DURABLUE STERILIZATION WRAP
Device Facts
| Record ID | K123289 |
|---|---|
| Device Name | DURABLUE STERILIZATION WRAP |
| Applicant | Cardinal Health-Medical Products and Services |
| Product Code | FRG · General Hospital |
| Decision Date | Feb 28, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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 using the following modalities: - 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. 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. For pre-vacuum steam sterilization, the wrap has been validated for dry times for Models CH100 and CH200 and 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 sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.
Device Story
DuraBlue™ Sterilization Wrap consists of double-layer 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. Used by healthcare providers in clinical settings to wrap medical instruments prior to sterilization. Design supports simultaneous double-wrapping and aseptic opening. Device acts as a microbial barrier to maintain sterility of enclosed contents for 180 days post-sterilization. Six models (CH100-CH600) accommodate varying load weights (3-25 lbs) and specific lumen configurations. Healthcare providers use the wrap to ensure instrument sterility until point of use, reducing risk of contamination.
Clinical Evidence
Bench testing only. Validation included sterilization efficacy, microbial barrier properties (aerosol challenge), event-related shelf life (180 days), material compatibility, and biocompatibility per ISO 10993. Testing confirmed sterility maintenance for 180 days post-sterilization for all indicated modalities and models.
Technological Characteristics
Material: 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. Six models (CH100-CH600) vary by basis weight. Sterilization modalities: Pre-vacuum steam (270°F/132°C) and 100% Ethylene Oxide (55°C). Biocompatibility: ISO 10993 compliant.
Indications for Use
Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam (270°F/132°C, 4 min) or 100% ethylene oxide (725-735 mg/L, 131°F/55°C, 40-80% RH, 60 min). Maintains sterility of enclosed contents for 180 days.
Regulatory Classification
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.
Predicate Devices
- DuraBlue™ Sterilization Wrap - Pre-vacuum Steam (K112211)
- DuraBlue™ Sterilization Wrap - Ethylene Oxide (EO) (K120542)
Submission Summary (Full Text)
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# 1-123289
Image /page/0/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of a stylized graphic of three curved lines above the text "CardinalHealth". The text is in a bold, sans-serif font, with "Cardinal" in a darker shade than "Health".
1430 Waukegan Road McGraw Park, IL 60085
www.cardinal.com
| 510(k) SUMMARY<br>DuraBlue™ Sterilization Wrap | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Manufacturer: | Cardinal Health 200, LLC<br>1430 Waukegan Road<br>McGaw Park, IL 60085 |
| Regulatory Affairs Contact: | Lavenia Ford<br>1430 Waukegan Road<br>McGaw Park, IL 60085 |
| Telephone Number: | (847) 887-3323 |
| Date summary Prepared: | February 12, 2013 |
| Trade Name: | DuraBlue™ Sterilization Wrap |
| Classification: | Class II per 21 CFR § 880.6850 |
| Classification Name: | Sterilization Wrap |
| Common Name: | Sterilization Wrap |
| Product Code: | FRG |
| Predicate Device: | K112211 - DuraBlue™ Sterilization Wrap - Pre-vacuum Steam (4<br>min/270°C) |
| | K120542 - DuraBlue™ Sterilization Wrap - Ethylene Oxide(EO) (725-<br>735 mg/L at 55°C/40%-80%RH/60 min) |
#### 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 pre-vacuum steam at 270°F/132°C for 4 minutes, or 100% ethylene oxide (EO) with a concentration of 725-735 mgL at 131°F/55°C and 40%-80% relative humidity for 60 minutes. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.
The only modification to the predicate devices involving the clarification of the sterlity maintenance information provided in the Indication for Use portion of the Instructions for Use Labeling.
FEB 2 8 2013
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- . Predicate Statement:
- "The wrap is intended to allow sterilization of the enclosed medical device(s) and o maintain sterility of the enclosed device(s) for 30 days."
- . Proposed Statement:
- o "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."
This modification is based on Event-Related Shelf Life testing that demonstrates that the DuraBlue™ Sterilization Wrap maintains sterility of the enclosed contents for 180 days following sterilization by prevacuum steam or EO.
This submission covers six different models of Cardinal Heatth DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.
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| Element of | PROPOSED | PREDICATE | PREDICATE |
|-----------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Comparison | Cardinal Health DuraBlue™ | Cardinal Health DuraBlue™ | Cardinal Health DuraBlue™ |
| | Sterilization Wrap - Pre-vacuum | Sterilization Wrap - Pre- | Sterilization Wrap - Ethylene |
| | Steam or EO | vacuum Steam<br>(K112211) | Oxide (EO)<br>(K120542) |
| Key Claims | 180 day Maintenance of Sterility | • Indications for use with<br>pre-vacuum sterilization | • Indications for use with<br>Ethylene Oxide<br>sterilization |
| | Testing for all modalities | | |
| Product | 100% polypropylene spunbond-<br>meltblown-spunbond (SMS) fabric | Same | Same |
| Properties | | | |
| Intended | Cardinal Health DuraBlue™ | Cardinal Health DuraBlue™ | Cardinal Health DuraBlue™ |
| Use | Sterilization Wrap is intended to | Sterilization Wrap is intended | Sterilization Wrap is intended |
| | enclose another medical device that is | to be used to enclose another | to be used to enclose another |
| | to be sterilized by a health care | medical device that is to be | medical device that is to be |
| | provider using the following modalities: | sterilized by a health care | sterilized by a health care |
| | • pre-vacuum steam at 270°F/132°C | provider by pre-vacuum steam<br>at 270°F/132°C for 4 minutes.<br>The wrap is not indicated for | provider by 100% ethylene<br>oxide (EO) with a |
| | for 4 minutes | use with gravity steam | concentration of 725-735 mg/L |
| | • 100% ethylene oxide (EO) with a | sterilization. | at 131°F/55°C and 40%-80% |
| | concentration of 725-735 mg/L at | | relative humidity for 60 |
| | 131°F/55°C and 40%-80% relative | | minutes. |
| | humidity for 60 minutes | The wrap is intended to allow | |
| | The wrap is intended to allow | sterilization of the enclosed | The wrap is intended to allow |
| | sterilization of the enclosed medical | medical device(s) and to | sterilization of the enclosed |
| | device(s) and to maintain sterility of the | maintain sterility of the<br>enclosed devices for 30 days. | medical device(s) and to |
| | enclosed device(s). Maintenance of<br>package sterility was validated with | | maintain sterility of the<br>enclosed devices for 30 days. |
| | real-time aging testing for a duration of | The wrap has been validated | The wrap has been validated |
| | 180 days following each indicated | for dry times for pre-vacuum | for an aeration time of 8 hours |
| | modality. | steam sterilization of 20 | at 55°C. |
| | | minutes for Models CH100 | |
| | For pre-vacuum steam sterilization, | and CH200, and for 30 | Models CH400, CH500, and |
| | the wrap has been validated for dry | minutes for Models CH300, | CH600 have been validated |
| | times of 20 minutes for Models CH100 | CH400, CH500 and CH600. | for sterilization of two lumens |
| | and CH200 and 30 minutes for Models | | of 3 mm diameter or larger and |
| | CH300, CH400, CH500, and CH600, | | 400 mm in length or less for<br>EO sterilization. |
| | | | |
| | For EO sterilization, the wrap has<br>been validated for an aeration time of | | |
| | 8 hours at 55°C. | | |
| Length of | Pre-vacuum steam: 180 days | Pre-vacuum steam: 30 days | Ethylene oxide: 30 days |
| Maintenance | | | |
| of Sterility | Ethylene oxide: 180 days | | |
| Testing | | | |
| Lumen<br>Claims | Pre-vacuum steam: Models CH400,<br>CH500 and CH600 have been | Pre-vacuum Steam: Models | Ethylene Oxide (EO): Models |
| | validated for sterilization of two lumens | CH400, CH500 and CH600<br>have been validated for | CH400, CH500, and CH600 |
| | of 3mm diameter or larger and 400mm | sterilization of lumens of 3mm | have been validated for<br>sterilization of two lumens of |
| | in length or less. | diameter or larger and 400mm | 3mm diameter or larger and |
| | | in length or less. | 400mm in length or less. |
| | Ethylene Oxide (EO): Same as | | |
| | K120542 | | |
# Table 1: Overall Comparison to Predicate Devices
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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 using the following modalities:
- 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
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.
For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.
For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55℃. Models CH400, CH500, and CH600 have been validated for sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.
| Sterilization<br>Wrap Model | Intended Load | Maximum Recommended<br>Wrapped Package Content<br>Weight |
|-----------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------|
| | | Pre-Vacuum Steam and EO |
| CH100 | Very light weight package<br>(for example: batteries) | 3 lbs |
| CH200 | Light weight package<br>(for example: telescope with light cord) | 6 lbs |
| CH300 | Light to moderate weight package<br>(for example: general use medical instruments) | 9 lbs |
| CH400 | Moderate to heavy weight package<br>(for example: general use medical instruments) | 13 lbs |
| CH500 | Heavy weight package<br>(for example: general use medical instruments) | 17 lbs |
| CH600 | Very heavy weight package<br>(for example: general use medical instruments) | 25 lbs |
#### Table 2 - Wrap Model Recommendations
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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 1. D x 400 mm), and 8 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
• CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm I. D x 400 mm), and 12 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
• CH600: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm I. D x 400 mm), and 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. trav.
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 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
· CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm 1. D 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 I. D x 400 mm), and 19.5 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. trav.
Note: The loads used in the Sterlify Validation Study corresponded to the maximum wrapped package content weights in Table 2.
#### 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 .
- Are indicated for the same sterilization parameters .
- Are indicated for the same Maximum Wrapped Package Content Weights .
#### 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. Testing included sterlization efficacy, physical properties, event related maintenance of package sterlity, and biocompatibility in compliance with the methods of ISO 10993 for pre-vacuum steam and EO. Data from testing demonstrates that the DuraBlue™ Sterilization Wrap maintains sterlity of the enclosed contents for 180 days following sterilization by pre-vacuum steam and EO.
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Table 3: Performance Testing of Proposed DuraBlue Sterilization Wrap sterilized by Pre-vacuum steam or EO
| Performance Properties | | Results |
|---------------------------------------------------------------|-----------------------------|----------------|
| Sterilization Efficacy | | PASS |
| Microbial Barrier<br>Properties | Aerosol Challenge | PASS |
| | Event Related Shelf<br>Life | PASS- 180 days |
| Material Compatibility with Indicated<br>Sterilization Method | | Compatible |
| Biocompatibility | | PASS |
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
# February 28, 2013
Cardinal Health-Medical Products and Services C/O Mr. Ned Devine Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062
Re: K123289
Trade/Device Name: Cardinal Health DuraBlue 114 Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 15, 2013 Received: February 19, 2013
# 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.
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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 devicerelated 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,
Kwame O. Ulmer for
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 company name. The graphic is composed of several curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
Indications for Use
510(k) Number (if known): K123289
Device Name: Cardinal Health DuraBlue™ Sterilization Wrap
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 using the following modalities:
- 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
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.
For pre-vacuum steam sterilization, the wrap has been validated for dry times for Models CH100 and CH200 and 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 sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.
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) Shani J. Smith =============================================================================================================================================================== 2013.02.28 15:52:20=05'00'
Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k)
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Table 1 - Wrap Model Recommendations
| Sterilization<br>Wrap Model | Intended Load | Maximum Recommended<br>Wrapped Package Content<br>Weight |
|-----------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------|
| | | Pre-Vacuum Steam and EO |
| CH100 | Very light weight package<br>(for example: batteries) | 3 lbs |
| CH200 | Light weight package<br>(for example: telescope with light cord) | 6 lbs |
| CH300 | Light to moderate weight package<br>(for example: general use medical instruments) | 9 lbs |
| CH400 | Moderate to heavy weight package<br>(for example: general use medical instruments) | 13 lbs |
| CH500 | Heavy weight package<br>(for example: general use medical instruments) | 17 lbs |
| CH600 | Very heavy weight package<br>(for example: general use medical instruments) | 25 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 ¶. D x 400 mm), and 8 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
• CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm I. D x 400 mm), and 12 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
• CH600: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm I. D x 400 mm), and 20 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
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The following loads were used in the 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 lbs of metal mass in a 23 in. x 11 in. x 3.5 in. tray.
· CH500: 4 stacked tray liners (20 in. x 25 in.), 2 lumens (3 mm I. 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.
Note: The loads used in the Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 1.
