← Product Code [KCT](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT) · K112535 # GENESIS REUSABLE RIGID CONTAINER SYSTEM (K112535) _Carefusion 2200, Inc. · KCT · Apr 27, 2012 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K112535 ## Device Facts - **Applicant:** Carefusion 2200, Inc. - **Product Code:** [KCT](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT.md) - **Decision Date:** Apr 27, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6850 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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 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. ## Device Story Genesis Reusable Rigid Sterilization Container System consists of stackable, rigid containers (lid, bottom, filter, tamper-evident arrows, data cards) used to house medical devices during sterilization and storage. Used in clinical settings by healthcare providers. Inputs include medical instruments placed in baskets/racks within the container. The system acts as a protective barrier, allowing sterilant ingress/egress via filters while maintaining a microbial barrier post-sterilization. Tamper-evident arrows provide visual confirmation of processing and container integrity. Benefits include organized, secure, and sterile storage of instruments until point-of-use. Healthcare providers use the system to ensure instrument sterility, directly impacting surgical safety by preventing contamination. ## Clinical Evidence Bench testing only. No clinical data. Performance validated via ST 77:2006 standards. Sterilization efficacy demonstrated 12-log reduction and SAL of 10^-6 using biological overkill method. 180-day event-related shelf life confirmed sterility maintenance. Microbial challenge testing using Bacillus atrophaeus (1x10^6 CFU) demonstrated 100% negative growth. ## Technological Characteristics Materials: Anodized Aluminum (5000/1100 series), Stainless Steel (300/400 series), Closed Cell Silicone Foam, Silicone Elastomer, Radel. Design: Rigid, stackable, reusable containers with filter-based microbial barrier. Sterilization: Dynamic air removal steam, immediate use steam, 100% Ethylene Oxide. Connectivity: None. Software: None. ## Regulatory 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 - Genesis Sterilization Container ([K844652](/device/K844652.md)) - Genesis Deep Lid Sterilization Container ([K983299](/device/K983299.md)) - Genesis STERRAD Sterilization Container ([K012931](/device/K012931.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ APR 2 7 2012 KIT2535 . ## 510(k) SUMMARY Following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92. : and the comments of the comments of . | Name | CareFusion | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA | | Phone number | 847-473-7334 | | Fax number | 847-473-7790 | | Establishment Registration
Number | 1423507 | | Name of contact person | Kate Fuller | | Date prepared | April 12, 2012 | | NAME OF DEVICE | | | 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 | 880.6850 | | Product Code(s) | KCT | | Legally marketed
device(s) to which
equivalence is claimed | K844652 - Genesis Sterilization Container
K983299 - Genesis Deep Lid Sterilization Container
K012931 - Genesis STERRAD Sterilization Container | | Reason for 510(k)
submission | One filter for all sterilization modalities New container sizes Expand indications for use to include Immediate Use Sterilization Modify parameters for Pre-Vacuum Steam and 100% Ethylene Oxide Replace 88/12 Ethylene Oxide with 100% Ethylene Oxide | | 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. | : {1}------------------------------------------------ | | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO
THE PREDICATE DEVICE | | |--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | New/Modified Device | Predicate | | Container | Anodized Aluminum 5000 and
1100 Series; Stainless Steel 300
series | Genesis Container (K844652); Genesis
Deep Lid Container (K983299) Genesis
STERRAD Compatible Container
(K012931) | | Gasket | Closed Cell Silicone Foam | SAME | | Filter Material | SMS Polypropylene for all
Modalities | SAME for STERRAD modality;
Non woven Cellulose for Steam and EO | | Baskets | 304 Stainless; Electropolished | SAME | | Dividers, Brackets | Aluminum 5000 Series | SAME | | Clips, Posts, Pins | 300 and 400 Series Stainless | SAME | | Silicone Bars, Mats | Silicone Elastomer | 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; and 100%
Ethylene Oxide | ST 77 2006 Containment
Devices for Reusable
Medical Device Sterilization | Testing demonstrated a 12 log reduction and
sterility assurance level (SAL) of 10 6 using
biological (BI) overkill method and half-cycle
validation. | | 180 Day Event Related
Shelf Life for all Sterilization
Modalities | ST 77:2006 Containment
Devices for Reusable
Medical Device Sterilization | 180 Day Event Related Shelf life studies
demonstrated sterility maintenance for all
sterilization modalities. | | Microbial Challenge | ST.77:2006 Containment
Devices for Reusable
Medical Device Sterilization | Whole package microbial challenge test
exposing a container to a minimum of 1 x10 6
Bacillus atrophaeus colony forming units (CFU)
via an aerosol challenge demonstrating 10 0%
negative growth | . . . : : . . EQUIVALENCE ANDION OF OF OLINERS ............................................................................................................................................. . · . : : . . : , . : . . · : i . : . . . . . : . . : {2}------------------------------------------------ ## AND A CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL AND CLINICAL DATAS OF SYcteds The results of the non-clinical tests show that the Genesis Reusable Rigid Container System meets or exceeds The results of the non-clinical test in conventially coulvalent The results of the non-cimical tests show that the Ochools Nouses of the predicate devices. # SERVICE CARDER THE CINTENDED USE OF DEVICE TO FOR SECTION CONSERVENT SERVER SERVEN | Intended 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 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. | | Sterilization Method | Cycle Parameters | Total System Weight | Applicable Containers/Accessories | |-------------------------------------------|--------------------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dynamic Air Removal
(Pre-Vacuum) Steam | Exposure Temperature: 270°F
(132°C) | 25 lbs. | Solid Bottom Containers;
Perforated Bottom
Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450 mm) | | | Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Dry Time Cycle: 30 minutes | | Devices or Device
Configurations entailing
conjoined surfaces which
meet, touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective Plate | | | Minimum Cool Time: 60 minutes
(may vary according to load contents) | | Materials: Stainless Steel
Aluminum;
Silicone; Radel | | | Stack Height: Maximum 3 | | | {3}------------------------------------------------ | Sterilization Method | Cycle Parameters | Total System Weight | Applicable Containers/Accessories | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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: Stainless Steel,
Aluminum;
Silicone; Radel | | 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)
Device or Device
Configurations entailing
conjoined surfaces which
meet, touch or unite;
Silicone Support Bars;
Laparoscopic Racks;

Materials: Stainless Steel,
Aluminum, Silicone, Radel | Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), Examples of instrument types that are conjoined increases roresps, kerrison rongeurs, specula. and self retaining retractors, needle holders, ostectores that are commercly ob and self retaining retractors, needle holders, ostections is rollegely of the morely obstructed. These types of devices Note: Air tight occluded challenges are devices entai Note: Air tight occluded challenges are devices Encaling our association Container System. have not been validated for use in the Genesis Reusable Sterilization Container Sys : 、 . . · . {4}------------------------------------------------ | | 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: 2.68mm (ID) x
450mm (L) | Yes, maximum 2 | 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 | Radel,
Stainless Steel
Aluminum
Silicone | No | | | Maximum Total
Container System
Weight | 25 lbs. | No | | Perforated Bottom
Container | Non Stacking Baskets | Yes | Yes | | | Stacking Baskets | Yes | No | | | Lumen: 2.68mm (ID) x
450mm (L) | Yes, maximum 2 | 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 CD2-10BDL
and DINCD2-8B
container models are
not validated for use in
100% Ethylene Oxide
sterilization | 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 | Radel
Stainless Steel
Aluminum
Silicone | Radel
Stainless Steel
Aluminum
Silicone | | Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100% Ethylene Oxide | | | 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 | Radel
Stainless Steel
Aluminum
Silicone | Radel
Stainless Steel
Aluminum
Silicone | | | | | | | | | | | | | Maximum Total
Container System
Weight | 25 lbs. | 15 lbs. | . . . . . . . . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . . {5}------------------------------------------------ and the count 1. 1. 1. 1. 1. 100 - 100 - 100 · : . . . . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : ## . Solid Bottom Containers : 上一篇: ... : . ... ... : 1 . . . . : 1 - 1 - 1 - 1 - 1 - 1 - : . . : : | Solid Bottom Containers | | | Container | |-------------------------|--------------------------|--------------------------|--------------| | Catalog
Code | Description | Container Dimension (in) | 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 | {6}------------------------------------------------ | Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb) | |-----------------|---------------------------|--------------------------|--------------------------| | 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 | | | DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | | | DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | | | DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | | | DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | | : Comments of the country : : . . . . . . . . . . . : : · | 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 | | 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 | | Page 7 of 8 | | | | {7}------------------------------------------------ | Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb) | |-----------------|----------------------------|--------------------------|--------------------------| | 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 | 1. 1. 1. 1. | 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}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the eagle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 APR 2 7 2012 Ms. Kate Fuller Regulatory Manager CareFusion 2200, Inc. 1500 Waukegan Road McGaw Park, Illinois 60085 Re: K112535 Trade/Device Name: Genesis Reusable Rigid Sterilization Container System and Accessories Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 13, 2012 Received: April 13, 2012 Dear Ms.Fuller: 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. {9}------------------------------------------------ ## Page 2 - Ms. Fuller Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ 1500 Waukegan Road McGaw Park, IL 600085 847-473-7334 tel. carefusion.com CareFusion Indications for Use 510(k) Number: K112535 Device Name: Genesis Reusable Rigid Sterilization Container System and Accessories Indications for Use: The Genesis Reusable Rigid Sterilization Container System is a device intended to The Genesis Reusable Right Stellization Contraction of the Markhcare be used to enclose another medical device that is to be sterilized by a healthcare be used to enclose another medical device in edical device and maintains provider. It allows sterilization of the enclosed medical device and maintains provider. It allows stermization of or a maximum of 180 days. sterility of the enclosed device until used for a maximum of 180 days. Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, Containers are suitable for dynamic alling and 100% othylene oxide Containers are suitable for dynamis arilization and 100% ethylene oxide immediate use pre-vacuum steam sterilization and 100% ethylene oxide minnediate use pre-vasualisms and in the instructions for use. Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to r and accessory items devices deving sterilization and storage of Reusable baskets and accessory Rems (pins) of the supering sterilization and storage of the container. Data cards are used to record information regarding a specific sterilization process . In the card to record information revident while providing a microbial Data cards are used to record information in a microsiding a microbial load. Filter media allows ingress and egress of sterilant what the container load. Filter media allows ingress and og our sual indication that the contains i barrier. Tamper evident arrows provised prior to use. Each arrow contains a system has not been inadvertently opened prior as a visual indication th system has not been madvertently opened that serves as a visual indication that modality-specific external process indication ovelo parameter. Data card modality-specific external process matcator that other corrected. Data cards, the system has been exposed to a specific sterilization cycle parameter. Data cards, the system has been arrows are single use only. Prescription Use (Per 21 CFR 801.109) (please do not write below this line. continue on another page) Ely L.L. F. Clavin-Will (Division Sign-Off) Over the Counter Use Concurrence of CDRH, Office of Device Evaluation Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 7 510(k) Number: {11}------------------------------------------------ | 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: Stainless
Steel, Aluminum;
Silicone; Radel | | 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: Stainless
Steel, Aluminum;
Silicone; Radel | | Sterilization Method | Cycle Parameters | Total System Weight | Applicable Containers/Accessories | | 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)
Device or Device Configurations
entailing conjoined surfaces which meet,
touch or unite;
Silicone Support Bars;
Laparoscopic Racks;

Materials: Stainless Steel, Aluminum,
Silicone, Radel | ality . . . : . : : {12}------------------------------------------------ Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), Examples of instrument types that are conformed includers, osteotomes/chisels, rongeurs, hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeur specula. specula. Note: Air tight occluded challenges are devices entailing surfaces that are completely obstruction System Note: All tight occided Challenges are devices chiese and the Serilization Container System. of devices have not been validated for use in the Genesis Reusable Sterilization Page 3 of 7 {13}------------------------------------------------ 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: 2.68mm (ID) x
450mm (L) | Yes, maximum 2 | 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 | Radel,
Stainless Steel
Aluminum
Silicone | No | | | Maximum Total
Container System
Weight | 25 lbs. | No | | Perforated Bottom
Container | Non Stacking Baskets | Yes | Yes | | | Stacking Baskets | Yes | No | | | Lumen: 2.68mm (ID) x
450mm (L) | Yes, maximum 2 | 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 | | Note: The CD2-10BDL
and DINCD2-8B
container models are
not validated for use in
100% Ethylene Oxide
sterilization | 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 | | Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100% Ethylene Oxide | | STERRAD Compatible
Containers | Materials | Radel
Stainless Steel
Aluminum
Silicone | Radel
Stainless Steel
Aluminum
Silicone | | | Maximum Total Weight | 25 lbs. | 15 lbs. | | | 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 | | | 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 | Radel
Stainless Steel
Aluminum
Silicone | Radel
Stainless Steel
Aluminum
Silicone | | | Maximum Total
Container System
Weight | 25 lbs. | 15 lbs. | . {14}------------------------------------------------ |… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K112535](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K112535) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com