent | . . : : {13}------------------------------------------------ #### Summary of Testing DuraBlue™ Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in the FDA's Guidance Document Premarket Notifications for Medical Sterlization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002) in this submission and the predicate Premarket Notifications. Testing included sterilization efficacy for the modification of the stainless steel lumen claims for the Amsco® V-PRO® Lumen Cycle; and event related maintenance of package sterility for each indicated sterilization process. Data from testing demonstrates that the DuraBlue™ Sterilization Wrap maintains sterlity of the enclosed contents for 365 days following sterilization by pre-vacuum steam, EO, or Amsco® V-PRO™ (Lumen, Non Lumen, and Flexible Cycles), and STERRAD® 100S, STERRAD® NX (Standard and Advanced cycle), and STERRAD® 100NX (Standard, Flex, Express, and DUO cycles). Additionally, the DuraBlue™ Sterilization Wrap has been validated for use with the modified lumen sterilization claims when used with the Amsco® V-PRO® Lumen cycle. | Performance Properties | | Results | |---------------------------------------------------------------|-----------------------------|-------------------| | Sterilization Efficacy | | PASS | | Microbial Barrier Properties | Aerosol Challenge | PASS | | | Event Related Shelf Life | PASS- 365 days | | Material Compatibility with Indicated Sterilization Method | | Compatible | | Biocompatibility | | Non-irritating | #### Table 5: Performance Testing of Proposed DuraBlue™ Sterilized by Pro-vacuum steam, EO, AMSCO® V-PRO®, STERRAD® 100S, STERRAD® 100NX, STERRAD® NX system #### Conclusions: Based on the results of the biocompatibility and physical performance testing, DuraBlue™ Sterilization Wrap is safe for its intended use. The DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate device, in terms of general intended use, physical performance testing, material composition, sterilization process and compatibility, configurations/dimensions, and safety and effectiveness. {14}------------------------------------------------ Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure with three wing-like extensions. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 13, 2013 Cardinal Health 200, LLC Ms. Lavenia Ford Manager, Regulatory Affairs 1430 Waukegan Road WAUKEGAN IL 60085 Re: K132060 Trade/Device Name: DuraBlue™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 19, 2013 Received: November 20, 2013 Dear Ms. Ford: 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. {15}------------------------------------------------ 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address Sincerely yours. http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. FOR Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {16}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 610(k) Number (if known) K132060 - 1.52 (2007) - 1. Davice Name DuraBlueTM Sterilization Wrap Indications for Use (Desaribe) DuraBlue . Sterilization Wryp is intended to be used to enclose mother mat is to be sterlized by a health care provider using: · Pro-vacum steam at 270°F/132°C for 4 minutes · 100% edivine oxide (BO) with a concentration of 725-735 mg/L at 131 m/s/550 and 40%-80% relative burnins. · Advanced Sterilization Products (ASP) STERRAD® 1008 system. · Advanced Sterilization Products (ASP) STHRRAD® NX cystem, Standard and Advanced Cyclos · Advanced Sterlization Products (ASP) STERRAD® 100NX system. Standard, Flox, Essuress, and DUO Cycles · Luman, Non Lumen, and Flaxible Orches in the Amsold V-PRO® 1 Pius and Amsood V-PRO® max Love Temperature Sterilization Systems The very is intended to allow storifical of the maintain devices) and to maintain starflity of the ensiness devices writt used For are recomments the was has been valifisted for dry times of 20 minutes for Modals CH 100 and CH200. and for 30 minutes for Madels CH300, CH500 and CH60. Models CH400 and CH60 have been validated for are-resum steam sterilization of two himens 3 mm in diameter or larger and 400 mm in length or less. For BO storilization, the very has been validated for an constion time of 8 bours at 55 °C. Models CH400 have been validated for BO sterilization of two lumens of 3 mm diameter or larger and 400 mm in leagth or less. All models of DunBlag™ Sterlization Wap been validated for Advanced Statilization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less. All models of DuralBluer Warp have been velidated for use with the Advanced Sterlization Products (ASP) 8TBRRAD® NX and STERRAD® 100NX cycles in Table 1. All models of Durillion & Starilization Wrap have been validated for use with the STERIS Amsoco V-PRO® overes in Table 2. The DuraBluard Starilization Wrap was validated to be effectively as need during the programmed STERIS Amscod V-PRO® sterilization cvoles. Type of Use (Select ans or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on lest page. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED, THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR CONSTITUTION Concurrence of Center for Devices and Radiotogical Haath (CDRH) (Signature) Image /page/16/Picture/24 description: The image contains a signature and the text "Mar Runner -5 2013 05'00". The text is stacked vertically, with "Mar Runner -5" at the top, followed by "2013", and then "05'00" at the bottom. The signature is to the left of the text. FORM FDA 3881 (9/13) · **SUPERIOR Home Services (303) 452-5749** {17}------------------------------------------------ Croble 1: Validated Advanced Sterlilzation Products (ASP) STERRAD® NX and STERRAD® 100NX Cycles . | Advanced Sterilization Products (ASP) STERRAD® System and Cycle | Maximum Recommended Chamber Load | Intended Load | |-----------------------------------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ASP STERRAD® NX Standard Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: an inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens an inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens | | ASP STERRAD® NX Advanced Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of the following lumen dimensions per chamber load: an inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens OR One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter | | ASP STERRAD® 100NX Standard Cycle | 21.4 lbs…

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