(40 days)
Not Found
No
The document describes a physical sterilization wrap and its performance characteristics, with no mention of AI or ML technology.
No.
The device is a sterilization wrap intended to maintain the sterility of other medical devices, not to provide therapy itself.
No
This device is a sterilization wrap, not a diagnostic device. Its purpose is to maintain the sterility of other medical devices, not to diagnose medical conditions.
No
The device is a physical sterilization wrap made of polypropylene fabric, not software. The description focuses on material properties and performance in sterilization processes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 using samples from the human body.
- Device Description: The description focuses on the material and design of the wrap for sterilization purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or screening. This sterilization wrap does not fit that description.
N/A
Intended Use / Indications for Use
Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using the following modalities:
- Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles.
- Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
Cardinal Health DuraBlue™ Sterlization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to enclose another medical device that is to be sterilized by a health care provider by Standard, Flex, Express, and Duo cycles of the Johnson & Johnson STERRAD® 100NX and the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX hydrogen peroxide gas plasma sterilization system. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The proposed DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days.
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)
Performance testing has been completed on Cardinal Health DuraBlue™ Sterilization Wrap for the new indication for use with the Standard. Flex, Express, and DUO cycles of the Johnson & Johnson STERRAD® 100NX and the additional maintenance of sterility with the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterilization of the enclosed contents. Physical properties testing also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated modalities and storaqe because the polypropylene material is inert and very stable. Additionally, the DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days following sterilization via the indicated Johnson & Johnson STERRAD® NX and 100NX cycles.
Table 1: Performance Testing of Proposed DuraBlue Sterilization Wrap sterilized by STERRAD® 100NX or STERRAD® NX system
| Performance Properties | Results |
|---|---|
| Sterilization Efficacy | PASS |
| Microbial Barrier Properties | Aerosol Challenge - PASS |
| Event Related Shelf Life - PASS- 180 days | |
| Material Compatibility with Indicated Sterilization Method | Compatible |
| Biocompatibility | PASS |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K122507 - DuraBlue™ Sterilization Wrap - Johnson & Johnson STERRAD NX
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).
0
123.857
Image /page/0/Picture/1 description: The image contains the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that intersect, resembling a bird in flight or an abstract design. The text "CardinalHealth" is written in a bold, sans-serif font.
1430 Waukegan Road McGraw Park, IL 60085
JAN 2 3 2013
510(k) SUMMARY DuraBlue™ Sterilization Wrap
Manufacturer:
Cardinal Health 200, LLC 1430 Waukegan Road McGaw Park, IL 60085
Regulatory Affairs Contact:
Lavenia Ford 1430 Waukegan Road McGaw Park, IL 60085
DuraBlue™ Sterilization Wrap
(847) 887-3323 Telephone Number:
Date summary Prepared: December 20, 2012
Trade Name:
Class II per 21 CFR § 880.6850 Classification:
Sterilization Wrap
Classification Name: Sterilization Wrap
Common Name:
Product Code: FRG
Predicate Device:
K122507 - DuraBlue™ Sterilization Wrap - Johnson & Johnson STERRAD NX
Description:
Cardinal Health DuraBlue™ Sterlization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to enclose another medical device that is to be sterilized by a health care provider by Standard, Flex, Express, and Duo cycles of the Johnson & Johnson STERRAD® 100NX and the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX hydrogen peroxide gas plasma sterilization system. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The proposed DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days.
Extensive performance testing has also been completed on Cardinal Health DuraBlue™ Sterilization Wrap in the this submission for the new indication for use with the Standard. Flex, Express, and DUO cycles of the Johnson & Johnson STERRAD® 100NX and the additional maintenance of sterility with the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterilization of the enclosed
1
contents. 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 modalities and storaqe because the polypropylene material is inert and very stable. Additionally, the DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days following sterilization via the indicated Johnson & Johnson STERRAD® NX and 100NX cycles.
Table 1: Performance Testing of Proposed DuraBlue Sterilization Wrap sterilized by STERRAD® 100NX or STERRAD® NX system
| Performance Properties | Results | |
|---|---|---|
| Sterilization Efficacy | PASS | |
| Microbial Barrier | ||
| Properties | Aerosol Challenge | PASS |
| Event Related Shelf | ||
| Life | PASS- 180 days | |
| Material Compatibility with Indicated | ||
| Sterilization Method | Compatible | |
| Biocompatibility | PASS |
This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.
Indications for Use:
Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using the following modalities:
- Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. .
- Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles .
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality.
All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Johnson & Johnson STERRAD® 100NX and STERRAD® NX cycles in Table 1 and 2.
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Table 1 - Validated Johnson & Johnson STERRAD® 100NX Sterilization Cycles
| Johnson & Johnson
STERRAD® System
and Cycle | Maximum
Recommended
Chamber Load | Intended Load |
|-------------------------------------------------------|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Johnson & Johnson
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) |
| Johnson & Johnson
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) |
| Johnson & Johnson
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 |
| Johnson & Johnson
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 |
3
| Johnson &
Johnson
STERRAD®
System and
Cycle | Maximum Recommended
Chamber Load | Intended Load |
|-------------------------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Johnson &
Johnson
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
lumensan inside diameter of 2 mm or larger and a length of
400 mm or shorter of single-channel stainless steel
lumens |
| Johnson &
Johnson
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 |
l
Table 2 – Validated Johnson & Johnson STERRAD® NX Sterilization Cycles
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| Sterilization
Wrap Model | Intended Load | Maximum Recommended Wrapped
Package Content Weight2 |
|-----------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------|
| CH100 | Very light weight package
(for example: batteries) | 10.7 lbs |
| CH200 | Light weight package
(for example: telescope with light cord) | 10.7 lbs |
| CH300 | Light to moderate weight package
(for example: general use medical instruments) | 10.7 lbs |
| CH400 | Moderate to heavy weight package
(for example: general use medical instruments) | 10.7 lbs |
| CH500 | Heavy weight package
(for example: general use medical instruments) | 10.7 lbs |
| CH600 | Very heavy weight package
(for example: general use medical instruments) | 10.7 lbs |
Table 3 - Wrap Model Recommendations1
The following loads were used in the Sterility Maintenance Validation Study:
- · CH100: 23 in. x 11 in. x 4 in. tray containing metal instruments
- · CH200: 23 in. x 11 in. x 4 in. tray containing metal instruments
- · CH300: 23 in. x 11 in. x 4 in. tray containing metal instruments
- · CH400: 23 in. x 11 in. x 4 in. tray containing metal instruments
- · CH500: 23 in. x 11 in. x 4 in. tray containing metal instruments
- · CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments
Note: The loads used in the Sterility Maintenance Validation Study corresponded to the maximum wrapped package content weights in Table 2.
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 DuraBlue™ Sterilization Wraps.
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Substantial Equivalence
The proposed DuraBlue" 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 configurations/dimensions .
- Demonstrate maintenance of package sterility within the period of time for which performance . data demonstrating maintenance of sterility has been provided
- 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 Johnson & Johnson STERRAD® 100NX and STERRAD® NX sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue ™ Sterilization Wrap sterilized with the Johnson & Johnson STERRAD® 100NX Standard, Flex, Express, and Duo cycles or the Johnson & Johnson STERRAD® NX Standard or Advanced cycles is substantially equivalent to Cardinal Health DuraBlue™ Sterilization Wrap sterilizedwith the Johnson & Johnson STERRAD® NX system. The data demonstrates that the DuraBlue™ Sterilization Wrap is compatible with the Standard, Flex, Express, and Duo cycles of the Johnson STERRAD® 100NX and the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX Sterilization System.
Summary of Testing
DuraBlue™ 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. 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 DuraBlue™ Sterilization Wrap intended for use with the Johnson & Johnson STERRAD® 100NX Sterilization System or the Johnson & Johnson STERRAD® NX is substantially equivalent to the DuraBlue™ Sterilization Wrap intended for use with the Johnson & Johnson STERRAD® NX Sterilization System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2013
Cardinal Health 200, Limited Liability Company C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062
Re: K123857
Trade/Device Name: DuraBlue™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 8, 2013 Received: January 10, 2013
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowed your corrent the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
7
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Anthony Ls m
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/8/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the text "CardinalHealth". The graphic appears to be three curved lines that converge at one point.
Indications for Use
510(k) Number (if known): K123857
· Device Name: Cardinal Health DuraBlue™ Sterilization Wrap
STERRAD® 100NX Sterilization System, Standard, Flex, Express, and Duo Cycles
STERRAD® NX Sterilization System, Standard and Advanced Cycles
Indications for Use:
Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using the following modalities:
- Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. .
- Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time testing for a duration of 180 days for each indicated modality.
All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Johnson & All models of Burabled - Otonialism - Sterman - NX cycles in Table 1 and 2.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Devices Evaluation (ODE)
Ramesh C. Panguluri -S 2013.01.23 12:25:02 -05'00'
Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k)