(223 days)
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.
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.
The Cardinal Health™ Sterilization Wrap is intended to enclose medical devices for sterilization and maintain their sterility until use. The device has been tested against various sterilization methods and loads.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Negative for growth | Negative for growth (tested per ANSI/AAMI TIR 12, ANSI/AAMI ST79/A4) |
| Maintenance of Package Sterility | Negative for growth (Microbial Aerosol Challenge) | Negative for growth (tested per ANSI/AAMI TIR12, ANSI/AAMI ST79 A1&A2) |
| Event Related Shelf Life | No growth (for specified durations depending on sterilization method) | 365 days for Pre-vacuum steam, Gravity steam, EO, STERRAD® 100S, STERRAD® NX, STERRAD® 100NX, VPRO 1, VPRO 1 Plus, VPRO maX, VPRO 60, VP4; 30 days for STERRAD® 200 (tested per ANSI/AAMI TIR12, ANSI/AAMI ST79 A1&A2) |
| Biocompatibility - Irritation | Negligible irritant | Negligible irritant (tested per ISO 10993-10) |
| Biocompatibility - Leachability | Non-Aged: Extract Appearance: Clear, free of color; pH: Comparable to negative control | Non-Aged: Extract Appearance: Clear, free of color; pH: Comparable to negative control (tested per ISO 6588-2) |
| Aged 30 days: Extract Appearance: Clear, free of color; pH: Comparable to negative control | Aged 30 days: Extract Appearance: Clear, free of color; pH: Comparable to negative control (tested per ISO 6588-2) | |
| Biocompatibility - Residuals | None detected | None detected (tested per ISO 10993-7) |
| Sterilization Efficacy | Negative for growth | Negative for growth (tested per ANSI/AAMI TIR 12, ANSI/AAMI ST79/A4) |
| Material Compatibility (Physical Properties) | Compatible (i.e., integrity of wrap properties not compromised after sterilization and storage) | Compatible (tested for Basis weight, Air permeability, Material burst strength, Grab Tensile strength, Trapezoidal Tear strength, Hydrostatic Pressure per ASTM standards) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes various validation studies performed for different sterilization methods and wrap models. The studies involved a range of loads, including medical instruments with different geometries, lumens, flexible endoscopes, towels, drapes, and metal mass. The specific sample sizes for each test set (e.g., number of wrapped packages, number of sterilization cycles) are not explicitly stated as numerical values in the provided text.
The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given that it is a 510(k) submission for a medical device and describes "Performance testing," it is implied to be prospective testing conducted in a controlled environment to validate the device's claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set. The nature of the device (sterilization wrap) and the tests performed (microbial growth, physical properties, biocompatibility) suggest that the "ground truth" would be established through laboratory analyses and adherence to standardized testing protocols (e.g., ANSI/AAMI, ISO, ASTM), rather than expert consensus on subjective observations.
4. Adjudication Method for the Test Set:
An adjudication method is not mentioned, as it is not typically applicable to the type of objective, quantitative testing (e.g., microbial growth, physical property measurements) described for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is irrelevant for a sterilization wrap, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study was not done. This term is applicable to AI algorithms, not physical medical devices like sterilization wraps. The performance evaluation focuses on the physical and microbiological properties of the wrap itself.
7. The Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Microbial Growth/Sterility: Absence of microbial growth, determined by standard microbiological culture techniques after sterilization and shelf-life challenges.
- Physical Properties: Quantitative measurements of material characteristics (e.g., weight, air permeability, tensile strength, tear strength, burst strength, hydrostatic pressure) compared against defined specifications before and after sterilization.
- Biocompatibility: Absence of detectable residuals, clear and pH-neutral extracts, and negligible irritant response as determined by standardized ISO tests.
8. The Sample Size for the Training Set:
A training set is not applicable to this device. This concept relates to machine learning models, whereas the Cardinal Health™ Sterilization Wrap is a physical product evaluated through traditional laboratory and material science testing.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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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
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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
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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.
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Table 1- Dimensions, types and models
| DimensionalSpecifications | Cardinal Health™ Sterilization Wrap Models | |||||
|---|---|---|---|---|---|---|
| CH100 | CH200 | CH300 | CH400 | CH500 | CH600 | |
| 12 in. x 12 in.(30 cm. x 30 cm.) | 1*23 | 123 | ||||
| 15 in. x 15 in.(38 cm. x 38 cm.) | 123 | |||||
| 18 in. x 18 in.(45 cm. x 45 cm.) | 123 | 123 | 1 | 123 | ||
| 20 in. x 20 in.(50 cm. x 50 cm.) | 123 | |||||
| 24 in. x 24 in.(60 cm. x 60 cm.) | 123 | 123 | 123 | 123 | 123 | |
| 30 in. x 30 in.(76 cm. x 76 cm.) | 123 | 123 | 123 | 1 | 123 | |
| 36 in. x 36 in.(91 cm. x 91 cm.) | 123 | 123 | 123 | 123 | 123 | 123 |
| 40 in. x 40 in.(101 cm. x 101 cm.) | 123 | 123 | 123 | 123 | 123 | 123 |
| 45 in. x 45 in.(114 cm. x 114 cm.) | 123 | 123 | 123 | 123 | 123 | |
| 48 in. x 48 in.(121 cm. x 121 cm.) | 123 | 123 | 123 | 123 | 123 | 123 |
| 54 in. x 54 in.(137 cm. x 137 cm.) | 123 | 123 | 123 | 123 | 123 | 123 |
| 60 in. x 60 in.(152 cm. x 152 cm.) | 123 | |||||
| 54 in. x 72 in.(137 cm. x 182 cm.) | 123 | 123 | 123 | 123 | 123 | 123 |
| 54 in. x 90 in.(137 cm. x 228 cm.) | 123 |
*Product configurations:
-
Single Layer Sterilization Wrap
-
Dual Layer Sterilization Wrap
-
Two Color Sterilization Wrap - Double-layer wrap
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Table 2 – Validated Advanced Sterilization Products STERRAD® 100NX and STERRAD® 200 Sterilization Cycles and Intended Loads
| AdvancedSterilizationProducts (ASP)STERRAD®System | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| ASPSTERRAD® NXStandard Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of thefollowing lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens |
| ASPSTERRAD® NXAdvanced Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of thefollowing 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 lumensOROne single-channel Flexible Endoscope with or without a silicone mat and no additionalload. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm orlarger and a length of 850 mm or shorter |
| ASPSTERRAD® 100NXStandard Cycle | 21.4 lbs | Reusable metal and non-metal medical devices, including up to 10 lumens of thefollowing 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 sterilizationcycle) |
| ASPSTERRAD® 100NXFlex Cycle | 12.2 lbs | One or two single-channel Flexible Endoscope with or without a silicone mat and noadditional load. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm orlarger and a length of 850 mm or shorter (A maximum of two flexible endoscopes,one per tray per sterilization cycle) |
| ASPSTERRAD® 100NXExpress Cycle | 10.7 lbs | Non-lumened reusable metal and non-metal medical devices requiring surfacesterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid orsemi-rigid endoscopes without lumens |
| ASPSTERRAD® 100NXDuo Cycle | 13.2 lbs | One or two single-channel Flexible Endoscope with or without a silicone mat and noadditional load. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm orlarger and a length of 875 mm or shorter |
| ASPSTERRAD® 200 | 36.48 lbs | Reusable metal and non-metal medical devices, including up to 12 lumens of thefollowing 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 | MaximumRecommendedChamber 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 |
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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 | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| Lumen Cycle | 11 lbs | Reusable metal and non-metal medical devices, including up to 12 lumens of thefollowing dimensions per chamber load:• Single channel of an inside diameter of 0.77 mm or larger with a lengthof 410 mm or shorter• Dual channel of an inside diameter of 0.77 mm or larger with a length of410 mm or shorter• Triple channel of an inside diameter of 1.2 mm or larger with a length of275 mm or shorter and 1.8 mm or larger with a length of 310 mm orshorter 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 additionalload other thanintended traycontents | Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of twoconfigurations:1. One tray containing a flexible endoscope with a light cord (if not integral toendoscope) and silicone mat:• The flexible endoscope(s) may contain either a single channel or dualchannel with an inside diameter of 1 mm or larger and a length of 990mm or shorter |
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| Validationload # | Load Description | Load weight11Excluding the 25lb loading rack |
|---|---|---|
| 1 | Validation load #1 consisted of general medical instruments, representing the followinggeometries:• Clamp• Serrated surface• Box-lock• Handle• Button• Pivot hinge• StopcockType of packaging used: wrapped plastic tray, including silicone mats and brackets, PouchGeneral medical instruments were spread out over three trays, six pouches and onewrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing the followinggeometries:• Gliding mechanism• Hinges and screws• Serrated surface• Luer-lock• Spring• Rigid non-lumen scopesType of packaging used: wrapped aluminum tray, including silicone mats and brackets,rigid aluminum container and PouchGeneral medical instruments were spread out over one container, three trays, and sixpouches. | 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 wrappedtrays or containers, including appropriate silicone brackets or mats. Eight general medicalinstruments, 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 thepresence of other packaged medical devices. Three double channel semi-rigidendoscopes (ureterscope - 0.7 mm x 500 mm and 1.1 mm x 500 mm) were packagedindividually in wrapped trays or containers including appropriate silicone brackets or mats.Additional rigid channel instruments or stainless steel rigid lumens were added to eachpackage. Two additional general medical instruments, each packaged in a pouch, wereadded. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscopewith inside diameter of 1.0 mm and length of 850 mm and Bronchoscope with insidediameter 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 wrappedtrays or containers including appropriate silicone brackets or mats. No additional itemswere added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing the followinggeometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminum sterilizer container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing the followinggeometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over three aluminum sterilization containers, eachweighing 25 lb | 75 lb |
Table 5: Validated TSO3 STERIZONE® VP4 Cycle 1 Loads
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Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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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, LLC3651 BirchwoodWaukegan, 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™ SterilizationWrap for use with Pre-Vacuum Steam (4 min/270°F), GravitySteam (30 min/250°F), 100% Ethylene Oxide (EO), AdvancedSterilization Products (ASP) STERRAD® 100S, STERRAD®200, STERRAD® NX, STERRAD® 100NX Systems, andSTERIS V-PRO® 1, V-PRO® 1 Plus, and V-PRO® maX LowTemperature Sterilization Systems |
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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.
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| EN - Dimensional SpecificationsFR - Spécifications des dimensionsES - 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) | 123 | 123 | ||||
| 15 in. x 15 in.(38 cm x 38 cm) | 123 | |||||
| 18 in. x 18 in.(45 cm x 45 cm) | 123 | 123 | 1 | 123 | ||
| 20 in. x 20 in.(50 cm x 50 cm) | 123 | |||||
| 24 in. x 24 in.(60 cm x 60 cm) | 123 | 123 | 123 | 123 | 123 | |
| 30 in. x 30 in.(76 cm x 76 cm) | 123 | 123 | 123 | 1 | 123 | |
| 36 in. x 36 in.(91 cm x 91 cm) | 123 | 123 | 123 | 123 | 123 | 123 |
| 40 in. x 40 in.(101 cm x 101 cm) | 123 | 123 | 123 | 123 | 123 | 123 |
| 45 in. x 45 in.(114 cm x 114 cm) | 123 | 123 | 123 | 123 | 123 | 123 |
| 48 in. x 48 in.(121 cm x 121 cm) | 123 | 123 | 123 | 123 | 123 | 123 |
| 54 in. x 54 in.(137 cm x 137 cm) | 123 | 123 | 123 | 123 | 123 | 123 |
| 60 in. x 60 in.(152 cm x 152 cm) | 123 | |||||
| 54 in. x 72 in.(137 cm x 182 cm) | 1 | 123 | 123 | 123 | 123 | 123 |
| 54 in. x 90 in.(137 cm x 228 cm) | 123 |
Table 1- Dimensions, types and models
EN - 1. Single Layer Sterilization Wrap
-
Dual Layer Sterilization Wrap
-
Two Color Sterilization Wrap
Product Description
The Cardinal Health™ Sterilization Wrap is made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, Two Color are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides.
In accordance with standard hospital practices, two sheets are used to wrap a medical device or a collection of medical devices for sterilization. When wrapping with the Cardinal Health™ Sterilization Wrap, Single Layer model, two sheets are required. Cardinal Health™ Sterilization Wrap, Dual Layer or Cardinal Health™ Sterilization Wrap, Two Color models allow for Page 3 of 24
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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.
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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.
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Table 2 – Validated Advanced Sterilization Products STERRAD® NX, STERRAD® 100NX and STERRAD® 200 Sterilization Cycles and Intended Loads
| AdvancedSterilizationProducts (ASP)STERRAD®System | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| ASPSTERRAD® NXStandard Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 150 mm orshorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 400 mm orshorter of single-channel stainless steel lumens |
| ASPSTERRAD® NXAdvanced Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 500 mm orshorter of single-channel stainless steel lumensOROne single-channel Flexible Endoscope with or without a silicone matand no additional load. The flexible endoscope may contain:• a single-channel Teflon®/Polyethylene lumen with an insidediameter of 1 mm or larger and a length of 850 mm or shorter |
| ASPSTERRAD®100NXStandard Cycle | 21.4 lbs | Reusable metal and non-metal medical devices, including up to 10lumens of the following lumen dimensions per chamber load:• an inside diameter of 0.7 mm or larger and a length of 500 mm orshorter of single-channel stainless steel lumens (A maximum offive lumens per tray per sterilization cycle) |
| ASPSTERRAD®100NX Flex Cycle | 12.2 lbs | One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with an insidediameter of 1 mm or larger and a length of 850 mm or shorter (Amaximum of two flexible endoscopes, one per tray persterilization cycle) |
| ASPSTERRAD®100NX ExpressCycle | 10.7 lbs | Non-lumened reusable metal and non-metal medical devicesrequiring surface sterilization, or sterilization of mated stainless steeland titanium surfaces, and rigid or semi-rigid endoscopes withoutlumens |
| ASPSTERRAD®100NX Duo Cycle | 13.2 lbs | One or two single-channel Flexible Endoscope with or without asilicone mat and no additional load. The flexible endoscope maycontain:• a single-channel Teflon®/Polyethylene lumen with an insidediameter of 1 mm or larger and a length of 875 mm or shorter |
| ASPSTERRAD® 200 | 36.48 lbs | Reusable metal and non-metal medical devices, including up to 12lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 125 mm orshorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 250 mm orshorter of single-channel stainless steel lumens• an inside diameter of 3 mm or larger and a length of 400 mm orshorter of single-channel stainless steel lumens• an inside diameter of 6 mm or larger and a length of 310 mm orshorter of a single-channel Teflon®/Polyethylene lumen |
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Table 3: Validated STERIS V-PRO® 1, V-PRO® 1 Plus and V-PRO® maX Cycles and Intended Loads
| STERIS V-PRO®Cycle | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical devices, including up to 20lumens of the following dimensions per chamber load:an inside diameter of 1 mm or larger and a length of125 mm or shorter an inside diameter of 2 mm or larger and a length of250 mm or shorter an inside diameter of 3 mm or larger and a length of400 mm or shorter |
| Non LumenCycle | 19.65 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | 24 lbs | Single or dual lumen surgical flexible endoscopes andbronchoscopes in either of two load configurations: |
| 1. Two trays, each containing a flexible endoscope with a lightcord (if not integral to endoscope) and mat with no additionalload | ||
| 2. One tray containing a flexible endoscope with a light cord (ifnot integral to endoscope) and mat and an additional traycontaining non-lumened medical devices | ||
| The flexible endoscope(s) may contain either:a single lumen with an inside diameter of 1 mm orlarger and a length of 1050 mm or shorter two lumens, with one lumen having an inside diameterof 1 mm or larger and a length of 998 mm or shorterand the other lumen having an inside diameter of 1mm or larger and a length of 850 mm or shorter |
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| STERIS V-PRO®Cycle | MaximumRecommendedChamber 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-LumenCycle | 12 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | No additionalload other thanintended traycontents | 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
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| Validationload # | Load Description | Load weight¹¹Excluding the 25 lbloading rack |
|---|---|---|
| 1 | Validation load #1 consisted of general medical instruments, representing the followinggeometries:• Clamp• Serrated surface• Box-lock• Handle• Button• Pivot hinge• StopcockType of packaging used: wrapped plastic tray, including silicone mats and brackets, PouchGeneral medical instruments were spread out over three trays, six pouches and onewrapped instrument. | 11 lb |
| 2 | Validation load #2 consisted of general medical instruments, representing the followinggeometries:• Gliding mechanism• Hinges and screws• Serrated surface• Luer-lock• Spring• Rigid non-lumen scopesType of packaging used: wrapped aluminum tray, including silicone mats and brackets,rigid aluminum container and PouchGeneral medical instruments were spread out over one container, three trays, and sixpouches. | 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 wrappedtrays or containers, including appropriate silicone brackets or mats. Eight general medicalinstruments, 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 thepresence of other packaged medical devices. Three double channel semi-rigidendoscopes (ureterscope - 0.7 mm x 500 mm and 1.1 mm x 500 mm) were packagedindividually in wrapped trays or containers including appropriate silicone brackets or mats.Additional rigid channel instruments or stainless steel rigid lumens were added to eachpackage. Two additional general medical instruments, each packaged in a pouch, wereadded. | 19 lb |
| 5 | Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscopewith inside diameter of 1.0 mm and length of 850 mm and Bronchoscope with insidediameter 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 wrappedtrays or containers including appropriate silicone brackets or mats. No additional itemswere added. | 21 lb |
| 6 | Validation load #6 consisted of general medical instruments, representing the followinggeometries:• Distal end (swivel parts)• Hinge with screw• CannulaGeneral medical instruments packaged in one aluminum sterilizer container. | 9 lb |
| 7 | Validation load #7 consisted of general medical instruments, representing the followinggeometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments, spread out over three aluminum sterilization containers, each | 75 lb |
Table 5: Validated TSO3 STERIZONE® VP4 Cycle 1 Loads
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Table 6: Wrap Model Recommendations4
| Intended Load | Maximum Recommended Wrapped Package Content Weights² | ||||||
|---|---|---|---|---|---|---|---|
| SterilizationWrap Model | Pre-Vacuum& GravitySteam, EOandSTERIZONE®VP4 | AdvancedSterilizationProducts(ASP)STERRAD®100S | AdvancedSterilizationProducts(ASP)STERRAD® NXand 100NX | AdvancedSterilizationProducts(ASP)STERRAD®200 | STERISV-PRO®1, 1Plus,max | STERISV-PRO®60 | |
| CH100 | Very light weight package(for example: towel packsor batteries). | 3 lbs | 3 lbs | 10.7 lbs | 9.12 lbs | 3 lbs | 3 lbs |
| CH200 | Light weight package(for example: telescopewith light cord). | 6 lbs | 6 lbs | 10.7 lbs | 9.12 lbs | 6.5 lbs | 6 lbs |
| CH300 | Light to moderate weightpackage(for example: general usemedical instruments). | 9 lbs | 9.7 lbs | 10.7 lbs | 9.12 lbs | 9 lbs | 9 lbs |
| CH400 | Moderate to heavy weightpackage(for example: general usemedical instruments). | 13 lbs | 9.7 lbs | 10.7 lbs | 9.12 lbs | 9.1 lbs | 12 lbs |
| CH500 | Heavy weight package(for example: general usemedical instruments). | 17 lbs | 9.7 lbs | 10.7 lbs | 9.12 lbs | 9.1 lbs | 12 lbs |
| CH600 | Very heavy weightpackage(for example: general usemedical 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
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- · 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.
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- · 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.
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| Summary of the technological characteristics and the Performance of the device compared to thepredicate device | |||
|---|---|---|---|
| Element of comparison | PREDICATECardinal HealthTMSterilization Wrap(K151445, K151788,K161910) | PROPOSEDCardinal HealthTMSterilization Wrap(K181174) | Comparison topredicate |
| Manufacturer | Cardinal Health Inc. | Cardinal Health Inc. | Same |
| Regulation/ ProductCode | Sterilization Wrap:880.6850/ FRG | Sterilization Wrap:880.6850/ FRG | Same |
| Trade Name | Cardinal HealthTMSterilization Wrap | Cardinal HealthTMSterilization Wrap | Same |
| Intended Use | Cardinal HealthTMSterilization Wrap isintended to encloseanother medical devicethat is to be sterilizedby a health careprovider using:• Pre-vacuum steam at270°F/132°C for 4minutes• Gravity steam at250°F/121°C for30 minutes• 100% ethylene oxide(EO) with aconcentration of725-735 mg/L at131°F/55°C and40%-80% relativehumidity for 60minutes• AdvancedSterilizationProducts (ASP)STERRAD® 100SSystem• AdvancedSterilizationProducts (ASP) | Cardinal HealthTMSterilization Wrap isintended to encloseanother medical devicethat is to be sterilizedby a health careprovider using:• Pre-vacuum steam at270°F/132°C for 4minutes• Gravity steam at250°F/121°C for30 minutes• 100% ethylene oxide(EO) with aconcentration of725-735 mg/L at131°F/55°C and40%-80% relativehumidity for 60minutes• AdvancedSterilizationProducts (ASP)STERRAD® 100SSystem• AdvancedSterilizationProducts (ASP) | Same. The newdevice has beenadditionally testedfor use withSTERIS V-PRO®60 System andTSO3STERIZONE®VP4 SystemCycle 1. |
Table 7: Summary of the Technological Characteristics and Performance
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| STERRAD® 200 System Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced Cycles Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and DUO cycles Lumen, Non Lumen, and Flexible Cycles by the STERIS V-PRO® 1, V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used. | STERRAD® 200 System Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced Cycles Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and DUO cycles Lumen, Non Lumen, and Flexible Cycles by the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® max and V-PRO® 60 Low Temperature Sterilization Systems TSO3 STERIZONE® VP4 System Cycle 1(Refer to Table 5 for Load) The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used. |
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| Prescription vs. OTC | OTC | OTC | Same |
|---|---|---|---|
| Single Use Only vs.Reusable | Single use only | Single Use only | Same |
| Material Composition | Polypropylene fabricusing SMS(spunbound-meltdown-spunbound) productionprocess | Polypropylene fabricusing SMS(spunbound-meltdown-spunbound)production process | Same |
| Chemical Properties | Polypropylene withblue pigment andantistatic treatmentPolypropylene withgreen pigment andantistatic treatment | Polypropylene withblue pigment andantistatic treatmentPolypropylene withgreen pigment andantistatic treatment | Same |
| Device Design | Dual layer, fold-over:Double layer wrapcomprised of a singlesheet of bluepigmented SMS fabricthat has been foldedover in half andultrasonically sealed toitself on the three non-folded edgesDual Layer: Double-layer wrap comprisedof two separate sheetsof blue pigmentedSMS fabric that havebeen ultrasonicallysealed on two opposingedgesSingle Layer: Single-layer wrap comprisedof a single sheet ofblue pigmented SMSfabric | Dual layer, fold-over:Double layer wrapcomprised of a singlesheet of bluepigmented SMS fabricthat has been foldedover in half andultrasonically sealed toitself on the three non-folded edgesDual Layer: Double-layer wrap comprisedof two separate sheetsof blue pigmentedSMS fabric that havebeen ultrasonicallysealed on twoopposing edgesSingle Layer: Single-layer wrap comprisedof a single sheet ofblue pigmented SMSfabric | Same |
| SterilizationParameters | Two Color: Double-layer wrap comprisedof one sheet of bluepigmented SMS fabricand one sheet of greenpigmented SMS fabricthat have beenultrasonically sealed ontwo opposing edges | Two Color: Double-layer wrap comprisedof one sheet of bluepigmented SMS fabricand one sheet of greenpigmented SMS fabricthat have beenultrasonically sealed ontwo opposing edges | |
| Pre-vacuum steam at270°F/132°C for 4minutes | Pre-vacuum steam at270°F/132°C for 4minutes | Same. The newdevice has beenadditionally testedfor use withSTERIS V-PRO®60 System andTSO3STERIZONE®VP4 SystemCycle 1. | |
| Gravity steam at250°F/121°C for 30minutes | Gravity steam at250°F/121°C for 30minutes | ||
| 100% ethylene oxide(EO) with aconcentration of 725-735 mg/L at131°F/55°Cand 40%-80% relative humidityfor 60 minutes | 100% ethylene oxide(EO) with aconcentration of 725-735 mg/L at131°F/55°Cand 40%-80% relative humidityfor 60 minutes | ||
| Advanced SterilizationProducts (ASP)STERRAD® 100SSystem | Advanced SterilizationProducts (ASP)STERRAD® 100SSystem | ||
| Advanced SterilizationProducts (ASP)STERRAD® 200System | Advanced SterilizationProducts (ASP)STERRAD® 200System | ||
| Advanced SterilizationProducts (ASP)STERRAD® NXSystem, Standard andAdvanced Cycles | Advanced SterilizationProducts (ASP)STERRAD® NXSystem, Standard andAdvanced Cycles | ||
| Advanced SterilizationProducts (ASP)STERRAD® 100NX,Standard, Flex,Express, and DUOcycles | Advanced SterilizationProducts (ASP)STERRAD® 100NX,Standard, Flex,Express, and DUOcycles | ||
| Lumen, Non-Lumen,and Flexible Cycles inthe STERIS V-PRO®1, V-PRO® 1 Plus andV-PRO® maX LowTemperatureSterilization Systems | Lumen, Non-Lumen,and Flexible Cycles inthe STERIS V-PRO®1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 LowTemperatureSterilization Systems | ||
| TSO3 STERIZONE®VP4 System Cycle 1 | |||
| Models/ Dimensions | Six basis weightsmodelsFourteen sizes(See Table 8 fordimensions) | Six basis weightsmodelsFourteen sizes(See Table 8 fordimensions) | Same |
| Maximum WrappedPackage ContentWeights(corresponding tominimum to | Pre-vacuum Steam: 3 to25 pounds | Pre-vacuum Steam: 3 to25 pounds | Same |
| maximum basisweights of wrapmodels) | Gravity Steam: 3 to 25poundsEO: 3 to 25 poundsSTERRAD® 100S: 3 to9.7 poundsSTERRAD® 200: 9.12poundsSTERRAD® NX: 10.7poundsSTERRAD® 100NX:10.7 poundsSTERIS V-PRO® 1, V-PRO® 1 Plus and V- | Gravity Steam: 3 to 25poundsEO: 3 to 25 poundsSTERRAD® 100S: 3 to9.7 poundsSTERRAD® 200: 9.12poundsSTERRAD® NX: 10.7poundsSTERRAD® 100NX:10.7 poundsSTERIS V-PRO® 1, V-PRO® 1 Plus and V-PRO®maX: 3 to 9.1pounds | |
| PRO® maX: 3 to 9.1 pounds | STERIS V-PRO® 60: 3 to 12 poundsSTERIZONE® VP4: 3 to 25 pounds | Same | |
| Maintenance ofSterility | Prevac steam = 365 daysGravity steam = 365 daysEO = 365 daysSterrad 100S = 365 daysSterrad 200 = 30 daysSterrad NX = 365 daysSterrad 100NX = 365 daysVPRO 1 = 365 daysVPRO 1 Plus = 365 daysVPRO maX = 365 days | VPRO 60 = 365 daysVP4 = 365 days | Same |
| Sterilant Penetration,ANSI/AAMI TIR 12,ANSI/AAMIST79/A4 | Negative for growth | Negative for growth | Same |
| Maintenance ofpackage sterility(Microbial AerosolChallenge)ANSI/AAMI TIR 12,ANSI/ AAMI /A4 | Negative for growth | Negative for growth | Same |
| Event related shelflife, ANSI/AAMI TIR12, ANSI/ AAMIST79/A4, PremarketNotification 510(k)Submissions forMedical SterilizationPackaging Systems inHealth Care Facilities;Draft Guidance forIndustry and FDA | No growth | No growth | Same |
| Biocompatibility –Irritation, ISO 10993-10 | Negligible irritant | Negligible irritant | Same |
| Leachability, ISO6588-2 | Non-Aged- ExtractAppearance: Clear,free of color- pH: Comparable tonegative controlAged 30 days- ExtractAppearance: Clear,free of color- pH: Comparable tonegative control | Non-Aged- ExtractAppearance: Clear,free of color- pH: Comparable tonegative controlAged 30 days- ExtractAppearance: Clear,free of color- pH: Comparable tonegative control | Same |
| Residuals, ISO 10993-7 | None detected | None detected | Same |
| Sterilization EfficacyANSI/AAMI TIR 12,ANSI/ AAMIST79/A4 | Negative for growth | Negative for growth | Same |
| MaterialCompatibility,PremarketNotification 510(k)Submissions forMedical SterilizationPackaging Systems inHealth Care Facilities;Draft Guidance forIndustry and FDA, -- Basis weight,ASTMD3776/D3776M-09- Air permeability,ASTM D737-04 | Compatible | Compatible | Same |
| - Material burststrength, ASTMD3786- Grab Tensilestrength, ASTMD5034-09- Trapezoidal Tearstrength, ASTMD5587-15- Hydrostatic Pressure,AATC127-2014 |
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Cardinal Health™ Sterilization Wrap is manufactured according to the Device Description in Table 8 below:
| WrapDimensions | Side A | Side B | Tolerance |
|---|---|---|---|
| 12"x12" | 12" | 12" | ±0.5" |
| 15"x15" | 15" | 15" | ±0.5" |
| 18"x18" | 18" | 18" | ±0.5" |
| 20"x20" | 20" | 20" | ±0.5" |
| 24"x24" | 24" | 24" | ±0.5" |
| 30"x30" | 30" | 30" | ±0.5" |
| 36"x36" | 36" | 36" | ±0.5" |
| 40"x40" | 40" | 40" | ±1" |
| 45"x45" | 45" | 45" | ±1" |
| 48"x48" | 48" | 48" | ±1" |
| 54"x54" | 54" | 54" | ±1" |
| 60"x60" | 60" | 60" | ±1" |
| 54"x72" | 54" | 72" | ±1" |
| 54"x90" | 54" | 90" | ±1" |
Table 8 – Device Description
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Summary of Non-Clinical Testing
Performance testing included sterilization efficacy, event related maintenance of package sterility, physical properties, and biocompatibility in compliance with the methods of ISO 10993.
Extensive performance testing has been completed on Cardinal Health™ Sterilization Wrap in this submission of the new indications for use with STERIS V-PRO® 60 and TSO3 STERIZONE® VP4. Data from testing demonstrates that the Cardinal Health™ Sterilization Wrap allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices after sterilization with the STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 systems.
Physical properties testing (Basis weight, Air permeability, Grab tensile strength, Trapezoidal tear strength, Bursting strength and Hydrostatic pressure) included in this submission also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated sterilization processes and storage because the polypropylene material is inert and very stable. These material compatibility results also demonstrate that the device meets the requirements of ISO 11607.
The proposed device (Cardinal Health™ Sterilization Wrap) has been evaluated for biocompatibility according to ISO 10993 test methods and is considered toxicologically acceptable for its intended use. All materials used in the Cardinal Health™ Sterilization Wrap have been evaluated through irritation, leachability and residuals testing after sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems.
The data shows that the biocompatibility of the Cardinal Health™ Sterilization Wrap following sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems is substantially equivalent to the biocompatibility of the predicate.
Performance testing demonstrates that both devices:
- Have the same intended use ●
- Have the same material composition
- Have the same physical and chemical properties
- Have the same dimensions
- Demonstrate maintenance of package sterility
- The physical properties of all wrap models have been characterized both before and after ● exposure to sterilization by STERIS V-PRO® 60 and TSO3 STERIZONE® VP4. The data demonstrates that the Cardinal Health™ Sterilization Wrap is compatible with the STERIS V-PRO® 60 and TSO3 STERIZONE® VP4 sterilization systems.
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Table 9: Summary of Non-Clinical Testing
| Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence | ||
|---|---|---|
| Non-Clinical Test | Standard | Results Summary |
| Microbial Barrier Properties | ||
| Maintenance of Package Sterility(Microbial Aerosol Challenge) | ANSI/AAMI TIR12, ANSI/AAMIST79 A1&A2 | Negative for growth |
| Event Related Shelf Life Test –365 days | ANSI/AAMI TIR12, ANSI/AAMIST79 A1&A2 | No growth |
| Material Compatibility withIndicated Sterilization Method- Basis weight,- Air permeability- Material burst strength- Grab Tensile strength- Trapezoidal Tear strength- Hydrostatic Pressure | ASTM D3776/D3776M-09 (2013)ASTM D737-04 (2012)ASTM D3786ASTM D5034-09 (2013)ASTM D5587-15AATC127-2014 | Compatible |
| Post-Sterilization Biocompatibility Testing | ||
| Residuals | ISO 10993-7 | None detected |
| Leachability | ISO 6588-2 | Non-Aged- Extract Appearance:Clear, free of color- pH: Comparable tonegative controlAged 30 days- Extract Appearance:Clear, free of color- pH: Comparable tonegative control |
| Irritation | ISO 10993, 10:2010 | Negligible irritant |
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Summary of Clinical Testing: Not applicable
Conclusions Drawn from Non-Clinical Data:
Based on the conclusions drawn from the intended use, technological characteristics, and nonclinical tests conducted, results demonstrate that the subject device is as effective and performs at least as well as the legally marketed device Cardinal Health™ Sterilization Wrap.
§ 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).