(121 days)
The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.
Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to recording 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 container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication 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 Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.
The provided document is a 510(k) premarket notification for a medical device (Genesis™ Reusable Rigid Sterilization Container System). It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance tests.
Here's an analysis of the acceptance criteria and study information provided, focusing on the available details:
Description of Acceptance Criteria and Device Performance
The device under review is the Genesis™ Reusable Rigid Sterilization Container System. The primary function of this system is to enclose other medical devices for sterilization and maintain their sterility for up to 180 days. The acceptance criteria for this device revolve around demonstrating its efficacy in sterilization and maintaining sterility under various conditions.
The study presented focuses on non-clinical performance testing to validate the sterilization efficacy and dry time of the container system for specific sterilization modalities and contents.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Characteristic / Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Efficacy: Pre-vacuum Steam | |
| - Standard/Test/FDA Guidance: 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. |
| Dry Time for Dynamic Air Removal (Pre-vacuum steam modality) | |
| - Standard/Test/FDA Guidance: ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated validated method of drying by absence of visible moisture. |
Additional Performance Parameters and Conditions (from "Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality" and "Accessories and Device Challenges by Sterilization Modality and Container Style" tables):
| Sterilization Method | Cycle Parameters / Contents / Configurations | Applicable Containers/Accessories / Performance |
|---|---|---|
| Dynamic Air Removal (Pre-Vacuum) Steam (Regular & Immediate Use) | - Exposure Temp: 270°F (132°C)- Pre-conditioning Pulses: 3- Exposure Time: 4 Minutes- Dry Time Cycle: 30 minutes (Regular)- Minimum Cool Time: 60 minutes (Regular)- Stack Height: Max 3- Total System Weight: 25 lbs.- Lumen Devices: 2.68 mm x 450 mm (Qty 16), 1.37 mm x 242 mm (Qty 10), 3 mm x 400 mm (Qty 2) | Demonstrated efficacy for Solid and Perforated Bottom Containers, Stacking/Non-Stacking Baskets, various Lumen Devices (specified quantities), Devices with conjoined surfaces, Silicone Support Bars/Mats, Laparoscopic Racks, Optional Protective Plates. Materials include Metals, Polymers, Composites. (Performance is "Yes" for all listed components/configurations under these steam methods). |
| 100% Ethylene Oxide | - EO Sterilant Conc: 100% EO, 725 mg/L- Pre-Conditioning Time: 30 mins- Temperature: 130°F (55°C)- Exposure Time: 60 mins- Relative Humidity: 50-80%- Aeration: 8 hours @ 109.4°F (43°C)- No stacking- Total System Weight: 15 lbs.- Lumen Devices: 3.0 mm x 400 mm (Qty 5) | Demonstrated efficacy for Perforated Bottom Containers (except CD2-10BDL and DINCD2-8B), Non-Stacking Baskets, Lumen Devices (specified quantity), Devices with conjoined surfaces, Silicone Support Bars, Laparoscopic Racks. Materials include Stainless Steel, Aluminum, Silicone, Radel. (Performance is "Yes" for listed components/configurations under EO). |
The document explicitly states: "The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria." This indicates that for all the criteria mentioned in the tables, the device successfully demonstrated compliance through the stated non-clinical tests.
2. Sample size(s) used for the test set and the data provenance:
- The document mentions "Testing" for sterilization efficacy and dry time but does not specify the exact sample sizes (number of containers, number of cycles, number of biological indicators, etc.) for the test sets.
- Data provenance is not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. Given it's a 510(k) submission for a medical device by a US-based company (CareFusion 2200 Inc, Vernon Hills, IL), and referring to an FDA guidance document (ST 77 2013), it is prospective testing conducted in a controlled laboratory setting, likely within the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes non-clinical performance testing of a sterilization container, not a diagnostic or AI-driven medical imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists) is not applicable.
- The "ground truth" for sterilization efficacy is established by scientific principles and validated biological indicators (BI) and sterility assurance levels (SAL) as per recognized standards (ST 77 2013). The validation of dry time is based on the "absence of visible moisture." These are objective measurements rather than subjective expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- As this is non-clinical performance testing, adjudication methods typically used for subjective clinical assessments are not applicable. The results are based on objective laboratory measurements and adherence to specified performance standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this is not applicable. The document is for a physical medical device (sterilization container), not an AI algorithm or a diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. This document pertains to a physical sterilization container.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance of the sterilization container is based on objective measurements of sterilization efficacy and dryness as defined by recognized industry standards (ST 77 2013).
- For sterilization efficacy: achieving a 12 log reduction and a Sterility Assurance Level (SAL) of 10^-6 using biological indicators (overkill method).
- For dry time: absence of visible moisture.
8. The sample size for the training set:
- Not applicable. This relates to a physical device evaluated through non-clinical performance testing, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As indicated in point 8, there is no training set for this type of device evaluation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
CareFusion 2200 Inc. Ms. Jane Weber Regulatory Affairs Manager 75 N. Fairway Drive Vernon Hills, IL 60061
Re: K142529
Trade/Device Name: Genesis™ Reusable Rigid Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories Regulatory Class: II Product Code: KCT Dated: December 5, 2014 Received: December 8, 2014
Dear Ms. 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.
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Page 2 - Ms. Weber
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K142529
Device Name
Genesis Reusable Rigid Sterilization Container System
Indications for Use (Describe)
The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.
Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to recording 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 container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication 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)
X 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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
{3}------------------------------------------------
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Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality
| SterilizationMethod | Cycle Parameters | TotalSystemWeight | ApplicableContainers/Accessories |
|---|---|---|---|
| Dynamic AirRemoval(Pre-Vacuum)Steam | Exposure Temperature: 270°F(132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesDry Time Cycle: 30 minutesMinimum Cool Time: 60 minutes(may vary according to load contents)Stack Height: Maximum 3 | 25 lbs. | Solid Bottom Containers;Perforated Bottom Containers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mm x 450 mm) - Qty 16Lumen Devices (1.37 mm x 242 mm) - Qty 10Devices or Device Configurationsentailing conjoined surfaces whichmeet, touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional Protective PlateMaterials: Metals, Polymers,Composites |
| Dynamic AirRemoval(Pre-Vacuum)SteamImmediate Use | Exposure Temperature: 270°F(132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesStack Height: Maximum 3Note: Devices must be usedimmediately and cannot bestored for later use. | 25 lbs. | Solid Bottom Containers;Perforated Bottom Containers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mm x 450 mm) - Qty 16Lumen Devices (1.37 mm x 242 mm) - Qty 10Devices or Device Configurationsentailing conjoined surfaces whichmeet, touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional Protective Plate*Materials: Metals, Polymers,Composites |
| 100% EthyleneOxide | EO Sterilant Concentration:100% EO, 725 mg/LPre-Conditioning Time: 30minutesTemperature: 130°F (55°C)Exposure Time: 60 minutesRelative Humidity: 50-80%Aeration: 8 hours @ 109.4°F(43°C)No stacking | 15 lbs. | Perforated Bottom Containersexcept CD2-10BDL and DINCD2-8B);Non Stacking BasketsLumen Devices (3.0 mm x 400 mm) - Qty 5Device or Device Configurationsentailing conjoined surfaces whichmeet, touch or unite;Silicone Support Bars;Laparoscopic Racks;Materials: Stainless Steel,Aluminum, Silicone, Radel |
{5}------------------------------------------------
Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeurs, kerrison rongeurs, specula.
Note: Air tight occluded challenges are devices entailing surfaces that are completely obstructed. These types of devices have not been validated for use in the Genesis Reusable Sterilization Container System.
*Materials: Intrinsically stable metals. Composites, thermosetting polymers with constant use temperatures above 135°C.
Examples of intrinsically stable metals include stainless steel, titanium (CP and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/ Styrene) and POM (Polyoxymethylene). Examples of thermosetting polymers are Phenolic and Silicone. Examples of composites include carbon fiber reinforced epoxy (CFRE).
{6}------------------------------------------------
| Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100 % Ethylene Oxide |
|---|---|---|---|
| Solid Bottom | Non Stacking Baskets | Yes | No |
| Container | Stacking Baskets | Yes | No |
| Lumen: 1.37 mm (ID) x 242mm(L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | No | |
| Occluded/Mated Challenge | Yes | No | |
| Silicone Support Bar | Yes | No | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | No | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | No | |
| Data Card | MD1-1 | No | |
| Tamper-Evident Arrow | White AS Series | No | |
| Stack Height | 3 | No | |
| Materials | Materials: Metals,Polymers, Composites | No | |
| Maximum Total Container SystemWeight | 25 lbs. | No | |
| Perforated Bottom | Non Stacking Baskets | Yes | Yes |
| Container | Stacking Baskets | Yes | No |
| Lumen: 1.37 mm (ID) x 242mm(L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Note: The CD2- | Laparoscopic Rack | Yes | Yes |
| 10BDL and | Optional Protective Plate | Yes | No |
| DINCD2-8B | Filter | NST series | NST series |
| container models | Data Cards | MD1-1 | MD1-1 |
| are not validated | Tamper Evident Arrow | White AS Series | Yellow AG Series |
| for use in 100% | Stack Height | 3 max | No stacking |
| Ethylene Oxidesterilization | Materials | Materials: Metals,Polymers, Composites | Radel, Stainless Steel,Aluminum, Silicone |
| Maximum Total Weight | 25 lbs. | 15 lbs. | |
| STERRAD | Non Stacking Baskets | Yes | Yes |
| Compatible | Stacking Baskets | Yes | No |
| Containers | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | No |
| Lumen: 3.0mm (ID) x 400mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated Challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | Yes | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | NST Series | |
| Data Cards | MD1-1 | MD1-1 | |
| Tamper-Evident Arrow | White AS Series | Yellow AG Series | |
| Stack Height | 3 Maximum | No stacking | |
| Materials | Materials: Metals,Polymers, Composites | Radel, Stainless Steel,Aluminum, Silicone | |
| Maximum Total Container SystemWeight | 25 lbs. | 15 lbs. |
Accessories and Device Challenges by Sterilization Modality and Container Style
{7}------------------------------------------------
Solid Bottom Containers
| Catalog Code | Description | Container Dimension (in) | ContainerWeight(lb.) |
|---|---|---|---|
| CD0-4C | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.4 |
| CD1-4C | Half Length Container | 11.8 x 12.4 x 4.5 | 4.8 |
| CD1-5C | Half Length Container | 11.8 x 12.4 x 5.3 | 5.0 |
| CD1-6C | Half Length Container | 11.8 x 12.4 x 6.1 | 5.2 |
| CD2-4C | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.4 |
| CD2-5C | Mid Length Container | 19.2 x 12.4 x 5.3 | 6.7 |
| CD2-6C | Mid Length Container | 19.2 x 12.4 x 6.1 | 6.9 |
| CD2-8C | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.3 |
| CD3-4C | Full Length Container | 23.1 x 12.4 x 4.5 | 7.8 |
| CD3-5C | Full Length Container | 23.1 x 12.4 x 5.3 | 7.9 |
| CD3-6C | Full Length Container | 23.1 x 12.4 x 6.1 | 8.2 |
| CD3-7C | Full Length Container | 23.1 x 12.4 x 7.0 | 8.5 |
| CD7-5C | Extra Long Container | 25.2 x 12.4 x 5.9 | 8.5 |
| CD7-6C | Extra Long Container | 25.2 x 12.4 x 6.7 | 8.8 |
| CD7-9C | Extra Long Container | 25.2 x 12.4 x 8.4 | 9.7 |
| CD4-3C | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 6.7 |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 6.9 |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.3 |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.0 |
| DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | 5.2 |
Perforated Bottom Containers
| Catalog Code | Description | Container Dimension (in) | ContainerWeight(lb.) |
|---|---|---|---|
| CD0-4B | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4B | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5B | Half Length Container | 11.8 x 12.4 x 5.3 | 5.5 |
| CD1-6B | Half Length Container | 11.8 x 12.4 x 6.1 | 5.7 |
| CD2-4B | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5B | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.1 |
| CD2-6B | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.4 |
| CD2-8B | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.8 |
| CD3-4B | Full Length Container | 23.1 x 12.4 x 4.5 | 8.5 |
| CD3-5B | Full Length Container | 23.1 x 12.4 x 5.3 | 8.8 |
| CD3-6B | Full Length Container | 23.1 x 12.4 x 6.1 | 9.0 |
| CD3-7B | Full Length Container | 23.1 x 12.4 x 7.0 | 9.4 |
| CD7-5B | Extra Long Container | 25.2 x 12.4 x 5.9 | 9.0 |
| CD7-6B | Extra Long Container | 25.2 x 12.4 x 6.7 | 9.4 |
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| Catalog Code | Description | Container Dimension (in) | ContainerWeight(lb.) |
|---|---|---|---|
| CD7-9B | Extra Long Container | 25.2 x 12.4 x 8.4 | 10.0 |
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.7 |
STERRAD Style Containers
| Catalog Code | Description | Container Dimension (In) | ContainerWeight(lb.) |
|---|---|---|---|
| CD0-4ST | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4ST | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5ST | Half Length Container | 11.8 x 12.4 x 5.3 | 5.4 |
| CD1-6ST | Half Length Container | 11.8 x 12.4 x 6.1 | 5.6 |
| CD2-4ST | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5ST | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.0 |
| CD2-6ST | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.2 |
| CD2-8ST | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.7 |
| CD3-4ST | Full Length Container | 23.1 x 12.4 x 4.5 | 8.4 |
| CD3-5ST | Full Length Containers | 23.1 x 12.4 x 5.3 | 8.6 |
| CD3-6ST | Full Length Containers | 23.1 x 12.4 x 6.1 | 8.9 |
| CD3-7ST | Full Length Containers | 23.1 x 12.4 x 7.0 | 9.3 |
| CD4-3ST | Small Narrow Shallow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5ST | Small Narrow Container | 20.8 x 7.3 x 5.2 | 4.8 |
| CD5-3ST | Large Narrow Shallow Container | 28.1 x 11.2 x 5.0 | 8.9 |
| CD5-61ST | Large Narrow Shallow Container | 28.1 x 11.2 x 6.4 | 9.4 |
| CD0-3ST | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
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eFusion
K142529 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| 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 | 05-JAN-2015 |
| DEVICE INFORMATION | |
| Trade or proprietaryname | Genesis™ Reusable Rigid Sterilization Container System |
| Common or usual name | Sterilization Container |
| Classification name | Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories |
| Classification panel | 80 |
| Regulation | Class II per 21CFR 880.6850, Product code KCT |
| Product Code(s) | KCT |
| Legally marketeddevice(s) to whichequivalence is claimed | Genesis™ Reusable Sterilization Container SystemK140850 |
| Reason for 510(k)submission | Expand indications for use regarding the quantity and types of lumen devicesto be sterilized using the pre-vacuum steam sterilization modality in theGenesis Container System. |
| Device description | The Genesis Reusable Rigid Container System is an assortment of rigid,reusable, stackable containers that are used to sterilize other medical devicesand maintain sterility of these devices until used. The container system iscomprised of a lid, bottom, filter, tamper evident arrows, and data cards.The container system houses baskets of varying depths and organizingaccessory devices that are used to organize and to secure surgicalinstrumentation and/or other medical devices. |
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UMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | Predicate Device - K140850 | 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 1100series; 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 |
| Material Compatibility(materials to be sterilizedwithin container) | Intrinsically stable metals, composites,thermoplastics and thermosetting polymerswith constant use temperatures above 135°C. | Same |
| Volume to Vent Ratio | $24.0 \text{ to } 182.3 \frac{in^3}{in^2}$ | Same |
| Sterilization parametersfor Pre-Vacuum steam forLumen devices | Lumens: 2.68 mm (ID) x 450 mm (L) – Qty 2 | Lumens: 2.68 mm (ID) x 450 mm (L) –Qty 16Lumens 1.37 mm (ID) x 242 mm (L) –Qty 10 |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|---|---|---|
| Sterilization Efficacy: Pre-vacuum Steam | 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 |
| Dry Time for Dynamic Air Removal (Pre-vacuum steam modality) | ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated validated method of drying by absence of visible moisture |
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EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization containers perform as intended and based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device, Class II (21 CFR 880.6850), Product code KCT.
INDICATIONS FOR USE
The Genesis Reusable Rigid 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 dynamic air removal (pre-vacuum) steam sterilization, immediate use prevacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
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Sterilization Parameters for the Genesis Reusable Rigid Container System by Modality
| SterilizationMethod | Cycle Parameters | TotalSystemWeight | ApplicableContainers/Accessories |
|---|---|---|---|
| Dynamic AirRemoval(Pre-Vacuum)Steam | Exposure Temperature: 270°F(132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesDry Time Cycle: 30 minutesMinimum Cool Time: 60minutes(may vary according to loadcontents)Stack Height: Maximum 3 | 25 lbs. | Solid Bottom Containers;Perforated Bottom Containers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mm x 450mm) - Qty 16Lumen Devices (1.37 mm x 242mm) - Qty 10Devices or Device Configurationsentailing conjoined surfaces whichmeet, touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional Protective PlateMaterials: Metals, Polymers,Composites |
| Dynamic AirRemoval(Pre-Vacuum)SteamImmediate Use | Exposure Temperature: 270°F(132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesStack Height: Maximum 3Note: Devices must be usedimmediately and cannot bestored for later use. | 25 lbs. | Solid Bottom Containers;Perforated Bottom Containers;Stacking BasketsNon-Stacking BasketsLumen Devices (2.68 mm x 450mm) - Qty 16Lumen Devices (1.37 mm x 242mm) - Qty 10Devices or Device Configurationsentailing conjoined surfaces whichmeet, touch or unite;Silicone Support BarsSilicone MatsLaparoscopic RacksOptional Protective Plate*Materials: Metals, Polymers,Composites |
| 100% EthyleneOxide | EO Sterilant Concentration:100% EO, 725 mg/LPre-Conditioning Time: 30minutesTemperature: 130°F (55°C)Exposure Time: 60 minutesRelative Humidity: S0-80%Aeration: 8 hours @ 109.4°F(43°C)No stacking | 15 lbs. | Perforated Bottom Containersexcept CD2-10BDL and DINCD2-8B);Non Stacking BasketsLumen Devices (3.0 mm x 400mm) — Qty 5Device or Device Configurationsentailing conjoined surfaces whichmeet, touch or unite;Silicone Support Bars;Laparoscopic Racks;Materials: Stainless Steel,Aluminum, Silicone, Radel |
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Image /page/13/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a yellow accent on the top right.
Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeurs, kerrison rongeurs, specula.
Note: Air tight occluded challenges are devices entailing surfaces that are completely obstructed. These types of devices have not been validated for use in the Genesis Reusable Sterilization Container System.
*Materials: Intrinsically stable metals. Composites, and thermosetting polymers with constant use temperatures above 135°C.
Examples of intrinsically stable metals include stainless steel, titanium (CP and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/ Styrene) and POM (Polyoxymethylene). Examples of thermosetting polymers are Phenolic and Silicone. Examples of composites include carbon fiber reinforced epoxy (CFRE).
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| Accessories and Device Challenges by Sterilization Modality and Container Style | ||
|---|---|---|
| --------------------------------------------------------------------------------- | -- | -- |
| Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100 % Ethylene Oxide |
|---|---|---|---|
| Solid BottomContainer | Non Stacking Baskets | Yes | No |
| Stacking Baskets | Yes | No | |
| Lumen: 1.37 mm (ID) x 242 mm (L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | No | |
| Occluded/Mated Challenge | Yes | No | |
| Silicone Support Bar | Yes | No | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | No | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | No | |
| Data Card | MD1-1 | No | |
| Tamper-Evident Arrow | White AS Series | No | |
| Stack Height | 3 | No | |
| Materials | Materials: Metals,Polymers, Composites | No | |
| Maximum Total Container SystemWeight | 25 lbs. | No | |
| Perforated BottomContainer | Non Stacking Baskets | Yes | Yes |
| Stacking Baskets | Yes | No | |
| Lumen: 1.37 mm (ID) x 242 mm(L) | Yes, maximum 10 | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No | |
| Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated Challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | Yes | |
| Optional Protective Plate | Yes | No | |
| Filter | NST series | NST series | |
| Data Cards | MD1-1 | MD1-1 | |
| Tamper Evident Arrow | White AS Series | Yellow AG Series | |
| Stack Height | 3 max | No stacking | |
| Materials | Materials: Metals,Polymers, Composites | Radel, Stainless Steel,Aluminum, Silicone | |
| Maximum Total Weight | 25 lbs. | 15 lbs. | |
| STERRADCompatibleContainers | Non Stacking Baskets | Yes | Yes |
| Stacking Baskets | Yes | No | |
| Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | No | |
| Lumen: 3.0mm (ID) x 400mm (L) | Yes, maximum 2 | Yes, maximum 5 | |
| Occluded/Mated Challenge | Yes | Yes | |
| Silicone Support Bars | Yes | Yes | |
| Silicone Mat | Yes | No | |
| Laparoscopic Rack | Yes | Yes | |
| Optional Protective Plate | Yes | No | |
| Filter | NST Series | NST Series | |
| Data Cards | MD1-1 | MD1-1 | |
| Tamper-Evident Arrow | White AS Series | Yellow AG Series | |
| Stack Height | 3 Maximum | No stacking | |
| Materials | Materials: Metals,Polymers, Composites | Radel, Stainless Steel,Aluminum, Silicone | |
| Maximum Total Container SystemWeight | 25 lbs. | 15 lbs. | |
| Note: The CD2-10BDL and DINCD2-8B container models are not validated for use in 100% Ethylene Oxide sterilization |
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Image /page/15/Picture/1 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a small orange accent in the upper left corner.
Solid Bottom Containers
| Catalog Code | Description | Container Dimension (in) | ContainerWeight(lb.) |
|---|---|---|---|
| CD0-4C | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.4 |
| CD1-4C | Half Length Container | 11.8 x 12.4 x 4.5 | 4.8 |
| CD1-5C | Half Length Container | 11.8 x 12.4 x 5.3 | 5.0 |
| CD1-6C | Half Length Container | 11.8 x 12.4 x 6.1 | 5.2 |
| CD2-4C | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.4 |
| CD2-5C | Mid Length Container | 19.2 x 12.4 x 5.3 | 6.7 |
| CD2-6C | Mid Length Container | 19.2 x 12.4 x 6.1 | 6.9 |
| CD2-8C | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.3 |
| CD3-4C | Full Length Container | 23.1 x 12.4 x 4.5 | 7.8 |
| CD3-5C | Full Length Container | 23.1 x 12.4 x 5.3 | 7.9 |
| CD3-6C | Full Length Container | 23.1 x 12.4 x 6.1 | 8.2 |
| CD3-7C | Full Length Container | 23.1 x 12.4 x 7.0 | 8.5 |
| CD7-5C | Extra Long Container | 25.2 x 12.4 x 5.9 | 8.5 |
| CD7-6C | Extra Long Container | 25.2 x 12.4 x 6.7 | 8.8 |
| CD7-9C | Extra Long Container | 25.2 x 12.4 x 8.4 | 9.7 |
| CD4-3C | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 6.7 |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 6.9 |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.3 |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.0 |
| DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | 5.2 |
Perforated Bottom Containers
| Catalog Code | Description | Container Dimension (in) | ContainerWeight(lb.) |
|---|---|---|---|
| CD0-4B | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4B | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5B | Half Length Container | 11.8 x 12.4 x 5.3 | 5.5 |
| CD1-6B | Half Length Container | 11.8 x 12.4 x 6.1 | 5.7 |
| CD2-4B | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5B | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.1 |
| CD2-6B | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.4 |
| CD2-8B | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.8 |
| CD3-4B | Full Length Container | 23.1 x 12.4 x 4.5 | 8.5 |
| CD3-5B | Full Length Container | 23.1 x 12.4 x 5.3 | 8.8 |
| CD3-6B | Full Length Container | 23.1 x 12.4 x 6.1 | 9.0 |
| CD3-7B | Full Length Container | 23.1 x 12.4 x 7.0 | 9.4 |
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| Catalog Code | Description | Container Dimension (in) | ContainerWeight(lb.) |
|---|---|---|---|
| CD7-5B | Extra Long Container | 25.2 x 12.4 x 5.9 | 9.0 |
| CD7-6B | Extra Long Container | 25.2 x 12.4 x 6.7 | 9.4 |
| CD7-9B | Extra Long Container | 25.2 x 12.4 x 8.4 | 10.0 |
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.7 |
STERRAD Style Containers
| Catalog Code | Description | Container Dimension (In) | ContainerWeight(lb.) |
|---|---|---|---|
| CD0-4ST | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4ST | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5ST | Half Length Container | 11.8 x 12.4 x 5.3 | 5.4 |
| CD1-6ST | Half Length Container | 11.8 x 12.4 x 6.1 | 5.6 |
| CD2-4ST | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5ST | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.0 |
| CD2-6ST | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.2 |
| CD2-8ST | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.7 |
| CD3-4ST | Full Length Container | 23.1 x 12.4 x 4.5 | 8.4 |
| CD3-5ST | Full Length Containers | 23.1 x 12.4 x 5.3 | 8.6 |
| CD3-6ST | Full Length Containers | 23.1 x 12.4 x 6.1 | 8.9 |
| CD3-7ST | Full Length Containers | 23.1 x 12.4 x 7.0 | 9.3 |
| CD4-3ST | Small Narrow Shallow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5ST | Small Narrow Container | 20.8 x 7.3 x 5.2 | 4.8 |
| CD5-3ST | Large Narrow Shallow Container | 28.1 x 11.2 x 5.0 | 8.9 |
| CD5-61ST | Large Narrow Shallow Container | 28.1 x 11.2 x 6.4 | 9.4 |
| CD0-3ST | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
§ 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).