Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization container system, a physical enclosure for medical devices during sterilization. The description focuses on its mechanical and barrier properties, and the performance studies evaluate sterilization efficacy and container integrity. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.

Therapeutic

No.
The device is intended to sterilize, organize, and secure other medical devices, and maintain their sterility, not to treat a patient directly or indirectly.

Diagnostic

No

Explanation: This device is a sterilization container system, not a diagnostic device. It is designed to enclose, sterilize, and maintain the sterility of other medical devices. Its function is to facilitate the sterilization process, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a lid, bottom, filter, tamper evident arrows, data cards, baskets, and organizing accessory devices. The performance studies also focus on the physical properties and efficacy of these components in the sterilization process. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to enclose and sterilize other medical devices, maintaining their sterility until use. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions.
Device Description: The description focuses on the physical components of a container system designed for sterilization and storage.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The performance studies focus on sterilization efficacy and container integrity, not diagnostic performance.

Therefore, the Genesis™ Low Temperature Sterilization Container System falls under the category of a medical device used for sterilization and storage, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Genesis(TM) Low Temperature 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 su sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for various STERRAD and V-PRO low temperature sterilization modalities when used as described in the instructions for use.

Reusable baskets and accessory items (pins, div.) 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 evide a visual indication that the contamer system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication 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.

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

The Genesis™ Low Temperature Container System is an assortment of rigid, reusable, stackable containers that are used to enclose 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 Data – Non Clinical
The following non-clinical performance tests were provided in support of the substantial equivalence determination.

Sterilization Efficacy - Lethality
STERRAD NX (Standard, Advanced)
STERRAD 100 NX ( Standard, Flex, Express)
V-PRO (Non-Lumen, Lumen, Flexible)
Results Summary: Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method

Aerosol Challenge
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen
Results Summary: Containers subjected to an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample demonstrated no growth of the indicator organism following the incubation period.

Cycled Aerosol / Limits of Reuse
STERRAD 100NX Standard
VPRO 1-Plus/60 Lumen
Results Summary: After 100 simulated full use cycles or the equivalent followed by an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample demonstrated no growth of the indicator organism following the incubation period.

Simulated Use
STERRAD NX Advanced
STERRAD 100NX Flex
VPRO maX Flexible
VPRO 60 Flexible
Results Summary: Testing demonstrated no recovery of viable challenge organism (all sterile results) from the lumens on the test device after processing within a worst case Genesis Container as part of a worst case cycle simulated use container validation load.

Shelf Life / Package Integrity
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen
Results Summary: All sample devices remained sterile (exhibit no growth) following exposure to a full sterilization cycle and weekly rotation events at a 180 day storage duration.

Filter Material Properties
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen
Results Summary: All filter properties were found to be acceptable.

Biocompatibility
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen
Results Summary: Blood hemolysis testing demonstrated that any accessories used in the Genesis™ Low Temperature Sterilization Container System are acceptable for use after processing in the low temperature sterilization modalities.

There was no clinical testing performed in support of the substantial equivalence determination.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Genesis™ Rigid Reusable Sterilization Container System, K142529

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.

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2016

CareFusion 2200 Inc. Ms. Jane Weber Manager, Regulatory Affairs 75 N. Fairway Drive Vernon Hills, Illinois 60061

Re: K153554

Trade/Device Name: Genesis™ Low Temperature Reusable Rigid Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 22, 2016 Received: February 23, 2016

Dear Ms. Jane 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153554

Device Name

Genesis(TM) Low Temperature Reusable Rigid Sterilization Container System

Indications for Use (Describe)

The Genesis(TM) Low Temperature 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 su sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for various STERRAD and V-PRO low temperature sterilization modalities when used as described in the instructions for use.

Reusable baskets and accessory items (pins, div.) 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 evide a visual indication that the contamer system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|× 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)

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Sterilization Cycle Parameters for the Genesis Low Temperature Reusable Rigid Container System by Modality

| Sterilization Cycle
Parameters | Total System
Weight | Load Configuration
Applicable Containers / Accessories | Contents/Configuration | STERRAD NX Standard | STERRAD NX Advanced | STERRAD 100NX Standard | STERRAD 100NX Flex | STERRAD 100NX Express | Contents/Configuration | V-PRO 1 Plus, max Non-Lumen | V-PRO 1, 1 Plus, maX Lumen | V-PRO maX Flexible | Contents/Configuration | V-PRO 60 Non-Lumen | V-PRO 60 Lumen | V-PRO 60 Flexible |
|--------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------|---------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|
| STERRAD NX Standard
Push button cycle with non-adjustable parameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Lumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10
Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD NX | Baskets | Yes | Yes | Yes | Yes | Yes | Baskets | Yes | Yes | Yes | Baskets | Yes | Yes | Yes |
| STERRAD NX Advanced
Push button cycle with non-adjustable parameters | 10.7 lbs.
(Endoscope load: no additional load) | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Lumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10
Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10
Lumen Devices (1.0 mm x 500 mm) Stainless Steel, Qty. 10
Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 1
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD NX | Stacking Baskets | Yes | Yes | Yes | Yes | Yes | Stacking Baskets | Yes | Yes | No | Stacking Baskets | Yes | Yes | No |
| STERRAD 100NX Standard
Push button cycle with non-adjustable parameters | 21.4 lbs. | Perforated Bottom Low Temperature Containers;
Stacking baskets
Lumen Devices (0.7 mm x 500 mm) Stainless Steel, Qty. 10
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD
100NX | Lumen: 0.7 mm (ID) x 500 mm (L)
Stainless Steel | No | No | Yes, max 10 | No | No | Single Channel 0.77mm (ID) x 500 mm (L) Stainless Steel; | No | Yes, max 20 | No | Single Channel 0.77mm (ID) x 410 mm (L) Stainless Steel;
Dual Channel 0.77 mm (ID) x 410 mm (L) Stainless Steel; | No | Yes, max 12 | No |
| STERRAD 100NX Flex
Push button cycle with non-adjustable parameters | No additional
load | Perforated Bottom Low Temperature Containers;
Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 2
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD
100NX | Lumen: 1.0 mm (ID) x 150 mm (L)
Stainless Steel | Yes, max 10 | Yes, max 10 | Yes, max 10 | No | No | Dual Channel 0.77 mm (ID) x 527 mm (L) Stainless Steel; | | | | Triple Channel 1.2 mm (ID) x 275 mm (L), 1.8 mm (ID) x 310 mm (L), 2.8 mm (ID) x 317 mm (L) Stainless Steel | No | No | Yes |
| STERRAD 100NX Express
Push button cycle with non-adjustable parameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD
100NX | Lumen: 2.0 mm (ID) x 400mm (L)
Stainless Steel | Yes, max 10 | Yes, max 10 | Yes, max 10 | No | No | Triple Channel 1.2 mm (ID) x 275 mm (L), 1.8 mm (ID) x 310 mm (L), 2.8 mm (ID) x 317 mm (L) Stainless Steel | No | No | Yes
QTY. 2 (with no additional load)
QTY 1 (with instruments for 24 lbs total load) | Flexible Endoscopes:
Single Lumen 1.0 mm (ID) x 990 mm (L) OR
Two lumens 1.0 mm (ID) x 990 mm (L) | | | QTY. 1 (with no additional load) |
| Sterilization Cycle
Parameters | Total System
Weight | Load Configuration | Lumen: 1.0 mm (ID) x 500 mm (L)
Stainless Steel | No | Yes, max 10 | Yes, max 10 | No | No | Flexible Endoscopes:
Single Lumen 1.0 mm (ID) x 1050 mm (L) OR
Two lumens | | | | Occluded/Mated challenge | Yes | Yes | Yes |
| V-PRO 1 Plus maX Non-Lumen
Push button cycle with non-adjustable parameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO | Lumen 1.0 mm (ID) x 850 mm (L)
PE/PTFE | No | Yes, max 1 | No | Yes, max 2 | No | 1.0 mm (ID) x 998 mm (L)1.0 mm (ID) x 850 mm (L) | Yes | Yes | Yes | Silicone Support Bars | Yes | Yes | Yes |
| V-PRO 1, 1 Plus maX Lumen
Push button cycle with non-adjustable parameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Single Channel (0.77 mm x 500mm) Stainless Steel; Dual channel (0.77 mm x 527mm) Stainless Steel; Triple Channel (1.2 mm x 275 mm, 1.8 mm x 310 mm, 2.8 mm x 317 mm) Stainless Steel; Max 20 lumens per load
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO | Occluded/Mated challenge | Yes | Yes | Yes | No | Yes | Occluded/Mated challenge | Yes | Yes | Yes | Silicone Mat | Yes | Yes | Yes |
| V-PRO maX Flexible
Push button cycle with non-adjustable parameters | 2 scopes, or
One scope + instruments for total of 24.0 lbs. | Perforated Bottom Low Temperature Containers;
Flexible Endoscopes - Qty. 2 w/ no additional load; Qty. 1 w/ instrument load for 24 lbs total
Single Lumen (1 mm x 1050mm) or
Two lumens, one (1 mm x 998 mm) the other (1 mm x 850 mm)
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO | Silicone Support Bars | Yes | Yes | Yes | Yes | Yes | Silicone Support Bars | Yes | Yes | Yes | Filter | DST Series | DST Series | DST Series |
| V-PRO 60 Non-Lumen
Push button cycle with non-adjustable parameters | 12.0 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO 60 | Silicone Mat | No | No | No | No | No | Silicone Mat | Yes | Yes | Yes | Data Cards | MH1-1 | MH1-1 | MH1-1 |
| V-PRO 60 Lumen
Push button cycle with non-adjustable parameters | 11.0 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Single Channel (0.77 mm x 410 mm) Stainless Steel; Dual Channel (0.77 mm x 410 mm) Stainless Steel; Triple Channel (1.2 mm x 275 mm, 1.8 mm x 310 mm, 2.8 mm x 317 mm) Stainless Steel; Max 12 lumens per load
Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO 60 | Filter | DST series | DST series | DST series | DST series | DST series | Filter | DST Series | DST Series | DST Series | Tamper Evident Arrow | Pink AH Series | Pink AH Series | Pink AH Series |
| | | | Data Cards | MH1-1 | MH1-1 | MH1-1 | MH1-1 | MH1-1 | Data Cards | MH1-1 | MH1-1 | MH1-1 | Stack Height | No stacking | No stacking | No stacking |
| Sterilization Cycle
Parameters | Total System
Weight | Load Configuration
Applicable Containers / Accessories | Tamper Evident Arrow | Pink AH Series | Pink AH Series | Pink AH Series | Pink AH Series | Pink AH Series | Tamper Evident Arrow | Pink AH Series | Pink AH Series | Pink AH Series | Materials | Compatible with materials cleared for V-PRO 60 | Compatible with materials cleared for V-PRO 60 | Compatible with materials cleared for V-PRO 60 |
| V-PRO 60 Flexible

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K153554 INDICATIONS FOR USE

6

K153554 INDICATIONS FOR USE

Examples of instrument types that are conjoined include: a lumen secured to a silicone bar, an instrument placed on a silicone mat, a double action instrument with mated parts held open.

Note: Air tight occluded challenges - devices with surfaces that are completely obstructed - have not been validated for use in the Genesis Low Temperature Reusable Sterilization Container System.

*Materials: For examples of materials supported in the STERRAD 100NX, V-PRO 1, V-PRO 1 Plus, V-PRO maX, and V-PRO 60 sterilization modalities, please refer to the corresponding Instructions for Use from the sterilizer manufacturer.

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53554 INDICATIONS FOR US

Accessories and Device Challenges by STERRAD Sterilization Modalities for all Perforated Bottom Container

8

53554 INDICATIONS FOR USE

ccessories and Device Challenges by V-PRO 1 / 1 Plus / maX Sterilization Modalities for all Perforated Bottom Container

9

53554 INDICATIONS FOR USE

Accessories and Device Challenges by V-PRO 60 Sterilization Modalities for all Perforated Bottom Containers

10

K153554 INDICATIONS FOR USE

Perforated Bottom Containers

| Catalog Code | Description | Container Dimension (in) | Container
Weight
(Ibs.) |
|--------------|------------------------------------|--------------------------|-------------------------------|
| CD0-3LT | Mini - Perforated Bottom | 10.2 x 7.2 x 3.2 | 2.6 |
| CD0-4LT | Quarter Length - Perforated Bottom | 9.5 x 12.4 x 3.8 | 3.7 |
| DINCD1-5LT | Half-Length - Perforated Bottom | 11.6 x 11.4 x 5.4 | 4.8 |
| DINCD1-6LT | Half-Length - Perforated Bottom | 11.6 x 11.4 x 6.1 | 5.0 |
| DINCD2-5LT | Mid-Length - Perforated Bottom | 19.2 x 11.4 x 5.4 | 6.5 |
| DINCD2-6LT | Mid-Length - Perforated Bottom | 19.2 x 11.4 x 6.1 | 6.7 |
| DINCD2-8LT | Mid-Length - Perforated Bottom | 19.2 x 11.4 x 7.8 | 7.2 |
| DINCD3-5LT | Full-Length - Perforated Bottom | 23.1 x 11.4 x 5.4 | 7.6 |
| DINCD3-6LT | Full-Length - Perforated Bottom | 23.1 x 11.4 x 6.1 | 7.9 |
| DINCD3-7LT | Full-Length - Perforated Bottom | 23.1 x 11.4 x 7.1 | 8.2 |
| CD4-3LT | Small Narrow - Perforated Bottom | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5LT | Small Narrow - Perforated Bottom | 20.8 x 7.3 x 5.2 | 4.8 |

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Image /page/11/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange shield with a white arrow pointing downwards and to the left, followed by the word "CareFusion" in gray. Below the word "CareFusion" are the words "has joined BD" in a smaller, lighter font.

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

I. 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	18-MAR-2016
II. DEVICE INFORMATION
Name of Device	Genesis™ Low Temperature Reusable Rigid Container System
Common or usual name	Sterilization Container
Classification name	Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories
Regulatory Class	Class II per 21CFR 880.6850, Product code KCT
Product Code	KCT

III. PREDICATE DEVICE

Genesis™ Rigid Reusable Sterilization Container System, K142529

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The Genesis™ Low Temperature Container System is an assortment of rigid, reusable, stackable containers that are used to enclose 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.

V. INDICATIONS FOR USE

The Genesis™ Low Temperature Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a health care provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed medical device until used for a maximum of 180 days.

Containers are suitable for various STERRAD and V-PRO low temperature sterilization modalities 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

12

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.

| VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

DEVICE
Characteristic	Predicate Device - K142529	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
Volume to Vent Ratio	24.0 to 182.3 in3 / in2	29.3 to 87.3 in3/in²
Sterilization Modalities	Pre-Vacuum Steam
100% Ethylene Oxide	STERRAD® NX Standard
STERRAD® NX Advanced
STERRAD® 100NX Standard
STERRAD® 100NX Flex
STERRAD® 100NX Express
V-PRO 1 Lumen
V-PRO 1 Plus Lumen
V-PRO 1 Plus Non-Lumen
V-PRO maX Lumen
V-PRO max Non-Lumen
V-PRO maX Flexible
V-PRO 60 Lumen
V-PRO 60 Non-Lumen
V-PRO 60 Flexible
Characteristic	Standard / Test / FDA
Guidance	Results Summary
Sterilization Efficacy - Lethality
STERRAD NX (Standard,
Advanced)
STERRAD 100 NX (
Standard, Flex, Express)
V-PRO (Non-Lumen, Lumen,
Flexible)	ANSI AAMI 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
Aerosol Challenge
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen	ANSI AAMI ST 77 2013
Containment Devices for
Reusable Medical
Device Sterilization	Containers subjected to an aerosol challenge
test with an exposure of 1.0 - 5.0 x 106 CFU.
Agar vessels placed in each container sample
demonstrated no growth of the indicator
organism following the incubation period
Cycled Aerosol / Limits of
Reuse
STERRAD 100NX Standard
VPRO 1-Plus/60 Lumen	ANSI AAMI ST 77 2013
Containment Devices for
Reusable Medical
Device Sterilization	After 100 simulated full use cycles or the
equivalent followed by an aerosol challenge
test with an exposure of 1.0 - 5.0 x 106 CFU.
Agar vessels placed in each container sample
demonstrated no growth of the indicator
organism following the incubation period
Simulated Use
STERRAD NX Advanced
STERRAD 100NX Flex
VPRO maX Flexible
VPRO 60 Flexible	ANSI AAMI ST 77 2013
Containment Devices for
Reusable Medical
Device Sterilization	Testing demonstrated no recovery of viable
challenge organism (all sterile results) from
the lumens on the test device after processing
within a worst case Genesis Container as part
of a worst case cycle simulated use container
validation load
Shelf Life / Package Integrity
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen	ANSI AAMI ST 77 2013
Containment Devices for
Reusable Medical
Device Sterilization	All sample devices remained sterile (exhibit
no growth) following exposure to a full
sterilization cycle and weekly rotation events
at a 180 day storage duration
Filter Material Properties
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen	Filter properties
(Bacterial Filtration
Efficiency, Trapezoidal
Tear Strength, and Burst
Strength) prior to and
after exposure to a full
sterilization cycle were
reported	All filter properties were found to be
acceptable
Biocompatibility
STERRAD NX Advanced
STERRAD 100NX Standard
VPRO 60 Lumen	ISO 10993-4 2009	Blood hemolysis testing demonstrated that
any accessories used in the Genesis™ Low
Temperature Sterilization Container System
are acceptable for use after processing in the
low temperature sterilization modalities

13

PERFORMANCE DATA – NON CLINICAL VII.

The following non-clinical performance tests were provided in support of the substantial equivalence determination.

There was no clinical testing performed in support of the substantial equivalence determination.

14

IX. CONCLUSIONS DRAWN FROM NON-CLINCAL DATA

The Genesis™ Low Temperature Container System has been validated to meet the established performance criteria. The device is substantially equivalent to the predicate device.

15

Sterilization Cycle Parameters for the Genesis Low Temperature Reusable Rigid Container System by Modality

| Sterilization Cycle
Parameters | Total
System
Weight | Load Configuration
Applicable Containers / Accessories |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STERRAD NX Standard
Push button cycle with
non-adjustable
parameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Lumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10
Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10
Devices or Device Configurations entailing conjoined surfaces
which meet, touch or unite
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD NX |
| STERRAD NX Advanced
Push button cycle with
non-adjustable
parameters | (Endoscope
load: no
additional
load) | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Lumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10
Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10
Lumen Devices (1.0 mm x 500 mm) Stainless Steel, Qty. 10
Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 1
Devices or Device Configurations entailing conjoined surfaces
which meet, touch or unite;
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD NX |
| STERRAD 100NX
Standard
Push button cycle with
non-adjustable
parameters | 21.4 lbs. | Perforated Bottom Low Temperature Containers;
Stacking baskets
Lumen Devices (0.7 mm x 500 mm) Stainless Steel, Qty. 10
Devices or Device Configurations entailing conjoined surfaces
which meet, touch or unite;
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD
100NX |
| STERRAD 100NX Flex
Push button cycle with
non-adjustable
parameters | No additional
load | Perforated Bottom Low Temperature Containers;
Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 2
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD
100NX |
| STERRAD 100NX
Express
Push button cycle with
non-adjustable
parameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Devices or Device Configurations entailing conjoined surfaces
which meet, touch or unite;
Silicone Support Bars
*Materials: Compatible with materials cleared for STERRAD
100NX |
| Sterilization Cycle
Parameters | Load Configuration | |
| | Total System
Weight | Applicable Containers / Accessories |
| V-PRO 1 Plus maX Non-
Lumen
Push button cycle with
non-adjustable
parameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Devices or Device Configurations entailing conjoined
surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO |
| V-PRO 1, 1 Plus maX
Lumen
Push button cycle with
non-adjustable
parameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Single Channel (0.77 mm x 500mm) Stainless Steel; Dual
channel (0.77 mm x 527mm) Stainless Steel; Triple
Channel (1.2 mm x 275 mm, 1.8 mm x 310 mm, 2.8 mm x
317 mm) Stainless Steel; Max 20 lumens per load
Devices or Device Configurations entailing conjoined
surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO |
| V-PRO maX Flexible
Push button cycle with
non-adjustable
parameters | 2 scopes,
or
One scope +
instruments for
total of 24.0 lbs. | Perforated Bottom Low Temperature Containers;
Flexible Endoscopes - Qty. 2 w/ no additional load; Qty. 1
w/ instrument load for 24 lbs total
Single Lumen (1 mm x 1050mm) or
Two lumens, one (1 mm x 998 mm) the other (1 mm x 850
mm)
Devices or Device Configurations entailing conjoined
surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO |
| V-PRO 60 Non-Lumen
Push button cycle with
non-adjustable
parameters | 12.0 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Devices or Device Configurations entailing conjoined
surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO 60 |
| Sterilization Cycle
Parameters | Total System
Weight | Applicable Containers / Accessories |
| V-PRO 60 Lumen

Push button cycle with
non-adjustable
parameters | 11.0 lbs. | Perforated Bottom Low Temperature Containers;
Stacking Baskets
Single Channel (0.77 mm x 410 mm) Stainless Steel; Dual
Channel (0.77 mm x 410 mm) Stainless Steel; Triple
Channel (1.2 mm x 275 mm, 1.8 mm x 310 mm, 2.8 mm x
317 mm) Stainless Steel; Max 12 lumens per load
Devices or Device Configurations entailing conjoined
surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO 60 |
| V-PRO 60 Flexible

Push button cycle with
non-adjustable
parameters | No additional
load | Perforated Bottom Low Temperature Containers;
Flexible Endoscopes, Qty. 1
Single Lumen (1.0 mm x 990 mm) or
Two Lumens (1.0 mm x 990 mm)
Devices or Device Configurations entailing conjoined
surfaces which meet, touch or unite;
Silicone Support Bars
Silicone Mats
*Materials: Compatible with materials cleared for V-PRO 60 |

16

17

Examples of instrument types that are conjoined include: a lumen secured to a silicone bar, an instrument placed on a silicone mat, a double action instrument with mated parts held open.

Note: Air tight occluded challenges - devices with surfaces that are completely obstructed - have not been validated for use in the Genesis Low Temperature Reusable Sterilization Container System.

*Materials: For examples of materials supported in the STERRAD 100NX, V-PRO 1, V-PRO 1 Plus, V-PRO maX, and V-PRO 60 sterilization modalities, please refer to the corresponding Instructions for Use from the sterilizer manufacturer.

18

Accessories and Device Challenges by STERRAD Sterilization Modalities for all Perforated Bottom Containers

| Contents/Configuration | STERRAD NX
Standard | STERRAD NX
Advanced | STERRAD 100NX
Standard | STERRAD 100NX
Flex | STERRAD 100NX
Express |
|----------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| Baskets | Yes | Yes | Yes | Yes | Yes |
| Stacking Baskets | Yes | Yes | Yes | No | Yes |
| Lumen: 0.7 mm (ID) x 500 mm (L)
Stainless Steel | No | No | Yes, max 10 | No | No |
| Lumen: 1.0 mm (ID) x 150 mm (L)
Stainless Steel | Yes, max 10 | Yes, max 10 | Yes, max 10 | No | No |
| Lumen: 2.0 mm (ID) x 400mm (L)
Stainless Steel | Yes, max 10 | Yes, max 10 | Yes, max 10 | No | No |
| Lumen: 1.0 mm (ID) x 500 mm (L)
Stainless Steel | No | Yes, max 10 | Yes, max 10 | No | No |
| Lumen 1.0 mm (ID) x 850 mm (L)
PE/PTFE | No | Yes, max 1 | No | Yes, max 2 | No |
| Occluded/Mated challenge | Yes | Yes | Yes | No | Yes |
| Silicone Support Bars | Yes | Yes | Yes | Yes | Yes |
| Silicone Mat | No | No | No | No | No |
| Filter | DST series | DST series | DST series | DST series | DST series |
| Data Cards | MH1-1 | MH1-1 | MH1-1 | MH1-1 | MH1-1 |
| Tamper Evident Arrow | Pink AH Series | Pink AH Series | Pink AH Series | Pink AH Series | Pink AH Series |
| Stack Height | No stacking | No stacking | No stacking | No stacking | No stacking |
| Materials | Compatible with
materials cleared
for STERRAD NX | Compatible with
materials cleared
for STERRAD NX | Compatible with
materials cleared
for STERRAD
100NX | Compatible with
materials cleared
for STERRAD
100NX | Compatible with
materials cleared
for STERRAD
100NX |
| Maximum Total Weight | 10.7 lbs. | Lumen load: 10.7
Ibs .; Endoscope
load: no additional
load | 21.4 lbs. | No additional load | 10.7 lbs. |

19

Accessories and Device Challenges by V-PRO 1 / 1 Plus / maX Sterilization Modalities for all Perforated Bottom Containers

| Contents/Configuration | V-PRO 1 Plus,
maX
Non-Lumen | V-PRO 1,
1 Plus, maX Lumen | V-PRO maX Flexible |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------|
| Baskets | Yes | Yes | Yes |
| Stacking Baskets | Yes | Yes | No |
| Single Channel 0.77mm (ID) x 500 mm (L)
Stainless Steel; | No | Yes, max 20 | No |
| Dual Channel 0.77 mm (ID) x 527 mm (L)
Stainless Steel; | | | |
| Triple Channel 1.2 mm (ID) x 275 mm (L),
1.8 mm (ID) x 310 mm (L), 2.8 mm (ID) x
317 mm (L) Stainless Steel | | | |
| Flexible Endoscopes: | No | No | Yes |
| Single Lumen 1.0 mm (ID) x 1050 mm (L)
OR | | | QTY. 2 (with no additional load) |
| Two lumens | | | QTY 1 (with instruments for 24
lbs total load) |
| 1.0 mm (ID) x 998 mm (L) 1.0 mm (ID) x 850 mm (L) | | | |
| Occluded/Mated challenge | Yes | Yes | Yes |
| Silicone Support Bars | Yes | Yes | Yes |
| Silicone Mat | Yes | Yes | Yes |
| Filter | DST Series | DST Series | DST Series |
| Data Cards | MH1-1 | MH1-1 | MH1-1 |
| Tamper Evident Arrow | Pink AH Series | Pink AH Series | Pink AH Series |
| Stack Height | No stacking | No stacking | No stacking |
| Materials | Compatible with materials
cleared for V-PRO | Compatible with materials
cleared for V-PRO | Compatible with materials
cleared for V-PRO |
| Maximum Total Weight | 19.65 lbs. | 19.65 lbs. | 2 scopes,
or one scope plus instruments
for total of 24 lbs. |

20

Accessories and Device Challenges by V-PRO 60 Sterilization Modalities for all Perforated Bottom Containers

| Contents/Configuration | V-PRO 60
Non-Lumen | V-PRO 60
Lumen | V-PRO 60
Flexible |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------|
| Baskets | Yes | Yes | Yes |
| Stacking Baskets | Yes | Yes | No |
| Single Channel 0.77mm (ID) x 410 mm (L)
Stainless Steel;
Dual Channel 0.77 mm (ID) x 410 mm (L)
Stainless Steel;
Triple Channel 1.2 mm (ID) x 275 mm (L), 1.8 mm (ID) x 310 mm (L), 2.8 mm (ID) x 317 mm
(L) Stainless Steel | No | Yes, max 12 | No |
| Flexible Endoscopes:
Single Lumen 1.0 mm (ID) x 990 mm (L)
OR
Two lumens 1.0 mm (ID) x 990 mm (L) | No | No | Yes QTY. 1 (with no additional load) |
| Occluded/Mated challenge | Yes | Yes | Yes |
| Silicone Support Bars | Yes | Yes | Yes |
| Silicone Mat | Yes | Yes | Yes |
| Filter | DST Series | DST Series | DST Series |
| Data Cards | MH1-1 | MH1-1 | MH1-1 |
| Tamper Evident Arrow | Pink AH Series | Pink AH Series | Pink AH Series |
| Stack Height | No stacking | No stacking | No stacking |
| Materials | Compatible with materials
cleared for V-PRO 60 | Compatible with materials
cleared for V-PRO 60 | Compatible with materials
cleared for V-PRO 60 |
| Maximum Total Weight | 12.0 lbs. | 11.0 lbs. | No additional load |

21

Perforated Bottom Containers

| Catalog Code | Description | Container Dimension
(in) | Container
Weight
(lbs.) |
|--------------|------------------------------------|-----------------------------|-------------------------------|
| CD0-3LT | Mini - Perforated Bottom | 10.2 x 7.2 x 3.2 | 2.6 |
| CD0-4LT | Quarter Length - Perforated Bottom | 9.5 x 12.4 x 3.8 | 3.7 |
| DINCD1-5LT | Half-Length - Perforated Bottom | 11.6 x 11.4 x 5.4 | 4.8 |
| DINCD1-6LT | Half-Length - Perforated Bottom | 11.6 x 11.4 x 6.1 | 5.0 |
| DINCD2-5LT | Mid-Length - Perforated Bottom | 19.2 x 11.4 x 5.4 | 6.5 |
| DINCD2-6LT | Mid-Length - Perforated Bottom | 19.2 x 11.4 x 6.1 | 6.7 |
| DINCD2-8LT | Mid-Length - Perforated Bottom | 19.2 x 11.4 x 7.8 | 7.2 |
| DINCD3-5LT | Full-Length - Perforated Bottom | 23.1 x 11.4 x 5.4 | 7.6 |
| DINCD3-6LT | Full-Length - Perforated Bottom | 23.1 x 11.4 x 6.1 | 7.9 |
| DINCD3-7LT | Full-Length - Perforated Bottom | 23.1 x 11.4 x 7.1 | 8.2 |
| CD4-3LT | Small Narrow - Perforated Bottom | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5LT | Small Narrow - Perforated Bottom | 20.8 x 7.3 x 5.2 | 4.8 |