(121 days)
Not Found
No
The document describes a physical sterilization container system and its components, with no mention of software, data analysis, or any AI/ML related terms or concepts.
No
The device is strictly used for the sterilization and storage of other medical devices, and does not directly treat or diagnose a medical condition.
No
Explanation: The device is a sterilization container system designed to enclose and maintain the sterility of other medical devices. Its function relates to sterilization and storage, not to diagnosing conditions or diseases.
No
The device description clearly outlines physical components such as a lid, bottom, filter, tamper evident arrows, data cards, baskets, and organizing accessory devices, indicating it is a hardware-based medical device.
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 is a container system for sterilizing and storing medical devices.
- Device Description: The description reinforces that it's a system of rigid containers used for sterilizing and maintaining the sterility of other medical devices.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This is the core function of an IVD.
- Performance Studies: The performance studies focus on sterilization efficacy and drying time, which are relevant to the sterilization process, not diagnostic testing.
Therefore, the Genesis Reusable Rigid Sterilization Container System is a device used in the sterilization and storage of other medical devices, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.
Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test Summary-New Device:
Sterilization Efficacy: Pre-vacuum Steam
Standard/Test/FDA Guidance: ST 77 2013 Containment Devices for Reusable Medical Device Sterilization
Results Summary: Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method
Dry Time for Dynamic Air Removal (Pre-vacuum steam modality)
Standard/Test/FDA Guidance: ST 77 2013 Containment Devices for Reusable Medical Device Sterilization
Results Summary: Testing demonstrated validated method of drying by absence of visible moisture
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization containers perform as intended and based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device, Class II (21 CFR 880.6850), Product code KCT.
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human face in profile, with three overlapping profiles to represent the department's focus on health, human services, and the well-being of the nation. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
CareFusion 2200 Inc. Ms. Jane Weber Regulatory Affairs Manager 75 N. Fairway Drive Vernon Hills, IL 60061
Re: K142529
Trade/Device Name: Genesis™ Reusable Rigid Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories Regulatory Class: II Product Code: KCT Dated: December 5, 2014 Received: December 8, 2014
Dear Ms. Weber:
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.
1
Page 2 - Ms. Weber
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/Resourcesfor You/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
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/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K142529
Device Name
Genesis Reusable Rigid Sterilization Container System
Indications for Use (Describe)
The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.
Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality
| Sterilization
Method | Cycle Parameters | Total
System
Weight | Applicable
Containers/Accessories |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dynamic Air
Removal
(Pre-Vacuum)
Steam | Exposure Temperature: 270°F
(132°C)
Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Dry Time Cycle: 30 minutes
Minimum Cool Time: 60 minutes
(may vary according to load contents)
Stack Height: Maximum 3 | 25 lbs. | Solid Bottom Containers;
Perforated Bottom Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450 mm) - Qty 16
Lumen Devices (1.37 mm x 242 mm) - Qty 10
Devices or Device Configurations
entailing conjoined surfaces which
meet, touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective Plate
Materials: Metals, Polymers,
Composites |
| Dynamic Air
Removal
(Pre-Vacuum)
Steam
Immediate Use | Exposure Temperature: 270°F
(132°C)
Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Stack Height: Maximum 3
Note: Devices must be used
immediately and cannot be
stored for later use. | 25 lbs. | Solid Bottom Containers;
Perforated Bottom Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450 mm) - Qty 16
Lumen Devices (1.37 mm x 242 mm) - Qty 10
Devices or Device Configurations
entailing conjoined surfaces which
meet, touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective Plate
*Materials: Metals, Polymers,
Composites |
| 100% Ethylene
Oxide | EO Sterilant Concentration:
100% EO, 725 mg/L
Pre-Conditioning Time: 30
minutes
Temperature: 130°F (55°C)
Exposure Time: 60 minutes
Relative Humidity: 50-80%
Aeration: 8 hours @ 109.4°F
(43°C)
No stacking | 15 lbs. | Perforated Bottom Containers
except CD2-10BDL and DINCD2-
8B);
Non Stacking Baskets
Lumen Devices (3.0 mm x 400 mm) - Qty 5
Device or Device Configurations
entailing conjoined surfaces which
meet, touch or unite;
Silicone Support Bars;
Laparoscopic Racks;
Materials: Stainless Steel,
Aluminum, Silicone, Radel |
5
Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeurs, kerrison rongeurs, specula.
Note: Air tight occluded challenges are devices entailing surfaces that are completely obstructed. These types of devices have not been validated for use in the Genesis Reusable Sterilization Container System.
*Materials: Intrinsically stable metals. Composites, thermosetting polymers with constant use temperatures above 135°C.
Examples of intrinsically stable metals include stainless steel, titanium (CP and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/ Styrene) and POM (Polyoxymethylene). Examples of thermosetting polymers are Phenolic and Silicone. Examples of composites include carbon fiber reinforced epoxy (CFRE).
6
| Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100 % Ethylene Oxide |
|---|---|---|---|
| Solid Bottom | Non Stacking Baskets | Yes | No |
| Container | Stacking Baskets | Yes | No |
| Lumen: 1.37 mm (ID) x 242 | |||
| mm(L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | No | |
| Occluded/Mated Challenge | Yes | No | |
| Silicone Support Bar | Yes | No | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | No | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | No | |
| Data Card | MD1-1 | No | |
| Tamper-Evident Arrow | White AS Series | No | |
| Stack Height | 3 | No | |
| Materials | Materials: Metals, | ||
| Polymers, Composites | No | ||
| Maximum Total Container System | |||
| Weight | 25 lbs. | No | |
| Perforated Bottom | Non Stacking Baskets | Yes | Yes |
| Container | Stacking Baskets | Yes | No |
| Lumen: 1.37 mm (ID) x 242 | |||
| mm(L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Note: The CD2- | Laparoscopic Rack | Yes | Yes |
| 10BDL and | Optional Protective Plate | Yes | No |
| DINCD2-8B | Filter | NST series | NST series |
| container models | Data Cards | MD1-1 | MD1-1 |
| are not validated | Tamper Evident Arrow | White AS Series | Yellow AG Series |
| for use in 100% | Stack Height | 3 max | No stacking |
| Ethylene Oxide | |||
| sterilization | Materials | Materials: Metals, | |
| Polymers, Composites | Radel, Stainless Steel, | ||
| Aluminum, Silicone | |||
| Maximum Total Weight | 25 lbs. | 15 lbs. | |
| STERRAD | Non Stacking Baskets | Yes | Yes |
| Compatible | Stacking Baskets | Yes | No |
| Containers | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | No |
| Lumen: 3.0mm (ID) x 400mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated Challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | Yes | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | NST Series | |
| Data Cards | MD1-1 | MD1-1 | |
| Tamper-Evident Arrow | White AS Series | Yellow AG Series | |
| Stack Height | 3 Maximum | No stacking | |
| Materials | Materials: Metals, | ||
| Polymers, Composites | Radel, Stainless Steel, | ||
| Aluminum, Silicone | |||
| Maximum Total Container System | |||
| Weight | 25 lbs. | 15 lbs. |
Accessories and Device Challenges by Sterilization Modality and Container Style
7
Solid Bottom Containers
| Catalog Code | Description | Container Dimension (in) | Container
Weight
(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD0-4C | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.4 |
| CD1-4C | Half Length Container | 11.8 x 12.4 x 4.5 | 4.8 |
| CD1-5C | Half Length Container | 11.8 x 12.4 x 5.3 | 5.0 |
| CD1-6C | Half Length Container | 11.8 x 12.4 x 6.1 | 5.2 |
| CD2-4C | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.4 |
| CD2-5C | Mid Length Container | 19.2 x 12.4 x 5.3 | 6.7 |
| CD2-6C | Mid Length Container | 19.2 x 12.4 x 6.1 | 6.9 |
| CD2-8C | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.3 |
| CD3-4C | Full Length Container | 23.1 x 12.4 x 4.5 | 7.8 |
| CD3-5C | Full Length Container | 23.1 x 12.4 x 5.3 | 7.9 |
| CD3-6C | Full Length Container | 23.1 x 12.4 x 6.1 | 8.2 |
| CD3-7C | Full Length Container | 23.1 x 12.4 x 7.0 | 8.5 |
| CD7-5C | Extra Long Container | 25.2 x 12.4 x 5.9 | 8.5 |
| CD7-6C | Extra Long Container | 25.2 x 12.4 x 6.7 | 8.8 |
| CD7-9C | Extra Long Container | 25.2 x 12.4 x 8.4 | 9.7 |
| CD4-3C | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 6.7 |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 6.9 |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.3 |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.0 |
| DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | 5.2 |
Perforated Bottom Containers
| Catalog Code | Description | Container Dimension (in) | Container
Weight
(lb.) |
|--------------|--------------------------|--------------------------|------------------------------|
| CD0-4B | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4B | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5B | Half Length Container | 11.8 x 12.4 x 5.3 | 5.5 |
| CD1-6B | Half Length Container | 11.8 x 12.4 x 6.1 | 5.7 |
| CD2-4B | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5B | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.1 |
| CD2-6B | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.4 |
| CD2-8B | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.8 |
| CD3-4B | Full Length Container | 23.1 x 12.4 x 4.5 | 8.5 |
| CD3-5B | Full Length Container | 23.1 x 12.4 x 5.3 | 8.8 |
| CD3-6B | Full Length Container | 23.1 x 12.4 x 6.1 | 9.0 |
| CD3-7B | Full Length Container | 23.1 x 12.4 x 7.0 | 9.4 |
| CD7-5B | Extra Long Container | 25.2 x 12.4 x 5.9 | 9.0 |
| CD7-6B | Extra Long Container | 25.2 x 12.4 x 6.7 | 9.4 |
8
| Catalog Code | Description | Container Dimension (in) | Container
Weight
(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD7-9B | Extra Long Container | 25.2 x 12.4 x 8.4 | 10.0 |
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.7 |
STERRAD Style Containers
| Catalog Code | Description | Container Dimension (In) | Container
Weight
(lb.) |
|--------------|--------------------------------|--------------------------|------------------------------|
| CD0-4ST | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4ST | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5ST | Half Length Container | 11.8 x 12.4 x 5.3 | 5.4 |
| CD1-6ST | Half Length Container | 11.8 x 12.4 x 6.1 | 5.6 |
| CD2-4ST | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5ST | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.0 |
| CD2-6ST | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.2 |
| CD2-8ST | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.7 |
| CD3-4ST | Full Length Container | 23.1 x 12.4 x 4.5 | 8.4 |
| CD3-5ST | Full Length Containers | 23.1 x 12.4 x 5.3 | 8.6 |
| CD3-6ST | Full Length Containers | 23.1 x 12.4 x 6.1 | 8.9 |
| CD3-7ST | Full Length Containers | 23.1 x 12.4 x 7.0 | 9.3 |
| CD4-3ST | Small Narrow Shallow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5ST | Small Narrow Container | 20.8 x 7.3 x 5.2 | 4.8 |
| CD5-3ST | Large Narrow Shallow Container | 28.1 x 11.2 x 5.0 | 8.9 |
| CD5-61ST | Large Narrow Shallow Container | 28.1 x 11.2 x 6.4 | 9.4 |
| CD0-3ST | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
9
eFusion
K142529 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion 2200 Inc |
| Address | 75 N. Fairway Dr. |
| Vernon Hills, IL 60061 | |
| Phone number | (847) 362-8094 |
| Fax number | (312) 949-0272 |
| Establishment | |
| Registration Number | 1423507 |
| Name of contact person | Jane Weber, Regulatory Affairs Manager |
| Date prepared | 05-JAN-2015 |
| DEVICE INFORMATION | |
| Trade or proprietary | |
| name | Genesis™ Reusable Rigid Sterilization Container System |
| Common or usual name | Sterilization Container |
| Classification name | Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories |
| Classification panel | 80 |
| Regulation | Class II per 21CFR 880.6850, Product code KCT |
| Product Code(s) | KCT |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | Genesis™ Reusable Sterilization Container System |
| K140850 | |
| Reason for 510(k) | |
| submission | Expand indications for use regarding the quantity and types of lumen devices |
| to be sterilized using the pre-vacuum steam sterilization modality in the | |
| Genesis Container System. | |
| Device description | The Genesis Reusable Rigid Container System is an assortment of rigid, |
| reusable, stackable containers that are used to sterilize other medical devices | |
| and maintain sterility of these devices until used. The container system is | |
| comprised of a lid, bottom, filter, tamper evident arrows, and data cards. | |
| The container system houses baskets of varying depths and organizing | |
| accessory devices that are used to organize and to secure surgical | |
| instrumentation and/or other medical devices. |
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UMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | Predicate Device - K140850 | New/Modified Device |
|---|---|---|
| Intended Use | A sterilization container system 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 | ||
| medical device until used. | Same | |
| Container | Anodized aluminum 5000 and 1100 | |
| series; stainless steel 300 series | Same | |
| Gasket | Closed cell silicone foam | Same |
| Filter | SMS polypropylene for all sterilization | |
| modalities | Same | |
| Baskets | 304 Stainless Steel, electropolished | Same |
| Dividers, brackets | Aluminum 5000 series | Same |
| Clips, posts, pins | Stainless steel 300 and 400 series | Same |
| Silicone bars, mats | Silicone Elastomer | Same |
| Material Compatibility | ||
| (materials to be sterilized | ||
| within container) | Intrinsically stable metals, composites, | |
| thermoplastics and thermosetting polymers | ||
| with constant use temperatures above 135°C. | Same | |
| Volume to Vent Ratio | $24.0 \text{ to } 182.3 \frac{in^3}{in^2}$ | Same |
| Sterilization parameters | ||
| for Pre-Vacuum steam for | ||
| Lumen devices | Lumens: 2.68 mm (ID) x 450 mm (L) – Qty 2 | Lumens: 2.68 mm (ID) x 450 mm (L) – |
| Qty 16 | ||
| Lumens 1.37 mm (ID) x 242 mm (L) – | ||
| Qty 10 |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|---|---|---|
| Sterilization Efficacy: Pre-vacuum Steam | ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method |
| Dry Time for Dynamic Air Removal (Pre-vacuum steam modality) | ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated validated method of drying by absence of visible moisture |
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EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization containers perform as intended and based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device, Class II (21 CFR 880.6850), Product code KCT.
INDICATIONS FOR USE
The Genesis Reusable Rigid Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a health care provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed medical device until used for a maximum of 180 days.
Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use prevacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
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Sterilization Parameters for the Genesis Reusable Rigid Container System by Modality
| Sterilization
Method | Cycle Parameters | Total
System
Weight | Applicable
Containers/Accessories |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dynamic Air
Removal
(Pre-Vacuum)
Steam | Exposure Temperature: 270°F
(132°C)
Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Dry Time Cycle: 30 minutes
Minimum Cool Time: 60
minutes
(may vary according to load
contents)
Stack Height: Maximum 3 | 25 lbs. | Solid Bottom Containers;
Perforated Bottom Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450
mm) - Qty 16
Lumen Devices (1.37 mm x 242
mm) - Qty 10
Devices or Device Configurations
entailing conjoined surfaces which
meet, touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective Plate
Materials: Metals, Polymers,
Composites |
| Dynamic Air
Removal
(Pre-Vacuum)
Steam
Immediate Use | Exposure Temperature: 270°F
(132°C)
Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Stack Height: Maximum 3
Note: Devices must be used
immediately and cannot be
stored for later use. | 25 lbs. | Solid Bottom Containers;
Perforated Bottom Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450
mm) - Qty 16
Lumen Devices (1.37 mm x 242
mm) - Qty 10
Devices or Device Configurations
entailing conjoined surfaces which
meet, touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective Plate
*Materials: Metals, Polymers,
Composites |
| 100% Ethylene
Oxide | EO Sterilant Concentration:
100% EO, 725 mg/L
Pre-Conditioning Time: 30
minutes
Temperature: 130°F (55°C)
Exposure Time: 60 minutes
Relative Humidity: S0-80%
Aeration: 8 hours @ 109.4°F
(43°C)
No stacking | 15 lbs. | Perforated Bottom Containers
except CD2-10BDL and DINCD2-
8B);
Non Stacking Baskets
Lumen Devices (3.0 mm x 400
mm) — Qty 5
Device or Device Configurations
entailing conjoined surfaces which
meet, touch or unite;
Silicone Support Bars;
Laparoscopic Racks;
Materials: Stainless Steel,
Aluminum, Silicone, Radel |
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Image /page/13/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a yellow accent on the top right.
Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeurs, kerrison rongeurs, specula.
Note: Air tight occluded challenges are devices entailing surfaces that are completely obstructed. These types of devices have not been validated for use in the Genesis Reusable Sterilization Container System.
*Materials: Intrinsically stable metals. Composites, and thermosetting polymers with constant use temperatures above 135°C.
Examples of intrinsically stable metals include stainless steel, titanium (CP and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/ Styrene) and POM (Polyoxymethylene). Examples of thermosetting polymers are Phenolic and Silicone. Examples of composites include carbon fiber reinforced epoxy (CFRE).
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| Accessories and Device Challenges by Sterilization Modality and Container Style | ||
|---|---|---|
| --------------------------------------------------------------------------------- | -- | -- |
| Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100 % Ethylene Oxide |
|---|---|---|---|
| Solid Bottom | |||
| Container | Non Stacking Baskets | Yes | No |
| Stacking Baskets | Yes | No | |
| Lumen: 1.37 mm (ID) x 242 mm (L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | No | |
| Occluded/Mated Challenge | Yes | No | |
| Silicone Support Bar | Yes | No | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | No | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | No | |
| Data Card | MD1-1 | No | |
| Tamper-Evident Arrow | White AS Series | No | |
| Stack Height | 3 | No | |
| Materials | Materials: Metals, | ||
| Polymers, Composites | No | ||
| Maximum Total Container System | |||
| Weight | 25 lbs. | No | |
| Perforated Bottom | |||
| Container | Non Stacking Baskets | Yes | Yes |
| Stacking Baskets | Yes | No | |
| Lumen: 1.37 mm (ID) x 242 mm(L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated Challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | Yes | |
| Optional Protective Plate | Yes | No | |
| Filter | NST series | NST series | |
| Data Cards | MD1-1 | MD1-1 | |
| Tamper Evident Arrow | White AS Series | Yellow AG Series | |
| Stack Height | 3 max | No stacking | |
| Materials | Materials: Metals, | ||
| Polymers, Composites | Radel, Stainless Steel, | ||
| Aluminum, Silicone | |||
| Maximum Total Weight | 25 lbs. | 15 lbs. | |
| STERRAD | |||
| Compatible | |||
| Containers | Non Stacking Baskets | Yes | Yes |
| Stacking Baskets | Yes | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | No | |
| Lumen: 3.0mm (ID) x 400mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated Challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | Yes | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | NST Series | |
| Data Cards | MD1-1 | MD1-1 | |
| Tamper-Evident Arrow | White AS Series | Yellow AG Series | |
| Stack Height | 3 Maximum | No stacking | |
| Materials | Materials: Metals, | ||
| Polymers, Composites | Radel, Stainless Steel, | ||
| Aluminum, Silicone | |||
| Maximum Total Container System | |||
| Weight | 25 lbs. | 15 lbs. | |
| Note: The CD2-10BDL and DINCD2-8B container models are not validated for use in 100% Ethylene Oxide sterilization |
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Image /page/15/Picture/1 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a small orange accent in the upper left corner.
Solid Bottom Containers
| Catalog Code | Description | Container Dimension (in) | Container
Weight
(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD0-4C | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.4 |
| CD1-4C | Half Length Container | 11.8 x 12.4 x 4.5 | 4.8 |
| CD1-5C | Half Length Container | 11.8 x 12.4 x 5.3 | 5.0 |
| CD1-6C | Half Length Container | 11.8 x 12.4 x 6.1 | 5.2 |
| CD2-4C | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.4 |
| CD2-5C | Mid Length Container | 19.2 x 12.4 x 5.3 | 6.7 |
| CD2-6C | Mid Length Container | 19.2 x 12.4 x 6.1 | 6.9 |
| CD2-8C | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.3 |
| CD3-4C | Full Length Container | 23.1 x 12.4 x 4.5 | 7.8 |
| CD3-5C | Full Length Container | 23.1 x 12.4 x 5.3 | 7.9 |
| CD3-6C | Full Length Container | 23.1 x 12.4 x 6.1 | 8.2 |
| CD3-7C | Full Length Container | 23.1 x 12.4 x 7.0 | 8.5 |
| CD7-5C | Extra Long Container | 25.2 x 12.4 x 5.9 | 8.5 |
| CD7-6C | Extra Long Container | 25.2 x 12.4 x 6.7 | 8.8 |
| CD7-9C | Extra Long Container | 25.2 x 12.4 x 8.4 | 9.7 |
| CD4-3C | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 6.7 |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 6.9 |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.3 |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.0 |
| DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | 5.2 |
Perforated Bottom Containers
| Catalog Code | Description | Container Dimension (in) | Container
Weight
(lb.) |
|--------------|--------------------------|--------------------------|------------------------------|
| CD0-4B | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4B | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5B | Half Length Container | 11.8 x 12.4 x 5.3 | 5.5 |
| CD1-6B | Half Length Container | 11.8 x 12.4 x 6.1 | 5.7 |
| CD2-4B | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5B | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.1 |
| CD2-6B | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.4 |
| CD2-8B | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.8 |
| CD3-4B | Full Length Container | 23.1 x 12.4 x 4.5 | 8.5 |
| CD3-5B | Full Length Container | 23.1 x 12.4 x 5.3 | 8.8 |
| CD3-6B | Full Length Container | 23.1 x 12.4 x 6.1 | 9.0 |
| CD3-7B | Full Length Container | 23.1 x 12.4 x 7.0 | 9.4 |
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| Catalog Code | Description | Container Dimension (in) | Container
Weight
(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD7-5B | Extra Long Container | 25.2 x 12.4 x 5.9 | 9.0 |
| CD7-6B | Extra Long Container | 25.2 x 12.4 x 6.7 | 9.4 |
| CD7-9B | Extra Long Container | 25.2 x 12.4 x 8.4 | 10.0 |
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.7 |
STERRAD Style Containers
| Catalog Code | Description | Container Dimension (In) | Container
Weight
(lb.) |
|--------------|--------------------------------|--------------------------|------------------------------|
| CD0-4ST | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4ST | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5ST | Half Length Container | 11.8 x 12.4 x 5.3 | 5.4 |
| CD1-6ST | Half Length Container | 11.8 x 12.4 x 6.1 | 5.6 |
| CD2-4ST | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5ST | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.0 |
| CD2-6ST | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.2 |
| CD2-8ST | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.7 |
| CD3-4ST | Full Length Container | 23.1 x 12.4 x 4.5 | 8.4 |
| CD3-5ST | Full Length Containers | 23.1 x 12.4 x 5.3 | 8.6 |
| CD3-6ST | Full Length Containers | 23.1 x 12.4 x 6.1 | 8.9 |
| CD3-7ST | Full Length Containers | 23.1 x 12.4 x 7.0 | 9.3 |
| CD4-3ST | Small Narrow Shallow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5ST | Small Narrow Container | 20.8 x 7.3 x 5.2 | 4.8 |
| CD5-3ST | Large Narrow Shallow Container | 28.1 x 11.2 x 5.0 | 8.9 |
| CD5-61ST | Large Narrow Shallow Container | 28.1 x 11.2 x 6.4 | 9.4 |
| CD0-3ST | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |