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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Genesis Reusable Rigid Container System, based on the provided text:

Acceptance Criteria and Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Sterilization Efficacy (Pre-Vacuum Steam; and 100% Ethylene Oxide)	12 log reduction and sterility assurance level (SAL) of 10⁻⁶	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	Maintenance of sterility for all sterilization modalities for 180 days.	180 Day Event Related Shelf life studies demonstrated sterility maintenance for all sterilization modalities.
Microbial Challenge	Negative growth after exposure to a minimum of 1 x 10⁶ Bacillus atrophaeus colony forming units (CFU)	Whole package microbial challenge test exposing a container to a minimum of 1 x 10⁶ Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth.

Study Information

The provided document describes non-clinical performance testing for the Genesis Reusable Rigid Container System.

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "Testing" and "studies" but does not quantify the number of units or cycles tested for each characteristic.
- Data Provenance: The studies are described as "non-clinical tests" and "Performance Test Summary-New Device". The manufacturer is CareFusion, based in McGaw Park, IL, USA. This suggests the data is likely from internal laboratory testing conducted by the manufacturer. It is prospective testing for the purpose of validating the new/modified device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the ground truth appears to be established through standardized methods for sterilization efficacy (biological indicators, microbial challenges) rather than expert consensus on observational data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the ground truth is determined by objective laboratory measurements and standardized biological/microbial tests, not by human adjudication of subjective assessments.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers assessing cases with and without AI assistance for diagnostic accuracy. The Genesis Reusable Rigid Container System is a sterilization container, not a diagnostic imaging device, so such a study would not be relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The reported performance data for sterilization efficacy, shelf life, and microbial challenge are "standalone" in the sense that they are objective measurements of the device's ability to perform its intended function (sterilization and maintaining sterility) without human intervention in the outcome assessment (beyond setting up the tests). The device itself is not an algorithm, but its function is evaluated without a human-in-the-loop interacting with its core sterilizing mechanism.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established through objective biological and microbiological testing standards. Specifically:
  - Sterilization Efficacy: Achieved a 12 log reduction and SAL of 10⁻⁶ using biological indicators (BI) and an overkill method, as per ST 77:2006.
  - Microbial Challenge: Demonstrated 100% negative growth following exposure to a specified concentration of Bacillus atrophaeus CFU via aerosol, also as per ST 77:2006.
  - Shelf Life: Sterility maintenance demonstrated over 180 days.
The sample size for the training set:
- This information is not applicable. The device is a physical sterilization container, not a software algorithm that requires a training set. The performance is validated through physical and biological testing.
How the ground truth for the training set was established:
- This information is not applicable as there is no training set for this device.

Summary

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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 RegistrationNumber	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 marketeddevice(s) to whichequivalence is claimed	K844652 - Genesis Sterilization ContainerK983299 - Genesis Deep Lid Sterilization ContainerK012931 - 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 devicesand maintain sterility of these devices until used. The container system iscomprised of a lid, bottom, filter, tamper evident arrows, and data cards.The container system houses baskets of varying depths and organizing.

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	SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TOTHE PREDICATE DEVICE
Characteristic	New/Modified Device	Predicate
Container	Anodized Aluminum 5000 and1100 Series; Stainless Steel 300series	Genesis Container (K844652); GenesisDeep Lid Container (K983299) GenesisSTERRAD Compatible Container(K012931)
Gasket	Closed Cell Silicone Foam	SAME
Filter Material	SMS Polypropylene for allModalities	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 SUBSTANTIALEQUIVALENCE
	Performance Test Summary-New Device
Characteristic	Standard/Test/FDAGuidance	Results Summary
Sterilization Efficacy: Pre-Vacuum Steam; and 100%Ethylene Oxide	ST 77 2006 ContainmentDevices for ReusableMedical Device Sterilization	Testing demonstrated a 12 log reduction andsterility assurance level (SAL) of 10 6 usingbiological (BI) overkill method and half-cyclevalidation.
180 Day Event RelatedShelf Life for all SterilizationModalities	ST 77:2006 ContainmentDevices for ReusableMedical Device Sterilization	180 Day Event Related Shelf life studiesdemonstrated sterility maintenance for allsterilization modalities.
Microbial Challenge	ST.77:2006 ContainmentDevices for ReusableMedical Device Sterilization	Whole package microbial challenge testexposing a container to a minimum of 1 x10 6Bacillus atrophaeus colony forming units (CFU)via an aerosol challenge demonstrating 10 0%negative growth

EQUIVALENCE ANDION OF OF OLINERS .............................................................................................................................................

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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 BottomContainers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mm x 450 mm)
	Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesDry Time Cycle: 30 minutes		Devices or DeviceConfigurations entailingconjoined surfaces whichmeet, touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional Protective Plate
	Minimum Cool Time: 60 minutes(may vary according to load contents)		Materials: Stainless SteelAluminum;Silicone; Radel
	Stack Height: Maximum 3

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Sterilization Method	Cycle Parameters	Total System Weight	Applicable Containers/Accessories
Dynamic Air Removal(Pre-Vacuum) SteamImmediate Use	Exposure Temperature: 270°F (132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesStack Height: Maximum 3Note: Devices must be usedimmediately and cannot be storedfor later use.	25 lbs.	Solid Bottom Containers;Perforated BottomContainers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mmx 450 mm)Devices or DeviceConfigurations entailingconjoined surfaces whichmeet, touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional Protective PlateMaterials: Stainless Steel,Aluminum;Silicone; Radel
100% Ethylene Oxide	EO Sterilant Concentration: 100%EO, 725 mg/LPre-conditioning Time: 30 minutesTemperature: 130°F (55°C)Exposure Time: 60 minutesRelative Humidity: 50-80%Aeration: 8 hours @ 109.4°F (43°C)No stacking	15 lbs.	Perforated BottomContainers except CD2-10BDL and DINCD2-8B);Non Stacking BasketsLumen Devices (3.0 mm x400 mm)Device or DeviceConfigurations entailingconjoined surfaces whichmeet, 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 :

、

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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: 2.68mm (ID) x450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400 mm (L)	Yes, maximum 2	No
	Occluded/MatedChallenge	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 SteelAluminumSilicone	No
	Maximum TotalContainer SystemWeight	25 lbs.	No
Perforated BottomContainer	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400mm (L)	Yes, maximum 2	Yes, maximum 5
	Occluded/Matedchallenge	Yes	Yes
	Silicone Support Bars	Yes	Yes
	Silicone Mat	Yes	No
Note: The CD2-10BDLand DINCD2-8Bcontainer models arenot validated for use in100% Ethylene Oxidesterilization	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	RadelStainless SteelAluminumSilicone	RadelStainless SteelAluminumSilicone
Type of Container	Contents/Configuration	Pre-Vacuum Steam	100% Ethylene Oxide
	Maximum Total Weight	25 lbs.	15 lbs.
STERRAD CompatibleContainers	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x450mm (L)	Yes, maximum 2	No
	Lumen: 3.0mm (ID) x400mm (L)	Yes, maximum 2	Yes, maximum 5
	Occluded/MatedChallenge	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	RadelStainless SteelAluminumSilicone	RadelStainless SteelAluminumSilicone


	Maximum TotalContainer SystemWeight	25 lbs.	15 lbs.

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and the count

100 - 100 - 100

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. Solid Bottom Containers

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Solid Bottom Containers			Container
CatalogCode	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

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CatalogCode	Description	Container Dimension (in)	ContainerWeight (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

: . . .

. . . . . . . .

CatalogCode	Description	Container Dimension (in)	ContainerWeight (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

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CatalogCode	Description	Container Dimension (in)	ContainerWeight (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

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

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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.

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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

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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:

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Sterilization Method	Cycle Parameters	Total System Weight	ApplicableContainers/Accessories
Dynamic Air Removal(Pre-Vacuum) Steam	Exposure Temperature: 270°F(132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesDry Time Cycle: 30 minutesMinimum Cool Time: 60 minutes(may vary according to load contents)Stack Height: Maximum 3	25 lbs.	Solid BottomContainers;Perforated BottomContainers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mm x 450 mm)Devices or Device Configurationsentailing conjoined surfaces which meet,touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional ProtectivePlateMaterials: StainlessSteel, Aluminum;Silicone; Radel
Dynamic Air Removal(Pre-Vacuum) SteamImmediate Use	Exposure Temperature: 270°F(132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesStack Height: Maximum 3Note: Devices must be usedimmediately and cannot bestored for later use.	25 lbs.	Solid BottomContainers;Perforated BottomContainers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mm x 450 mm)Devices or Device Configurationsentailing conjoined surfaces which meet,touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional ProtectivePlateMaterials: StainlessSteel, Aluminum;Silicone; Radel
Sterilization Method	Cycle Parameters	Total System Weight	Applicable Containers/Accessories
100% Ethylene Oxide	EO Sterilant Concentration:100% EO, 725 mg/LPre-conditioning Time: 30 minutesTemperature: 130°F (55°C)Exposure Time: 60 minutesRelative Humidity: 50-80%Aeration: 8 hours @ 109.4°F (43°C)No stacking	15 lbs.	Perforated Bottom Containers exceptCD2-10BDL andDINCD2-8B);Non Stacking BasketsLumen Devices (3.0 mm x 400 mm)Device or Device Configurationsentailing conjoined surfaces which meet,touch or unite;Silicone Support Bars;Laparoscopic Racks;Materials: Stainless Steel, Aluminum,Silicone, Radel

ality

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: :

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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

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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: 2.68mm (ID) x450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400mm (L)	Yes, maximum 2	No
	Occluded/MatedChallenge	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 SteelAluminumSilicone	No
	Maximum TotalContainer SystemWeight	25 lbs.	No
Perforated BottomContainer	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400mm (L)	Yes, maximum 2	Yes, maximum 5
	Occluded/Matedchallenge	Yes	Yes
	Silicone Support Bars	Yes	Yes
	Silicone Mat	Yes	No
	Laparoscopic Rack	Yes	Yes
Note: The CD2-10BDLand DINCD2-8Bcontainer models arenot validated for use in100% Ethylene Oxidesterilization	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 CompatibleContainers	Materials	RadelStainless SteelAluminumSilicone	RadelStainless SteelAluminumSilicone
	Maximum Total Weight	25 lbs.	15 lbs.
	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x450mm (L)	Yes, maximum 2	No
	Lumen: 3.0mm (ID) x400mm (L)	Yes, maximum 2	Yes
	Occluded/MatedChallenge	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	RadelStainless SteelAluminumSilicone	RadelStainless SteelAluminumSilicone
	Maximum TotalContainer SystemWeight	25 lbs.	15 lbs.

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CatalogCode	Description	Container Dimension (in)	ContainerWeight (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

the country of the count

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CatalogCode	Description	Container Dimension (in)	ContainerWeight (lb.)
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 DIN Container	11.6 x 11.4 x 6.1	5.2

contraction and consisted to

: : : : :

CatalogCode	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

ﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ

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CatalogCode	Description	Container Dimension (in)	ContainerWeight (lb.)
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

CatalogCode	Description	Container Dimension (In)	ContainerWeight (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

. . . . . . . . . . . . . . . . .

. . . . . . .

Regulation Number and Section

§ 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).