(282 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 by using:
• Advanced Sterilization Products (ASP) STERRAD® 200 System
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices until it is used.
The Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wraps are provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, Two Color comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.
They are intended to be used to enclose another medical device that is to be sterilized by a health care provider using the Advanced Sterilization Products (ASP) STERRAD® 200 System.
This document is an FDA 510(k) premarket notification for a medical device: Cardinal Health™ Sterilization Wrap. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets acceptance criteria through an AI/ML-driven study.
Therefore, the information required for a study proving a device meets acceptance criteria, especially for an AI/ML device (e.g., sample size for test/training set, expert involvement, MRMC study, ground truth establishment), is not present in this document. This submission is for a physical product (a sterilization wrap) and relies on non-clinical testing for performance and safety.
Let's break down why the requested information isn't available and what information is provided:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Summary of Non-Clinical Testing" in Table 4 (on page 13). This table essentially acts as the acceptance criteria and the reported performance for the physical device.
| Acceptance Criteria (Study) | Performance (Results Summary) |
|---|---|
| Microbial Barrier Properties: Maintenance of Package Integrity Test (Microbial Aerosol Challenge) | PASSED |
| Microbial Barrier Properties: Event Related Shelf Life Test - 365 days | PASSED |
| Sterrad® 200 Sterilant Penetration | PASSED |
| Material Compatibility with Indicated Sterilization Method (Basis weight, Air permeability, Material burst strength, Tensile strength and elongation, Tear strength, Hydrostatic Pressure, Lint Generation) | Compatible |
| Biocompatibility Testing: Cytotoxicity ISO 10993-5: 2009 | Non-cytotoxic, under the conditions of the test |
| Biocompatibility Testing: Sensitization, ISO 10993-10: 2010 | Non-sensitizing, under the conditions of the test |
| Biocompatibility Testing: Irritation, ISO 10993-10:2010 | Non-irritating, under the conditions of the test |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document because it's not relevant to a physical product's performance testing in the context of this 510(k) submission. The testing would involve laboratory evaluation of material properties and sterilization efficacy, not data sets for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there is no "ground truth" establishment in the sense of expert annotation for an AI/ML algorithm. The ground truth for this device's performance is determined by established laboratory testing standards (e.g., ISO, ASTM, AATCC standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human interpretation or adjudication involved in the performance testing for this device in the context of an AI/ML evaluation.
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
This is not applicable as the device is not an AI/ML product and does not involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI/ML product.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established scientific and engineering principles and standardized test methods (e.g., ASTM, ISO, AATCC standards) for material properties (e.g., burst strength, air permeability), microbial barrier efficacy, and biocompatibility. It's not a clinical "ground truth" derived from patient outcomes or expert consensus on medical images.
8. The sample size for the training set
This is not applicable as there is no AI/ML training set for this device.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML training set for this device.
In summary:
This FDA 510(k) document is for a traditional medical device (sterilization wrap) and demonstrates substantial equivalence through a series of non-clinical laboratory tests rather than AI/ML performance studies. The questions posed in the prompt are highly specific to AI/ML device evaluation, which is why the answers are predominantly "Not applicable" in this context.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized graphic of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing line that forms a wave-like shape at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2017
Cardinal Health 200, LLC Tatyana Bogdan Director, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085
Re: K161910
Trade/Device Name: Cardinal Health™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG Dated: March 10, 2017 Received: March 17, 2017
Dear Tatyana Bogdan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161910
Device Name Cardinal HealthTM Sterilization Wrap
Indications for Use (Describe)
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using:
· Advanced Sterilization Products (ASP) STERRAD® 200 System
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices until it is used.
All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200 in Table 1.
Table 1 – Validated Advanced Sterilization Products STERRAD® 200 Sterilization Cycle and Intended Load
| AdvancedSterilizationProducts (ASP)STERRAD®System | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| 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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| SterilizationWrap Model | Intended Load | Maximum RecommendedWrapped PackageContent Weights2 |
|---|---|---|
| Advanced SterilizationProducts (ASP)STERRAD® 200 | ||
| CH100 | Very light weight package(for example: towel packs or batteries). | 9.12 lbs |
| CH200 | Light weight package(for example: telescope with light cord). | 9.12 lbs |
| CH300 | Light to moderate weight package(for example: general use medical instruments). | 9.12 lbs |
| CH400 | Moderate to heavy weight package(for example: general use medical instruments). | 9.12 lbs |
| CH500 | Heavy weight package(for example: general use medical instruments). | 9.12 lbs |
| CH600 | Very heavy weight package(for example: general use medical instruments). | 9.12 lbs |
Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the Cardinal Health™ Sterilization Wraps.
The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® 200 Sterility Validation Studies:
· CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 2.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/5/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic above the company name. The graphic is made up of four curved lines that resemble a bird in flight. The company name is written in a bold, sans-serif font.
Cardinal Health
1500 Waukegan Road
Waukegan, IL 60085
Waukegan, IL 60085
cardinalhealth.com
510(k) SUMMARY
Cardinal Health™ Sterilization Wrap
| Manufacturer: | Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Tatyana Bogdan1500 Waukegan RoadWaukegan, IL 60085 |
| Telephone Number: | (847) 887-6812 |
| Fax Number: | (847) 887-2461 |
| Date summary Prepared: | April 20, 2017 |
| Product Trade Name: | Cardinal HealthTM Sterilization Wrap |
| Classification: | Class II per 21 CFR § 880.6850 |
| Classification Name: | Sterilization Wrap |
| Common Name: | Sterilization Wrap |
| Product Code: | FRG |
| Predicate Device: | K151445 - Cardinal HealthTM Sterilization Wrap |
| Reason for 510(k)Submission: | Additional product offering of a legally marketed device |
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Device Description:
The Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wraps are provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, Two Color comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.
They are intended to be used to enclose another medical device that is to be sterilized by a health care provider using the Advanced Sterilization Products (ASP) STERRAD® 200 System.
The Cardinal Health™ Sterilization Wraps are available in the models and dimensions below.
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| DimensionalSpecifications | Cardinal Health™ Sterilization Wrap Models | |||||
|---|---|---|---|---|---|---|
| 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 | 123 | 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 | 123 | 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 |
-
- Single Layer Sterilization Wrap
-
- Dual Layer Sterilization Wrap
-
- Two Color Sterilization Wrap
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Indications for Use
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using:
- Advanced Sterilization Products (ASP) STERRAD® 200 System .
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices until used.
All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200 in Table 1.
Table 1 – Validated Advanced Sterilization Products STERRAD® 200 Cycle and Intended Load
| AdvancedSterilizationProducts (ASP)STERRAD® System | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| ASPSTERRAD® 200 | 36.48 lbs | Reusable metal and non-metal medical devices, including up to12 lumens of the following lumen dimensions per chamber load:• an inside diameter of 1 mm or larger and a length of 125 mmor shorter of single-channel stainless steel lumens• an inside diameter of 2 mm or larger and a length of 250 mmor shorter of single-channel stainless steel lumens• an inside diameter of 3 mm or larger and a length of 400 mmor shorter of single-channel stainless steel lumens• an inside diameter of 6 mm or larger and a length of 310 mmor shorter of a single-channel Teflon®/Polyethylene lumen |
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| SterilizationWrap Model | Maximum Recommended WrappedPackage Content Weights2 | |
|---|---|---|
| Intended Load | Advanced Sterilization Products (ASP)STERRAD® 200 | |
| CH100 | Very light weight package(for example: towel packs or batteries). | 9.12 lbs |
| CH200 | Light weight package(for example: telescope with light cord). | 9.12 lbs |
| CH300 | Light to moderate weight package(for example: general use medical instruments). | 9.12 lbs |
| CH400 | Moderate to heavy weight package(for example: general use medical instruments). | 9.12 lbs |
| CH500 | Heavy weight package(for example: general use medical instruments). | 9.12 lbs |
| CH600 | Very heavy weight package(for example: general use medical instruments). | 9.12 lbs |
Table 2: Wrap Model Recommendations 1
The following loads were used in the Advanced Sterilization Products (ASP) STERRAD® 200 Sterility Validation Studies:
· CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 2.
1 Individual results may differ due to factors such as variations in handling practices, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight and size of individual content types that were validated for the Cardinal Health™ Sterilization Wraps.
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Table 3: Summary of the Technological Characteristics and Performance
| Summary of the technological characteristics and Performance of the device compared to thepredicate device | ||
|---|---|---|
| Element ofComparison | PREDICATECardinal Health™ Sterilization Wrap(K151445) | PROPOSEDCardinal Health™ Sterilization Wrap(K161910) |
| Manufacturer | Cardinal Health Inc. | Cardinal Health Inc. |
| Regulation/Product Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG |
| Trade Name | Cardinal Health™ Sterilization Wrap | Cardinal Health™ Sterilization Wrap |
| Intended Use | Cardinal Health™ Sterilization Wrap isintended to enclose another medical devicethat is to be sterilized by a health careprovider using:• Advanced Sterilization Products (ASP)STERRAD® 200 SystemThe wrap is intended to allow sterilization ofthe enclosed medical device(s) and tomaintain sterility of the enclosed device(s)until used. | Cardinal Health™ Sterilization Wrap isintended to enclose another medicaldevice that is to be sterilized by a healthcare provider using:• Advanced Sterilization Products (ASP)STERRAD® 200 SystemThe wrap is intended to allow sterilizationof the enclosed medical device(s) and tomaintain sterility of the enclosed device(s)until used. |
| Prescriptionvs. OTC | OTC | OTC |
| Single UseOnly vs.Reusable | Single Use Only | Single Use Only |
| MaterialComposition | Polypropylene fabric using SMS (spunbond-meltblown-spunbond) production process | Polypropylene fabric using SMS(spunbond-meltblown-spunbond)production process |
| ChemicalProperties | Polypropylene with blue pigment andantistatic treatment | Polypropylene with blue pigment andantistatic treatmentPolypropylene with green pigment andantistatic treatment |
| Element ofComparison | PREDICATECardinal Health™ Sterilization Wrap(K151445) | PROPOSEDCardinal Health™ Sterilization Wrap(K161910) |
| Device Design | Dual Layer, fold-over: Double-layerwrap comprised of a single sheet of bluepigmented SMS fabric that has beenfolded over in half and ultrasonicallysealed to itself on the three non-foldededges | Dual Layer, fold-over: Double-layer wrapcomprised of a single sheet of bluepigmented SMS fabric that has beenfolded over in half and ultrasonicallysealed to itself on the three non-foldededges |
| Dual Layer: Double-layer wrapcomprised of two separate sheets ofblue pigmented SMS fabric that havebeen ultrasonically sealed on twoopposing edges | Dual Layer: Double-layer wrapcomprised of two separate sheets of bluepigmented SMS fabric that have beenultrasonically sealed on two opposingedges | |
| Single Layer: Single-layer wrapcomprised of a single sheet of bluepigmented SMS fabric | Single Layer: Single-layer wrapcomprised of a single sheet of bluepigmented SMS fabric | |
| Two Color: Double-layer wrap comprisedof one sheet of blue pigmented SMSfabric and one sheet of green pigmentedSMS fabric that have been ultrasonicallysealed on two opposing edges | ||
| Sterilization | Advanced Sterilization Products (ASP) | Advanced Sterilization Products (ASP) |
| Parameters | STERRAD® 200 System | STERRAD® 200 System |
| Models/ | Six basis weights models | Six basis weights models |
| Dimensions | Fourteen sizes | Fourteen sizes |
| MaximumWrappedPackage ContentWeights | STERRAD® 200: 9.12 pounds | STERRAD® 200: 9.12 pounds |
| Maintenance ofSterility | STERRAD® 200: 365 days | STERRAD® 200: 365 days |
| SterilantPenetration | Passed | Passed |
| Biocompatibility -Cytotoxicity, ISO10993-5: 2009 | Non-cytotoxic , under the conditions ofthe test | Non-cytotoxic , under the conditions of thethe test |
| Biocompatibility -Sensitization, ISO10993-10: 2010 | Non-sensitizing, under the conditions ofthe test | Non-sensitizing, under the conditions ofthe test |
| Biocompatibility -Irritation, ISO10993-10:2010 | Non-irritating, under the conditions ofthe test | Non-irritating, under the conditions of thethe test |
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Discussion of Similarities and Differences:
The proposed Cardinal Health™ Sterilization Wrap is substantially equivalent in intended use, indication for use, materials, characteristics, dimensions and product features to the predicate device Cardinal Health™ Sterilization Wrap (K151445). Both devices have identical manufacturing processes.
The difference between the proposed and the predicate device is an additional product offering, Two Color, Dual-layer wrap to the previously cleared and currently marketed Single Color Dual-layer sterilization wrap. The additional product offering is the same design as the Single Color, Dual Layer offering with one exception; there is one sheet of green pigmented SMS fabric and one sheet of blue SMS that has been ultrasonically sealed on two opposing edges. This change was made to address customer preferences for end user identification of instrument trays for aesthetic purposes only.
This pigment difference does not impact safety or efficacy of the product. The Two Color Sterilization Wrap offering is of the same design, technology, base raw material, and has the same intended use, with the only difference being the addition of a green pigment. There has been no change to the performance from one color to two color. Non-clinical data as seen in Table 4 demonstrates that the additional product offering is substantially equivalent to predicate device.
Summary of Non-Clinical Testing
Performance testing included sterilization efficacy, event related maintenance of package sterility, physical properties, and biocompatibility in compliance with the methods of ISO 10993. Data from testing demonstrates that the Cardinal Health™ Sterilization Wrap allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices after sterilization with the Advanced Sterilization Products (ASP) STERRAD® 200 System.
| Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence | ||
|---|---|---|
| Study | Results Summary | |
| Microbial Barrier Properties | Maintenance of Package Integrity Test(Microbial Aerosol Challenge) | PASSED |
| Event Related Shelf Life Test - 365 days | PASSED | |
| Sterrad® 200 Sterilant Penetration | PASSED | |
| Material Compatibility with Indicated Sterilization MethodBasis weight, ASTM D3776-09Air permeability, ASTM D737-04 (2012)Material burst strength, ASTM D3786-13Tensile strength and elongation, ASTM D5034-09Tear strength, ASTM D5587-15Hydrostatic Pressure, AATCC127-2014Lint Generation, WSP 160.1 (12) | Compatible | |
| Post-SterilizationBiocompatibility Testing | Cytotoxicity ISO 10993-5: 2009 | Non-cytotoxic, under theconditions of the test |
| Sensitization, ISO 10993-10: 2010 | Non-sensitizing, under theconditions of the test | |
| Irritation, ISO 10993-10:2010 | Non-irritating, under theconditions of the test |
Table 4: Summary of Non-Clinical Testing
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Summary of Clinical Testing:
Not applicable
Conclusions Drawn from Non-Clinical Data:
Non-clinical data demonstrates that the Cardinal Health™ Sterilization Wrap are as safe, as effective, and performed as well as the legally marketed device identified in this summary.
§ 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).