Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical sterilization wrap made of polypropylene fabric and does not involve any computational or data processing components that would utilize AI or ML.

Therapeutic

No
The device is a sterilization wrap intended to maintain sterility of other medical devices, not to provide therapy itself.

Diagnostic

No

Explanation: The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization wrap made of polypropylene fabric, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cardinal Health™ Sterilization Wrap is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body.
Device Description: The description focuses on the material composition and physical properties of the wrap, designed for packaging and sterilization processes.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing human specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on specimen analysis.
- Reagents, calibrators, controls, or instruments specifically designed for in vitro testing.

The Cardinal Health™ Sterilization Wrap is a medical device used in the sterilization process of other medical devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cardinal Health™ Sterilisation Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
· Gravity steam at 250°F/121°C for 30 minutes.
· Pre-vacuum steam at 270°F/132°C for 4 minutes.
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/l at 131°F/55°C and 40%-80% relative humidity for 60 minutes.

· Advanced Sterilization Products (ASP) STERRAD® 100S system.
· Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles.
· Advanced Sterilization Products (ASP) STERRAD® 100NX System, Standard, Flex, Express and Duo Cycles.
· Advanced Sterilization Products (ASP) STERRAD® 200 System.
• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems.
· TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load)

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

All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1. All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200 in Table 1.

All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 cycles in Tables 2 and 3. The Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 sterilization cycles.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the TSO3 STERIZONE® VP4 system with the intended loads as described in Table 4.

Product codes

FRG

Device Description

Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, TwoColor are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Health care provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-Clinical Testing:
Performance testing included sterilization efficacy, event related maintenance of package sterility, physical properties, and biocompatibility in compliance with the methods of ISO 10993.

Extensive performance testing has been completed on Cardinal Health™ Sterilization Wrap in this submission of the new indications for use with STERIS V-PRO® 60 and TSO3 STERIZONE® VP4. Data from testing demonstrates that the Cardinal Health™ Sterilization Wrap allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices after sterilization with the STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 systems.

Physical properties testing (Basis weight, Air permeability, Grab tensile strength, Trapezoidal tear strength, Bursting strength and Hydrostatic pressure) 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. These material compatibility results also demonstrate that the device meets the requirements of ISO 11607.

The proposed device (Cardinal Health™ Sterilization Wrap) has been evaluated for biocompatibility according to ISO 10993 test methods and is considered toxicologically acceptable for its intended use. All materials used in the Cardinal Health™ Sterilization Wrap have been evaluated through irritation, leachability and residuals testing after sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems.

The data shows that the biocompatibility of the Cardinal Health™ Sterilization Wrap following sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems is substantially equivalent to the biocompatibility of the predicate.

Performance testing demonstrates that both devices:

Have the same intended use ●
Have the same material composition
Have the same physical and chemical properties
Have the same dimensions
Demonstrate maintenance of package sterility
The physical properties of all wrap models have been characterized both before and after ● exposure to sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4. The data demonstrates that the Cardinal Health™ Sterilization Wrap is compatible with the STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151445, K151788, K161910

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 11, 2018

Cardinal Health 200 LLC Jillian Connery Manager Regulatory Affairs 3651 Birchwood Drive Waukegan, Illinois 60085

Re: K181174

Trade/Device Name: Cardinal Health Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: October 30, 2018 Received: November 01, 2018

Dear Jillian Connery:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray lii III -S

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

Enclosure

2

Indications for Use

510(k) Number (if known) K181174

Device Name Cardinal HealthTM Sterilization Wrap

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

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

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

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

· Advanced Sterilization Products (ASP) STERRAD® 100S system.
· Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles.

· Advanced Sterilization Products (ASP) STERRAD® 100NX System, Standard, Flex, Express and Duo Cycles.

· Advanced Sterilization Products (ASP) STERRAD® 200 System.

• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems.

· TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load)

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

All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1. All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200 in Table 1.

All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 cycles in Tables 2 and 3. The Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 sterilization cycles.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the TSO3 STERIZONE® VP4 system with the intended loads as described in Table 4.

3

Table 1- Dimensions, types and models

| Dimensional

Specifications	Cardinal Health™ Sterilization Wrap Models
	CH100	CH200	CH300	CH400	CH500	CH600
12 in. x 12 in.
(30 cm. x 30 cm.)	1*
2
3	1
2
3
15 in. x 15 in.
(38 cm. x 38 cm.)	1
2
3
18 in. x 18 in.
(45 cm. x 45 cm.)	1
2
3	1
2
3		1	1
2
3
20 in. x 20 in.
(50 cm. x 50 cm.)	1
2
3
24 in. x 24 in.
(60 cm. x 60 cm.)	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3
30 in. x 30 in.
(76 cm. x 76 cm.)	1
2
3	1
2
3	1
2
3	1	1
2
3
36 in. x 36 in.
(91 cm. x 91 cm.)	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3
40 in. x 40 in.
(101 cm. x 101 cm.)	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3
45 in. x 45 in.
(114 cm. x 114 cm.)	1
2
3		1
2
3	1
2
3	1
2
3	1
2
3
48 in. x 48 in.
(121 cm. x 121 cm.)	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3
54 in. x 54 in.
(137 cm. x 137 cm.)	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3
60 in. x 60 in.
(152 cm. x 152 cm.)					1
2
3
54 in. x 72 in.
(137 cm. x 182 cm.)	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3	1
2
3
54 in. x 90 in.
(137 cm. x 228 cm.)					1
2
3

*Product configurations:

Single Layer Sterilization Wrap
Dual Layer Sterilization Wrap
Two Color Sterilization Wrap - Double-layer wrap

4

Table 2 – Validated Advanced Sterilization Products STERRAD® 100NX and STERRAD® 200 Sterilization Cycles and Intended Loads

| Advanced
Sterilization
Products (ASP)
STERRAD®
System | 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 |
| ASP
STERRAD® 200 | 36.48 lbs | Reusable metal and non-metal medical devices, including up to 12 lumens of the
following lumen dimensions per chamber load:
• an inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-
channel stainless steel lumens
• an inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-
channel stainless steel lumens
• an inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-
channel stainless steel lumens
• an inside diameter of 6 mm or larger and a length of 310 mm or shorter of a single-
channel Teflon®/Polyethylene lumen |
| STERIS 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: Validated STERIS V-PRO® 1, V-PRO® 1 Plus and V-PRO® maX Cycles and Intended Loads

Table 4: Validated STERIS V-PRO® 60 Cycles and Intended Loads

| STERIS V-PRO®
Cycle | Maximum
Recommended
Chamber Load | Intended Load |
|------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Cycle | 11 lbs | Reusable metal and non-metal medical devices, including up to 12 lumens of the
following dimensions per chamber load:
• Single channel of an inside diameter of 0.77 mm or larger with a length
of 410 mm or shorter
• Dual channel of an inside diameter of 0.77 mm or larger with a length of
410 mm or shorter
• Triple channel of an inside diameter of 1.2 mm or larger with a length of
275 mm or shorter and 1.8 mm or larger with a length of 310 mm or
shorter and 2.8 mm or larger with a length of 317 mm or shorter |
| Non-Lumen Cycle | 12 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | No additional
load other than
intended tray
contents | Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two
configurations:

One tray containing a flexible endoscope with a light cord (if not integral to
endoscope) and silicone mat:
• The flexible endoscope(s) may contain either a single channel or dual
channel with an inside diameter of 1 mm or larger and a length of 990
mm or shorter |

6

| Validation
load # | Load Description | Load weight1
1Excluding the 25
lb loading rack |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 1 | Validation load #1 consisted of general medical instruments, representing the following
geometries:
• Clamp
• Serrated surface
• Box-lock
• Handle
• Button
• Pivot hinge
• Stopcock
Type of packaging used: wrapped plastic tray, including silicone mats and brackets, Pouch
General medical instruments were spread out over three trays, six pouches and one
wrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing the following
geometries:
• Gliding mechanism
• Hinges and screws
• Serrated surface
• Luer-lock
• Spring
• Rigid non-lumen scopes
Type of packaging used: wrapped aluminum tray, including silicone mats and brackets,
rigid aluminum container and Pouch
General medical instruments were spread out over one container, three trays, and six
pouches. | 20 lb |
| 3 | Validation load #3 consisted of three single channel flexible endoscopes (Ureteroscope)
with inside diameter of 1.0 mm and length of 850 mm, packaged individually in wrapped
trays or containers, including appropriate silicone brackets or mats. Eight general medical
instruments, each packaged in a pouch, were added. | 23 lb |
| 4 | Validation load #4 consisted of up to 15 rigid or semi-rigid channeled instruments in the
presence of other packaged medical devices. Three double channel semi-rigid
endoscopes (ureterscope - 0.7 mm x 500 mm and 1.1 mm x 500 mm) were packaged
individually in wrapped trays or containers including appropriate silicone brackets or mats.
Additional rigid channel instruments or stainless steel rigid lumens were added to each
package. Two additional general medical instruments, each packaged in a pouch, were
added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscope
with inside diameter of 1.0 mm and length of 850 mm and Bronchoscope with inside
diameter of 1.8 mm and length of 830 mm, and one double channel semi-rigid endoscope
(ureterscope - 0.7 mm x 500 mm and 1.1 mm x 500 mm) packaged individually in wrapped
trays or containers including appropriate silicone brackets or mats. No additional items
were added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing the following
geometries:
• Distal end (swivel parts)
• Hinge with screw
• Cannula
General medical instruments packaged in one aluminum sterilizer container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing the following
geometries:
• Box-lock hinge
• Pivot hinge
• Luer-lock
General medical instruments, spread out over three aluminum sterilization containers, each
weighing 25 lb | 75 lb |

Table 5: Validated TSO3 STERIZONE® VP4 Cycle 1 Loads

7

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

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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8

Image /page/8/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic element above the company name. The graphic element is made up of four curved lines. The text "CardinalHealth" is written in black.

3651 Birchwood Drive Waukegan Illinois 60085 www.cardinalhealth.com

510(k) SUMMARY

Cardinal Health™ Sterilization Wrap

| Manufacturer: | Cardinal Health 200, LLC
3651 Birchwood
Waukegan, IL 60085 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Jillian Connery |
| Telephone Number: | (614) 757-4045 |
| Fax Number: | (847) 887-2461 |
| Date summary Prepared: | December 10, 2018 |
| Trade Name: | Cardinal Health™ Sterilization Wrap |
| Classification: | Class II per 21 CFR § 880.6850 |
| Classification Name: | Sterilization Wrap |
| Common Name: | Sterilization Wrap |
| Product Code: | FRG |
| 510(k) number: | K181174 |
| Predicate Device: | K151445, K151788, K161910 – Cardinal Health™ Sterilization
Wrap for use with Pre-Vacuum Steam (4 min/270°F), Gravity
Steam (30 min/250°F), 100% Ethylene Oxide (EO), Advanced
Sterilization Products (ASP) STERRAD® 100S, STERRAD®
200, STERRAD® NX, STERRAD® 100NX Systems, and
STERIS V-PRO® 1, V-PRO® 1 Plus, and V-PRO® maX Low
Temperature Sterilization Systems |

9

Description:

Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, TwoColor are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.

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

Pre-vacuum steam at 270°F/132°C for 4 minutes ●
Gravity steam at 250°F/121°C for 30 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® 200 System ●
Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and ● Advanced Cycles
. Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and DUO cycles
Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-. PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems
TSO3 STERIZONE® VP4 System Cycle 1(Refer to Table 5 for Load)

Materials and Mode of Operation:

Principle mode of operation: Cardinal Health™ Sterilization Wraps have sufficient breathability to allow sterilization of the enclosed medical device and have sufficient barrier to maintain sterility of the enclosed devices, demonstrated for 365 days. Per AAMI ST79, two layers of sterilization wrap are required for use either non-sequentially using double layer sterilization wrap or sequentially / simultaneously using single layer sterilization wrap. The closure of the sterile barrier system is achieved through the resulting tortuous path from wrapping.

The Cardinal Health™ Sterilization Wraps are available in the models and dimensions below. The mode of operation, material dimensions, types and models are the same for both the predicate device and the subject device.

10

| EN - Dimensional Specifications
FR - Spécifications des dimensions
ES - Especificaciones dimensionales | Cardinal Health™
EN - Wrap Models | | ES - Modelos de envolturas | | FR - Modèles d'emballage | |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------|----------------------------|-------------|--------------------------|-------------|
| | CH100 | CH200 | CH300 | CH400 | CH500 | CH600 |
| 12 in. x 12 in.
(30 cm x 30 cm) | 1
2
3 | 1
2
3 | | | | |
| 15 in. x 15 in.
(38 cm x 38 cm) | 1
2
3 | | | | | |
| 18 in. x 18 in.
(45 cm x 45 cm) | 1
2
3 | 1
2
3 | | 1 | 1
2
3 | |
| 20 in. x 20 in.
(50 cm x 50 cm) | 1
2
3 | | | | | |
| 24 in. x 24 in.
(60 cm x 60 cm) | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | |
| 30 in. x 30 in.
(76 cm x 76 cm) | 1
2
3 | 1
2
3 | 1
2
3 | 1 | 1
2
3 | |
| 36 in. x 36 in.
(91 cm x 91 cm) | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 |
| 40 in. x 40 in.
(101 cm x 101 cm) | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 |
| 45 in. x 45 in.
(114 cm x 114 cm) | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 |
| 48 in. x 48 in.
(121 cm x 121 cm) | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 |
| 54 in. x 54 in.
(137 cm x 137 cm) | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 |
| 60 in. x 60 in.
(152 cm x 152 cm) | | | | | 1
2
3 | |
| 54 in. x 72 in.
(137 cm x 182 cm) | 1 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 | 1
2
3 |
| 54 in. x 90 in.
(137 cm x 228 cm) | | | | | 1
2
3 | |

Table 1- Dimensions, types and models

EN - 1. Single Layer Sterilization Wrap

Dual Layer Sterilization Wrap
Two Color Sterilization Wrap

Product Description

The Cardinal Health™ Sterilization Wrap is made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, Two Color are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides.

In accordance with standard hospital practices, two sheets are used to wrap a medical device or a collection of medical devices for sterilization. When wrapping with the Cardinal Health™ Sterilization Wrap, Single Layer model, two sheets are required. Cardinal Health™ Sterilization Wrap, Dual Layer or Cardinal Health™ Sterilization Wrap, Two Color models allow for Page 3 of 24

11

wrapping with two sheets simultaneously. Cardinal Health™ Sterilization Wrap allows for the use of the sequential or simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.

Indications for Use

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

Pre-vacuum steam at 270°F/132°C for 4 minutes ●
Gravity steam at 250°F/121°C for 30 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® 200 System ●
Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and ● Advanced Cycles
Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, ● Express, and DUO cycles
Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-● PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems
. TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for Load)

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices 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 gravity steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600.

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

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

12

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200, STERRAD® NX and STERRAD® 100NX cycles with the intended loads as described in Table 2.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 cycles with the intended loads as described in Tables 3 and 4. Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 sterilization cycles.

All models of Cardinal Health™ Sterilization Wrap have been validated for use with the TSO3 STERIZONE® VP4 system with the intended loads as described in Table 5.

13

Table 2 – Validated Advanced Sterilization Products STERRAD® NX, STERRAD® 100NX and STERRAD® 200 Sterilization Cycles and Intended Loads

| Advanced
Sterilization
Products (ASP)
STERRAD®
System | 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 |
| ASP
STERRAD® 200 | 36.48 lbs | Reusable metal and non-metal medical devices, including up to 12
lumens of the following lumen dimensions per chamber load:
• an inside diameter of 1 mm or larger and a length of 125 mm or
shorter of single-channel stainless steel lumens
• an inside diameter of 2 mm or larger and a length of 250 mm or
shorter of single-channel stainless steel lumens
• an inside diameter of 3 mm or larger and a length of 400 mm or
shorter of single-channel stainless steel lumens
• an inside diameter of 6 mm or larger and a length of 310 mm or
shorter of a single-channel Teflon®/Polyethylene lumen |

14

15

Table 3: Validated STERIS V-PRO® 1, V-PRO® 1 Plus and V-PRO® maX Cycles and Intended Loads

| STERIS 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 |

16

| STERIS V-PRO®
Cycle | Maximum
Recommended
Chamber Load | Intended Load |
|------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Cycle | 11 lbs | Reusable metal and non-metal medical devices, including up to 12 lumens of the following dimensions per chamber load:
Single channel of an inside diameter of 0.77 mm or larger with a length of 410 mm or shorter Dual channel of an inside diameter of 0.77 mm or larger with a length of 410 mm or shorter Triple channel of an inside diameter of 1.2 mm or larger with a length of 275 mm or shorter and 1.8 mm or larger with a length of 310 mm or shorter and 2.8 mm or larger with a length of 317 mm or shorter |
| Non-Lumen
Cycle | 12 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | No additional
load other than
intended tray
contents | Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two configurations:
One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and silicone mat: The flexible endoscope(s) may contain either a single channel or dual channel with an inside diameter of 1 mm or larger and a length of 990 mm or shorter |

Table 4: Validated STERIS V-PRO® 60 Cycles and Intended Loads

17

| Validation
load # | Load Description | Load weight¹
¹Excluding the 25 lb
loading rack |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 1 | Validation load #1 consisted of general medical instruments, representing the following
geometries:
• Clamp
• Serrated surface
• Box-lock
• Handle
• Button
• Pivot hinge
• Stopcock
Type of packaging used: wrapped plastic tray, including silicone mats and brackets, Pouch
General medical instruments were spread out over three trays, six pouches and one
wrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing the following
geometries:
• Gliding mechanism
• Hinges and screws
• Serrated surface
• Luer-lock
• Spring
• Rigid non-lumen scopes
Type of packaging used: wrapped aluminum tray, including silicone mats and brackets,
rigid aluminum container and Pouch
General medical instruments were spread out over one container, three trays, and six
pouches. | 20 lb |
| 3 | Validation load #3 consisted of three single channel flexible endoscopes (Ureteroscope)
with inside diameter of 1.0 mm and length of 850 mm, packaged individually in wrapped
trays or containers, including appropriate silicone brackets or mats. Eight general medical
instruments, each packaged in a pouch, were added. | 23 lb |
| 4 | Validation load #4 consisted of up to 15 rigid or semi-rigid channeled instruments in the
presence of other packaged medical devices. Three double channel semi-rigid
endoscopes (ureterscope - 0.7 mm x 500 mm and 1.1 mm x 500 mm) were packaged
individually in wrapped trays or containers including appropriate silicone brackets or mats.
Additional rigid channel instruments or stainless steel rigid lumens were added to each
package. Two additional general medical instruments, each packaged in a pouch, were
added. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscope
with inside diameter of 1.0 mm and length of 850 mm and Bronchoscope with inside
diameter of 1.8 mm and length of 830 mm, and one double channel semi-rigid endoscope
(ureterscope - 0.7 mm x 500 mm and 1.1 mm x 500 mm) packaged individually in wrapped
trays or containers including appropriate silicone brackets or mats. No additional items
were added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing the following
geometries:
• Distal end (swivel parts)
• Hinge with screw
• Cannula
General medical instruments packaged in one aluminum sterilizer container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing the following
geometries:
• Box-lock hinge
• Pivot hinge
• Luer-lock
General medical instruments, spread out over three aluminum sterilization containers, each
| 75 lb |

Table 5: Validated TSO3 STERIZONE® VP4 Cycle 1 Loads

18

Table 6: Wrap Model Recommendations4

	Intended Load	Maximum Recommended Wrapped Package Content Weights²
Sterilization
Wrap Model		Pre-Vacuum
& Gravity
Steam, EO
and
STERIZONE®
VP4	Advanced
Sterilization
Products
(ASP)
STERRAD®
100S	Advanced
Sterilization
Products
(ASP)
STERRAD® NX
and 100NX	Advanced
Sterilization
Products
(ASP)
STERRAD®
200	STERIS
V-PRO®
1, 1Plus,
max	STERIS
V-PRO®
60
CH100	Very light weight package
(for example: towel packs
or batteries).	3 lbs	3 lbs	10.7 lbs	9.12 lbs	3 lbs	3 lbs
CH200	Light weight package
(for example: telescope
with light cord).	6 lbs	6 lbs	10.7 lbs	9.12 lbs	6.5 lbs	6 lbs
CH300	Light to moderate weight
package
(for example: general use
medical instruments).	9 lbs	9.7 lbs	10.7 lbs	9.12 lbs	9 lbs	9 lbs
CH400	Moderate to heavy weight
package
(for example: general use
medical instruments).	13 lbs	9.7 lbs	10.7 lbs	9.12 lbs	9.1 lbs	12 lbs
CH500	Heavy weight package
(for example: general use
medical instruments).	17 lbs	9.7 lbs	10.7 lbs	9.12 lbs	9.1 lbs	12 lbs
CH600	Very heavy weight
package
(for example: general use
medical instruments).	25 lbs	9.7 lbs	10.7 lbs	9.12 lbs	9.1 lbs	12 lbs

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

· CH100: 16 huck towels (17 in. x 29 in.).
· CH200: 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.).
· CH300: 16 huck towels (17 in. x 29 in.), 1 fluid-resistant table cover (90 in. x 60 in.), 5 lbs of metal mass.

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

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

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

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

· CH100: 1 tray liner (23 in. x 19.5 in.), 1 1b of metal mass in a 13 in. x 9.2 in. x 3.2 in. tray.

· CH200: 1 tray liner (23 in. x 19.5 in.), 3 lbs of metal mass in a 13 in. x 9.2 in. x 3.2 in. tray. Page 11 of 24

19

· CH300: 1 tray liner (23 in. x 19.5 in.), 6 lbs of metal mass in a 22 in. x 10.6 in. x 2.4 in. tray.
· CH400: 1 tray liner (23 in. x 19.5 in.), 10 lbs of metal mass in a 22 in. x 10.6 in. x 2.4 in. tray.
· CH500: 1 tray liner (23 in. x 19.5 in.), 12 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
· CH600: 1 tray liner (23 in. x 19.5 in.), 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.

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

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

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

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

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

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

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

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

• CH100: Metal instruments.

· CH200 CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® 200 Sterility Validation Studies:

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

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

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

The following loads were used in the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX Sterility Validation Studies:

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

The following loads were used in the STERIS V-PRO® 60 Sterility Validation Studies: · CH100 - CH600: 21 in. x 10 in. x 3.5 in. tray containing metal instruments.

The following loads were used in the STERIZONE® VP4 Sterility Validation Studies: · CH100: 10 in. x 6 in. x 1.5 in. plastic tray containing metal instruments.

20

· CH200: 15 in. x 10 in. x 1.5 in. plastic tray containing metal instruments.
· CH300: 20 in. x 9.2 in. x 2.8 in. plastic tray containing metal instruments.
· CH400: 20 in. x 9 in. x 4 in. metal tray containing metal instruments.
CH500: 23 in. x 11 in. x 3.5 in. metal tray containing metal instruments.
· CH600: 21 in. x 10 in. x 5 in. metal tray containing metal instruments.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 6.

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

2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the Cardinal Health™ Sterilization Wraps.

21

| Summary of the technological characteristics and the Performance of the device compared to the

predicate device
Element of comparison	PREDICATE
Cardinal HealthTM
Sterilization Wrap
(K151445, K151788,
K161910)	PROPOSED
Cardinal HealthTM
Sterilization Wrap
(K181174)	Comparison to
predicate
Manufacturer	Cardinal Health Inc.	Cardinal Health Inc.	Same
Regulation/ Product
Code	Sterilization Wrap:
880.6850/ FRG	Sterilization Wrap:
880.6850/ FRG	Same
Trade Name	Cardinal HealthTM
Sterilization Wrap	Cardinal HealthTM
Sterilization Wrap	Same
Intended Use	Cardinal HealthTM
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
• Gravity steam at
250°F/121°C for
30 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)	Cardinal HealthTM
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
• Gravity steam at
250°F/121°C for
30 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)	Same. The new
device has been
additionally tested
for use with
STERIS V-PRO®
60 System and
TSO3
STERIZONE®
VP4 System
Cycle 1.

Table 7: Summary of the Technological Characteristics and Performance

22

STERRAD® 200 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 V-PRO® 1, V-PRO® 1 Plus and 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.	STERRAD® 200 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 V-PRO® 1, V-PRO® 1 Plus, V-PRO® max and V-PRO® 60 Low Temperature Sterilization Systems TSO3 STERIZONE® VP4 System Cycle 1(Refer to Table 5 for Load) The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

STERRAD® 200 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 V-PRO® 1, V-PRO® 1 Plus and 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.

STERRAD® 200 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 V-PRO® 1, V-PRO® 1 Plus, V-PRO® max and V-PRO® 60 Low Temperature Sterilization Systems TSO3 STERIZONE® VP4 System Cycle 1(Refer to Table 5 for Load) The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

23

Prescription vs. OTC	OTC	OTC	Same
Single Use Only vs.
Reusable	Single use only	Single Use only	Same
Material Composition	Polypropylene fabric
using SMS
(spunbound-meltdown-
spunbound) production
process	Polypropylene fabric
using SMS
(spunbound-
meltdown-spunbound)
production process	Same
Chemical Properties	Polypropylene with
blue pigment and
antistatic treatment

Polypropylene with
green pigment and
antistatic treatment | Polypropylene with
blue pigment and
antistatic treatment

Polypropylene with
green pigment and
antistatic treatment | Same |
| Device Design | Dual layer, fold-over:
Double layer wrap
comprised of a single
sheet of blue
pigmented SMS fabric
that has been folded
over in half and
ultrasonically sealed to
itself on the three non-
folded edges

Dual Layer: Double-
layer wrap comprised
of two separate sheets
of blue pigmented
SMS fabric that have
been ultrasonically
sealed on two opposing
edges

Single Layer: Single-
layer wrap comprised
of a single sheet of
blue pigmented SMS
fabric | Dual layer, fold-over:
Double layer wrap
comprised of a single
sheet of blue
pigmented SMS fabric
that has been folded
over in half and
ultrasonically sealed to
itself on the three non-
folded edges

Dual Layer: Double-
layer wrap comprised
of two separate sheets
of blue pigmented
SMS fabric that have
been ultrasonically
sealed on two
opposing edges

Single Layer: Single-
layer wrap comprised
of a single sheet of
blue pigmented SMS
fabric | Same |
| Sterilization
Parameters | Two Color: Double-
layer wrap comprised
of one sheet of blue
pigmented SMS fabric
and one sheet of green
pigmented SMS fabric
that have been
ultrasonically sealed on
two opposing edges | Two Color: Double-
layer wrap comprised
of one sheet of blue
pigmented SMS fabric
and one sheet of green
pigmented SMS fabric
that have been
ultrasonically sealed on
two opposing edges | |
| | Pre-vacuum steam at
270°F/132°C for 4
minutes | Pre-vacuum steam at
270°F/132°C for 4
minutes | Same. The new
device has been
additionally tested
for use with
STERIS V-PRO®
60 System and
TSO3
STERIZONE®
VP4 System
Cycle 1. |
| | Gravity steam at
250°F/121°C for 30
minutes | Gravity steam at
250°F/121°C for 30
minutes | |
| | 100% ethylene oxide
(EO) with a
concentration of 725-
735 mg/L at
131°F/55°Cand 40%-
80% relative humidity
for 60 minutes | 100% ethylene oxide
(EO) with a
concentration of 725-
735 mg/L at
131°F/55°Cand 40%-
80% relative humidity
for 60 minutes | |
| | Advanced Sterilization
Products (ASP)
STERRAD® 100S
System | Advanced Sterilization
Products (ASP)
STERRAD® 100S
System | |
| | Advanced Sterilization
Products (ASP)
STERRAD® 200
System | Advanced Sterilization
Products (ASP)
STERRAD® 200
System | |
| | Advanced Sterilization
Products (ASP)
STERRAD® NX
System, Standard and
Advanced Cycles | Advanced Sterilization
Products (ASP)
STERRAD® NX
System, Standard and
Advanced Cycles | |
| | Advanced Sterilization
Products (ASP)
STERRAD® 100NX,
Standard, Flex,
Express, and DUO
cycles | Advanced Sterilization
Products (ASP)
STERRAD® 100NX,
Standard, Flex,
Express, and DUO
cycles | |
| | Lumen, Non-Lumen,
and Flexible Cycles in
the STERIS V-PRO®
1, V-PRO® 1 Plus and
V-PRO® maX Low
Temperature
Sterilization Systems | Lumen, Non-Lumen,
and Flexible Cycles in
the STERIS V-PRO®
1, V-PRO® 1 Plus, V-
PRO® maX and V-
PRO® 60 Low
Temperature
Sterilization Systems | |
| | | TSO3 STERIZONE®
VP4 System Cycle 1 | |
| Models/ Dimensions | Six basis weights
models
Fourteen sizes
(See Table 8 for
dimensions) | Six basis weights
models
Fourteen sizes
(See Table 8 for
dimensions) | Same |
| Maximum Wrapped
Package Content
Weights
(corresponding to
minimum to | Pre-vacuum Steam: 3 to
25 pounds | Pre-vacuum Steam: 3 to
25 pounds | Same |
| maximum basis
weights of wrap
models) | Gravity Steam: 3 to 25
pounds

EO: 3 to 25 pounds

STERRAD® 100S: 3 to
9.7 pounds

STERRAD® 200: 9.12
pounds

STERRAD® NX: 10.7
pounds

STERRAD® 100NX:
10.7 pounds

STERIS V-PRO® 1, V-
PRO® 1 Plus and V- | Gravity Steam: 3 to 25
pounds

EO: 3 to 25 pounds

STERRAD® 100S: 3 to
9.7 pounds

STERRAD® 200: 9.12
pounds

STERRAD® NX: 10.7
pounds

STERRAD® 100NX:
10.7 pounds

Extract
Appearance: Clear,
free of color
pH: Comparable to
negative control

Aged 30 days

Extract
Appearance: Clear,
free of color
pH: Comparable to
negative control | Non-Aged
Extract
Appearance: Clear,
free of color
pH: Comparable to
negative control

Aged 30 days

Extract
Appearance: Clear,
free of color
pH: Comparable to
negative control | Same |
| Residuals, ISO 10993-
7 | None detected | None detected | Same |
| Sterilization Efficacy
ANSI/AAMI TIR 12,
ANSI/ AAMI
ST79/A4 | Negative for growth | Negative for growth | Same |
| Material
Compatibility,
Premarket
Notification 510(k)
Submissions for
Medical Sterilization
Packaging Systems in
Health Care Facilities;
Draft Guidance for
Industry and FDA, -
Basis weight,
ASTM
D3776/D3776M-09
Air permeability,
ASTM D737-04 | Compatible | Compatible | Same |
| - Material burst
strength, ASTM
D3786
Grab Tensile
strength, ASTM
D5034-09
Trapezoidal Tear
strength, ASTM
D5587-15
Hydrostatic Pressure,
AATC127-2014 | | | |

24

25

26

27

28

Cardinal Health™ Sterilization Wrap is manufactured according to the Device Description in Table 8 below:

| Wrap

Dimensions	Side A	Side B	Tolerance
12"x12"	12"	12"	±0.5"
15"x15"	15"	15"	±0.5"
18"x18"	18"	18"	±0.5"
20"x20"	20"	20"	±0.5"
24"x24"	24"	24"	±0.5"
30"x30"	30"	30"	±0.5"
36"x36"	36"	36"	±0.5"
40"x40"	40"	40"	±1"
45"x45"	45"	45"	±1"
48"x48"	48"	48"	±1"
54"x54"	54"	54"	±1"
60"x60"	60"	60"	±1"
54"x72"	54"	72"	±1"
54"x90"	54"	90"	±1"

Table 8 – Device Description

29

Summary of Non-Clinical Testing

Performance testing included sterilization efficacy, event related maintenance of package sterility, physical properties, and biocompatibility in compliance with the methods of ISO 10993.

Extensive performance testing has been completed on Cardinal Health™ Sterilization Wrap in this submission of the new indications for use with STERIS V-PRO® 60 and TSO3 STERIZONE® VP4. Data from testing demonstrates that the Cardinal Health™ Sterilization Wrap allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices after sterilization with the STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 systems.

Physical properties testing (Basis weight, Air permeability, Grab tensile strength, Trapezoidal tear strength, Bursting strength and Hydrostatic pressure) 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. These material compatibility results also demonstrate that the device meets the requirements of ISO 11607.

The proposed device (Cardinal Health™ Sterilization Wrap) has been evaluated for biocompatibility according to ISO 10993 test methods and is considered toxicologically acceptable for its intended use. All materials used in the Cardinal Health™ Sterilization Wrap have been evaluated through irritation, leachability and residuals testing after sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems.

The data shows that the biocompatibility of the Cardinal Health™ Sterilization Wrap following sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems is substantially equivalent to the biocompatibility of the predicate.

Performance testing demonstrates that both devices:

Have the same intended use ●
Have the same material composition
Have the same physical and chemical properties
Have the same dimensions
Demonstrate maintenance of package sterility
The physical properties of all wrap models have been characterized both before and after ● exposure to sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4. The data demonstrates that the Cardinal Health™ Sterilization Wrap is compatible with the STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems.

30

Table 9: Summary of Non-Clinical Testing

Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence
Non-Clinical Test	Standard	Results Summary
Microbial Barrier Properties
Maintenance of Package Sterility
(Microbial Aerosol Challenge)	ANSI/AAMI TIR12, ANSI/AAMI
ST79 A1&A2	Negative for growth
Event Related Shelf Life Test –
365 days	ANSI/AAMI TIR12, ANSI/AAMI
ST79 A1&A2	No growth
Material Compatibility with
Indicated Sterilization Method

Basis weight,
Air permeability
Material burst strength
Grab Tensile strength
Trapezoidal Tear strength
Hydrostatic Pressure | ASTM D3776/D3776M-
09 (2013)
ASTM D737-04 (2012)
ASTM D3786
ASTM D5034-09 (2013)
ASTM D5587-15
AATC127-2014 | Compatible |
| Post-Sterilization Biocompatibility Testing | | |
| Residuals | ISO 10993-7 | None detected |
| Leachability | ISO 6588-2 | Non-Aged
Extract Appearance:
Clear, free of color
pH: Comparable to
negative control
Aged 30 days
Extract Appearance:
Clear, free of color
pH: Comparable to
negative control |
| Irritation | ISO 10993, 10:2010 | Negligible irritant |

31

Summary of Clinical Testing: Not applicable

Conclusions Drawn from Non-Clinical Data:

Based on the conclusions drawn from the intended use, technological characteristics, and nonclinical tests conducted, results demonstrate that the subject device is as effective and performs at least as well as the legally marketed device Cardinal Health™ Sterilization Wrap.