Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization wrap made of fabric, and the description focuses on its material properties and performance in sterilization and maintaining sterility. There is no mention of any computational or analytical functions that would involve AI/ML.

Therapeutic

No.
The device is a sterilization wrap intended to maintain sterility of enclosed medical devices, not to provide therapeutic treatment.

Diagnostic

No

The device is a sterilization wrap intended to enclose other medical devices for sterilization and to maintain their sterility. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric, intended for use as sterilization wrap. It is not software.

IVD (In Vitro Diagnostic)

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 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 device is a sterilization wrap made of polypropylene fabric. This material and structure are consistent with packaging for medical devices, not with components or reagents used in diagnostic tests.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information
- Reagents or calibrators

The device is clearly intended to be part of the sterilization process for other medical devices used in healthcare settings.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 following modality:

Standard and Advanced cycles of the STERRAD® NX Sterilization System.
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 the following durations:
30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .
All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

Product codes

FRG

Device Description

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider by Standard and Advanced cycles of the 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.

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.

Extensive performance testing has been completed on Cardinal Health DuraBlue™ Sterilization Wrap. Successful completion of the sterilization performance tests demonstrated that the wrap both allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided.

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 sterilization performance tests demonstrated that the wrap both allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided.

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). 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 STERRAD® NX Sterilization System is substantially equivalent to the DuraBlue™ Sterilization Wrap intended for use with the STERRAD® 100S Sterilization System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112283, K120658

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

K122S07

CardinalHealth

1430 Waukegan Road McGraw Park, IL 60085

www.cardinal.com

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

August 09, 2012

Sterilization Wrap

Telephone Number:

Date summary Prepared:

DuraBlue™ Sterilization Wrap

Class II per 21 CFR § 880.6850

Classification Name:

Predicate Device:

Trade Name:

Classification:

K112283 - DuraBlue™ Sterilization Wrap - STERRAD 100S K120658 - DuraBlue™ Sterilization Wrap - STERRAD 100S

Description:

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider by Standard and Advanced cycles of the 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.

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.

Extensive performance testing has been completed on Cardinal Health DuraBlue™ Sterilization Wrap. Successful completion of the sterilization performance tests demonstrated that the wrap both allows for sterilization of the enclosed contents and also maintains sterility of the enclosed devices until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided.

SEP 2 6 2012

1

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 following modality:

Standard and Advanced cycles of the STERRAD® NX Sterilization System. .
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 the following durations:

30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

| STERRAD®
System and
Cycle | Maximum Recommended
Chamber Load | Intended Load |
|-------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| 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 |

- Validated STERRAD® NX Sterilization Cycle

2

| 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 2 - 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.

1Individual 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.

3

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 STERRAD® NX sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the STERRAD® NX Standard or Advanced cycles is substantially equivalent to Cardinal Health DuraBlue™ Sterilization Wrap sterilized with the STERRAD® 100S system. The data demonstrates that the DuraBlue™ Sterilization Wrap is compatible with the Standard and Advanced cycles of the 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). 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 STERRAD® NX Sterilization System is substantially equivalent to the DuraBlue™ Sterilization Wrap intended for use with the STERRAD® 100S Sterilization System.

4

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The caduceus is represented by a triple-stranded helix.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 2 6 2012

Cardinal Health 200, Limited Liability Company C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K122507

Trade/Device Name: Cardinal Health DuraBlue™ Sterilization Wrap Sterrad® NX Sterilization System, Standard and Advanced Cycles Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: September 11, 2012 Received: September 12, 2012

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.

5

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/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,

For

Q. Sheth

Sittin. D.

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

6

Image /page/6/Picture/0 description: The image shows 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 converge at a point, resembling a bird in flight or a stylized leaf. The text "CardinalHealth" is written in a bold, sans-serif font.

Indications for Use

510(k) Number (if known): K122507

Device Name: Cardinal Health DuraBlue™ Sterilization Wrap

STERRAD® NX Sterilization System, Standard and Advanced Cycles

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 following modality:

Standard and Advanced cycles of the STERRAD® NX Sterilization System .
The wrap is intended to allow steritization 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 the following durations:
30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .
All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

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)

Elijah F. (Lawrie-Willen)

Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K122507 510(k)

7

| STERRAD®
System and
Cycle | Maximum Recommended
Chamber Load | Intended Load |
|-------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| 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 |

Table 1 - Validated STERRAD® NX Sterilization Cycles

・

.

:

.

:

. ·

8

Table 2 - Wrap Model Recommendations 1

| 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 |

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. trav 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.

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.