(121 days)
No
The device is a sterilization wrap made of polypropylene fabric. The description focuses on its material properties, intended use for sterilization, and performance testing related to maintaining sterility and physical properties. There is no mention of any computational or analytical functions that would involve AI or ML.
No.
The device is a sterilization wrap intended to maintain sterility of devices, not to provide therapy itself.
No
The device, "Cardinal Health™ Sterilization Wrap," is intended to enclose medical devices for sterilization and maintain their sterility, not to diagnose medical conditions or diseases.
No
The device description clearly states the device is made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions based on in vitro examination of specimens.
- Device Description: The description details the material and construction of the sterilization wrap. This aligns with a packaging or barrier device, not a diagnostic test or instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases
The function of this device is to facilitate the sterilization process and maintain the sterility of other medical devices, which falls under the category of a general medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Performance Testing Results:
Sterilization Efficacy: PASS
Microbial Barrier Properties: Aerosol Challenge PASS
Maintenance of Sterility: PASS- 30 days for Gravity Steam; PASS – 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 Sterilization Method: Compatible
Biocompatibility:
Cytotoxicity, ISO 10993-5: 2009: Non-cytotoxic
Irritation, ISO 10993-10:2010: Non-irritating
Sensitization, ISO 10993-10: 2010: Non-sensitizing
Gravity Steam Sterility Validation Studies loads:
- 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.
Pre-vacuum steam Sterility Validation Studies loads:
- 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.
EO Sterility Validation Studies loads:
- 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.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies loads:
- 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 loads:
- CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
STERIS V-PRO® Sterility Validation Studies loads:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterilization Efficacy: PASS
Microbial Barrier Properties: Aerosol Challenge PASS
Maintenance of Sterility: PASS- 30 days for Gravity Steam; PASS – 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 Sterilization Method: Compatible
Biocompatibility: Non-cytotoxic, Non-irritating, Non-sensitizing
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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, and STERIS Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus, and Amsco® V-PRO® maX Low Temperature Sterilization System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
1
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
2
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.
3
Table 1 - Validated Advanced Sterilization Products STERRAD® NX® and STERRAD® 100NX® Sterilization Cycles and Intended Loads
| Advanced
Sterilization
Products (ASP)
STERRAD®
System | Maximum
Recommended
Chamber Load | Intended Load |
|-------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASP
STERRAD® NX®
Standard Cycle | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to 10
lumens of the following lumen dimensions per chamber load:
• an inside diameter of 1 mm or larger and a length of 150 mm or
shorter of single-channel stainless steel lumens
• an inside diameter of 2 mm or larger and a length of 400 mm or
shorter of single-channel stainless steel lumens |
| ASP
STERRAD® NX®
Advanced Cycle | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to 10
lumens of the following lumen dimensions per chamber load:
• an inside diameter of 1 mm or larger and a length of 500 mm or
shorter of single-channel stainless steel lumens
OR
One single-channel Flexible Endoscope with or without a silicone mat
and no additional load. The flexible endoscope may contain:
• a single-channel Teflon®/Polyethylene lumen with an inside
diameter of 1 mm or larger and a length of 850 mm or shorter |
| ASP
STERRAD®
100NX®
Standard Cycle | 21.4 lbs. | Reusable metal and non-metal medical devices, including up to 10
lumens of the following lumen dimensions per chamber load:
• an inside diameter of 0.7 mm or larger and a length of 500 mm or
shorter of single-channel stainless steel lumens (A maximum of
five lumens per tray per sterilization cycle) |
| ASP
STERRAD®
100NX® Flex
Cycle | 12.2 lbs. | One or two single-channel Flexible Endoscope with or without a
silicone mat and no additional load. The flexible endoscope may
contain:
• a single-channel Teflon®/Polyethylene lumen with an inside
diameter of 1 mm or larger and a length of 850 mm or shorter (A
maximum of two flexible endoscopes, one per tray per
sterilization cycle) |
| ASP
STERRAD®
100NX® Express
Cycle | 10.7 lbs. | Non-lumened reusable metal and non-metal medical devices
requiring surface sterilization, or sterilization of mated stainless steel
and titanium surfaces, and rigid or semi-rigid endoscopes without
lumens |
| ASP
STERRAD®
100NX® Duo
Cycle | 13.2 lbs. | One or two single-channel Flexible Endoscope with or without a
silicone mat and no additional load. The flexible endoscope may
contain:
• a single-channel Teflon®/Polyethylene lumen with an inside
diameter of 1 mm or larger and a length of 875 mm or shorter |
| STERIS
V-PRO® Cycle | Maximum Recommended
Chamber Load | Intended Load |
| Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical devices, including up to 20
lumens of the following dimensions per chamber load:
an inside diameter of 1 mm or larger and a length of
125 mm or shorter an inside diameter of 2 mm or larger and a length of
250 mm or shorter an inside diameter of 3 mm or larger and a length of
400 mm or shorter |
| Non Lumen
Cycle | 19.65 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | 24 lbs | Single or dual lumen surgical flexible endoscopes and
bronchoscopes in either of two load configurations:
Two trays, each containing a flexible endoscope with a light
cord (if not integral to endoscope) and mat with no additional
load 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 |
4
Table 2: Validated STERIS V-PRO® Cycles and Intended Loads
5
Table 3: Wrap Model Recommendations1
| Sterilization
Wrap Model | | Maximum Recommended Wrapped Package Content
Weights2 | | | |
|-----------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|------------------|
| | Intended Load | Pre-Vacuum,
Gravity Steam,
and EO | Advanced
Sterilization
Products
(ASP)
STERRAD®
100S | Advanced
Sterilization
Products
(ASP)
STERRAD® NX®
and 100NX® | STERIS
V-PRO® |
| CH100 | Very light weight package
(for example: towel packs or
batteries). | 3 lbs. | 3 lbs. | 10.7 lbs. | 3 lbs. |
| CH200 | Light weight package
(for example: telescope with
light cord). | 6 lbs. | 6 lbs. | 10.7 lbs. | 6.5 lbs. |
| CH300 | Light to moderate weight
package
(for example: general use
medical instruments). | 9 lbs. | 9.7 lbs. | 10.7 lbs. | 9 lbs. |
| CH400 | Moderate to heavy weight
package
(for example: general use
medical instruments). | 13 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |
| CH500 | Heavy weight package
(for example: general use
medical instruments). | 17 lbs. | 9.7 lbs. | 10.7 lbs. | 9.1 lbs. |
| CH600 | Very heavy weight package
(for example: general use
medical 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.
6
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.
7
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1500 Waukegan Road Waukegan, IL 60085 www.cardinalhealth.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health™ Sterilization Wrap
| Manufacturer: | Cardinal Health 200, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Megan Middaugh
1500 Waukegan Road
Waukegan, 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, and
STERIS Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus, and
Amsco® 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
| Advanced
Sterilization
Products (ASP)
STERRAD®
System | Maximum
Recommended
Chamber Load | Intended Load |
|-------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASP
STERRAD® NX®
Standard Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10
lumens of the following lumen dimensions per chamber load:
• an inside diameter of 1 mm or larger and a length of 150 mm or
shorter of single-channel stainless steel lumens
• an inside diameter of 2 mm or larger and a length of 400 mm or
shorter of single-channel stainless steel lumens |
| ASP
STERRAD® NX®
Advanced Cycle | 10.7 lbs | Reusable metal and non-metal medical devices, including up to 10
lumens of the following lumen dimensions per chamber load:
• an inside diameter of 1 mm or larger and a length of 500 mm or
shorter of single-channel stainless steel lumens
OR
One single-channel Flexible Endoscope with or without a silicone mat
and no additional load. The flexible endoscope may contain:
• a single-channel Teflon®/Polyethylene lumen with an inside
diameter of 1 mm or larger and a length of 850 mm or shorter |
| ASP
STERRAD®
100NX®
Standard Cycle | 21.4 lbs | Reusable metal and non-metal medical devices, including up to 10
lumens of the following lumen dimensions per chamber load:
• an inside diameter of 0.7 mm or larger and a length of 500 mm or
shorter of single-channel stainless steel lumens (A maximum of
five lumens per tray per sterilization cycle) |
| ASP
STERRAD®
100NX® Flex
Cycle | 12.2 lbs | One or two single-channel Flexible Endoscope with or without a
silicone mat and no additional load. The flexible endoscope may
contain:
• a single-channel Teflon®/Polyethylene lumen with an inside
diameter of 1 mm or larger and a length of 850 mm or shorter (A
maximum of two flexible endoscopes, one per tray per
sterilization cycle) |
| ASP
STERRAD®
100NX® Express
Cycle | 10.7 lbs | Non-lumened reusable metal and non-metal medical devices
requiring surface sterilization, or sterilization of mated stainless steel
and titanium surfaces, and rigid or semi-rigid endoscopes without
lumens |
| ASP
STERRAD®
100NX® Duo
Cycle | 13.2 lbs | One or two single-channel Flexible Endoscope with or without a
silicone mat and no additional load. The flexible endoscope may
contain:
• a single-channel Teflon®/Polyethylene lumen with an inside
diameter of 1 mm or larger and a length of 875 mm or shorter |
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| Table 2: Validated STERIS Amsco® V-PRO® Cycles and Intended Loads | ||||
|---|---|---|---|---|
| STERIS V-PRO®
Cycle | Maximum
Recommended
Chamber Load | Intended Load |
|------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Cycle | 19.65 lbs | Reusable metal and non-metal medical devices, including up to 20
lumens of the following dimensions per chamber load:
• an inside diameter of 1 mm or larger and a length of
125 mm or shorter
• an inside diameter of 2 mm or larger and a length of
250 mm or shorter
• an inside diameter of 3 mm or larger and a length of
400 mm or shorter |
| Non Lumen
Cycle | 19.65 lbs | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | 24 lbs | Single or dual lumen surgical flexible endoscopes and
bronchoscopes in either of two load configurations:
- Two trays, each containing a flexible endoscope with a light
cord (if not integral to endoscope) and mat with no additional
load - 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: Wrap Model Recommendations1
| | | Maximum Recommended Wrapped Package Content
Weights" | | | | |
|-----------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|------------------|--|
| Sterilization
Wrap Model | Intended Load | Pre-Vacuum,
Gravity Steam,
and EO | Advanced
Sterilization
Products
(ASP)
STERRAD®
100S | Advanced
Sterilization
Products
(ASP)
STERRAD® NX®
and 100NX® | STERIS
V-PRO® | |
| CH100 | Very light weight package
(for example: towel packs or
batteries). | 3 Ibs | 3 Ibs | 10.7 lbs | 3 Ibs | |
| CH200 | Light weight package
(for example: telescope with
light cord). | 6 Ibs | 6 Ibs | 10.7 lbs | 6.5 lbs | |
| CH300 | Light to moderate weight
package
(for example: general use
medical instruments). | g Ibs | 9.7 lbs | 10.7 lbs | 9 lbs | |
| CH400 | Moderate to heavy weight
package
(for example: general use
medical instruments). | 13 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | |
| CH500 | Heavy weight package
(for example: general use
medical instruments). | 17 lbs | 9.7 lbs | 10.7 lbs | 9.1 lbs | |
| CH600 | Very heavy weight package
(for example: general use
medical 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 of
Comparison | PREDICATE
Cardinal Health DuraBlueTM
Sterilization Wrap (K132060) | PROPOSED
Cardinal HealthTM Sterilization
Wrap | Comparison
to Predicate |
|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer | Cardinal Health Inc. | Same | Substantially
Equivalent |
| Regulation/
Product Code | Sterilization Wrap: 880.6850 /
FRG | Same | Substantially
Equivalent |
| Trade Name | Cardinal Health DuraBlueTM
Sterilization Wrap | Cardinal HealthTM Sterilization Wrap | Substantially
Equivalent |
| Intended Use | DuraBlueTM Sterilization Wrap is
intended 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
• 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 by the
STERIS V-PROTM1, V-
PROTM1 Plus and V-
PROTMMAX 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. | Cardinal HealthTM Sterilization Wrap
is intended 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 by the STERIS V-
PROTM1, V-PROTM1 Plus and
V-PROTMMAX 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. | Substantially
Equivalent |
| Element of
Comparison | PREDICATE
Cardinal Health DuraBlue™
Sterilization Wrap (K132060) | PROPOSED
Cardinal Health™ Sterilization
Wrap | Comparison
to Predicate |
| Material
Composition | Polypropylene fabric using SMS
(spunbond-meltblown-spunbond)
production process | Same | Substantially
Equivalent |
| Physical
Properties | Dual Layer, fold-over: Double-
layer wrap comprised of a single
sheet of blue pigmented SMS
fabric that has been folded over in
half and ultrasonically sealed to
itself on the three non-folded
edges | Dual Layer, fold-over: Double-
layer wrap comprised of a single
sheet of blue pigmented SMS fabric
that has been folded over in half
and ultrasonically sealed to itself on
the three non-folded edges
Dual Layer: Double-layer wrap
comprised of two separate sheets
of blue pigmented SMS fabric that
have been ultrasonically sealed on
two opposing edges
Two Color: Double-layer wrap
comprised of one sheet of blue
pigmented SMS fabric and one
sheet of green pigmented SMS
fabric that have been ultrasonically
sealed on two opposing edges ( )
Single Layer: Single-layer wrap
comprised of a single sheet of blue
pigmented SMS fabric | Substantially
Equivalent |
| Chemical
Properties | Polypropylene with blue pigment
and antistatic treatment | Polypropylene with blue pigment
and antistatic treatment
Polypropylene with green pigment
and antistatic treatment | Substantially
Equivalent |
| Element of Comparison | PREDICATE
Cardinal Health DuraBlue™
Sterilization Wrap (K132060) | PROPOSED
Cardinal Health™ Sterilization
Wrap | Comparison to Predicate |
| Sterilization
Parameters | Pre-vacuum steam at 270°F/132°C
for 4 minutes | Gravity steam at 250°F/121°C for
30 minutes | Substantially
Equivalent |
| | 100% ethylene oxide (EO) with a
concentration of 725-735 mg/L at
131°F/55°Cand 40%-80% relative
humidity for 60 minutes | Pre-vacuum steam at 270°F/132°C
for 4 minutes | |
| | Advanced Sterilization Products
(ASP) STERRAD® 100S System | 100% ethylene oxide (EO) with a
concentration of 725-735 mg/L at
131°F/55°Cand 40%-80% relative
humidity 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 DUO
cycles | Advanced Sterilization Products
(ASP) STERRAD® NX® System,
Standard and Advanced Cycles | |
| | Lumen, Non Lumen, and Flexible
Cycles in the STERIS V-PRO® 1,
V-PRO® 1 Plus and V-PRO® MAX
Low Temperature Sterilization
Systems | Advanced Sterilization Products
(ASP) STERRAD® 100NX®,
Standard, Flex, Express, and DUO
cycles | |
| | | Lumen, Non Lumen, and Flexible
Cycles in the STERIS V-PRO® 1,
V-PRO® 1 Plus and V-PRO® MAX
Low Temperature Sterilization
Systems | |
| Models/
Dimensions | Six basis weights models
Fourteen sizes
(See Table 4 for dimensions) | Same | |
| Maximum
Wrapped
Package
Content
Weights | Pre-vacuum Steam: 3 to 25 pounds
EO: 3 to 25 pounds
STERRAD® 100S: 3 to 9.7 pounds
STERRAD® NX®: 10.7 pounds
STERRAD® 100NX®: 10.7 pounds
STERIS V-PRO®: 3 to 9.1 pounds | Gravity Steam: 3 to 25 pounds
Pre-vacuum Steam: 3 to 25 pounds
EO: 3 to 25 pounds
STERRAD® 100S: 3 to 9.7 pounds
STERRAD® NX®: 10.7 pounds
STERRAD® 100NX®: 10.7 pounds
STERIS V-PRO®: 3 to 9.1 pounds | |
| Element of Comparison | PREDICATE
Cardinal Health
DuraBlue™
Sterilization Wrap
(K132060) | PROPOSED
Cardinal Health™
Sterilization Wrap | Comparison to
Predicate |
| Sterilization Efficacy | Pass | Pass | Substantially
Equivalent |
| Microbial Barrier Properties | Pass | Pass | Substantially
Equivalent |
| Maintenance of Sterility | PASS - 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 | PASS- 30 days for
Gravity Steam
PASS - 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 | Substantially
Equivalent |
| Material Compatibility | Compatible | Compatible | Substantially
Equivalent |
| Biocompatibility
(Cytotoxicity ISO 10993-5: 2009;
Sensitization, ISO 10993-10: 2010;
Irritation, ISO 10993-10:2010) | Non-cytotoxic
Non-sensitizing
Non-irritating | Non-cytotoxic
Non-sensitizing
Non-irritating | Substantially
Equivalent |
17
18
19
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.
20
Table 5: Performance Testing of Proposed Cardinal Health™ Sterilization Wrap
| Performance Properties | Results |
|---|---|
| Sterilization Efficacy | PASS |
| Microbial Barrier | |
| Properties | Aerosol Challenge |
| PASS | |
| Maintenance of Sterility | |
| PASS- 30 days for Gravity Steam |
PASS – 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 Sterilization
Method | Compatible |
| Biocompatibility | Cytotoxicity, ISO 10993-5:
2009
Non-cytotoxic |
| | Irritation, ISO 10993-10:2010
Non- irritating |
| | Sensitization, ISO 10993-10:
2010
Non-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.