. 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 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.

Device 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.

AI/ML Overview

The provided text describes the DuraBlue™ Sterilization Wrap and elaborates on its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Properties	Acceptance Criteria (Implied by testing to "Pass" or "Compatible")	Reported Device Performance
Sterilization Efficacy	Pass	PASS
Microbial Barrier Properties (Aerosol Challenge)	Pass	PASS
Event Related Shelf Life	180 days (predicate) -> 365 days (proposed)	PASS - 365 days
Material Compatibility with Indicated Sterilization Method	Compatible	Compatible
Biocompatibility	Non-cytotoxic, Non-sensitizing, Non-irritating	Non-irritating (implies non-cytotoxic and non-sensitizing)
Configuration/Dimensions	Six basis weights, Fourteen sizes (same as predicate)	Same
Maximum Wrapped Package Content Weights	Specific weights per sterilization method and wrap model (same as predicate)	Same

Study Proving Device Meets Acceptance Criteria:

The device's performance was proven through "extensive performance testing" and "sterility validation studies" in accordance with applicable requirements recommended in the FDA's Guidance Document: "Premarket Notifications for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)."

The primary modification for this 510(k) submission was the extension of real-time aging data from 180 days to 365 days to comply with regulations regarding maintaining sterility.

2. Sample Size Used for the Test Set and Data Provenance:

The document provides details of specific loads used for each type of sterilization validation study and for each wrap model (CH100 - CH600). These loads vary in composition (huck towels, drapes, metal mass, lumens) and weight.

Pre-vacuum Steam Sterility Validation Studies:
- CH100: 16 huck towels
- CH200: 2 huck towels, 3 fluid-resistant drapes
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs of metal mass
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs of metal mass
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs of metal mass
EO Sterility Validation Studies:
- CH100: 16 huck towels
- CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs of metal mass
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs of metal mass
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs of metal mass
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs of metal mass
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
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
STERIS Amsco® V-PRO® Sterility Validation Study:
- CH100: Metal Instruments
- CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments

The "Note" section on page 6 states: "The loads used in the Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3."

Data Provenance: The document does not specify the country of origin of the data. The studies are prospective in nature, as they involve testing the device's performance under various sterilization conditions and aging.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not explicitly provided in the document. The studies performed are laboratory-based performance tests and sterility validation studies rather than analyses requiring expert interpretation of medical images or clinical outcomes. Therefore, the "ground truth" would be established by the results of standardized biological and physical tests and measurements, often conducted by trained technicians in controlled environments.

4. Adjudication Method for the Test Set:

This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in diagnostic studies. Here, the "test set" refers to physical samples undergoing rigorous laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output, and the AI's assistance to human readers is being evaluated. The DuraBlue™ Sterilization Wrap is a sterilization packaging device, not a diagnostic tool requiring human interpretation aided by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

Not applicable in the context of an AI algorithm. The device itself is a physical product (sterilization wrap), and its performance is evaluated in a standalone manner (i.e., the wrap's ability to maintain sterility, its material properties, and compatibility with sterilization methods). There is no "algorithm" in the typical sense for this device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

Sterilization Efficacy: Demonstrated by the ability to achieve and maintain sterility, likely through biological indicator (BI) testing or other validated methods to confirm the absence of viable microorganisms.
Microbial Barrier Properties: Assessed through aerosol challenge tests, measuring the ability of the wrap to prevent microbial ingress.
Event-Related Shelf Life: Determined by real-time aging studies over 365 days, followed by integrity and sterility testing at various time points.
Material Compatibility: Physical property testing (e.g., tensile strength, tear resistance) after sterilization, and chemical compatibility assessments to ensure the polypropylene material is not compromised.
Biocompatibility: Standardized tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 or similar standards.

Essentially, the "ground truth" is established by objective, measurable results from validated laboratory tests and standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary

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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

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Description:

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

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. .

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. 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.

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.

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Table 1 ~ Validated Advanced Sterilization Products STERRAD® NX and STERRAD® 100NX Sterilization Cycles

AdvancedSterilizationProducts(ASP)STERRAD®System andCycle	MaximumRecommendedChamber Load	Intended Load
ASPSTERRAD® NXStandard Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 150mm or shorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 400mm or shorter of single-channel stainless steel lumens
ASPSTERRAD® NXAdvanced Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 500mm or shorter of single-channel stainless steel lumensOROne single-channel Flexible Endoscope with or without a siliconemat and no additional load. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850 mmor shorter
ASPSTERRAD® 100NXStandard Cycle	21.4 lbs	Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 0.7 mm or larger and a length of500 mm or shorter of single-channel stainless steellumens (A maximum of five lumens per tray persterilization cycle)
ASPSTERRAD® 100NX FlexCycle	12.2 lbs	One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850 mmor shorter (A maximum of two flexible endoscopes, oneper tray per sterilization cycle)
ASPSTERRAD® 100NXExpress Cycle	10.7 lbs	Non-lumened reusable metal and non-metal medical devicesrequiring surface sterilization, or sterilization of mated stainless steeland titanium surfaces, and rigid or semi-rigid endoscopes withoutlumens
ASPSTERRAD® 100NX DuoCycle	13.2 lbs	One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 875 mmor shorter

. '

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Table 2 – Validated STERIS Amsco® V-PRO® cycles

Amsco®V-PRO®Cycle	MaximumRecommendedChamber Load	Intended Load
LumenCycle	19.65 lbs	Reusable metal and non-metal medical devices, including up to 20 lumens of thefollowing 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
NonLumenCycle	19.65 lbs	Non-lumened reusable metal and non-metal medical devices
FlexibleCycle	24 lbs	Single or dual lumen surgical flexible endoscopes and bronchoscopes in either oftwo load configurations:1. Two trays, each containing a flexible endoscope with a light cord (if notintegral to endoscope) and mat with no additional load2. One tray containing a flexible endoscope with a light cord (if not integralto endoscope) and mat and an additional tray containing non-lumenedmedical devicesThe flexible endoscope(s) may contain either:a single lumen with an inside diameter of 1 mm or larger and a lengthof 1050 mm or shorter two lumens, with one lumen having an inside diameter of 1 mm orlarger and a length of 998 mm or shorter and the other lumen havingan inside diameter of 1 mm or larger and a length of 850 mm orshorter

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Table 3 - Wrap Model Recommendations'
---------------------------------------	--

		Maximum Recommended Wrapped Package ContentWeight2
SterilizationWrap Model	Intended Load	Pre-VacuumSteam and EO	AdvancedSterilizationProducts (ASP)STERRAD®100S	AdvancedSterilizationProducts(ASP)STERRAD®NX and 100NX	STERISAmsco®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 medicalinstruments)	9 lbs	9.7 lbs	10.7 lbs	9 lbs
CH400	Moderate to heavy weight package(for example: general use medicalinstruments)	13 lbs	9.7 lbs	10.7 lbs	9.1 lbs
CH500	Heavy weight package(for example: general use medicalinstruments)	17 lbs	9.7 lbs	10.7 lbs	9.1 lbs
CH600	Very heavy weight package(for example: general use medicalinstruments)	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

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Table 4: Overall Comparison to Predicate Devices

。

	PREDICATE	PROPOSED	Comparisonto Predicate
Element ofComparison	DuraBlue™ Sterilization Wrap(K123857, K123289, and K120658)	DuraBlue™ Sterilization Wrap
Intended Use	K123857: Cardinal Health DuraBlue™Sterilization Wrap is intended to beused to enclose another medical devicethat is to be sterilized by a health careprovider using the following modalities:• Johnson & Johnson STERRAD100NX system, Standard, Flex,Express, and DUO Cycles.• Johnson & Johnson STERRADNX system, Standard, andAdvanced Cycles.The wrap is intended to allowsterilization of the enclosed medicaldevice(s) and to maintain sterility of theenclosed device(s). Maintenance ofpackage sterility was validated withreal-time aging testing for a duration of180 days for each indicated modality.All models of DuraBlue™ SterilizationWrap have been validated for use withthe following Johnson & JohnsonSTERRAD® 100NX and STERRAD® NXcycles in Table 1 and 2.	DuraBlue™ Sterilization Wrap is intended toenclose another medical device that is to besterilized by a health care provider using:• Pre-vacuum steam at 270°F/132°C for 4minutes• 100% ethylene oxide (EO) with aconcentration of 725-735 mg/L at131°F/55°C and 40%-80% relativehumidity for 60 minutes• Advanced Sterilization Products (ASP)STERRAD® 100S System• Advanced Sterilization Products (ASP)STERRAD® NX System, Standard andAdvanced Cycles• Advanced Sterilization Products (ASP)STERRAD® 100NX, Standard, Flex,Express, and DUO cycles• Lumen, Non Lumen, and Flexible Cycles bythe STERIS Amsco® V-PRO™1, Amsco®V-PRO™1 Plus and Amsco® V-PRO™MAX Low TemperatureSterilization SystemsThe wrap is intended to allow sterilization ofthe enclosed medical device(s) and tomaintain sterility of the enclosed device(s)until used.For pre-vacuum steam sterilization, the wraphas been validated for dry times of 20 minutesfor Models CH100 and CH200 and 30 minutesfor Models CH300, CH400, CH500, andCH600. Models CH400, CH500, and CH600have been validated for pre-vacuum steamsterilization of two lumens 3 mm in diameteror larger and 400 mm in length or less.For EO sterilization, the wrap has beenvalidated for an aeration time of 8 hours at55°C. Models CH400, CH500, and CH600have been validated for EO sterilization of twolumens of 3 mm diameter or larger and 400mm in length or less.All models of DuraBlue™ Sterilization Wraphave been validated for AdvancedSterilization Products (ASP) STERRAD®100S sterilization of lumens 2.5 mm indiameter or larger and 250 mm in length orless	SubstantiallyEquivalent
	Johnson & Johnson STERRAD®100NX Standard cycle (Max ChamberLoad 21.4 lbs)• Reusable metal and non-metalmedical devices, including up to 10lumens of the following lumendimensions per chamber load:• an inside diameter of 0.7 mmor larger and a length of 500mm or shorter of single-channelstainless steel lumens• an inside diameter of 1 mm orlarger and a length of 1000 mmor shorter of single-channelTeflon®/Polyethylene lumens
	Johnson & Johnson STERRAD®100NX Flex cycle (Max Chamber Load21.4 lbs)• One or two single-channel FlexibleEndoscope with or without asilicone mat and no additional load.The flexible endoscope maycontain:

{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

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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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{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
- 1. 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 ofComparison	PREDICATEDuraBlue™ Sterilization Wrap(K123857, K123289, and K120658)	PROPOSEDDuraBlue™ Sterilization Wrap	Comparisonto Predicate
MaterialComposition	Polypropylene fabric using SMS (spunbond-meltblown-spunbond) production process	Same	SubstantiallyEquivalent
SterilizationParameters	Pre-vacuum steam at 270°F/132°C for 4 minutes100% ethylene oxide (EO) with a concentration of725-735 mg/L at 131°F/55°C and 40%-80% relativehumidity for 60 minutesAdvanced Sterilization Products (ASP)STERRAD® 100S SystemAdvanced Sterilization Products (ASP)STERRAD® NX System, Standard and AdvancedCyclesAdvanced Sterilization Products (ASP)STERRAD® 100NX, Standard, Flex, Express, andDUO cyclesAmsco® V-PRO®: Lumen, Non Lumen, andFlexible Cycles in the Amsco® V-PRO® 1, Amsco®V-PRO® 1 Plus and Amsco® V-PRO® MAX LowTemperature Sterilization Systems	Same	SubstantiallyEquivalent
Configurations/Dimensions	Six basis weightsFourteen sizes	Same	SubstantiallyEquivalent
MaximumWrappedPackageContent.Weights	Pre-vacuum Steam: 3 to 25 poundsEO: 3 to 25 poundsSTERRAD® 100S: 3 to 9.7 poundsSTERRAD® NX: 10.7 poundsSTERRAD® 100NX: 10.7 poundsAmsco® V-PRO®: 3 to 9.1 pounds	Same	SubstantiallyEquivalent
SterilizationPerformance	Pass	Same	SubstantiallyEquivalent
PhysicalPerformance	Pass	Same	SubstantiallyEquivalent
Biocompatibility	Non-cytotoxic, Non-sensitizing, Non-irritating	Same	SubstantiallyEquivalent

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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 BarrierProperties	Aerosol Challenge	PASS
	Event Related ShelfLife	PASS- 365days
Material Compatibility with IndicatedSterilization 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.

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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

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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

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Croble 1: Validated Advanced Sterlilzation Products (ASP) STERRAD® NX and STERRAD® 100NX Cycles .

AdvancedSterilizationProducts(ASP)STERRAD®System andCycle	MaximumRecommendedChamber Load	Intended Load
ASPSTERRAD® NXStandard Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to10 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
ASPSTERRAD® NXAdvanced Cycle	10.7 lbs	Reusable metal and non-metal medical devices, including up to10 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 OROne single-channel Flexible Endoscope with or without a siliconemat and no additional load. The flexible endoscope may contain:a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850 mmor shorter
ASPSTERRAD®100NXStandard Cycle	21.4 lbs	Reusable metal and non-metal medical devices, including up to10 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)
ASPSTERRAD®100NX FlexCycle	12.2 lbs	One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 850 mmor shorter (A maximum of two flexible endoscopes, one per tray per sterilization cycle)
ASPSTERRAD®100NX ExpressCycle	10.7 lbs	Non-lumened reusable metal and non-metal medical devicesrequiring surface sterilization, or sterilization of mated stainlesssteel and titanium surfaces, and rigid or semi-rigid endoscopeswithout lumens
ASPSTERRAD®100NX Duo Cycle	13.2 lbs	One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:a single-channel Teflon®/Polyethylene lumen with aninside diameter of 1 mm or larger and a length of 875 mmor shorter

. .

{18}------------------------------------------------

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

· ··········································································································································································· .

Amsco® V-PRO™ Cycle	MaximumRecommendedChamber Load	Intended Load
Lumen Cycle	19.65 lbs	Reusable metal and non-metal medical devices, Including up to 20lumens of the following dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of125 mm or shorter• an inside diameter of 2 mm or larger and a length of250 mm or shorter• an inside diameter of 3 mm or larger and a length of400 mm or shorter
Non LumenCycle	19.65 lbs	Non-lumened reusable metal and non-metal medical devices
Flexible Cycle	24 lbs	Single or dual lumen surgical flexible endoscopes andbronchoscopes in either of two load configurations:1. Two trays, each containing a flexible endoscope with a lightcord (if not integral to endoscope) and mat with no additionalload2. One tray containing a flexible endoscope with a light cord (ifnot integral to endoscope) and mat and an additional traycontaining non-lumened medical devicesThe flexible endoscope(s) may contain either:• a single lumen with an inside diameter of 1 mm orlarger and a length of 1050 mm or shorter• two lumens, with one lumen having an inside diameterof 1 mm or larger and a length of 898 mm or shorterand the other lumen having an inside diameter of 1mm or larger and a length of 850 mm or shorter

ﻨ

{19}------------------------------------------------

... Table 3: Wrap Model Recommendations

)

SterilizationWrap Model	Intended Load	Maximum Recommended Wrapped Package Content Weights2
		Pre-Vacuumand EO	AdvancedSterilizationProducts(ASP)STERRAD®100S	AdvancedSterilizationProducts(ASP)STERRAD® NXand 100NX	STERISAmsco®V-PRO®
CH100	Very light weight package(for example: towel packs orbatteries).	3 lbs	3 lbs	10.7 lbs	3 lbs
CH200	Light weight package(for example: telescope withlight cord).	6 lbs	6 lbs	10.7 lbs	6.5 lbs
CH300	Light to moderate weightpackage(for example: general usemedical Instruments).	9 lbs	9.7 lbs	10.7 lbs	9 lbs
CH400	Moderate to heavy weightpackage(for example: general usemedical instruments).	13 lbs	9.7 lbs	10.7 lbs	9.1 lbs
CH500	Heavy weight package(for example: general usemedical Instruments).	17 lbs	9.7 lbs	10.7 lbs	9.1 lbs
CH600	Very heavy weight package(for example: general usemedical instruments).	25 lbs	9.7 lbs	10.7 lbs	9.1 lbs

The following loads were used in the pre-vacuum steam Sterlilly 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.).

· CH800: 16 huck towals (17 In. x 20 in.), 1 fiuld-resistant table cover (80 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 ln. 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.

{20}------------------------------------------------

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

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

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

· CH300: 18 huck towals (17 in. x 29 in.), 1 fiuld-resistant table cover (80 in. x 60 in.), 5 lbs of metal mass. · CH400: 4 stacked tray liners (20 tn. x 25 tn.), 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.

· CH600: 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 (n.), 2 lumens (8 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 Sterliization Products (ASP) STERRAD® 100S Sterfilly Validation Studies:

· CH100: Metal Instruments.

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

The following loads were used in the Advanced Sterlization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterlily 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-PROD Sterliffy Validation Studies:

· CH100: Metal instruments.

· CH200 - CH600: 17 In. x 10 in. x 3.5 In. tray oontaining metal instruments.

Note: The loads used in each Stefilty 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 integularly shaped contents, which may out added stress on the wap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.

2 II Is recommended to not exceed the maximum wrapped package content weights Indicated for each wrap model. Furthermore, it is recommonded to not exceed the number, welchit and size of individual content types that were validated for the DuraBlue 14 Sterlilization Wraps.

{21}------------------------------------------------

This saction applies only to requirements of the Papervork Reduction Act of 1985.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to everage 79 hours per reaponse, including the time to review Instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other espect of this information collection, including suggestions for reducing this burden, to:

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An agency may not conduct or spansor, and a parson is not required to respond to, a collection of Information unless it displays a currently valid OMB number."

ﺋﯩﻠﯩﺮﯨﻨﻰ

Regulation Number and Section

§ 880.6850 Sterilization wrap.

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