Who is the manufacturer of Cardinal Health Sterilization Wrap?

Cardinal Health200, LLC filed the 510(k) submission for Cardinal Health Sterilization Wrap (K181174).

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).

What are the predicate devices for Cardinal Health Sterilization Wrap?

Cardinal Health™ Sterilization Wrap (K151445, K151788, K161910).

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

K181174 · Cardinal Health200, LLC · FRG · Dec 11, 2018 · General Hospital

Device Facts

Record ID	K181174
Device Name	Cardinal Health Sterilization Wrap
Applicant	Cardinal Health200, LLC
Product Code	FRG · General Hospital
Decision Date	Dec 11, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended 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 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.

Device Story

Cardinal Health Sterilization Wrap consists of 100% polypropylene spunbond-meltblown-spunbond (SMS) nonwoven fabric; available in six basis weights and various dimensions. Used by healthcare providers to enclose medical devices for sterilization; creates tortuous path barrier to maintain sterility. Single-use; applied via sequential or simultaneous double-wrapping technique. Validated for multiple sterilization modalities including steam, EO, and low-temperature systems (STERRAD, V-PRO, STERIZONE). Protects enclosed instruments during sterilization and storage; maintains sterility for up to 365 days. Healthcare providers inspect wrap integrity before use; ensures sterile delivery of surgical instruments.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via sterilization efficacy, microbial aerosol challenge, event-related shelf life (365 days), and physical property testing (ASTM D3776, D737, D3786, D5034, D5587, AATCC 127). Biocompatibility evaluated per ISO 10993 (irritation, leachability, residuals).

Technological Characteristics

Material: 100% polypropylene SMS trilaminate nonwoven fabric. Design: Single, dual, or two-color layers ultrasonically bonded. Sterilization compatibility: Steam, EO, and low-temperature plasma/vapor systems. Physical standards: ASTM D3776 (basis weight), ASTM D737 (air permeability), ASTM D3786 (burst strength), ASTM D5034 (tensile strength), ASTM D5587 (tear strength), AATCC 127 (hydrostatic pressure).

Indications for Use

Indicated for healthcare providers to enclose medical devices for sterilization via gravity steam, pre-vacuum steam, 100% ethylene oxide, and specific low-temperature sterilization systems (STERRAD, STERIS V-PRO, TSO3 STERIZONE). Maintains sterility of enclosed devices until use.

Regulatory Classification

Identification

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

Predicate Devices

Cardinal Health™ Sterilization Wrap (K151445, K151788, K161910)

Related Devices

K161910 — Cardinal Health Sterilization Wrap · Cardinal Health200, LLC · Apr 20, 2017
K151788 — Cardinal Health Sterilization Wrap · Cardinal Health200, LLC · Oct 30, 2015
K222151 — Sterilization Wrap · Kenpax International Limited · Mar 23, 2023
K132060 — DURABLUE STERILIZATION WRAP · Cardinal Health-Medical Products and Services · Dec 13, 2013
K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) · Primed Medical Products, Inc. · Oct 7, 2024

Submission Summary (Full Text)

{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: 1. Single Layer Sterilization Wrap 2. Dual Layer Sterilization Wrap 3. 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: 1. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {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 2. Dual Layer Sterilization Wrap 3. 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 | | | | |--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------…

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