(72 days)
Not Found
No
The device is a sterilization wrap made of polypropylene fabric, and the description focuses on its physical properties and sterilization performance, with no mention of AI or ML.
No
This device is a sterilization wrap intended to maintain the sterility of other medical devices, not to directly provide therapy to a patient. Its function is to facilitate the sterilization process and maintain a sterile environment for other medical devices.
No
The device is a sterilization wrap, not a diagnostic device. Its purpose is to maintain sterility of other medical devices after sterilization, not to diagnose medical conditions.
No
The device description clearly states it is a physical sterilization wrap made from polypropylene fabric, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose another medical device for sterilization and maintain its 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 construction 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 be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This sterilization wrap does not fit that definition.
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 by STERRAD® 100S System. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. All models have been validated for sterilization of lumens 2,5 mm in diameter or larger and 250 mm in length or less.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
Cardinal Health DuraBlue™ Sterilization Wrap is double layer sterilization wraps made from 100% polypropylene spunbond-methown-spunbond (SMS) fabric. The wrap in intended to be used to enclose another medical device that is to be sterilized by a health care provider by STERRAD® 100S System. This wrap design allows for use of the simulaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.
This submission covers six different models of Cardinal Heatth DuraBlue™ Sterlization Wrap. Each model is made from material of Caranal rieantl Durante in Sulabite in Suite Lacin While Leacher technology technology.
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)
Extensive performance testing has been completed on Cardinal Health DuraBlue™ Sterilization Wrap. Successful completion of the sterlization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents for at least 30 days.
DuraBlue™ Stenlization 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 Sterlization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDAJ (March 7, 2002). Testing included sterilization efficacy, event related maintonance of package sterlity, physical properties, and biocompatibility in compliance with the methods of ISO 1099. Data from testing demonstrates that the performance of the DuraBlue™ Stenlization Wrap is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Sterilization Wranz.
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.
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
112283
OCT 20 2011
" "
Image /page/0/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of three curved lines above the words "CardinalHealth". The lines are arranged in a way that they are parallel to each other. The text is in a bold, sans-serif font.
1430 Waukegan Road McGraw Park, IL 60085
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 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
(847) 887-3323
Telephone Number:
Date summary Prepared: September 28, 2011
DuraBlue™ Sterilization Wrap Trade Name:
Classification: Class II per 21 CFR § 880,6850
Classification Name: Sterilization Wrap
Predicate Device:
K092167- KIMGUARD ONE-STEP Sterilization Wrap (Models KC100, KC200, KC400, KC500 and KC600) for the Use With the Lumen Cycle of the Amsco V - PRO 1 Low Temperature Sterilization System and With the Lumen and Non Lumen Cycles of the Amsco V - PRO 1 Plus Low Temperature Sterilization System
Description:
Cardinal Health DuraBlue™ Sterilization Wrap is double layer sterilization wraps made from 100% polypropylene spunbond-methown-spunbond (SMS) fabric. The wrap in intended to be used to enclose another medical device that is to be sterilized by a health care provider by STERRAD® 100S System. This wrap design allows for use of the simulaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.
This submission covers six different models of Cardinal Heatth DuraBlue™ Sterlization Wrap. Each model is made from material of Caranal rieantl Durante in Sulabite in Suite Lacin While Leacher
technology technology.
Extensive performance testing has been completed on Cardinal Health DuraBlue™ Sterilization Wrap. Successful completion of the sterlization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents for at least 30 days.
1
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 by STERRAD® 100S System. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. All models have been validated for sterilization of lumens 2,5 mm in diameter or larger and 250 mm in length or less.
Wrap Model Recommendations 1
| Sterilization Wrap
Model | Intended Load | Maximum Recommended
Wrapped Package Content
Weights2 |
|-----------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------|
| CH100 | Very light weight package
(for example: batteries). | 3 lbs
(1.36 kg) |
| CH200 | Light weight package
(for example: telescope with light cord). | 6 lbs
(2.7 kg) |
| CH300 | Light to moderate weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
| CH400 | Moderate to heavy weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
| CH500 | Heavy weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
| CH600 | Very heavy weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
- · CH100: Metal instruments
- · CH200: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH300: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH400: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH500: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH600: 15 in. x 10 in. x 1.2 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,
2
Substantial Equivalence
The DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate devices.
- Both devices are double layer sterilization wraps which allow for use of the simultaneous double-. wrapping technique and for a sterilized pack to be opened aseptically.
- . Both devices are intended to be used with vaporized hydrogen peroxide sterilizers that operate at low temperatures and pressures.
- Both devices are available in six comparable models of varying basis weights, which are . recommended for use with the same maximum content weights.
- . Both devices have the same dimensional specifications.
- Both devices are100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate . nonwoven fabric.
- Both devices demonstrate maintenance of package sterility for at least 30 days following . sterilization by STERRAD® 100S.
- 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 STERRAD® 100S sterilization. The resulting data supports the conclusion that Cardinal Heath DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate, and the DuraBlue™ Stenlization Wraps are compatible with the identified STERRAD®100S System.
Summary of Testing
.
DuraBlue™ Stenlization 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 Sterlization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDAJ (March 7, 2002). Testing included sterilization efficacy, event related maintonance of package sterlity, physical properties, and biocompatibility in compliance with the methods of ISO 1099. Data from testing demonstrates that the performance of the DuraBlue™ Stenlization Wrap is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Sterilization Wranz.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardinal Health 200, LLC % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
OCT 2 0 2011
Re: K112283
Trade/Device Name: Cardinal Health DuraBlue™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: October 4, 2011 Received: October 5, 2011
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2- Mr. Devine
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/ReportalProblem/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, D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K112283
Device Name: Cardinal Health DuraBlue™ Sterilization Wrap
STERRAD® 100S
Indications for Use:
Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the STERRAD® 100S System. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed to 10 days. All models have been validated for sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.
| Sterilization Wrap
Model | Intended Load | Maximum Recommended
Wrapped Package Content
Weights² |
|-----------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------|
| CH100 | Very light weight package
(for example: batteries). | 3 lbs
(1.36 kg) |
| CH200 | Light weight package
(for example: telescope with light cord). | 6 lbs
(2.7 kg) |
| CH300 | Light to moderate weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
| CH400 | Moderate to heavy weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
| CH500 | Heavy weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
| CH600 | Very heavy weight package
(for example: general use medical instruments). | 9.7 lbs
(4.4 kg) |
Wrap Model Recommendations1
s
6
The following loads were used in the Sterility Maintenance Validation Study:
- · CH100: Metal instruments
- · CH200: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH300: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH400: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH500: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
- · CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
Note: The loads used in the Sterlity 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 heatthcare 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
Eld. R.U.
(Division Sign. Ofc.)
(Division) Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112283