(260 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization capabilities of a container system, with no mention of AI or ML.
No.
The device is a container system designed to organize, protect, and allow sterilization of surgical instruments, maintaining their sterility for a period during storage and transport within healthcare facilities. It does not treat or diagnose any medical condition in a patient.
No
This device is a container system designed to organize, protect, and allow sterilization of surgical instruments. It is not used for diagnosing medical conditions.
No
The device description clearly indicates it is a physical container system made of anodized aluminum and other materials, designed to organize, protect, and facilitate the sterilization of surgical instruments. It does not describe any software component as the primary medical device function.
Based on the provided information, the Symmetry Surgical Quad-Lock® Container System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to organize, protect, and allow sterilization of surgical instruments. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The device is a container system for surgical instruments, made of materials like anodized aluminum. This description aligns with a medical device used in the sterilization process, not an IVD.
- Performance Studies: The performance studies focus on sterilization efficacy, shelf life, reuse testing, biocompatibility, and functional strength. These are relevant to the function of a sterilization container, not the performance of an IVD in analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Symmetry Surgical Quad-Lock® Container System falls under the category of a medical device used in the sterilization process, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and by health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The intention of this Traditional 510(k) is to expand the cleared Indications for Use for the Symmetry Surgical Quad-Lock® Container. The device has been previously cleared for steam sterilization. Testing has been completed and supports the safety and effectiveness of the Quad-Lock® Container to support the system for expanded indications using EtO and low temperature H-O2 sterilization modalities.
Summary of Performance Testing:
- Sterilization efficacy and simulated use testing: Validated sterility assurance level of 10^-6. Results: Pass.
- Shelf life of sterile container: Maintenance of sterility after 30 days of storage. Results: Pass.
- Reuse Testing: Microbial Challenge following multiple sterilization cycles verified for up to 100 sterilization cycles. Results: Pass.
- Biocompatibility, extractables, and leachables: In vitro evaluations for these tests had acceptable results. Results: Pass.
- Functional strength of handles: Testing performed in accordance with ST77 had acceptable results. Results: Pass.
Clinical Performance Testing:
The intention of this Traditional 510(k) is to expand the cleared Indications for Use for the Symmetry Surgical Quad-Lock® Container Systems. The Codman Quad-Lock Sterilization Container Systems were originally cleared by the FDA under 510(k) K092437 and K120117. There were no Clinical Tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
| Table 1
| Sterilization Parameters | |||||
|---|---|---|---|---|---|
| Sterilization | |||||
| Modality | Cycle Type | Cycle | |||
| Parameters | Instrument | ||||
| Type | Qualified | ||||
| Lumen | |||||
| Size/Maximum | |||||
| Quantity | Load | ||||
| Requirements | |||||
| (Maximum | |||||
| Weight) | |||||
| Steam | Prevacuum | Temperature: | |||
| 132°C | |||||
| Exposure | |||||
| Time: 4 | |||||
| minutes | |||||
| Drying Time: | |||||
| 30 minutes | |||||
| Stackable – | |||||
| Yes, up to | |||||
| three | |||||
| containers | stainless steel, | ||||
| aluminum, | |||||
| titanium, | |||||
| plastic* and | |||||
| silicone surgical | |||||
| instruments | Full and Three | ||||
| Quarter Sizes: | |||||
| 3 mm x 400mm | |||||
| Half Size: | |||||
| 3mm x 250mm | |||||
| size | |||||
| 4 lumen per | |||||
| container | Full, Three | ||||
| Quarter and Half | |||||
| Sizes: | |||||
| 25 lbs | |||||
| Ethylene Oxide | 100% ETO | Concentration: | |||
| 725mg/L | |||||
| Temperature: | |||||
| 55°C | |||||
| Exposure | |||||
| Time: 60 | |||||
| minutes | |||||
| Humidity: 50- | |||||
| 70% | |||||
| Aeration time | |||||
| 8 hours at | |||||
| 110°F (43°C) | |||||
| Stackable – No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and | |||||
| silicone surgical | |||||
| instruments | Full and Three | ||||
| Quarter Sizes: | |||||
| 3 mm x 400mm | |||||
| Half Size: | |||||
| 2mm x 250mm | |||||
| 4 Lumen per | |||||
| container | Full, Three | ||||
| Quarter and Half | |||||
| Sizes: | |||||
| 25 lbs | |||||
| Low Temperature H2O2 Sterilizers by Model Name/Cycle Type | |||||
| Sterilization Parameters for each cycle type are set by the manufacturer | |||||
| STERRAD 100NX | Standard | Fixed Cycle | |||
| Type** | |||||
| Stackable – No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 2mm x 400mm | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 2mm x 250mm | |||||
| 5 Lumen per | |||||
| container | Full Size: | ||||
| 21.4 lbs | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 13.85 lbs | |||||
| Table 1 | |||||
| Sterilization Parameters | |||||
| Sterilization | |||||
| Modality | Cycle Type | Cycle | |||
| Parameters | Instrument | ||||
| Type | Qualified | ||||
| Lumen | |||||
| Size/Maximum | |||||
| Quantity | Load | ||||
| Requirements | |||||
| (Maximum | |||||
| Weight) | |||||
| DUO | Fixed Cycle | ||||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 2mm x 400mm | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 2mm x 250mm | |||||
| 5 Lumen per | |||||
| container | Full Size: | ||||
| 21.4 lbs | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 13.2 lbs | |||||
| FLEX | Fixed Cycle | ||||
| Type** | |||||
| Stackable - No | Porous Lumens | Full, Three Quarter | |||
| and Half Sizes: | |||||
| One 1mm x 850mm | |||||
| Flexible Endoscope | |||||
| per container | Full Size: | ||||
| 16.65 lbs | |||||
| Three Quarter | |||||
| Size: | |||||
| 12.40 lbs | |||||
| Half Size: | |||||
| 10.75 lbs | |||||
| STERRAD NX | Standard | Fixed Cycle | |||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 1mm x 400mm | |||||
| Three Quarter and | |||||
| Half Size: | |||||
| 2mm x 250mm | |||||
| 5 Lumen per | |||||
| container | Full Size: | ||||
| 21.4 lbs | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 13.85 lbs | |||||
| Advanced | Fixed Cycle | ||||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full, Three Quarter, | ||||
| and Half Sizes: | |||||
| 2mm x 250mm | |||||
| 5 Lumen per | |||||
| container | Full Size: | ||||
| 21.4 lbs | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 13.85 lbs | |||||
| Table 1 | |||||
| Sterilization Parameters | |||||
| Sterilization | |||||
| Modality | Cycle Type | Cycle Parameters | Instrument Type | Qualified | |
| Lumen | |||||
| Size/Maximum | |||||
| Quantity | Load | ||||
| Requirements | |||||
| (Maximum | |||||
| Weight) | |||||
| STERRAD 100S | Standard | Fixed Cycle | |||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 3mm x 400mm | |||||
| Three Quarter and | |||||
| Half Size: 2mm x | |||||
| 250mm | |||||
| 5 Lumen per | |||||
| container | Full, Three | ||||
| Quarter, and Half | |||||
| Sizes: | |||||
| 18.2 lbs | |||||
| STERIS | |||||
| V-PRO™ 1 PLUS | Lumen or | ||||
| No Lumen | Cycle time = 55 | ||||
| minutes | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 3mm x 400mm | |||||
| Three Quarter and | |||||
| Half Sizes: 2mm x | |||||
| 250mm | |||||
| 10 lumen per | |||||
| container | Full, Three | ||||
| Quarter, and Half | |||||
| Sizes: | |||||
| 19.65 lbs |
4
5
*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.
6
| Table 2
| Container System Compatibility by Cycle Type | |||||
|---|---|---|---|---|---|
| Product Code | Size | Pre- | |||
| Vacuum | |||||
| Steam | 100% | ||||
| Ethylene | |||||
| Oxide | STERRAD | ||||
| 100S | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Standard | |||||
| 100NX FLEX | |||||
| 100NX DUO | STERIS | ||||
| V-Pro 1 | |||||
| Plus | |||||
| 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 | |||||
| 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 | |||||
| Container System Compatibility by Cycle Type | |||||
| Product Code | Size | Pre- | |||
| Vacuum | |||||
| Steam | 100% | ||||
| Ethylene | |||||
| Oxide | STERRAD | ||||
| 100S | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Standard | |||||
| 100NX FLEX | |||||
| 100NX DUO | STERIS | ||||
| V-Pro 1 | |||||
| Plus | |||||
| Lumen | |||||
| Container Component Compatibility | |||||
| 508742 | 200mm (8 inch) | YES | YES | NO | NO |
| 508743 | 260mm (10 inch) | YES | YES | NO | NO |
| Three-Quarter | |||||
| 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 | |||||
| Length | |||||
| 508956 | Grey | YES | YES | YES | YES |
| 508957 | Yellow | YES | NO | NO | NO |
| Table 2 | |||||
| Container System Compatibility by Cycle Type | |||||
| Product Code | Size | Pre- | |||
| Vacuum | |||||
| Steam | 100% | ||||
| Ethylene | |||||
| Oxide | STERRAD | ||||
| 100S | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Standard | |||||
| 100NX FLEX | |||||
| 100NX DUO | STERIS | ||||
| V-Pro 1 | |||||
| Plus | |||||
| 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 | |||||
| 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 | |||||
| Container System Compatibility by Cycle Type | |||||
| Product Code | Size | Pre- | |||
| Vacuum | |||||
| Steam | 100% | ||||
| Ethylene | |||||
| Oxide | STERRAD | ||||
| 100S | |||||
| NX Standard | |||||
| NX Advanced | |||||
| 100NX Standard | |||||
| 100NX FLEX | |||||
| 100NX DUO | STERIS | ||||
| V-Pro 1 | |||||
| Plus | |||||
| 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 | |||||
| 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 |
7
8
9
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| Table 2 | |||||||
|---|---|---|---|---|---|---|---|
| Product Code | Size | Pre- | |||||
| Vacuum | |||||||
| Steam | 100% | ||||||
| Ethylene | |||||||
| Oxide | Container System Compatibility by Cycle Type | ||||||
| STERRAD | |||||||
| 100S | |||||||
| NX Standard | |||||||
| NX Advanced | |||||||
| 100NX Standard | |||||||
| 100NX FLEX | |||||||
| 100NX DUO | STERIS | ||||||
| V-Pro 1 | |||||||
| Plus | |||||||
| 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 | |||||
| inch) | YES | YES | YES | YES | |||
| 508513 | Three- | ||||||
| Quarter | 26mm (1 | ||||||
| inch) | YES | YES | YES | YES | |||
| 508514 | Full | 26mm (1 | |||||
| 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 |
11
K152111
510(k) Summary As required by 21 CFR 807.92
| Date Prepared: | April 8, 2016 |
|---|---|
| Company Name: | Symmetry Surgical, Inc. |
| 3034 Owen Drive, Antioch TN 37013 | |
| 1-800-251-3000 | |
| 1-615-964-5567 (fax) | |
| Contact Person | Michele Lucey |
| Lakeshore Medical Device Consulting LLC | |
| 128 Blye Hill Landing | |
| Newbury NH | |
| 603-763-3455 | |
| Lucey_m@msn.com | |
| Device Proprietary Name: | |
| Container System Device Common Name: | Symmetry Surgical Quad-Lock® Container System |
| 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
12
- 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
| Sterilization Parameters | |||||
|---|---|---|---|---|---|
| Sterilization | |||||
| Modality | Cycle Type | Cycle | |||
| Parameters* | Instrument | ||||
| Type | Qualified | ||||
| Lumen | |||||
| Size/Maximum | |||||
| Quantity | Load | ||||
| Requirements | |||||
| (Maximum | |||||
| Weight) | |||||
| Steam | Prevacuum | Temperature: | |||
| 132°C | |||||
| Exposure | |||||
| Time: 4 | |||||
| minutes | |||||
| Drying Time: | |||||
| 30 minutes | |||||
| Stackable – | |||||
| Yes, up to three | |||||
| containers | stainless steel, | ||||
| aluminum, | |||||
| titanium, plastic* | |||||
| and silicone | |||||
| surgical | |||||
| instruments | Full and Three | ||||
| Quarter Sizes : | |||||
| 3 mm x 400mm | |||||
| Half Size: | |||||
| 3mm x 250mm | |||||
| size | |||||
| 4 lumen per | |||||
| container | Full, Three | ||||
| Quarter and Half | |||||
| Sizes: | |||||
| 25 lbs | |||||
| Ethylene Oxide | 100% ETO | Concentration: | |||
| 725mg/L | |||||
| Temperature: | |||||
| 55°C | |||||
| Exposure | |||||
| Time: 60 | |||||
| minutes | |||||
| Humidity: 50- | |||||
| 70% | |||||
| Aeration time 8 | stainless steel, | ||||
| aluminum, | |||||
| titanium, and | |||||
| silicone surgical | |||||
| instruments | Full and Three | ||||
| Quarter Sizes: | |||||
| 3 mm x 400mm | |||||
| Half Size: | |||||
| 2mm x 250mm | |||||
| 4 Lumen per | |||||
| container | Full, Three | ||||
| Quarter and Half | |||||
| Sizes: | |||||
| 25 lbs | |||||
| Sterilization | |||||
| Modality | Cycle Type | Cycle | |||
| Parameters* | Instrument | ||||
| Type | Qualified | ||||
| Lumen | |||||
| Size/Maximum | |||||
| Quantity | Load | ||||
| Requirements | |||||
| (Maximum | |||||
| Weight) | |||||
| Table 1 | |||||
| Sterilization Parameters | |||||
| hours at 110°F | |||||
| (43°C) | |||||
| Stackable - No | |||||
| Low Temperature H2O2 Sterilizers by Model Name/Cycle Type | |||||
| Sterilization Parameters for each cycle type are set by the manufacturer | |||||
| STERRAD | |||||
| 100NX | Standard | Fixed Cycle | |||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 2mm x 400mm | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 2mm x 250mm | |||||
| 5 Lumen per | |||||
| container | Full Size: | ||||
| 21.4 lb | |||||
| Three Quarter | |||||
| and Half Sizes: | |||||
| 13.85 lbs | |||||
| DUO | Fixed Cycle | ||||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 2mm x 400mm | |||||
| Three Quarter and | |||||
| Half Sizes: | |||||
| 2mm x 250mm | |||||
| 5 Lumen per | |||||
| container | Full Size: | ||||
| 21.4 lbs | |||||
| Three Quarter | |||||
| and Half Sizes: | |||||
| 13.2 lbs | |||||
| STERRAD | |||||
| 100NX | FLEX | Fixed Cycle | |||
| Type** | |||||
| Stackable - No | Porous Lumens | Full, Three | |||
| Quarter and Half | |||||
| Sizes: | |||||
| One 1mm x 850mm | |||||
| Flexible Endoscope | |||||
| per container | Full Size: | ||||
| 16.65 lbs | |||||
| Three Quarter | |||||
| Size : 12.40 lbs | |||||
| Half Size: | |||||
| 10.75 lbs | |||||
| STERRAD NX | Standard | Fixed Cycle | |||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 1mm x 400mm | |||||
| Three Quarter and | |||||
| Half Size: | |||||
| 2mm x 250mm | Full Size: | ||||
| 21.4 lbs | |||||
| Three Quarter | |||||
| and Half Sizes: | |||||
| 13.85 lbs | |||||
| Table 1 | |||||
| Sterilization Parameters | |||||
| Sterilization | |||||
| Modality | Cycle Type | Cycle | |||
| Parameters* | Instrument | ||||
| Type | Qualified | ||||
| Lumen | |||||
| Size/Maximum | |||||
| Quantity | Load | ||||
| Requirements | |||||
| (Maximum | |||||
| Weight) | |||||
| 5 Lumen per | |||||
| container | |||||
| Advanced | Fixed Cycle | ||||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full, Three | ||||
| Quarter, and Half | |||||
| Sizes: | |||||
| 2mm x 250mm | |||||
| 5 Lumen per | |||||
| container | Full Size: | ||||
| 21.4 lbs | |||||
| Three Quarter | |||||
| and Half Sizes: | |||||
| 13.85 lbs | |||||
| STERRAD 100S | Standard | Fixed Cycle | |||
| Type** | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 3mm x 400mm | |||||
| Three Quarter and | |||||
| Half Size: 2mm x | |||||
| 250mm | |||||
| 5 Lumen per | |||||
| container | Full, Three | ||||
| Quarter, and Half | |||||
| Sizes: | |||||
| 18.2 lbs | |||||
| STERIS | |||||
| V-PRO™ 1 PLUS | Lumen or No | ||||
| Lumen | Cycle time = | ||||
| 55 minutes | |||||
| Stackable - No | stainless steel, | ||||
| aluminum, | |||||
| titanium, and, | |||||
| silicone surgical | |||||
| instruments | Full Size: | ||||
| 3mm x 400mm | |||||
| Three Quarter and | |||||
| Half Sizes: 2mm x | |||||
| 250mm | |||||
| 10 lumen per | |||||
| container | Full, Three | ||||
| Quarter, and Half | |||||
| Sizes: | |||||
| 19.65 lbs |
13
14
*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.
15
| Table 2 | ||||||
|---|---|---|---|---|---|---|
| Container System Compatibility by Cycle Type | ||||||
| Product Code | Size | Pre- | ||||
| Vacuum | ||||||
| Steam | 100% | |||||
| Ethylene | ||||||
| Oxide | STERRAD | |||||
| 100S | ||||||
| NX Standard | ||||||
| NX Advanced | ||||||
| 100NX Standard | ||||||
| 100NX FLEX | ||||||
| 100NX DUO | STERIS | |||||
| V-Pro 1 | ||||||
| Plus | ||||||
| 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 | ||||||
| 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 | ||||||
| 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 | ||||||
| Product Code | Size | Pre- | ||||
| Vacuum | ||||||
| Steam | 100% | |||||
| Ethylene | ||||||
| Oxide | STERRAD | |||||
| 100S | ||||||
| NX Standard | ||||||
| NX Advanced | ||||||
| 100NX Standard | ||||||
| 100NX FLEX | ||||||
| 100NX DUO | STERIS | |||||
| V-Pro 1 | ||||||
| Plus | ||||||
| Lumen | ||||||
| Container Component Compatibility | ||||||
| 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 | ||||||
| Length | ||||||
| 508956 | Grey | YES | YES | YES | YES | |
| 508957 | Yellow | YES | NO | NO | NO | |
| 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 | ||||||
| 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 | ||||||
| Container System Compatibility by Cycle Type | ||||||
| Product Code | Size | Pre- | ||||
| Vacuum | ||||||
| Steam | 100% | |||||
| Ethylene | ||||||
| Oxide | STERRAD | |||||
| 100S | ||||||
| NX Standard | ||||||
| NX Advanced | ||||||
| 100NX Standard | ||||||
| 100NX FLEX | ||||||
| 100NX DUO | STERIS | |||||
| V-Pro 1 | ||||||
| Plus | ||||||
| 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 | ||||||
| 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 | |
| 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 inch) | YES | YES | YES | YES |
| 508513 | Three-Quarter | 26mm (1 inch) | YES | YES | YES | YES |
| 508514 | Full | 26mm (1 inch) | YES | YES | YES | YES |
| Table 2 | ||||||
| Container System Compatibility by Cycle Type | ||||||
| Product Code | Size | Pre- | ||||
| Vacuum | ||||||
| Steam | 100% | |||||
| Ethylene | ||||||
| Oxide | STERRAD | |||||
| 100S | ||||||
| NX Standard | ||||||
| NX Advanced | ||||||
| 100NX Standard | ||||||
| 100NX FLEX | ||||||
| 100NX DUO | STERIS | |||||
| V-Pro 1 | ||||||
| Plus | ||||||
| Lumen | ||||||
| Container Component Compatibility | ||||||
| Protective Mat | ||||||
| Product Code | Length | |||||
| 508550 | Half | YES | YES | NO | YES | |
| 508551 | Three-Quarter | YES | YES | NO | YES | |
| 508552 | Full | YES | YES | NO | YES |
16
17
18
19
Technological Characteristics:
The technological characteristics of this device, including design and materials, are similar to the predicate device, Codman" Sterilization Container (K092437, K120117). Table 3 provides a summary of the device characteristics compared to the predicate device:
| Similarities and
Differences | Predicate
Symmetry Surgical Quad-
Lock® Container Systems
(Previously Codman) | Predicate
Symmetry Surgical
Quad-Lock® Container
Systems
(Previously Codman) | Proposed
Symmetry Surgical Quad-Lock® Container Systems |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table 3 | | | |
| Substantial Equivalence Comparison | | | |
| 510(k) Number | K092437 | K120117 | This Submission |
| Trade Name | Codman Sterilization
Containers | Codman® Sterilization
Containers | Symmetry Surgical Quad-Lock® Container Systems |
| 510(k) Decision
Date | March 25, 2010 | April 16, 2012 | NA |
| FDA Product
Code | KCT | Same | Same |
| Classification
Section | 21CFR880.6850 | Same | Same |
| Classification
Name | Sterilization wrap containers,
trays, cassettes & other
accessories | Same | Same |
| Use Description | Means to organize and protect
instruments during sterilization
and storage | Same | Same |
| Materials | Aluminum alloy, Stainless
Steel & Silicone | Same | Same |
| Indications for
Use | The Symmetry Surgical Quad-
Lock® Sterilization Container
System is indicated for use by
hospitals and by health care
facilities to:
organize and protect
stainless steel,
aluminum, and titanium
general surgical
instruments that will be
sterilized allow sterilization of the
contained instruments by
prevacuum steam
sterilization maintain the sterility of the
contents for up to 180 days
during storage and transport
within the health care facility,
as long as the integrity of the
container has not been
compromised | The Symmetry Surgical
Quad-Lock® Sterilization
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 allow sterilization
of the contained
instruments by
prevacuum steam
sterilization maintain the sterility of
the contents for up to 180
days during storage and
transport within the health
care facility, as long as
the integrity of the
container has not been
compromised | The Symmetry Surgical Quad-Lock® 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 allow sterilization of the contained instruments by
prevacuum steam, ethylene oxide, and low
temperature hydrogen peroxide sterilization cycles
(validated parameters 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 New modalities have been validated to demonstrate |
20
| Table 3 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Substantial Equivalence Comparison | ||||||||||||
| Similarities and | ||||||||||||
| Differences | Predicate | |||||||||||
| Symmetry Surgical Quad- | ||||||||||||
| Lock® Container Systems | ||||||||||||
| (Previously Codman) | Predicate | |||||||||||
| Symmetry Surgical | ||||||||||||
| Quad-Lock® Container | ||||||||||||
| Systems | ||||||||||||
| (Previously Codman) | Proposed | |||||||||||
| Symmetry Surgical Quad-Lock® Container Systems | ||||||||||||
| compromised | differences. | |||||||||||
| *The inclusion of plastic instruments applies only to | ||||||||||||
| steam sterilization. | ||||||||||||
| Materials | Aluminum, stainless steel, | |||||||||||
| polycarbonate, silicone, nylon | Same | Same | ||||||||||
| Stacking | Caution: Do not stack the | |||||||||||
| containers in the sterilizer | The Symmetry Surgical | |||||||||||
| Quad-Lock® Container | ||||||||||||
| Systems can be stacked | ||||||||||||
| during sterilization with | ||||||||||||
| up to three containers. | Same as K120117 | |||||||||||
| Volume to Vent | ||||||||||||
| Ratio | ||||||||||||
| mm³/mm² | 1004-5316 | Same | Same | |||||||||
| Energy modality | None | Same | Same | |||||||||
| Maximum Weight | ||||||||||||
| of Container | For effective sterilization and | |||||||||||
| drying of any size Symmetry | ||||||||||||
| Surgical Quad-Lock® | ||||||||||||
| Container Systems, the | ||||||||||||
| recommended maximum | ||||||||||||
| combined weight of the single | ||||||||||||
| container, lid, basket and | ||||||||||||
| basket contents is 25 lb. (11.3 | ||||||||||||
| kg). | Same | For effective sterilization and drying of any size | ||||||||||
| Symmetry Surgical Quad-Lock® Container Systems, the | ||||||||||||
| recommended maximum combined weight of the single | ||||||||||||
| container, lid, basket and basket contents is defined for | ||||||||||||
| each container type. The weights are similar to the | ||||||||||||
| predicate. | ||||||||||||
| Container weights are specified in the labeling. No new | ||||||||||||
| issues are raised due to these differences. | ||||||||||||
| Sterilization Parameters | ||||||||||||
| Sterilization | ||||||||||||
| Parameters | Cycle Type - Pre-vacuum | |||||||||||
| Temperature - 132°C | ||||||||||||
| Exposure Time – 4 minutes | ||||||||||||
| Drying Time - 30 minutes | Same | Sterilization | ||||||||||
| Modality Cycle Type Cycle | ||||||||||||
| Parameters Steam Prevacuum Temperature: | ||||||||||||
| 132°C | ||||||||||||
| Exposure Time: 4 | ||||||||||||
| minutes | ||||||||||||
| Drying Time: 30 | ||||||||||||
| minutes | ||||||||||||
| Stackable - Yes, | ||||||||||||
| up to three | ||||||||||||
| containers Ethylene | ||||||||||||
| Oxide 100% ETO Concentration: | ||||||||||||
| 725mg/L | ||||||||||||
| Temperature: | ||||||||||||
| 55°C | ||||||||||||
| Exposure Time: | ||||||||||||
| 60 minutes | ||||||||||||
| Humidity: 50- | ||||||||||||
| 70% | ||||||||||||
| Stackable - No |
21
| Table 3
| Substantial Equivalence Comparison | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Similarities and | ||||||||||
| Differences | Predicate | |||||||||
| Symmetry Surgical Quad- | ||||||||||
| Lock® Container Systems | ||||||||||
| (Previously Codman) | Predicate | |||||||||
| Proposed | ||||||||||
| Symmetry Surgical Quad-Lock® Container Systems | ||||||||||
| Low Temperature H2O2 Sterilizers by Model | ||||||||||
| Name/Cycle Type | ||||||||||
| Sterilization Parameters for each cycle type | ||||||||||
| are set by the manufacturer | ||||||||||
| Stackable - No | ||||||||||
| Silicone Mat - Not compatible with Low | ||||||||||
| Temperature H2O2 sterilization cycles | ||||||||||
| STERRAD 100NX Standard | ||||||||||
| DUO | ||||||||||
| FLEX STERRAD NX Standard | ||||||||||
| Advanced STERRAD 100S Standard V-PRO™ 1 PLUS Lumen | ||||||||||
| No Lumen New modalities have been validated to demonstrate | ||||||||||
| efficacy. No new issues are raised due to these | ||||||||||
| differences. | ||||||||||
| Storage | The contents of the unopened | |||||||||
| containers will maintain | ||||||||||
| sterility for 180 days. | 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 New modalities have been validated to demonstrate | ||||||||||
| efficacy. No new issues are raised due to these | ||||||||||
| differences. | ||||||||||
| Reuse | The container may be used up | |||||||||
| to 100 sterilization cycles | Same | |||||||||
| Sterilization | ||||||||||
| Modality | Steam | Steam, Ethylene Oxide, and Low Temperature | ||||||||
| Hydrogen Peroxide. | ||||||||||
| New modalities have been validated to demonstrate | ||||||||||
| efficacy. No new issues are raised due to these |
22
| Table 3 | |||
|---|---|---|---|
| Substantial Equivalence Comparison | |||
| Similarities and | |||
| Differences | Predicate | ||
| Symmetry Surgical Quad- | |||
| Lock® Container Systems | |||
| (Previously Codman) | Predicate | ||
| Symmetry Surgical | |||
| Quad-Lock® Container | |||
| Systems | |||
| (Previously Codman) | Proposed | ||
| Symmetry Surgical Quad-Lock® Container Systems | |||
| differences. |
Non-Clinical Performance Testing
The intention of this Traditional 510(k) is to expand the cleared Indications for Use for the Symmetry Surgical Quad-Lock® Container. The device has been previously cleared for steam sterilization. Testing has been completed and supports the safety and effectiveness of the Quad-Lock® Container to support the system for expanded indications using EtO and low temperature H-O2 sterilization modalities. The following table summarizes the performance testing that has been completed for each sterilization modality that has been added:
| Summary of Performance Testing | ||
|---|---|---|
| Tests Performed | Description | Results |
| Sterilization efficacy and | ||
| simulated use testing | Validated sterility assurance level of $10^{-6}$ | Pass |
| Shelf life of sterile container | Maintenance of sterility after 30 days of | |
| storage | Pass | |
| Reuse Testing | Microbial Challenge following multiple | |
| sterilization cycles verified for up to100 | ||
| sterilization cycles | Pass | |
| Biocompatibility, extractables, | ||
| and leachables | In vitro evaluations for these tests had | |
| acceptable results | Pass | |
| Functional strength of handles | Testing performed in accordance with ST77 | |
| had acceptable results | Pass |
Clinical Performance Testing
The intention of this Traditional 510(k) is to expand the cleared Indications for Use for the Symmetry Surgical Quad-Lock® Container Systems. The Codman Quad-Lock Sterilization Container Systems were originally cleared by the FDA under 510(k) K092437 and K120117. There were no Clinical Tests performed.
Statement of Substantial Equivalence
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed the Symmetry Surgical Quad-Lock® Container Systems are substantially equivalent to the predicate devices, Codman™ Sterilization Containers (K092437 and K120117).