Who is the manufacturer of Cardinal Health Sterilization Wrap?

Cardinal Health200, LLC filed the 510(k) submission for Cardinal Health Sterilization Wrap (K161910).

What is the FDA product code for Cardinal Health Sterilization Wrap?

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

What is the regulatory pathway for Cardinal Health Sterilization Wrap?

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

Who can help prepare an FDA 510(k) submission like Cardinal Health Sterilization Wrap?

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

Cardinal Health Sterilization Wrap

K161910 · Cardinal Health200, LLC · FRG · Apr 20, 2017 · General Hospital

Device Facts

Record ID	K161910
Device Name	Cardinal Health Sterilization Wrap
Applicant	Cardinal Health200, LLC
Product Code	FRG · General Hospital
Decision Date	Apr 20, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

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.

Device Story

Cardinal Health™ Sterilization Wrap consists of 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Used by healthcare providers to wrap medical instruments prior to sterilization in the ASP STERRAD® 200 System. Available in six basis weights and various dimensions; configurations include single-layer, dual-layer, and two-color dual-layer (blue/green). Wraps are ultrasonically bonded. Device maintains sterility of enclosed contents for up to 365 days post-sterilization. Single-use only; OTC use.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including microbial barrier properties (microbial aerosol challenge), event-related shelf life (365 days), sterilant penetration, material physical properties (ASTM D3776, D737, D3786, D5034, D5587, AATCC127, WSP 160.1), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Material: 100% polypropylene SMS trilaminate nonwoven fabric. Construction: Ultrasonically bonded. Dimensions: 14 sizes available. Sterilization: Compatible with ASP STERRAD® 200 System. Standards: ISO 10993 (biocompatibility), ASTM D3776 (basis weight), ASTM D737 (air permeability), ASTM D3786 (burst strength), ASTM D5034 (tensile strength), ASTM D5587 (tear strength), AATCC 127 (hydrostatic pressure), WSP 160.1 (lint generation).

Indications for Use

Indicated for use by healthcare providers to enclose reusable metal and non-metal medical devices (including specific lumen dimensions) for sterilization via the ASP STERRAD® 200 System and to maintain sterility until use.

Regulatory Classification

Identification

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

Predicate Devices

Cardinal Health™ Sterilization Wrap (K151445)

Submission Summary (Full Text)

{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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 - 2. Dual Layer Sterilization Wrap - 3. 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.

Cardinal Health Sterilization Wrap

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Indications for Use

Device Story

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Indications for Use

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Identification

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Predicate Devices

Submission Summary (Full Text)

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