(146 days)
Not Found
No
The device description and intended use are focused on a physical sterilization container system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a sterilization container system, which is used to sterilize other medical devices and maintain their sterility. It does not directly treat or diagnose a disease or condition in a patient, which is the primary function of a therapeutic device.
No
This device is a sterilization container system, intended to enclose and sterilize other medical devices and maintain their sterility. It does not perform any diagnostic function.
No
The device description clearly outlines physical components like a lid, bottom, filter, tamper evident arrows, and data cards, indicating it is a hardware 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 and sterilize other medical devices. It is not used to perform tests on biological samples (like blood, urine, or tissue) to diagnose diseases or conditions.
- Device Description: The description focuses on the physical components of the container system and its function in sterilization and storage. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD-Specific Information: The document does not contain any information related to:
- Sample types: No mention of biological samples.
- Analytes: No mention of specific substances being measured or detected.
- Diagnostic purpose: The device's purpose is sterilization, not diagnosis.
- Performance metrics relevant to IVDs: Metrics like sensitivity, specificity, AUC, etc., which are crucial for evaluating IVDs, are not found.
The device is a sterilization container system, which falls under the category of medical devices used in healthcare settings for the preparation and storage of other medical devices.
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 removal (pre-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 record information 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 madvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual ndication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are sungle 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
healthcare 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
Characteristic: 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
Characteristic: 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
Characteristic: Leaching of colorants
Standard/Test/FDA Guidance: Chemical evaluation of colored lids to determine the potential of colorants to leach during repeated exposure to steam sterilization processing
Results Summary: Testing demonstrated that colored lids did not produce significant levels of extractable material prior to processing or after multiple processing cycles
N/A - No clinical tests were conducted for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method
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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2014
Carefusion 2200, Inc. Ms. Jane Weber Regulatory Affairs Manager 75 N. Fairway Drive Vernon Hills, IL 60061
Re: K140850
Trade/Device Name: Genesis Reusable Rigid Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories Regulatory Class: Class II Product Code: KCT Dated: August 1, 2014 Received: August 4, 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.
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
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerely yours,
Erin | Keith -S
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
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Admınıstratıon
Indications for Use
510(k) Number (if known) K140850
Device Name
Genesis Reusable Rigid Sterilization Container System
Indications for Use (Describe)
The Genesis Reusable Rugid 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 removal (pre-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 ttems (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 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 madvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual ndication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are sungle 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)
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not requrred to respond to, a collection of ınformatıon unless it dısplays a currently valıd OMB number "
4
| 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)
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)
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, |
Sterilization Parameters for the Genesis Reusable Rigid Container System by Modality
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).
5
Type of Container Contents/Configuration Pre-Vacuum Steam Solid Bottom Non Stacking Baskets Yes Container Stacking Baskets Yes Lumen: 2.68mm (ID) x 450mm (L) Yes, maximum 2 Lumen: 3 mm (ID) x 400 mm (L) Yes, maximum 2 Occluded/Mated Challenge Yes Silicone Support Bar Yes Silicone Mat Ye Laparoscopic Rack Yes Optional Protective Plate Yes Filter NST Series Data Card MD1-1 Tamper-Evident Arrow White AS Series Stack Height 3 Materials: Metals, Polymers, Materials Composites Maximum Total Container System 25 lbs. Weight Yes Perforated Bottom Non Stacking Baskets Container Stacking Baskets Yes Lumen: 2.68mm (ID) x 450mm (L) Yes. maximum 2 Lumen: 3 mm (ID) x 400 mm (L) Yes, maximum 2 Occluded/Mated challenge Yes Silicone Support Bars Yes Silicone Mat Yes Laparoscopic Rack Yes Optional Protective Plate Yes NST series Filter Note: The CD2-10BDL Data Cards MD1-1 and DINCD2-8B Tamper Evident Arrow White AS Series container models are Stack Height 3 max not validated for use Materials Materials: Metals, Polymers, in 100% Ethylene Composites Oxide sterilization Maximum Total Weight 25 Ibs. STERRAD Compatible Non Stacking Baskets Yes Containers Stacking Baskets Yes Lumen: 2.68mm (ID) x 450mm (L) Yes, maximum 2 Lumen: 3.0mm (ID) x 400mm (L) Yes, maximum 2 Occluded/Mated Challenge Yes Silicone Support Bars Yes Silicone Mat Yes Laparoscopic Rack Yes Optional Protective Plate Yes Filter NST Series Data Cards MD1-1 Tamper-Evident Arrow White AS Series Stack Height 3 Maximum Materials Materials: Metals, Polymers, Composites Maximum Total Container System 25 lbs. Weight
Accessories and Device Challenges by Sterilization Modality and Container Style
6
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
(b.) |
|--------------|--------------------------|--------------------------|-----------------------------|
| 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 |
7
Traditional 510(k) Premarket Notification
Genesis™ Reusable Sterilization Container System
| 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 |
8
Fusion
K140850 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 | 26-AUG-2014 |
| DEVICE INFORMATION | |
| Trade or proprietary | |
| name | Genesis Reusable Rigid 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 |
| Reason for 510(k) | |
| submission | Expand indications for use regarding the materials 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. |
9
Fusion
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | Predicate Device - K112535 | 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) | Stainless Steel, Aluminum, Silicone, Radel | Intrinsically stable metals, |
| composites, thermoplastics and | ||
| thermosetting polymers with constant | ||
| use temperatures above 135°C. | ||
| Volume to Vent Ratio | 24.0 to 182.3 in3 / in2 | Same |
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 | ||
| Leaching of colorants | Chemical evaluation of colored | |
| lids to determine the potential of | ||
| colorants to leach during | ||
| repeated exposure to steam | ||
| sterilization processing | Testing demonstrated that colored lids did | |
| not produce significant levels of extractable | ||
| material prior to processing or after multiple | ||
| processing cycles |
10
CareFusion
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL 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 be used 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.
11
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) | 25 lbs. | Solid Bottom Containers;
Perforated Bottom Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450
mm)
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 |
| | Stack Height: Maximum 3 | | |
| 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)
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. |
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 alluminum. 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).
12
Traditional 510(k) Premarket Notification: Genesis ™ Reusable Sterilization Container System
sion
| Type of Container | Contents/Configuration | Pre-Vacuum Steam |
|---|---|---|
| Solid Bottom | ||
| Container | Non Stacking Baskets | Yes |
| Stacking Baskets | Yes | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | |
| Occluded/Mated Challenge | Yes | |
| Silicone Support Bar | Yes | |
| Silicone Mat | Yes | |
| Laparoscopic Rack | Yes | |
| Optional Protective Plate | Yes | |
| Filter | NST Series | |
| Data Card | MD1-1 | |
| Tamper-Evident Arrow | White AS Series | |
| Stack Height | 3 | |
| Materials | Materials: Metals, Polymers, | |
| Composites | ||
| Maximum Total Container System | ||
| Weight | 25 lbs. | |
| Perforated Bottom | ||
| Container | Non Stacking Baskets | Yes |
| Stacking Baskets | Yes | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | |
| Occluded/Mated Challenge | Yes | |
| Silicone Support Bars | Yes | |
| Silicone Mat | Yes | |
| Laparoscopic Rack | Yes | |
| Optional Protective Plate | Yes | |
| Note: The CD2-10BDL | ||
| and DINCD2-8B | ||
| container models are | ||
| not validated for use | ||
| in 100% Ethylene | ||
| Oxide sterilization | Filter | NST Series |
| Data Cards | MD1-1 | |
| Tamper-Evident Arrow | White AS Series | |
| Stack Height | 3 max | |
| Materials | Materials: Metals, Polymers, | |
| Composites | ||
| Maximum Total Weight | 25 lbs. | |
| STERRAD Compatible | ||
| Containers | Non Stacking Baskets | Yes |
| Stacking Baskets | Yes | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | |
| Lumen: 3 mm (ID) x 400mm (L) | Yes, maximum 2 | |
| Occluded/Mated Challenge | Yes | |
| Silicone Support Bars | Yes | |
| Silicone Mat | Yes | |
| Laparoscopic Rack | Yes | |
| Optional Protective Plate | Yes | |
| Filter | NST Series | |
| Data Cards | MD1-1 | |
| Tamper-Evident Arrow | White AS Series | |
| Stack Height | 3 Maximum | |
| Materials | Materials: Metals, Polymers, | |
| Composites | ||
| Maximum Total Container System | ||
| Weight | 25 lbs. |
Accessories and Device Challenges by Sterilization Modality and Container Style
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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. The shield has a yellow accent on the top right. To the right of the logo is the text "CareFusion" in a dark gray sans-serif font.
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
(Ib.) |
|--------------|--------------------------|--------------------------|------------------------------|
| 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 |
14
sion
| Catalog Code | Description | Container Dimension (in) | Container
Weight
(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| 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 |
| 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 |