(76 days)
Not Found
No
The device is a physical sterilization wrap and the description focuses on its material properties and compatibility with various sterilization methods, with no mention of AI/ML.
No
The device is a sterilization wrap intended to maintain the sterility of other medical devices, not to directly treat or diagnose a medical condition.
No.
The device is a sterilization wrap intended to maintain the sterility of medical devices, not to diagnose medical conditions.
No
The device description clearly states it is a physical product made from polypropylene fabric, intended to enclose other medical devices for sterilization. It is a tangible, hardware-based medical device, 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. It does not mention any use in the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the material and function of the wrap as a sterilization packaging system.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the DuraBlue™ Sterilization Wrap falls under the category of a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DuraBlue™ Sterilization Wrap is intended to be used 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 system, Standard, Flex, Express, and . DUO Cycles
- Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® 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 device(s) until used.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
DuraBlue™ Sterilization 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 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
- 2 @ Cyrist Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® VPRO™ 1 Plus and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems .
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 device is identical to the device cleared in the predicate submissions. The only modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use labeling. This change is being made in order to comply with 21CFR880.6850 which states "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."
This submission covers six different models of DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material 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)
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 the predicate Premarket Notifications. Risk analysis showed that the modification to the information provided in the labeling does not present and increase or change in risk of illness or injury associated with the use of this device. The only modification to the labeling is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use ' labeling.
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.
K123857 – DuraBlue™ Sterilization Wrap – Johnson & Johnson STERRAD® NX and STERRAD® 100NX, K123289 - DuraBlue™ Sterilization Wrap - Pre-Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO), K120658 – DuraBlue™ Sterilization Wrap – STERRAD® 100S and Arreoooo - Barablao - StormEx. Pro TM 1 Plus, and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems
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
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 appears to be three curved lines that converge at a point, resembling a bird in flight or a stylized leaf. The text "CardinalHealth" is written in a simple, sans-serif font.
1430 Waukegan Road Waukegan, IL 60085
510(k) SUMMARY DuraBlue™ Sterilization Wrap
Manufacturer:
Cardinal Health 200, LLC 1430 Waukegan Road Waukegan, IL 60085
1430 Waukegan Road Waukegan, IL 60085
Requlatory Affairs Contact:
Telephone Number:
Fax Number:
Date summary Prepared:
Trade Name:
Classification:
Classification Name:
Common Name:
Product Code:
Predicate Device:
(847) 887-3323
(847) 887-2461
Lavenia Ford
June 14, 2013
DuraBlue™ Sterilization Wrap
Class II per 21 CFR § 880.6850
Sterilization Wrap
Sterilization Wrap
FRG
K123857 – DuraBlue™ Sterilization Wrap – Johnson & Johnson STERRAD® NX and STERRAD® 100NX
K123289 - DuraBlue™ Sterilization Wrap - Pre-Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO)
K120658 – DuraBlue™ Sterilization Wrap – STERRAD® 100S and Arreoooo - Barablao - StormEx. Pro TM 1 Plus, and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems
JUN 1 8 2013
1
Description:
DuraBlue™ Sterilization 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 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
- 2 @ Cyrist
Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® VPRO™ 1 Plus and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems .
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 device is identical to the device cleared in the predicate submissions. The only modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use labeling. This change is being made in order to comply with 21CFR880.6850 which states "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."
This submission covers six different models of 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
DuraBlue™ 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 . Cvcles
- Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and . DUO cvcles
- Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® VPRO™ 1 Plus and Amsco® 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 device(s) until used.
For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Y Models CH100 and CH200 and 30 minutes for Models CH300, CH500, and CH600. Models
2
CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of 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 sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.
All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) STERRAD® 100S sterlization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.
All models of DuraBlue™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX in Table 1.
All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO™ cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO™ sterilization cycles.
3
Table 1 – Validated Advanced Sterilization Products STERRAD® NX and STERRAD® 100NX Sterilization Cycles
,
:
| Advanced
Sterilization
Products
(ASP)
STERRAD®
System and
Cycle | 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 |
.
1000 Children
.
4
| Table 2 – Validated STERIS Amsco® V-PRO™ cycles | ||
|---|---|---|
| Amsco® 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 |
and the control control control control controlled
100 - 100 - 100 - 100 -
Table 2 – Validated STERIS Amsco® V-PRO™ cycles
5
Table 3 - Wrap Model Recommendations1
| | | Maximum Recommended Wrapped Package Content
Weight2 | | | |
|-----------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------|
| Sterilization
Wrap Model | Intended Load | Pre-Vacuum
Steam and EO | Advanced
Sterilization
Products (ASP)
STERRAD®
100S | Advanced
Sterilization
Products
(ASP)
STERRAD®
NX and 100NX | STERIS
Amsco®
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 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 I. D x 400 mm), and 8 Ibs 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 I. D x 400 mm), and 12 Ibs 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 I. D x 400 mm), and 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 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 I. D x 400 mm), and 7.5 Ibs 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 1. D x 400 mm), and 11.5 Ibs 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 1. D 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 Amsco® V-PRO™ sterility Validation Study:
- · CH100: Metal Instruments
- · CH200 CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments
Note: The loads used in the 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 DuraBlue™ Sterilization Wraps.
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
- Are indicated for the same sterilization parameters
- Are indicated for the same Maximum Wrapped Package Content Weight
7
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 the predicate Premarket Notifications. Risk analysis showed that the modification to the information provided in the labeling does not present and increase or change in risk of illness or injury associated with the use of this device. The only modification to the labeling is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use ' labeling.
8
Image /page/8/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 of medicine and health. The caduceus is depicted as a staff with a snake winding around it, and it is accompanied by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2013
Cardinal Health Ms. Lavenia Ford Manager, Regulatory Affairs 1430 Waukegan Road WAUKEGAN, IL 60085
Re: K130927
Trade/Device Name: DuraBlue™ Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: May 16, 2013 Received: May 20, 2013
Dear Ms. Ford:
We have reviewed vour 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.
9
Page 2 - Ms. Ford
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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 vours,
Susan Runner DDS, MA Mary S. Runner--S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Appendix 2 – Indications for Use
:
:
.
. . . . . .
:
:
.
11
Image /page/11/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The company name is written in a bold, sans-serif font.
Indications for Use
510(k) Number (if known):
Device Name: DuraBlue™ Sterilization Wrap
Indications for Use
DuraBlue™ Sterilization Wrap is intended to be used 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 system, Standard, Flex, Express, and . DUO Cycles
- Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® 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 device(s) until used.
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 OF NEEDED)
Concurrence of CDRH, Office of Devices Evaluation (ODE)
Susan Runner DOS,MA Mary S.
Runner -S
Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K130927 510(k)
12
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 °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 DuraBlue™ 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 DuraBlue™ 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 DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles.
13
Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Cycles
....
.
.
- -- · -
·
| Advanced
Sterilization
Products
(ASP)
STERRAD®
System and
Cycle | 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-channe! 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 |
14
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. trav.
· 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 Amsco® 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 irreqularly 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.