Who is the manufacturer of Genesis Low Temperature Reusable Rigid Container System?

Carefusion 2200, Inc. filed the 510(k) submission for Genesis Low Temperature Reusable Rigid Container System (K153554).

What is the FDA product code for Genesis Low Temperature Reusable Rigid Container System?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Genesis Low Temperature Reusable Rigid Container System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Genesis Low Temperature Reusable Rigid Container System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Genesis Low Temperature Reusable Rigid Container System

K153554 · Carefusion 2200, Inc. · KCT · Mar 21, 2016 · General Hospital

Device Facts

Record ID	K153554
Device Name	Genesis Low Temperature Reusable Rigid Container System
Applicant	Carefusion 2200, Inc.
Product Code	KCT · General Hospital
Decision Date	Mar 21, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

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 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™ Low Temperature Reusable Rigid Container System; rigid, stackable, reusable containers; used by healthcare providers to house medical devices during sterilization and storage. Components: lid, bottom, filter, tamper-evident arrows, data cards, baskets, and organizing accessories (pins, dividers, silicone bars/mats). Input: medical devices to be sterilized. Operation: devices placed in baskets/secured with accessories; container sealed with filter media; processed in STERRAD or V-PRO low-temperature sterilization cycles. Output: sterilized medical devices maintained in sterile state for up to 180 days. Tamper-evident arrows and data cards provide visual confirmation of cycle exposure and container integrity. Benefits: protects instruments, maintains sterility, organizes surgical sets.

Clinical Evidence

No clinical data. Bench testing only. Validation included 12-log reduction SAL (biological indicator overkill method), aerosol challenge (1.0-5.0 x 10^6 CFU), simulated use cycles, 180-day shelf-life/package integrity, filter material property testing, and blood hemolysis biocompatibility testing.

Technological Characteristics

Materials: Anodized aluminum (5000/1100 series), 300/400 series stainless steel, closed-cell silicone foam gaskets, SMS polypropylene filters. Form factor: Rigid, stackable, perforated-bottom containers. Sterilization: Low-temperature (STERRAD/V-PRO). Connectivity: None. Software: None.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during low-temperature sterilization (STERRAD and V-PRO modalities) and maintain sterility for up to 180 days. Suitable for various surgical instruments, including lumen devices and flexible endoscopes, within specified weight and configuration limits.

Regulatory Classification

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™ Rigid Reusable Sterilization Container System (K142529)

Submission Summary (Full Text)

{0}------------------------------------------------ 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### Sterilization 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 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 | Stack Height | No stacking | No stacking | No stacking | No stacking | No stacking | Stack Height | No stacking | No stacking | No stacking | Maximum Total Weight | 12.0 lbs. | 11.0 lbs. | No additional load | | Materials | Compatible with materials cleared for STERRAD NX | Compatible with materials cleared for STERRAD NX Lumen load: 10.7 Ibs.; Endoscope load: no additional load | Compatible with materials cleared for STERRAD 100NX | Compatible with materials cleared for STERRAD 100NX No additional load | Compatible with materials cleared for STERRAD 100NX | 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 | 10.7 lbs. | | 21.4 lbs. | | 10.7 lbs. | Maximum Total Weight | 19.65 lbs. | 19.65 lbs. | 2 scopes, or one scope plus instruments for total of 24 lbs | | | | | | | | {5}------------------------------------------------ # 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. {7}------------------------------------------------ # 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 | {11}------------------------------------------------ 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…

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Genesis Low Temperature Reusable Rigid Container System

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