(98 days)
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.
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.
The provided document describes the Genesis™ Low Temperature Reusable Rigid Sterilization Container System, detailing its indications for use and performance data to support its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Standard / FDA Guidance | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy - Lethality (STERRAD NX Standard, Advanced; STERRAD 100 NX Standard, Flex, Express; V-PRO Non-Lumen, Lumen, Flexible) | ANSI AAMI ST 77 2013 | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10^-6 using biological (BI) overkill method. This means the device effectively sterilizes the enclosed medical instruments to a high degree of confidence. |
| Aerosol Challenge (STERRAD NX Advanced, STERRAD 100NX Standard, VPRO 60 Lumen) | ANSI AAMI ST 77 2013 | 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. This indicates the container effectively acts as a microbial barrier and prevents contamination. |
| Cycled Aerosol / Limits of Reuse (STERRAD 100NX Standard, VPRO 1-Plus/60 Lumen) | ANSI AAMI ST 77 2013 | 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. This demonstrates the container maintains its microbial barrier effectiveness even after repeated use. |
| Simulated Use (STERRAD NX Advanced, STERRAD 100NX Flex, VPRO maX Flexible, VPRO 60 Flexible) | ANSI AAMI ST 77 2013 | 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. This confirms the device's ability to sterilize challenging configurations, such as lumens, under realistic usage scenarios. |
| Shelf Life / Package Integrity (STERRAD NX Advanced, STERRAD 100NX Standard, VPRO 60 Lumen) - For maintaining sterility for a maximum of 180 days. | ANSI AAMI ST 77 2013 | 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. This validates the 180-day sterility maintenance claim. |
| Filter Material Properties (Bacterial Filtration Efficiency, Trapezoidal Tear Strength, and Burst Strength) before and after sterilization (STERRAD NX Advanced, STERRAD 100NX Standard, VPRO 60 Lumen) | Filter properties were reported | All filter properties were found to be acceptable. This indicates the filter media maintains its physical and functional integrity after sterilization, which is crucial for maintaining the microbial barrier. |
| Biocompatibility (for accessories used in the system, processed in low-temperature sterilization modalities) | 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. This confirms that the materials interacting with the medical devices after sterilization are safe for patient contact. |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides details of the tests performed but does not explicitly state the exact sample sizes for each test set. For instance:
- Aerosol Challenge: "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..." implies multiple container samples were used, but the specific number is not given.
- Cycled Aerosol / Limits of Reuse: "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..." again implies multiple samples over 100 cycles, but the number of distinct items tested is not specified.
- Simulated Use: "no recovery of viable challenge organism...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." This suggests a focus on "worst-case" scenarios, likely involving a limited number of "test devices" and container configurations, but the exact count isn't in the provided text.
- Shelf Life / Package Integrity: "All sample devices remained sterile...following exposure to a full sterilization cycle and weekly rotation events at a 180 day storage duration" implies multiple "sample devices" but the number is not provided.
- Biocompatibility: "Blood hemolysis testing demonstrated that any accessories used..." does not specify the number of accessories or tests performed.
The data provenance is not specified regarding country of origin; however, the context of an FDA 510(k) submission implies testing conducted under relevant regulatory standards. The studies described are prospective in nature, as they involve performing specific tests (e.g., sterilization cycles, aerosol challenges, simulated use, shelf-life studies) to validate performance criteria for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document describes non-clinical performance tests, not clinical studies involving human experts for ground truth establishment. The "ground truth" for these tests is based on objective scientific measurements (e.g., presence/absence of microbial growth, sterility assurance levels, material property changes) as defined by established standards like ANSI AAMI ST 77 2013 and ISO 10993-4 2009. Therefore, there were no human experts establishing ground truth in the way one might for diagnostic imaging.
4. Adjudication Method for the Test Set:
Not applicable, as this is a non-clinical device performance study based on objective measurements against defined standards, not an assessment requiring human interpretation or adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This document pertains to the performance validation of a sterilization container system, which is a physical medical device, not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance:
No. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The ground truth used in these studies is objective, measurable criteria defined by recognized scientific standards and validated laboratory methods. This includes:
- Microbiological Negativity: Absence of microbial growth (biological indicators, indicator organisms in aerosol challenge) to establish sterility.
- Sterility Assurance Level (SAL): Quantitative measure (10^-6) of sterilization effectiveness.
- Physical and Mechanical Integrity: Maintaining filter properties (BFE, tear strength, burst strength), container integrity.
- Biocompatibility: Demonstrating no harmful interactions with blood (hemolysis testing).
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device undergoing performance validation, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical device.
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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
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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
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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 CycleParameters | Total SystemWeight | Load ConfigurationApplicable 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 StandardPush button cycle with non-adjustable parameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsLumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10Devices or Device Configurations entailing conjoined surfaces which meet, touch or uniteSilicone 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 AdvancedPush button cycle with non-adjustable parameters | 10.7 lbs.(Endoscope load: no additional load) | Perforated Bottom Low Temperature Containers;Stacking BasketsLumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10Lumen Devices (1.0 mm x 500 mm) Stainless Steel, Qty. 10Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 1Devices 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 StandardPush button cycle with non-adjustable parameters | 21.4 lbs. | Perforated Bottom Low Temperature Containers;Stacking basketsLumen Devices (0.7 mm x 500 mm) Stainless Steel, Qty. 10Devices or Device Configurations entailing conjoined surfaces which meet, touch or unite;Silicone Support Bars*Materials: Compatible with materials cleared for STERRAD100NX | 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 FlexPush button cycle with non-adjustable parameters | No additionalload | Perforated Bottom Low Temperature Containers;Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 2Silicone Support Bars*Materials: Compatible with materials cleared for STERRAD100NX | 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 ExpressPush button cycle with non-adjustable parameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsDevices or Device Configurations entailing conjoined surfaces which meet, touch or unite;Silicone Support Bars*Materials: Compatible with materials cleared for STERRAD100NX | 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 | YesQTY. 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) ORTwo lumens 1.0 mm (ID) x 990 mm (L) | QTY. 1 (with no additional load) | ||
| Sterilization CycleParameters | Total SystemWeight | 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) ORTwo lumens | Occluded/Mated challenge | Yes | Yes | Yes | |||
| V-PRO 1 Plus maX Non-LumenPush button cycle with non-adjustable parameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsDevices or Device Configurations entailing conjoined surfaces which meet, touch or unite;Silicone Support BarsSilicone 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 LumenPush button cycle with non-adjustable parameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsSingle 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 loadDevices or Device Configurations entailing conjoined surfaces which meet, touch or unite;Silicone Support BarsSilicone 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 FlexiblePush button cycle with non-adjustable parameters | 2 scopes, orOne 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 totalSingle Lumen (1 mm x 1050mm) orTwo 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 BarsSilicone 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-LumenPush button cycle with non-adjustable parameters | 12.0 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsDevices or Device Configurations entailing conjoined surfaces which meet, touch or unite;Silicone Support BarsSilicone 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 LumenPush button cycle with non-adjustable parameters | 11.0 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsSingle 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 loadDevices or Device Configurations entailing conjoined surfaces which meet, touch or unite;Silicone Support BarsSilicone 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 CycleParameters | Total SystemWeight | Load ConfigurationApplicable 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 FlexiblePush button cycle with non-adjustable parameters | No additionalload | Perforated Bottom Low Temperature Containers;Flexible Endoscopes, Qty. 1Single Lumen (1.0 mm x 990 mm) orTwo Lumens (1.0 mm x 990 mm)Devices or Device Configurations entailing conjoined surfaceswhich meet, touch or unite;Silicone Support BarsSilicone 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 withmaterials clearedfor STERRAD NX | Compatible withmaterials clearedfor STERRAD NXLumen load: 10.7Ibs.; Endoscopeload: no additionalload | Compatible withmaterials clearedfor STERRAD 100NX | Compatible withmaterials clearedfor STERRAD 100NXNo additional load | Compatible withmaterials clearedfor 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 |
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K153554 INDICATIONS FOR USE
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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
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53554 INDICATIONS FOR USE
ccessories and Device Challenges by V-PRO 1 / 1 Plus / maX Sterilization Modalities for all Perforated Bottom Container
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53554 INDICATIONS FOR USE
Accessories and Device Challenges by V-PRO 60 Sterilization Modalities for all Perforated Bottom Containers
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K153554 INDICATIONS FOR USE
Perforated Bottom Containers
| Catalog Code | Description | Container Dimension (in) | ContainerWeight(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 |
| EstablishmentRegistration 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
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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 PREDICATEDEVICE | ||
|---|---|---|
| Characteristic | Predicate Device - K142529 | New/Modified Device |
| Intended Use | A sterilization container system is a deviceintended to be used to enclose anothermedical device that is to be sterilized by ahealth care provider. It is intended to allowsterilization of the enclosed medical deviceand also to maintain sterility of the enclosedmedical 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 sterilizationmodalities | 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 Steam100% Ethylene Oxide | STERRAD® NX StandardSTERRAD® NX AdvancedSTERRAD® 100NX StandardSTERRAD® 100NX FlexSTERRAD® 100NX ExpressV-PRO 1 LumenV-PRO 1 Plus LumenV-PRO 1 Plus Non-LumenV-PRO maX LumenV-PRO max Non-LumenV-PRO maX FlexibleV-PRO 60 LumenV-PRO 60 Non-LumenV-PRO 60 Flexible |
| Characteristic | Standard / Test / FDAGuidance | Results Summary |
| Sterilization Efficacy - LethalitySTERRAD NX (Standard,Advanced)STERRAD 100 NX (Standard, Flex, Express)V-PRO (Non-Lumen, Lumen,Flexible) | ANSI AAMI ST 77 2013Containment Devices forReusable MedicalDevice Sterilization | Testing demonstrated a 12 log reduction anda sterility assurance level (SAL) of 10-6 usingbiological (BI) overkill method |
| Aerosol ChallengeSTERRAD NX AdvancedSTERRAD 100NX StandardVPRO 60 Lumen | ANSI AAMI ST 77 2013Containment Devices forReusable MedicalDevice Sterilization | Containers subjected to an aerosol challengetest with an exposure of 1.0 - 5.0 x 106 CFU.Agar vessels placed in each container sampledemonstrated no growth of the indicatororganism following the incubation period |
| Cycled Aerosol / Limits ofReuseSTERRAD 100NX StandardVPRO 1-Plus/60 Lumen | ANSI AAMI ST 77 2013Containment Devices forReusable MedicalDevice Sterilization | After 100 simulated full use cycles or theequivalent followed by an aerosol challengetest with an exposure of 1.0 - 5.0 x 106 CFU.Agar vessels placed in each container sampledemonstrated no growth of the indicatororganism following the incubation period |
| Simulated UseSTERRAD NX AdvancedSTERRAD 100NX FlexVPRO maX FlexibleVPRO 60 Flexible | ANSI AAMI ST 77 2013Containment Devices forReusable MedicalDevice Sterilization | Testing demonstrated no recovery of viablechallenge organism (all sterile results) fromthe lumens on the test device after processingwithin a worst case Genesis Container as partof a worst case cycle simulated use containervalidation load |
| Shelf Life / Package IntegritySTERRAD NX AdvancedSTERRAD 100NX StandardVPRO 60 Lumen | ANSI AAMI ST 77 2013Containment Devices forReusable MedicalDevice Sterilization | All sample devices remained sterile (exhibitno growth) following exposure to a fullsterilization cycle and weekly rotation eventsat a 180 day storage duration |
| Filter Material PropertiesSTERRAD NX AdvancedSTERRAD 100NX StandardVPRO 60 Lumen | Filter properties(Bacterial FiltrationEfficiency, TrapezoidalTear Strength, and BurstStrength) prior to andafter exposure to a fullsterilization cycle werereported | All filter properties were found to beacceptable |
| BiocompatibilitySTERRAD NX AdvancedSTERRAD 100NX StandardVPRO 60 Lumen | ISO 10993-4 2009 | Blood hemolysis testing demonstrated thatany accessories used in the Genesis™ LowTemperature Sterilization Container Systemare acceptable for use after processing in thelow temperature sterilization modalities |
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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.
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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.
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Sterilization Cycle Parameters for the Genesis Low Temperature Reusable Rigid Container System by Modality
| Sterilization CycleParameters | TotalSystemWeight | Load ConfigurationApplicable Containers / Accessories |
|---|---|---|
| STERRAD NX StandardPush button cycle withnon-adjustableparameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsLumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10Devices or Device Configurations entailing conjoined surfaceswhich meet, touch or uniteSilicone Support Bars*Materials: Compatible with materials cleared for STERRAD NX |
| STERRAD NX AdvancedPush button cycle withnon-adjustableparameters | (Endoscopeload: noadditionalload) | Perforated Bottom Low Temperature Containers;Stacking BasketsLumen Devices (1.0 mm x 150 mm) Stainless Steel, Qty. 10Lumen Devices (2.0 mm x 400 mm) Stainless Steel, Qty. 10Lumen Devices (1.0 mm x 500 mm) Stainless Steel, Qty. 10Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 1Devices or Device Configurations entailing conjoined surfaceswhich meet, touch or unite;Silicone Support Bars*Materials: Compatible with materials cleared for STERRAD NX |
| STERRAD 100NXStandardPush button cycle withnon-adjustableparameters | 21.4 lbs. | Perforated Bottom Low Temperature Containers;Stacking basketsLumen Devices (0.7 mm x 500 mm) Stainless Steel, Qty. 10Devices or Device Configurations entailing conjoined surfaceswhich meet, touch or unite;Silicone Support Bars*Materials: Compatible with materials cleared for STERRAD100NX |
| STERRAD 100NX FlexPush button cycle withnon-adjustableparameters | No additionalload | Perforated Bottom Low Temperature Containers;Lumen Devices (1.0 mm x 850 mm) PE/PTFE, Qty. 2Silicone Support Bars*Materials: Compatible with materials cleared for STERRAD100NX |
| STERRAD 100NXExpressPush button cycle withnon-adjustableparameters | 10.7 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsDevices or Device Configurations entailing conjoined surfaceswhich meet, touch or unite;Silicone Support Bars*Materials: Compatible with materials cleared for STERRAD100NX |
| Sterilization CycleParameters | Load Configuration | |
| Total SystemWeight | Applicable Containers / Accessories | |
| V-PRO 1 Plus maX Non-LumenPush button cycle withnon-adjustableparameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsDevices or Device Configurations entailing conjoinedsurfaces which meet, touch or unite;Silicone Support BarsSilicone Mats*Materials: Compatible with materials cleared for V-PRO |
| V-PRO 1, 1 Plus maXLumenPush button cycle withnon-adjustableparameters | 19.65 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsSingle Channel (0.77 mm x 500mm) Stainless Steel; Dualchannel (0.77 mm x 527mm) Stainless Steel; TripleChannel (1.2 mm x 275 mm, 1.8 mm x 310 mm, 2.8 mm x317 mm) Stainless Steel; Max 20 lumens per loadDevices or Device Configurations entailing conjoinedsurfaces which meet, touch or unite;Silicone Support BarsSilicone Mats*Materials: Compatible with materials cleared for V-PRO |
| V-PRO maX FlexiblePush button cycle withnon-adjustableparameters | 2 scopes,orOne scope +instruments fortotal of 24.0 lbs. | Perforated Bottom Low Temperature Containers;Flexible Endoscopes - Qty. 2 w/ no additional load; Qty. 1w/ instrument load for 24 lbs totalSingle Lumen (1 mm x 1050mm) orTwo lumens, one (1 mm x 998 mm) the other (1 mm x 850mm)Devices or Device Configurations entailing conjoinedsurfaces which meet, touch or unite;Silicone Support BarsSilicone Mats*Materials: Compatible with materials cleared for V-PRO |
| V-PRO 60 Non-LumenPush button cycle withnon-adjustableparameters | 12.0 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsDevices or Device Configurations entailing conjoinedsurfaces which meet, touch or unite;Silicone Support BarsSilicone Mats*Materials: Compatible with materials cleared for V-PRO 60 |
| Sterilization CycleParameters | Total SystemWeight | Applicable Containers / Accessories |
| V-PRO 60 LumenPush button cycle withnon-adjustableparameters | 11.0 lbs. | Perforated Bottom Low Temperature Containers;Stacking BasketsSingle Channel (0.77 mm x 410 mm) Stainless Steel; DualChannel (0.77 mm x 410 mm) Stainless Steel; TripleChannel (1.2 mm x 275 mm, 1.8 mm x 310 mm, 2.8 mm x317 mm) Stainless Steel; Max 12 lumens per loadDevices or Device Configurations entailing conjoinedsurfaces which meet, touch or unite;Silicone Support BarsSilicone Mats*Materials: Compatible with materials cleared for V-PRO 60 |
| V-PRO 60 FlexiblePush button cycle withnon-adjustableparameters | No additionalload | Perforated Bottom Low Temperature Containers;Flexible Endoscopes, Qty. 1Single Lumen (1.0 mm x 990 mm) orTwo Lumens (1.0 mm x 990 mm)Devices or Device Configurations entailing conjoinedsurfaces which meet, touch or unite;Silicone Support BarsSilicone Mats*Materials: Compatible with materials cleared for V-PRO 60 |
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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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Accessories and Device Challenges by STERRAD Sterilization Modalities for all Perforated Bottom Containers
| Contents/Configuration | STERRAD NXStandard | STERRAD NXAdvanced | STERRAD 100NXStandard | STERRAD 100NXFlex | STERRAD 100NXExpress |
|---|---|---|---|---|---|
| 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 withmaterials clearedfor STERRAD NX | Compatible withmaterials clearedfor STERRAD NX | Compatible withmaterials clearedfor STERRAD100NX | Compatible withmaterials clearedfor STERRAD100NX | Compatible withmaterials clearedfor STERRAD100NX |
| Maximum Total Weight | 10.7 lbs. | Lumen load: 10.7Ibs .; Endoscopeload: no additionalload | 21.4 lbs. | No additional load | 10.7 lbs. |
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Accessories and Device Challenges by V-PRO 1 / 1 Plus / maX Sterilization Modalities for all Perforated Bottom Containers
| Contents/Configuration | V-PRO 1 Plus,maXNon-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) x317 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 24lbs 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 materialscleared for V-PRO | Compatible with materialscleared for V-PRO | Compatible with materialscleared for V-PRO |
| Maximum Total Weight | 19.65 lbs. | 19.65 lbs. | 2 scopes,or one scope plus instrumentsfor total of 24 lbs. |
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Accessories and Device Challenges by V-PRO 60 Sterilization Modalities for all Perforated Bottom Containers
| Contents/Configuration | V-PRO 60Non-Lumen | V-PRO 60Lumen | V-PRO 60Flexible |
|---|---|---|---|
| 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)ORTwo 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 materialscleared for V-PRO 60 | Compatible with materialscleared for V-PRO 60 | Compatible with materialscleared for V-PRO 60 |
| Maximum Total Weight | 12.0 lbs. | 11.0 lbs. | No additional load |
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Perforated Bottom Containers
| Catalog Code | Description | Container Dimension(in) | ContainerWeight(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 |
§ 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).