Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization efficacy of a nonwoven fabric wrap, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a sterilization wrap used to maintain the sterility of enclosed medical devices, not to directly treat a medical condition or disease.

Diagnostic

No

The device is a sterilization wrap intended to maintain the sterility of enclosed medical devices after sterilization, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to enclose another medical device for sterilization and maintain its sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The description focuses on the material and construction of the wrap, designed for sterilization and maintaining sterility. It does not mention any components or functions related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes

The function of this device is clearly related to the sterilization and sterile storage of other medical devices, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 by using:

· Advanced Sterilization Products (ASP) STERRAD® 200 System

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

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

Table 1 – Validated Advanced Sterilization Products STERRAD® 200 Sterilization Cycle and Intended Load

ASP STERRAD® 200
Maximum Recommended Chamber Load: 36.48 lbs
Intended Load: 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

Table: Sterilization Wrap Model and Intended Load with Maximum Recommended Wrapped Package Content Weights for Advanced Sterilization Products (ASP) STERRAD® 200

CH100: Very light weight package (for example: towel packs or batteries). Maximum Recommended Wrapped Package Content Weights: 9.12 lbs
CH200: Light weight package (for example: telescope with light cord). Maximum Recommended Wrapped Package Content Weights: 9.12 lbs
CH300: Light to moderate weight package (for example: general use medical instruments). Maximum Recommended Wrapped Package Content Weights: 9.12 lbs
CH400: Moderate to heavy weight package (for example: general use medical instruments). Maximum Recommended Wrapped Package Content Weights: 9.12 lbs
CH500: Heavy weight package (for example: general use medical instruments). Maximum Recommended Wrapped Package Content Weights: 9.12 lbs
CH600: Very heavy weight package (for example: general use medical instruments). Maximum Recommended Wrapped Package Content Weights: 9.12 lbs

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.

Product codes (comma separated list FDA assigned to the subject device)

FRG

Device Description

The Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wraps are 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, Two Color 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 ST79:2010 and also 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 the Advanced Sterilization Products (ASP) STERRAD® 200 System.

The Cardinal Health™ Sterilization Wraps are available in the models and dimensions below.

Dimensional Specifications and Corresponding Cardinal Health™ Sterilization Wrap Models (CH100, CH200, CH300, CH400, CH500, CH600) with availability for Single Layer (1), Dual Layer (2), and Two Color (3) options:

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

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)

Non-clinical data demonstrates that the Cardinal Health™ Sterilization Wrap are as safe, as effective, and performed as well as the legally marketed device identified in this summary.

Performance testing included sterilization efficacy, event related maintenance of package sterility, physical properties, and biocompatibility in compliance with the methods of ISO 10993. 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 Advanced Sterilization Products (ASP) STERRAD® 200 System.

Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence:

Study: Microbial Barrier Properties
- Maintenance of Package Integrity Test (Microbial Aerosol Challenge): PASSED
- Event Related Shelf Life Test - 365 days: PASSED
Study: Sterrad® 200 Sterilant Penetration: PASSED
Study: Material Compatibility with Indicated Sterilization Method (Basis weight, Air permeability, Material burst strength, Tensile strength and elongation, Tear strength, Hydrostatic Pressure, Lint Generation): Compatible
Study: Post-Sterilization Biocompatibility Testing
- Cytotoxicity ISO 10993-5: 2009: Non-cytotoxic, under the conditions of the test
- Sensitization, ISO 10993-10: 2010: Non-sensitizing, under the conditions of the test
- Irritation, ISO 10993-10:2010: Non-irritating, under the conditions of the test

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151445

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized graphic of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing line that forms a wave-like shape at the bottom.

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

April 20, 2017

Cardinal Health 200, LLC Tatyana Bogdan Director, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085

Re: K161910

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: March 10, 2017 Received: March 17, 2017

Dear Tatyana Bogdan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -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) K161910

Device Name Cardinal HealthTM Sterilization Wrap

Indications for Use (Describe)

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 by using:

· Advanced Sterilization Products (ASP) STERRAD® 200 System

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

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

Table 1 – Validated Advanced Sterilization Products STERRAD® 200 Sterilization Cycle and Intended Load

| Advanced
Sterilization
Products (ASP)
STERRAD®
System | Maximum
Recommended
Chamber Load | Intended Load |
|-------------------------------------------------------------------|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |

3

| Sterilization
Wrap Model | Intended Load | Maximum Recommended
Wrapped Package
Content Weights2 |
|-----------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------|
| | | Advanced Sterilization
Products (ASP)
STERRAD® 200 |
| CH100 | Very light weight package
(for example: towel packs or batteries). | 9.12 lbs |
| CH200 | Light weight package
(for example: telescope with light cord). | 9.12 lbs |
| CH300 | Light to moderate weight package
(for example: general use medical instruments). | 9.12 lbs |
| CH400 | Moderate to heavy weight package
(for example: general use medical instruments). | 9.12 lbs |
| CH500 | Heavy weight package
(for example: general use medical instruments). | 9.12 lbs |
| CH600 | Very heavy weight package
(for example: general use medical instruments). | 9.12 lbs |

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.

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.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 2.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

4

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

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5

Image /page/5/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic above the company name. The graphic is made up of four curved lines that resemble a bird in flight. The company name is written in a bold, sans-serif font.

Cardinal Health
1500 Waukegan Road
Waukegan, IL 60085
Waukegan, IL 60085
cardinalhealth.com

510(k) SUMMARY

Cardinal Health™ Sterilization Wrap

| Manufacturer: | Cardinal Health 200, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|----------------------------------|----------------------------------------------------------------------|
| Regulatory Affairs Contact: | Tatyana Bogdan
1500 Waukegan Road
Waukegan, IL 60085 |
| Telephone Number: | (847) 887-6812 |
| Fax Number: | (847) 887-2461 |
| Date summary Prepared: | April 20, 2017 |
| Product Trade Name: | Cardinal HealthTM Sterilization Wrap |
| Classification: | Class II per 21 CFR § 880.6850 |
| Classification Name: | Sterilization Wrap |
| Common Name: | Sterilization Wrap |
| Product Code: | FRG |
| Predicate Device: | K151445 - Cardinal HealthTM Sterilization Wrap |
| Reason for 510(k)
Submission: | Additional product offering of a legally marketed device |

6

Device Description:

The Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wraps are 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, Two Color 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 ST79:2010 and also 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 the Advanced Sterilization Products (ASP) STERRAD® 200 System.

The Cardinal Health™ Sterilization Wraps are available in the models and dimensions below.

7

| 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
2
3	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
2
3	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

1. Single Layer Sterilization Wrap
1. Dual Layer Sterilization Wrap
1. Two Color Sterilization Wrap

8

Indications for Use

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 by using:

Advanced Sterilization Products (ASP) STERRAD® 200 System .
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices until used.

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

Table 1 – Validated Advanced Sterilization Products STERRAD® 200 Cycle and Intended Load

| Advanced
Sterilization
Products (ASP)
STERRAD® System | Maximum
Recommended
Chamber Load | Intended Load |
|----------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |

9

| Sterilization
Wrap Model | | Maximum Recommended Wrapped
Package Content Weights2 |
|-----------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------|
| | Intended Load | Advanced Sterilization Products (ASP)
STERRAD® 200 |
| CH100 | Very light weight package
(for example: towel packs or batteries). | 9.12 lbs |
| CH200 | Light weight package
(for example: telescope with light cord). | 9.12 lbs |
| CH300 | Light to moderate weight package
(for example: general use medical instruments). | 9.12 lbs |
| CH400 | Moderate to heavy weight package
(for example: general use medical instruments). | 9.12 lbs |
| CH500 | Heavy weight package
(for example: general use medical instruments). | 9.12 lbs |
| CH600 | Very heavy weight package
(for example: general use medical instruments). | 9.12 lbs |

Table 2: Wrap Model Recommendations 1

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.

Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 2.

1 Individual results may differ due to factors such as variations in handling practices, 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.

10

Table 3: Summary of the Technological Characteristics and Performance

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

predicate device
Element of
Comparison	PREDICATE
Cardinal Health™ Sterilization Wrap
(K151445)	PROPOSED
Cardinal Health™ Sterilization Wrap
(K161910)
Manufacturer	Cardinal Health Inc.	Cardinal Health Inc.
Regulation/
Product Code	Sterilization Wrap: 880.6850 / FRG	Sterilization Wrap: 880.6850 / FRG
Trade Name	Cardinal Health™ Sterilization Wrap	Cardinal Health™ Sterilization Wrap
Intended Use	Cardinal Health™ Sterilization Wrap is
intended to enclose another medical device
that is to be sterilized by a health care
provider using:
• Advanced Sterilization Products (ASP)
STERRAD® 200 System

The wrap is intended to allow sterilization of
the enclosed medical device(s) and to
maintain sterility of the enclosed device(s)
until used. | Cardinal Health™ Sterilization Wrap is
intended to enclose another medical
device that is to be sterilized by a health
care provider using:
• Advanced Sterilization Products (ASP)
STERRAD® 200 System

The wrap is intended to allow sterilization
of the enclosed medical device(s) and to
maintain sterility of the enclosed device(s)
until used. |
| Prescription
vs. OTC | OTC | OTC |
| Single Use
Only vs.
Reusable | Single Use Only | Single Use Only |
| Material
Composition | Polypropylene fabric using SMS (spunbond-
meltblown-spunbond) production process | Polypropylene fabric using SMS
(spunbond-meltblown-spunbond)
production process |
| Chemical
Properties | Polypropylene with blue pigment and
antistatic treatment | Polypropylene with blue pigment and
antistatic treatment

Polypropylene with green pigment and
antistatic treatment |
| Element of
Comparison | PREDICATE
Cardinal Health™ Sterilization Wrap
(K151445) | PROPOSED
Cardinal Health™ Sterilization Wrap
(K161910) |
| 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, 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 | 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 | Single Layer: Single-layer wrap
comprised of a single sheet of blue
pigmented SMS fabric |
| | | 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 |
| Sterilization | Advanced Sterilization Products (ASP) | Advanced Sterilization Products (ASP) |
| Parameters | STERRAD® 200 System | STERRAD® 200 System |
| Models/ | Six basis weights models | Six basis weights models |
| Dimensions | Fourteen sizes | Fourteen sizes |
| Maximum
Wrapped
Package Content
Weights | STERRAD® 200: 9.12 pounds | STERRAD® 200: 9.12 pounds |
| Maintenance of
Sterility | STERRAD® 200: 365 days | STERRAD® 200: 365 days |
| Sterilant
Penetration | Passed | Passed |
| Biocompatibility -
Cytotoxicity, ISO
10993-5: 2009 | Non-cytotoxic , under the conditions of
the test | Non-cytotoxic , under the conditions of the
the test |
| Biocompatibility -
Sensitization, ISO
10993-10: 2010 | Non-sensitizing, under the conditions of
the test | Non-sensitizing, under the conditions of
the test |
| Biocompatibility -
Irritation, ISO
10993-10:2010 | Non-irritating, under the conditions of
the test | Non-irritating, under the conditions of the
the test |

11

12

Discussion of Similarities and Differences:

The proposed Cardinal Health™ Sterilization Wrap is substantially equivalent in intended use, indication for use, materials, characteristics, dimensions and product features to the predicate device Cardinal Health™ Sterilization Wrap (K151445). Both devices have identical manufacturing processes.

The difference between the proposed and the predicate device is an additional product offering, Two Color, Dual-layer wrap to the previously cleared and currently marketed Single Color Dual-layer sterilization wrap. The additional product offering is the same design as the Single Color, Dual Layer offering with one exception; there is one sheet of green pigmented SMS fabric and one sheet of blue SMS that has been ultrasonically sealed on two opposing edges. This change was made to address customer preferences for end user identification of instrument trays for aesthetic purposes only.

This pigment difference does not impact safety or efficacy of the product. The Two Color Sterilization Wrap offering is of the same design, technology, base raw material, and has the same intended use, with the only difference being the addition of a green pigment. There has been no change to the performance from one color to two color. Non-clinical data as seen in Table 4 demonstrates that the additional product offering is substantially equivalent to predicate device.

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

Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence
Study	Results Summary
Microbial Barrier Properties	Maintenance of Package Integrity Test
(Microbial Aerosol Challenge)	PASSED
	Event Related Shelf Life Test - 365 days	PASSED
Sterrad® 200 Sterilant Penetration	PASSED
Material Compatibility with Indicated Sterilization Method
Basis weight, ASTM D3776-09
Air permeability, ASTM D737-04 (2012)
Material burst strength, ASTM D3786-13
Tensile strength and elongation, ASTM D5034-09
Tear strength, ASTM D5587-15
Hydrostatic Pressure, AATCC127-2014
Lint Generation, WSP 160.1 (12)	Compatible
Post-Sterilization
Biocompatibility Testing	Cytotoxicity ISO 10993-5: 2009	Non-cytotoxic, under the
conditions of the test
	Sensitization, ISO 10993-10: 2010	Non-sensitizing, under the
conditions of the test
	Irritation, ISO 10993-10:2010	Non-irritating, under the
conditions of the test

Table 4: Summary of Non-Clinical Testing

13

Summary of Clinical Testing:

Not applicable

Conclusions Drawn from Non-Clinical Data:

Non-clinical data demonstrates that the Cardinal Health™ Sterilization Wrap are as safe, as effective, and performed as well as the legally marketed device identified in this summary.