Symmetry Surgical Quad-Lock Container System
Device Facts
| Record ID | K152111 |
|---|---|
| Device Name | Symmetry Surgical Quad-Lock Container System |
| Applicant | Symmetry Surgical, Inc. |
| Product Code | KCT · General Hospital |
| Decision Date | Apr 14, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to: · organize and protect stainless steel, aluminum, plastic* and silicone surgical instruments that will be sterilized · allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1) · When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised · When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is intended for use with stainless steel, aluminum, plastic and silicone surgical instruments. *The use of plastic instruments has only been confirmed for steam sterilization.
Device Story
Symmetry Surgical Quad-Lock® Container System is a rigid sterilization container used in hospitals/healthcare facilities to organize, protect, and maintain sterility of surgical instruments (stainless steel, aluminum, titanium, plastic, silicone) during sterilization, storage, and transport. The system comprises a container base, filter lid, security lid, and internal accessories (baskets/trays). It functions as a barrier system during sterilization cycles (prevacuum steam, ethylene oxide, low-temperature hydrogen peroxide). The device is manually operated by sterile processing staff. The container maintains sterility for up to 180 days (steam) or 30 days (EtO/H2O2) post-sterilization. It facilitates safe handling and storage of instruments, ensuring they remain sterile until point-of-use in the OR or clinic. The system is reusable for up to 100 cycles.
Clinical Evidence
No clinical data. Bench testing only. Performance testing included sterilization efficacy (SAL 10^-6), 30-day shelf-life maintenance, 100-cycle reuse microbial challenge, biocompatibility (extractables/leachables), and functional strength testing per ST77.
Technological Characteristics
Materials: Anodized aluminum, stainless steel, silicone. Design: Rigid container system with filter/security lids and internal baskets. Sterilization: Prevacuum steam, 100% EtO, low-temp H2O2 (STERRAD/V-PRO models). Connectivity: None. Reusable (up to 100 cycles).
Indications for Use
Indicated for hospitals and healthcare facilities to organize and protect stainless steel, aluminum, titanium, plastic (steam only), and silicone surgical instruments during sterilization and storage. Compatible with prevacuum steam, ethylene oxide, and low-temperature hydrogen peroxide sterilization cycles.
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
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with three human profiles incorporated into its design. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2016
Symmetry Surgical, Inc. c/o Ms. Michele Lucey Regulatory Affairs Consultant Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255
Re: K152111
Trade/Device Name: Symmetry Surgical Quad-Lock™ Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: March 11, 2016 Received: March 15, 2016
Dear Ms. Michele Lucey:
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
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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 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/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 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 vours.
*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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## Indications for Use
510(k) Number (if known) K152111
#### Device Name
Symmetry Surgical Quad-Lock® Container System
Indications for Use (Describe) Indications for Use:
The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to: · organize and protect stainless steel, aluminum, plastic* and silicone surgical instruments that will be sterilized · allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1)
· When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised
· When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised
The system has not been tested for maintenance of sterility after transportation outside the health care facility.
The system is intended for use with stainless steel, aluminum, plastic and silicone surgical instruments.
*The use of plastic instruments has only been confirmed for steam sterilization.
For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container, the recommended maximum combined weight of the single container, lid. basket/tray contents is defined in Table 1. For each cvcle type the qualified lumen size is the minimum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.
| 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) |
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| Table 1<br>Sterilization Parameters | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Sterilization<br>Modality | Cycle Type | Cycle<br>Parameters | Instrument<br>Type | Qualified<br>Lumen<br>Size/Maximum<br>Quantity | Load<br>Requirements<br>(Maximum<br>Weight) |
| Steam | Prevacuum | Temperature:<br>132°C<br>Exposure<br>Time: 4<br>minutes<br>Drying Time:<br>30 minutes<br>Stackable –<br>Yes, up to<br>three<br>containers | stainless steel,<br>aluminum,<br>titanium,<br>plastic* and<br>silicone surgical<br>instruments | Full and Three<br>Quarter Sizes:<br>3 mm x 400mm<br>Half Size:<br>3mm x 250mm<br>size<br>4 lumen per<br>container | Full, Three<br>Quarter and Half<br>Sizes:<br>25 lbs |
| Ethylene Oxide | 100% ETO | Concentration:<br>725mg/L<br>Temperature:<br>55°C<br>Exposure<br>Time: 60<br>minutes<br>Humidity: 50-<br>70%<br>Aeration time<br>8 hours at<br>110°F (43°C)<br>Stackable – No | stainless steel,<br>aluminum,<br>titanium, and<br>silicone surgical<br>instruments | Full and Three<br>Quarter Sizes:<br>3 mm x 400mm<br>Half Size:<br>2mm x 250mm<br>4 Lumen per<br>container | Full, Three<br>Quarter and Half<br>Sizes:<br>25 lbs |
| Low Temperature H2O2 Sterilizers by Model Name/Cycle Type<br>Sterilization Parameters for each cycle type are set by the manufacturer | | | | | |
| STERRAD 100NX | Standard | Fixed Cycle<br>Type**<br>Stackable – No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>2mm x 400mm<br>Three Quarter and<br>Half Sizes:<br>2mm x 250mm<br>5 Lumen per<br>container | Full Size:<br>21.4 lbs<br>Three Quarter and<br>Half Sizes:<br>13.85 lbs |
| Table 1<br>Sterilization Parameters | | | | | |
| Sterilization<br>Modality | Cycle Type | Cycle<br>Parameters | Instrument<br>Type | Qualified<br>Lumen<br>Size/Maximum<br>Quantity | Load<br>Requirements<br>(Maximum<br>Weight) |
| | DUO | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>2mm x 400mm<br>Three Quarter and<br>Half Sizes:<br>2mm x 250mm<br>5 Lumen per<br>container | Full Size:<br>21.4 lbs<br>Three Quarter and<br>Half Sizes:<br>13.2 lbs |
| | FLEX | Fixed Cycle<br>Type**<br>Stackable - No | Porous Lumens | Full, Three Quarter<br>and Half Sizes:<br>One 1mm x 850mm<br>Flexible Endoscope<br>per container | Full Size:<br>16.65 lbs<br>Three Quarter<br>Size:<br>12.40 lbs<br>Half Size:<br>10.75 lbs |
| STERRAD NX | Standard | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>1mm x 400mm<br>Three Quarter and<br>Half Size:<br>2mm x 250mm<br>5 Lumen per<br>container | Full Size:<br>21.4 lbs<br>Three Quarter and<br>Half Sizes:<br>13.85 lbs |
| | Advanced | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full, Three Quarter,<br>and Half Sizes:<br>2mm x 250mm<br>5 Lumen per<br>container | Full Size:<br>21.4 lbs<br>Three Quarter and<br>Half Sizes:<br>13.85 lbs |
| Table 1<br>Sterilization Parameters | | | | | |
| Sterilization<br>Modality | Cycle Type | Cycle Parameters | Instrument Type | Qualified<br>Lumen<br>Size/Maximum<br>Quantity | Load<br>Requirements<br>(Maximum<br>Weight) |
| STERRAD 100S | Standard | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>3mm x 400mm<br>Three Quarter and<br>Half Size: 2mm x<br>250mm<br>5 Lumen per<br>container | Full, Three<br>Quarter, and Half<br>Sizes:<br>18.2 lbs |
| STERIS<br>V-PRO™ 1 PLUS | Lumen or<br>No Lumen | Cycle time = 55<br>minutes<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>3mm x 400mm<br>Three Quarter and<br>Half Sizes: 2mm x<br>250mm<br>10 lumen per<br>container | Full, Three<br>Quarter, and Half<br>Sizes:<br>19.65 lbs |
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*The use of plastic instruments has only been confirmed for steam sterilization.
**For all STERRAD manufactured sterilizers all cycle parameters are preset by the manufacturer and cannot be reset by the user.
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| Table 2<br>Container System Compatibility by Cycle Type | | | | | |
|---------------------------------------------------------|-----------------|-------------------------|---------------------------|--------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | Size | Pre-<br>Vacuum<br>Steam | 100%<br>Ethylene<br>Oxide | STERRAD<br>100S<br>NX Standard<br>NX Advanced<br>100NX Standard<br>100NX FLEX<br>100NX DUO | STERIS<br>V-Pro 1<br>Plus<br>Lumen |
| Container Component Compatibility | | | | | |
| Filter Bottom Container Base | | | | | |
| Full Length | Height | | | | |
| 508726 | 100mm (4 inch) | YES | YES | YES | YES |
| 508727 | 135mm (5 inch) | YES | YES | YES | YES |
| 508728 | 150mm (6 inch) | YES | YES | YES | YES |
| 508729 | 200mm (8 inch) | YES | YES | YES | YES |
| 508730 | 260mm (10 inch) | YES | YES | YES | YES |
| Three-Quarter<br>Length | | | | | |
| 508736 | 100mm (4 inch) | YES | YES | YES | YES |
| 508737 | 135mm (5 inch) | YES | YES | YES | YES |
| 508738 | 150mm (6 inch) | YES | YES | YES | YES |
| Half Length | | | | | |
| 508731 | 100mm (4 inch) | YES | YES | YES | YES |
| 508732 | 135mm (5 inch) | YES | YES | YES | YES |
| 508733 | 150mm (6 inch) | YES | YES | YES | YES |
| 508734 | 200mm (8 inch) | YES | YES | YES | YES |
| 508735 | 260mm (10 inch) | YES | YES | YES | YES |
| Solid Bottom Container Base | | | | | |
| Full Length | | | | | |
| 508739 | 100mm (4 inch) | YES | YES | NO | NO |
| 508740 | 135mm (5 inch) | YES | YES | NO | NO |
| 508741 | 150mm (6 inch) | YES | YES | NO | NO |
| Table 2<br>Container System Compatibility by Cycle Type | | | | | |
| Product Code | Size | Pre-<br>Vacuum<br>Steam | 100%<br>Ethylene<br>Oxide | STERRAD<br>100S<br>NX Standard<br>NX Advanced<br>100NX Standard<br>100NX FLEX<br>100NX DUO | STERIS<br>V-Pro 1<br>Plus<br>Lumen |
| Container Component Compatibility | | | | | |
| 508742 | 200mm (8 inch) | YES | YES | NO | NO |
| 508743 | 260mm (10 inch) | YES | YES | NO | NO |
| Three-Quarter<br>Length | | | | | |
| 508749 | 100mm (4 inch) | YES | YES | NO | NO |
| 508750 | 135mm (5 inch) | YES | YES | NO | NO |
| 508751 | 150mm (6 inch) | YES | YES | NO | NO |
| Half Length | | | | | |
| 508744 | 100mm (4 inch) | YES | YES | NO | NO |
| 508745 | 135mm (5 inch) | YES | YES | NO | NO |
| 508746 | 150mm (6 inch) | YES | YES | NO | NO |
| 508747 | 200 (8 inch) | YES | YES | NO | NO |
| 508748 | 260 (10 inch) | YES | YES | NO | NO |
| Filter Lids | | | | | |
| Product Code | Color | | | | |
| Full Length | | | | | |
| 508944 | Grey | YES | YES | YES | YES |
| 508945 | Yellow | YES | NO | NO | NO |
| 508946 | Green | YES | NO | NO | NO |
| 508947 | Blue | YES | NO | NO | NO |
| 508948 | Red | YES | NO | NO | NO |
| 508949 | Black | YES | NO | NO | NO |
| Three-Quarter<br>Length | | | | | |
| 508956 | Grey | YES | YES | YES | YES |
| 508957 | Yellow | YES | NO | NO | NO |
| Table 2<br>Container System Compatibility by Cycle Type | | | | | |
| Product Code | Size | Pre-<br>Vacuum<br>Steam | 100%<br>Ethylene<br>Oxide | STERRAD<br>100S<br>NX Standard<br>NX Advanced<br>100NX Standard<br>100NX FLEX<br>100NX DUO | STERIS<br>V-Pro 1<br>Plus<br>Lumen |
| | | | | Container Component Compatibility | |
| 508958 | Green | YES | NO | NO | NO |
| 508959 | Blue | YES | NO | NO | NO |
| 508960 | Red | YES | NO | NO | NO |
| 508961 | Black | YES | NO | NO | NO |
| Half Length | | | | | |
| 508950 | Grey | YES | YES | YES | YES |
| 508951 | Yellow | YES | NO | NO | NO |
| 508952 | Green | YES | NO | NO | NO |
| 508953 | Blue | YES | NO | NO | NO |
| 508954 | Red | YES | NO | NO | NO |
| 508955 | Black | YES | NO | NO | NO |
| Security Lids | | | | | |
| Product Code | Color | | | | |
| Full Length | | | | | |
| 508869 | Grey | YES | YES | YES | YES |
| 508870 | Yellow | YES | YES | YES | YES |
| 508871 | Green | YES | YES | YES | YES |
| 508872 | Blue | YES | YES | YES | YES |
| 508873 | Red | YES | YES | YES | YES |
| 508874 | Black | YES | YES | YES | YES |
| Three-Quarter<br>Length | | | | | |
| 508881 | Grey | YES | YES | YES | YES |
| 508882 | Yellow | YES | YES | YES | YES |
| 508883 | Green | YES | YES | YES | YES |
| 508884 | Blue | YES | YES | YES | YES |
| Table 2<br>Container System Compatibility by Cycle Type | | | | | |
| Product Code | Size | Pre-<br>Vacuum<br>Steam | 100%<br>Ethylene<br>Oxide | STERRAD<br>100S<br>NX Standard<br>NX Advanced<br>100NX Standard<br>100NX FLEX<br>100NX DUO | STERIS<br>V-Pro 1<br>Plus<br>Lumen |
| Container Component Compatibility | | | | | |
| 508885 | Red | YES | YES | YES | YES |
| 508886 | Black | YES | YES | YES | YES |
| Half Length | | | | | |
| 508875 | Grey | YES | YES | YES | YES |
| 508876 | Yellow | YES | YES | YES | YES |
| 508877 | Green | YES | YES | YES | YES |
| 508878 | Blue | YES | YES | YES | YES |
| 508879 | Red | YES | YES | YES | YES |
| 508880 | Black | YES | YES | YES | YES |
| Basket Configurations | | | | | |
| Product Code | Height | | | | |
| Full Length | | | | | |
| 508500 | 30mm (1 inch) | YES | YES | YES | YES |
| 508501 | 50mm (2 inch) | YES | YES | YES | YES |
| 508502 | 70mm (3 inch) | YES | YES | YES | YES |
| 508503 | 100mm (4 inch) | YES | YES | YES | YES |
| Three-Quarter<br>Length | | | | | |
| 508508 | 30mm (1 inch) | YES | YES | YES | YES |
| 508509 | 50mm (2 inch) | YES | YES | YES | YES |
| 508510 | 70mm (3 inch) | YES | YES | YES | YES |
| 508511 | 100mm (4 inch) | YES | YES | YES | YES |
| Half Length | | | | | |
| 508504 | 30mm (1 inch) | YES | YES | YES | YES |
| 508505 | 50mm (2 inch) | YES | YES | YES | YES |
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| Table 2 | | | | | | | |
|-----------------------------------|-------------------|-------------------------|---------------------------|--------------------------------------------------------------------------------------------|------------------------------------|-----|-----|
| Product Code | Size | Pre-<br>Vacuum<br>Steam | 100%<br>Ethylene<br>Oxide | Container System Compatibility by Cycle Type | | | |
| | | | | STERRAD<br>100S<br>NX Standard<br>NX Advanced<br>100NX Standard<br>100NX FLEX<br>100NX DUO | STERIS<br>V-Pro 1<br>Plus<br>Lumen | | |
| Container Component Compatibility | | | | | | | |
| 508506 | 70mm (3 inch) | YES | YES | YES | YES | | |
| 508507 | 100mm (4 inch) | YES | YES | YES | YES | | |
| Wire Base Configurations | | | | | | | |
| Product Code | Length | Height | | | | | |
| 508512 | Half | 26mm (1<br>inch) | YES | YES | YES | YES | |
| 508513 | Three-<br>Quarter | 26mm (1<br>inch) | YES | YES | YES | YES | |
| 508514 | Full | 26mm (1<br>inch) | YES | YES | YES | YES | |
| Protective Mat | | | | | | | |
| Product Code | Length | | | | | | |
| 508550 | Half | | | YES | NO | YES | |
| 508551 | Three-Quarter | | | | YES | NO | YES |
| 508552 | Full | | | YES | NO | YES | |
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# K152111
### 510(k) Summary As required by 21 CFR 807.92
| Date Prepared: | April 8, 2016 |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | Symmetry Surgical, Inc.<br>3034 Owen Drive, Antioch TN 37013<br>1-800-251-3000<br>1-615-964-5567 (fax) |
| Contact Person | Michele Lucey<br>Lakeshore Medical Device Consulting LLC<br>128 Blye Hill Landing<br>Newbury NH<br>603-763-3455<br>Lucey_m@msn.com |
| Device Proprietary Name:<br>Container System Device Common Name: | Symmetry Surgical Quad-Lock® Container System<br>Container Sterilization System |
| Classification Name: | Container Sterilization System |
| Device Classification: | Class II (21 CFR 880.6850) (KCT) |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for Submission: | Expand Indications for Use |
| Predicate Device(s): | K092437, K120117 Codman™ Sterilization Container |
### Device Description:
The Symmetry Surgical Quad-Lock® Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The filter lids, security lids, and container bottoms are made from anodized aluminum. The security lids help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, filter lid, security lid, filters and other accessories.
### Indications for Use:
Intended Use:
The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to:
- . organize and protect stainless steel, aluminum, titanium, plastic* and silicone surgical instruments that will be sterilized
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- allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1)
- When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility ● of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised
- . When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised
The system has not been tested for maintenance of sterility after transportation outside the health care facility.
The system is intended for use with stainless steel, aluminum, plastic* and silicone surgical instruments.
*The use of plastic instruments has only been confirmed for steam sterilization.
For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container. the recommended maximum combined weight of the single container, lid, basket/tray contents is defined in Table 1. For each cycle type the qualified lumen size is the minimum diameter and maximum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.
| Table 1<br>Sterilization Parameters | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Sterilization<br>Modality | Cycle Type | Cycle<br>Parameters* | Instrument<br>Type | Qualified<br>Lumen<br>Size/Maximum<br>Quantity | Load<br>Requirements<br>(Maximum<br>Weight) |
| Steam | Prevacuum | Temperature:<br>132°C<br>Exposure<br>Time: 4<br>minutes<br>Drying Time:<br>30 minutes<br>Stackable –<br>Yes, up to three<br>containers | stainless steel,<br>aluminum,<br>titanium, plastic*<br>and silicone<br>surgical<br>instruments | Full and Three<br>Quarter Sizes :<br>3 mm x 400mm<br>Half Size:<br>3mm x 250mm<br>size<br>4 lumen per<br>container | Full, Three<br>Quarter and Half<br>Sizes:<br>25 lbs |
| Ethylene Oxide | 100% ETO | Concentration:<br>725mg/L<br>Temperature:<br>55°C<br>Exposure<br>Time: 60<br>minutes<br>Humidity: 50-<br>70%<br>Aeration time 8 | stainless steel,<br>aluminum,<br>titanium, and<br>silicone surgical<br>instruments | Full and Three<br>Quarter Sizes:<br>3 mm x 400mm<br>Half Size:<br>2mm x 250mm<br>4 Lumen per<br>container | Full, Three<br>Quarter and Half<br>Sizes:<br>25 lbs |
| Sterilization<br>Modality | Cycle Type | Cycle<br>Parameters* | Instrument<br>Type | Qualified<br>Lumen<br>Size/Maximum<br>Quantity | Load<br>Requirements<br>(Maximum<br>Weight) |
| Table 1<br>Sterilization Parameters | | | | | |
| | | hours at 110°F<br>(43°C)<br>Stackable - No | | | |
| Low Temperature H2O2 Sterilizers by Model Name/Cycle Type<br>Sterilization Parameters for each cycle type are set by the manufacturer | | | | | |
| STERRAD<br>100NX | Standard | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>2mm x 400mm<br>Three Quarter and<br>Half Sizes:<br>2mm x 250mm<br>5 Lumen per<br>container | Full Size:<br>21.4 lb<br>Three Quarter<br>and Half Sizes:<br>13.85 lbs |
| | DUO | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>2mm x 400mm<br>Three Quarter and<br>Half Sizes:<br>2mm x 250mm<br>5 Lumen per<br>container | Full Size:<br>21.4 lbs<br>Three Quarter<br>and Half Sizes:<br>13.2 lbs |
| STERRAD<br>100NX | FLEX | Fixed Cycle<br>Type**<br>Stackable - No | Porous Lumens | Full, Three<br>Quarter and Half<br>Sizes:<br>One 1mm x 850mm<br>Flexible Endoscope<br>per container | Full Size:<br>16.65 lbs<br>Three Quarter<br>Size : 12.40 lbs<br>Half Size:<br>10.75 lbs |
| STERRAD NX | Standard | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>1mm x 400mm<br>Three Quarter and<br>Half Size:<br>2mm x 250mm | Full Size:<br>21.4 lbs<br>Three Quarter<br>and Half Sizes:<br>13.85 lbs |
| Table 1<br>Sterilization Parameters | | | | | |
| Sterilization<br>Modality | Cycle Type | Cycle<br>Parameters* | Instrument<br>Type | Qualified<br>Lumen<br>Size/Maximum<br>Quantity | Load<br>Requirements<br>(Maximum<br>Weight) |
| | | | | 5 Lumen per<br>container | |
| | Advanced | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full, Three<br>Quarter, and Half<br>Sizes:<br>2mm x 250mm<br>5 Lumen per<br>container | Full Size:<br>21.4 lbs<br>Three Quarter<br>and Half Sizes:<br>13.85 lbs |
| STERRAD 100S | Standard | Fixed Cycle<br>Type**<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>3mm x 400mm<br>Three Quarter and<br>Half Size: 2mm x<br>250mm<br>5 Lumen per<br>container | Full, Three<br>Quarter, and Half<br>Sizes:<br>18.2 lbs |
| STERIS<br>V-PRO™ 1 PLUS | Lumen or No<br>Lumen | Cycle time =<br>55 minutes<br>Stackable - No | stainless steel,<br>aluminum,<br>titanium, and,<br>silicone surgical<br>instruments | Full Size:<br>3mm x 400mm<br>Three Quarter and<br>Half Sizes: 2mm x<br>250mm<br>10 lumen per<br>container | Full, Three<br>Quarter, and Half<br>Sizes:<br>19.65 lbs |
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*The use of plastic instruments has only been confirmed for steam sterilization
**For all STERRAD manufactured sterilizers all cycle parameters are preset by the manufacturer and cannot be reset by the user.
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| Table 2 | | | | | | |
|---------------------------------------------------------|-----------------------------------|-------------------------|---------------------------|--------------------------------------------------------------------------------------------|------------------------------------|-----|
| Container System Compatibility by Cycle Type | | | | | | |
| Product Code | Size | Pre-<br>Vacuum<br>Steam | 100%<br>Ethylene<br>Oxide | STERRAD<br>100S<br>NX Standard<br>NX Advanced<br>100NX Standard<br>100NX FLEX<br>100NX DUO | STERIS<br>V-Pro 1<br>Plus<br>Lumen | |
| Container Component Compatibility | | | | | | |
| Filter Bottom Container Base | | | | | | |
| Full Length | Height | | | | | |
| 508726 | 100mm (4 inch) | YES | YES | YES | YES | |
| 508727 | 135mm (5 inch) | YES | YES | YES | YES | |
| 508728 | 150mm (6 inch) | YES | YES | YES | YES | |
| 508729 | 200mm (8 inch) | YES | YES | YES | YES | |
| 508730 | 260mm (10 inch) | YES | YES | YES | YES | |
| Three-Quarter<br>Length | | | | | | |
| 508736 | 100mm (4 inch) | YES | YES | YES | YES | |
| 508737 | 135mm (5 inch) | YES | YES | YES | YES | |
| 508738 | 150mm (6 inch) | YES | YES | YES | YES | |
| Half Length | | | | | | |
| 508731 | 100mm (4 inch) | YES | YES | YES | YES | |
| 508732 | 135mm (5 inch) | YES | YES | YES | YES | |
| 508733 | 150mm (6 inch) | YES | YES | YES | YES | |
| 508734 | 200mm (8 inch) | YES | YES | YES | YES | |
| 508735 | 260mm (10 inch) | YES | YES | YES | YES | |
| Solid Bottom Container Base | | | | | | |
| Full Length | | | | | | |
| 508739 | 100mm (4 inch) | YES | YES | NO | NO | |
| 508740 | 135mm (5 inch) | YES | YES | NO | NO | |
| 508741 | 150mm (6 inch) | YES | YES | NO | NO | |
| 508742 | 200mm (8 inch) | YES | YES | NO | NO | |
| 508743 | 260mm (10 inch) | YES | YES | NO | NO | |
| Three-Quarter<br>Length | | | | | | |
| 508749 | 100mm (4 inch) | YES | YES | NO | NO | |
| 508750 | 135mm (5 inch) | YES | YES | NO | NO | |
| 508751 | 150mm (6 inch) | YES | YES | NO | NO | |
| Half Length | | | | | | |
| 508744 | 100mm (4 inch) | YES | YES | NO | NO | |
| 508745 | 135mm (5 inch) | YES | YES | NO | NO | |
| 508746 | 150mm (6 inch) | YES | YES | NO | NO | |
| 508747 | 200 (8 inch) | YES | YES | NO | NO | |
| 508748 | 260 (10 inch) | YES | YES | NO | NO | |
| Table 2 | | | | | | |
| Container System Compatibility by Cycle Type | | | | |…
