(121 days)
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:
·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, Standard, Flex, Express, and DUO cycles
• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus and STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed devices until it is used.
Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. This product is a single-use device and for over-the-counter use only.
This document describes the validation of Cardinal Health™ Sterilization Wrap, specifically to demonstrate its substantial equivalence to a predicate device and support its use with gravity steam sterilization.
Here's the breakdown of acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Property | Reported Device Performance |
|---|---|
| Sterilization Efficacy | PASS |
| Microbial Barrier Properties (Aerosol Challenge) | PASS |
| Maintenance of Sterility (Gravity Steam) | PASS - 30 days |
| Maintenance of Sterility (Pre-vacuum Steam, EO, STERRAD, STERIS V-PRO) | PASS - 365 days |
| Material Compatibility with Indicated Sterilization Method (all methods) | Compatible |
| Biocompatibility (Cytotoxicity ISO 10993-5:2009) | Non-cytotoxic |
| Biocompatibility (Irritation ISO 10993-10:2010) | Non-irritating |
| Biocompatibility (Sensitization ISO 10993-10:2010) | Non-sensitizing |
Study Proving Device Meets Acceptance Criteria:
The study is referred to as "extensive performance testing" and "sterility validation studies" completed on Cardinal Health™ Sterilization Wrap. This included:
- Sterilization Performance Tests: Demonstrated that the wrap allows for sterilization of enclosed contents and maintains sterility.
- Physical Properties Testing: Supported that the integrity of the wrap properties is not compromised after sterilization by the indicated processes and storage.
- Biocompatibility Testing: Conducted in compliance with ISO 10993 methods.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document lists specific "loads" used for each sterilization method and for each wrap model (CH100-CH600) during "Sterility Validation Studies" (pages 5-6 and 13-14). These loads represent the test sets for demonstrating sterilization efficacy, microbial barrier, and maintenance of sterility.
- Gravity Steam Sterility Validation Studies:
- CH100: 1 tray liner, 1 lb metal mass.
- CH200: 1 tray liner, 3 lbs metal mass.
- CH300: 1 tray liner, 6 lbs metal mass.
- CH400: 1 tray liner, 10 lbs metal mass.
- CH500: 1 tray liner, 12 lbs metal mass.
- CH600: 1 tray liner, 20 lbs metal mass.
- Pre-vacuum Steam Sterility Validation Studies:
- CH100: 16 huck towels.
- CH200: 2 huck towels, 3 fluid-resistant drapes.
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass.
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs metal mass.
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs metal mass.
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs metal mass.
- EO Sterility Validation Studies:
- CH100: 16 huck towels.
- CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs metal mass.
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass.
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs metal mass.
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs metal mass.
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs metal mass.
- 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.
- 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.
- STERIS V-PRO® Sterility Validation Studies:
- CH100: Metal instruments.
- CH200-CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.
The data provenance is not specified beyond the fact that Cardinal Health is a US-based company, suggesting the studies likely occurred in the USA. The nature of these validation studies (evaluating specific loads under controlled sterilization conditions) implicitly indicates they were prospective studies for the purpose of demonstrating device performance and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This document pertains to the physical and biological performance of a sterilization wrap. The "ground truth" for such devices is established through laboratory testing following recognized standards for sterilization efficacy (e.g., sterility testing, microbial barrier testing) and physical/biocompatibility characteristics. It does not involve human expert interpretation of images or clinical data in the same way an AI diagnostic device would. Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications like radiologists is not applicable here. The ground truth is determined by the results of validated scientific and engineering tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As explained above, the "test set" involves physical samples subjected to defined sterilization processes and subsequent lab analyses, not human interpretation of data requiring adjudication.
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
Not applicable. This device is a sterilization wrap, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical product (a sterilization wrap), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on objective laboratory measurements and tests designed to assess:
- Sterilization Efficacy: Absence of microbial growth after sterilization.
- Microbial Barrier Properties: Resistance to microbial penetration.
- Maintenance of Sterility: Absence of microbial contamination after storage period.
- Physical Properties: Integrity and strength of the wrap material after sterilization.
- Material Compatibility: No adverse interaction with sterilization agents or enclosed devices.
- Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as per ISO standards.
This ground truth is established through adherence to recognized industrial and medical device standards (e.g., AAMI ST79, ISO 10993) and scientific testing methodologies.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/software product that requires a "training set" in the context of machine learning. The term "training set" is usually associated with AI model development.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the image of the faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Cardinal Health 200, LLC Ms. Megan Middaugh Regulatory Affairs Manager 1500 Waukegan Road Waukegan, IL 60085
Re: K151788
Trade/Device Name: Cardinal Health™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: October 8, 2015 Received: October 9, 2015
Dear Ms. Middaugh:
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. Iisting 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.
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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 forth in the quality systems (QS) 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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)
K151788
Device Name Cardinal HealthTM Sterilization Wrap
Indications for Use (Describe)
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:
·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, Standard, Flex, Express, and DUO cycles
• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus and STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed devices until it is used.
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 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, 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 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.
All models of 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 Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® cycles in Table 2. Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® sterilization cycles.
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Table 1 - Validated Advanced Sterilization Products STERRAD® NX® and STERRAD® 100NX® Sterilization Cycles and Intended Loads
| AdvancedSterilizationProducts (ASP)STERRAD®System | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| ASPSTERRAD® NX®Standard 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® NX®Advanced 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®100NX®Standard 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® FlexCycle | 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® DuoCycle | 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 |
| STERISV-PRO® Cycle | Maximum RecommendedChamber 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:Two trays, each containing a flexible endoscope with a lightcord (if not integral to endoscope) and mat with no additionalload 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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Table 2: Validated STERIS V-PRO® Cycles and Intended Loads
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Table 3: Wrap Model Recommendations1
| SterilizationWrap Model | Maximum Recommended Wrapped Package ContentWeights2 | ||||
|---|---|---|---|---|---|
| Intended Load | Pre-Vacuum,Gravity Steam,and EO | AdvancedSterilizationProducts(ASP)STERRAD®100S | AdvancedSterilizationProducts(ASP)STERRAD® NX®and 100NX® | STERISV-PRO® | |
| CH100 | Very light weight package(for example: towel packs orbatteries). | 3 lbs. | 3 lbs. | 10.7 lbs. | 3 lbs. |
| CH200 | Light weight package(for example: telescope withlight cord). | 6 lbs. | 6 lbs. | 10.7 lbs. | 6.5 lbs. |
| CH300 | Light to moderate weightpackage(for example: general usemedical instruments). | 9 lbs. | 9.7 lbs. | 10.7 lbs. | 9 lbs. |
| CH400 | Moderate to heavy weightpackage(for example: general usemedical instruments). | 13 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |
| CH500 | Heavy weight package(for example: general usemedical instruments). | 17 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |
| CH600 | Very heavy weight package(for example: general usemedical instruments). | 25 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |
The following loads were used in the Gravity Steam Sterility Validation Studies:
- CH100: 1 tray liner (23 in. x 19.5 in.), 1 lb 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.
- 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.
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The following loads were used in the pre-vacuum steam 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 1bs 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 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 bs 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. trav.
· 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® 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® Sterility Validation Studies:
- · CH100: Metal instruments.
· CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.
Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3.
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.
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/8/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a red graphic element above the text "CardinalHealth". The graphic element is composed of four curved lines that resemble a stylized bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
1500 Waukegan Road Waukegan, IL 60085 www.cardinalhealth.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health™ Sterilization Wrap
| Manufacturer: | Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Megan Middaugh1500 Waukegan RoadWaukegan, IL 60085 |
| Telephone Number: | (847) 887-6812 |
| Fax Number: | (847) 887-2461 |
| Date summary Prepared: | October 26, 2015 |
| 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 |
| Predicate Device: | K132060 - DuraBlue™ Sterilization Wrap for use with Pre-Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO),Advanced Sterilization Products (ASP) STERRAD® 100S,STERRAD® 100NX, and STERRAD® NX Systems, andSTERIS Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus, andAmsco® V-PRO® maX Low Temperature Sterilization System |
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Description:
Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. This product is 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:
- 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, Standard, Flex, Express, and DUO cycles
- Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-. PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems
Extensive performance testing has been completed on Cardinal Health™ Sterilization Wrap in this submission of the new indication for use with gravity steam sterilization. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices. Physical properties testing 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.
The trade name of Cardinal Health DuraBlue™ Sterilization Wrap has been changed to Cardinal Health™ Sterilization Wrap. This name change has no impact on the safety and efficacy of the product.
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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:
- 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, Standard, Flex, . Express, and DUO cycles
- Lumen, Non Lumen, and Flexible Cycles in the STERISV-PRO® 1, STERIS V-● PRO® 1 Plus and STERIS 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 devices until used.
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 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 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.
All models of Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles with the intended loads as described in Table 1.
All models of Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® cycles with the intended loads as described in Table 2. Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® sterilization cycles.
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Table 1 – Validated Advanced Sterilization Products STERRAD® NX® and STERRAD® 100NX® Sterilization Cycles and Intended Loads
| AdvancedSterilizationProducts (ASP)STERRAD®System | MaximumRecommendedChamber Load | Intended Load |
|---|---|---|
| ASPSTERRAD® NX®Standard 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® NX®Advanced 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®100NX®Standard 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® FlexCycle | 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® DuoCycle | 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 |
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| Table 2: Validated STERIS Amsco® V-PRO® 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 additionalload2. One tray containing a flexible endoscope with a light cord (ifnot integral to endoscope) and mat and an additional traycontaining non-lumened medical devicesThe 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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Table 3: Wrap Model Recommendations1
| Maximum Recommended Wrapped Package ContentWeights" | ||||||
|---|---|---|---|---|---|---|
| SterilizationWrap Model | Intended Load | Pre-Vacuum,Gravity Steam,and EO | AdvancedSterilizationProducts(ASP)STERRAD®100S | AdvancedSterilizationProducts(ASP)STERRAD® NX®and 100NX® | STERISV-PRO® | |
| CH100 | Very light weight package(for example: towel packs orbatteries). | 3 Ibs | 3 Ibs | 10.7 lbs | 3 Ibs | |
| CH200 | Light weight package(for example: telescope withlight cord). | 6 Ibs | 6 Ibs | 10.7 lbs | 6.5 lbs | |
| CH300 | Light to moderate weightpackage(for example: general usemedical instruments). | g Ibs | 9.7 lbs | 10.7 lbs | 9 lbs | |
| CH400 | Moderate to heavy weightpackage(for example: general usemedical instruments). | 13 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | |
| CH500 | Heavy weight package(for example: general usemedical instruments). | 17 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | |
| CH600 | Very heavy weight package(for example: general usemedical instruments). | 25 Ibs | 9.7 lbs | 10.7 lbs | 9.1 lbs |
The following loads were used in the gravity steam Sterility Validation Studies:
- CH100: 1 tray liner (23 in. x 19.5 in.), 1 lb 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.
- 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.
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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 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® 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® Sterility Validation Studies:
- CH100: Metal instruments.
- · CH200 CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.
Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3.
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'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.
Substantial Equivalence
The proposed Cardinal Health™ Sterilization Wrap is substantially equivalent to the predicate devices. 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 ●
- . Performance and safety attributes are substantially equivalent to the predicate. The physical properties of all wrap models have been characterized both before and after exposure to gravity steam sterilization. The resulting data supports the conclusion that Cardinal Health™ Sterilization Wrap sterilized with gravity steam is substantially equivalent to Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the prevacuum steam. The data demonstrates that the Cardinal Health™ Sterilization Wrap is compatible with the gravity steam sterilization.
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| Table 4: Overall Comparison to Predicate Device | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ------------------------------------------------- | -- |
| Element ofComparison | PREDICATECardinal Health DuraBlueTMSterilization Wrap (K132060) | PROPOSEDCardinal HealthTM SterilizationWrap | Comparisonto Predicate |
|---|---|---|---|
| Manufacturer | Cardinal Health Inc. | Same | SubstantiallyEquivalent |
| Regulation/Product Code | Sterilization Wrap: 880.6850 /FRG | Same | SubstantiallyEquivalent |
| Trade Name | Cardinal Health DuraBlueTMSterilization Wrap | Cardinal HealthTM Sterilization Wrap | SubstantiallyEquivalent |
| Intended Use | DuraBlueTM Sterilization Wrap isintended to enclose anothermedical device that is to besterilized by a health careprovider using:• Pre-vacuum steam at270°F/132°C for 4 minutes• 100% ethylene oxide (EO) witha concentration of 725-735mg/L at 131°F/55°C and40%-80% relative humidity for60 minutes• Advanced Sterilization Products(ASP) STERRAD® 100SSystem• Advanced Sterilization Products(ASP) STERRAD® NX®System, Standard andAdvanced Cycles• Advanced Sterilization Products(ASP) STERRAD® 100NX®,Standard, Flex, Express, andDUO cycles• Lumen, Non Lumen, andFlexible Cycles by theSTERIS V-PROTM1, V-PROTM1 Plus and V-PROTMMAX LowTemperature SterilizationSystemsThe wrap is intended to allowsterilization of the enclosedmedical device(s) and to maintainsterility of the enclosed device(s)until used. | Cardinal HealthTM Sterilization Wrapis intended to enclose anothermedical device that is to besterilized by a health care providerusing:• Gravity steam at 250°F/121°C for30 minutes• Pre-vacuum steam at270°F/132°C for 4 minutes• 100% ethylene oxide (EO) with aconcentration of 725-735 mg/Lat 131°F/55°C and 40%-80%relative humidity for 60 minutes• Advanced Sterilization Products(ASP) STERRAD® 100SSystem• Advanced Sterilization Products(ASP) STERRAD® NX®System, Standard andAdvanced Cycles• Advanced Sterilization Products(ASP) STERRAD® 100NX®,Standard, Flex, Express, andDUO cycles• Lumen, Non Lumen, and FlexibleCycles by the STERIS V-PROTM1, V-PROTM1 Plus andV-PROTMMAX LowTemperature SterilizationSystemsThe wrap is intended to allowsterilization of the enclosed medicaldevice(s) and to maintain sterility ofthe enclosed device(s) until used. | SubstantiallyEquivalent |
| Element ofComparison | PREDICATECardinal Health DuraBlue™Sterilization Wrap (K132060) | PROPOSEDCardinal Health™ SterilizationWrap | Comparisonto Predicate |
| MaterialComposition | Polypropylene fabric using SMS(spunbond-meltblown-spunbond)production process | Same | SubstantiallyEquivalent |
| PhysicalProperties | Dual Layer, fold-over: Double-layer wrap comprised of a singlesheet of blue pigmented SMSfabric that has been folded over inhalf and ultrasonically sealed toitself on the three non-foldededges | Dual Layer, fold-over: Double-layer wrap comprised of a singlesheet of blue pigmented SMS fabricthat has been folded over in halfand ultrasonically sealed to itself onthe three non-folded edgesDual Layer: Double-layer wrapcomprised of two separate sheetsof blue pigmented SMS fabric thathave been ultrasonically sealed ontwo opposing edgesTwo Color: Double-layer wrapcomprised of one sheet of bluepigmented SMS fabric and onesheet of green pigmented SMSfabric that have been ultrasonicallysealed on two opposing edges ( )Single Layer: Single-layer wrapcomprised of a single sheet of bluepigmented SMS fabric | SubstantiallyEquivalent |
| ChemicalProperties | Polypropylene with blue pigmentand antistatic treatment | Polypropylene with blue pigmentand antistatic treatmentPolypropylene with green pigmentand antistatic treatment | SubstantiallyEquivalent |
| Element of Comparison | PREDICATECardinal Health DuraBlue™Sterilization Wrap (K132060) | PROPOSEDCardinal Health™ SterilizationWrap | Comparison to Predicate |
| SterilizationParameters | Pre-vacuum steam at 270°F/132°Cfor 4 minutes | Gravity steam at 250°F/121°C for30 minutes | SubstantiallyEquivalent |
| 100% ethylene oxide (EO) with aconcentration of 725-735 mg/L at131°F/55°Cand 40%-80% relativehumidity for 60 minutes | Pre-vacuum steam at 270°F/132°Cfor 4 minutes | ||
| Advanced Sterilization Products(ASP) STERRAD® 100S System | 100% ethylene oxide (EO) with aconcentration of 725-735 mg/L at131°F/55°Cand 40%-80% relativehumidity for 60 minutes | ||
| Advanced Sterilization Products(ASP) STERRAD® NX® System,Standard and Advanced Cycles | Advanced Sterilization Products(ASP) STERRAD® 100S System | ||
| Advanced Sterilization Products(ASP) STERRAD® 100NX®,Standard, Flex, Express, and DUOcycles | Advanced Sterilization Products(ASP) STERRAD® NX® System,Standard and Advanced Cycles | ||
| Lumen, Non Lumen, and FlexibleCycles in the STERIS V-PRO® 1,V-PRO® 1 Plus and V-PRO® MAXLow Temperature SterilizationSystems | Advanced Sterilization Products(ASP) STERRAD® 100NX®,Standard, Flex, Express, and DUOcycles | ||
| Lumen, Non Lumen, and FlexibleCycles in the STERIS V-PRO® 1,V-PRO® 1 Plus and V-PRO® MAXLow Temperature SterilizationSystems | |||
| Models/Dimensions | Six basis weights modelsFourteen sizes(See Table 4 for dimensions) | Same | |
| MaximumWrappedPackageContentWeights | Pre-vacuum Steam: 3 to 25 poundsEO: 3 to 25 poundsSTERRAD® 100S: 3 to 9.7 poundsSTERRAD® NX®: 10.7 poundsSTERRAD® 100NX®: 10.7 poundsSTERIS V-PRO®: 3 to 9.1 pounds | Gravity Steam: 3 to 25 poundsPre-vacuum Steam: 3 to 25 poundsEO: 3 to 25 poundsSTERRAD® 100S: 3 to 9.7 poundsSTERRAD® NX®: 10.7 poundsSTERRAD® 100NX®: 10.7 poundsSTERIS V-PRO®: 3 to 9.1 pounds | |
| Element of Comparison | PREDICATECardinal HealthDuraBlue™Sterilization Wrap(K132060) | PROPOSEDCardinal Health™Sterilization Wrap | Comparison toPredicate |
| Sterilization Efficacy | Pass | Pass | SubstantiallyEquivalent |
| Microbial Barrier Properties | Pass | Pass | SubstantiallyEquivalent |
| Maintenance of Sterility | PASS - 365 days forPre-vacuum Steam,Ethylene Oxide,STERRAD® 100S,STERRAD® NX,STERRAD® 100NX,STERIS V-PRO® 1,V-PRO® 1 Plus andV-PRO®MAX Low | PASS- 30 days forGravity SteamPASS - 365 days forPre-vacuum Steam,Ethylene Oxide,STERRAD® 100S,STERRAD® NX,STERRAD® 100NX,STERIS V-PRO® 1, V-PRO® 1 Plus and V-PRO®MAX Low | SubstantiallyEquivalent |
| Material Compatibility | Compatible | Compatible | SubstantiallyEquivalent |
| Biocompatibility(Cytotoxicity ISO 10993-5: 2009;Sensitization, ISO 10993-10: 2010;Irritation, ISO 10993-10:2010) | Non-cytotoxicNon-sensitizingNon-irritating | Non-cytotoxicNon-sensitizingNon-irritating | SubstantiallyEquivalent |
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Summary of Testing
Cardinal Health™ Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in the FDA's Guidance Document Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002) in this submission and the predicate Premarket Notifications.
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 performance of the Cardinal Health™ Sterilization Wrap intended for use with the additional indication of gravity steam sterilization is substantially equivalent to the predicate device.
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Table 5: Performance Testing of Proposed Cardinal Health™ Sterilization Wrap
| Performance Properties | Results |
|---|---|
| Sterilization Efficacy | PASS |
| Microbial BarrierProperties | Aerosol ChallengePASS |
| Maintenance of SterilityPASS- 30 days for Gravity SteamPASS – 365 days for Pre-vacuum Steam,Ethylene Oxide, STERRAD® 100S, STERRAD®NX, STERRAD® 100NX, STERIS V-PRO® 1, V-PRO® 1 Plus and V-PRO®MAX Low | |
| Material Compatibility with Indicated SterilizationMethod | Compatible |
| Biocompatibility | Cytotoxicity, ISO 10993-5:2009Non-cytotoxic |
| Irritation, ISO 10993-10:2010Non- irritating | |
| Sensitization, ISO 10993-10:2010Non-sensitizing |
Conclusions:
Based on the results of the biocompatibility, sterilization, and physical performance testing, Cardinal Health™ Sterilization Wrap is safe for its intended use. The Cardinal Health™ Sterilization Wrap is substantially equivalent to the predicate device, in terms of general intended use, physical performance testing, material composition, sterilization process and compatibility, and configurations/dimensions.
§ 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).