(260 days)
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.
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.
The provided text describes the acceptance criteria and a study to demonstrate the performance of the Symmetry Surgical Quad-Lock™ Container System.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Achieve a sterilization assurance level (SAL) of 10-6 for prevacuum steam, ethylene oxide (EtO), and low-temperature hydrogen peroxide (H2O2) sterilization cycles. | Prevacuum Steam: - Temperature: 132°C - Exposure Time: 4 minutes - Drying Time: 30 minutes - Stackable: Yes, up to three containers - Qualified Lumen Size (Full/Three Quarter): 3mm x 400mm - Qualified Lumen Size (Half Size): 3mm x 250mm - Maximum Quantity: 4 lumen per container - Load Requirements: 25 lbs (all sizes) Ethylene Oxide: - Concentration: 725mg/L - Temperature: 55°C - Exposure Time: 60 minutes - Humidity: 50-70% - Aeration Time: 8 hours at 110°F (43°C) - Stackable: No - Qualified Lumen Size (Full/Three Quarter): 3mm x 400mm - Qualified Lumen Size (Half Size): 2mm x 250mm - Maximum Quantity: 4 Lumen per container - Load Requirements: 25 lbs (all sizes) Low Temperature H2O2 Sterilizers: (Parameters are set by sterilizer manufacturer) - STERRAD 100NX Standard/DUO: Fixed Cycle Type, Stackable: No - Qualified Lumen Size (Full Size): 2mm x 400mm - Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm - Maximum Quantity: 5 Lumen per container - Load Requirements (Full): 21.4 lbs - Load Requirements (Three Quarter/Half): 13.85 lbs (DUO: 13.2 lbs) - STERRAD 100NX FLEX: Fixed Cycle Type, Stackable: No - Qualified Lumen Size (All Sizes): One 1mm x 850mm Flexible Endoscope per container - Load Requirements (Full): 16.65 lbs - Load Requirements (Three Quarter): 12.40 lbs - Load Requirements (Half): 10.75 lbs - STERRAD NX Standard/Advanced: Fixed Cycle Type, Stackable: No - Qualified Lumen Size (Full Size): 1mm x 400mm (Standard) / 2mm x 250mm (Advanced) - Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm - Maximum Quantity: 5 Lumen per container - Load Requirements (Full): 21.4 lbs - Load Requirements (Three Quarter/Half): 13.85 lbs - STERRAD 100S Standard: Fixed Cycle Type, Stackable: No - Qualified Lumen Size (Full Size): 3mm x 400mm - Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm - Maximum Quantity: 5 Lumen per container - Load Requirements (All Sizes): 18.2 lbs - STERIS V-PRO™ 1 PLUS Lumen/No Lumen: Cycle time = 55 minutes, Stackable: No - Qualified Lumen Size (Full Size): 3mm x 400mm - Qualified Lumen Size (Three Quarter/Half Sizes): 2mm x 250mm - Maximum Quantity: 10 lumen per container - Load Requirements (All Sizes): 19.65 lbs All sterilization efficacy and simulated use testing to achieve SAL of 10-6 passed. |
| Maintenance of Sterility (Shelf Life) | Maintain sterility for up to 180 days with prevacuum steam sterilization. Maintain sterility for up to 30 days with ethylene oxide and low-temperature hydrogen peroxide sterilization cycles. | Prevacuum Steam: Sterility maintained for up to 180 days during storage and transport within the healthcare facility, as long as container integrity is not compromised. Ethylene Oxide & Low Temperature H2O2: Sterility maintained for up to 30 days during storage and transport within the healthcare facility, as long as container integrity is not compromised. The shelf life testing for 30 days of storage passed. |
| Reuse Testing | Demonstrate microbial challenge following multiple sterilization cycles for up to 100 sterilization cycles. | Microbial Challenge following multiple sterilization cycles verified for up to 100 sterilization cycles passed. |
| Biocompatibility | In vitro evaluations for biocompatibility, extractables, and leachables must have acceptable results. | In vitro evaluations for these tests had acceptable results. |
| Functional Strength of Handles | Testing performed in accordance with ST77 (presumably ANSI/AAMI ST77, a standard for sterile packaging). | Testing performed in accordance with ST77 had acceptable results. |
2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for the test set for its performance studies (sterilization efficacy, shelf life, reuse testing, biocompatibility, or functional strength).
The data provenance is not explicitly mentioned as a country of origin or whether it's retrospective or prospective; however, the submission is from "Symmetry Surgical, Inc." which is based in Antioch, TN, USA, suggesting the studies likely occurred in the US. The studies are described as "performance testing" and "non-clinical tests," implying they were conducted specifically for this submission, making them prospective in nature for this application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies are described as laboratory-based performance testing rather than studies requiring expert interpretation of results for ground truth establishment (e.g., medical image analysis).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided in the document. The studies described are objective performance tests (e.g., sterilization assurance levels, material properties) that do not typically involve human adjudication in the way medical diagnostic studies do.
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:
This information is not applicable and therefore not provided in the document. The device is a sterilization container system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and therefore not provided in the document. The device is a physical medical device (sterilization container), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance studies appears to be based on objective, measurable criteria derived from scientific and engineering principles for sterilization, material integrity, and functionality. For instance, "sterilization efficacy" ground truth is defined by achieving a specified Sterilization Assurance Level (SAL of 10-6), which is typically confirmed through validated microbiological testing (e.g., biological indicators). Shelf life is determined by maintaining sterility over time, also verified through microbiological methods. Biocompatibility relies on established in vitro evaluation standards.
8. The sample size for the training set:
This information is not applicable and therefore not provided in the document. The product is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.
{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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| Table 1Sterilization Parameters | |||||
|---|---|---|---|---|---|
| SterilizationModality | Cycle Type | CycleParameters | InstrumentType | QualifiedLumenSize/MaximumQuantity | LoadRequirements(MaximumWeight) |
| Steam | Prevacuum | Temperature:132°CExposureTime: 4minutesDrying Time:30 minutesStackable –Yes, up tothreecontainers | stainless steel,aluminum,titanium,plastic* andsilicone surgicalinstruments | Full and ThreeQuarter Sizes:3 mm x 400mmHalf Size:3mm x 250mmsize4 lumen percontainer | Full, ThreeQuarter and HalfSizes:25 lbs |
| Ethylene Oxide | 100% ETO | Concentration:725mg/LTemperature:55°CExposureTime: 60minutesHumidity: 50-70%Aeration time8 hours at110°F (43°C)Stackable – No | stainless steel,aluminum,titanium, andsilicone surgicalinstruments | Full and ThreeQuarter Sizes:3 mm x 400mmHalf Size:2mm x 250mm4 Lumen percontainer | Full, ThreeQuarter and HalfSizes:25 lbs |
| Low Temperature H2O2 Sterilizers by Model Name/Cycle TypeSterilization Parameters for each cycle type are set by the manufacturer | |||||
| STERRAD 100NX | Standard | Fixed CycleType**Stackable – No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:2mm x 400mmThree Quarter andHalf Sizes:2mm x 250mm5 Lumen percontainer | Full Size:21.4 lbsThree Quarter andHalf Sizes:13.85 lbs |
| Table 1Sterilization Parameters | |||||
| SterilizationModality | Cycle Type | CycleParameters | InstrumentType | QualifiedLumenSize/MaximumQuantity | LoadRequirements(MaximumWeight) |
| DUO | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:2mm x 400mmThree Quarter andHalf Sizes:2mm x 250mm5 Lumen percontainer | Full Size:21.4 lbsThree Quarter andHalf Sizes:13.2 lbs | |
| FLEX | Fixed CycleType**Stackable - No | Porous Lumens | Full, Three Quarterand Half Sizes:One 1mm x 850mmFlexible Endoscopeper container | Full Size:16.65 lbsThree QuarterSize:12.40 lbsHalf Size:10.75 lbs | |
| STERRAD NX | Standard | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:1mm x 400mmThree Quarter andHalf Size:2mm x 250mm5 Lumen percontainer | Full Size:21.4 lbsThree Quarter andHalf Sizes:13.85 lbs |
| Advanced | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full, Three Quarter,and Half Sizes:2mm x 250mm5 Lumen percontainer | Full Size:21.4 lbsThree Quarter andHalf Sizes:13.85 lbs | |
| Table 1Sterilization Parameters | |||||
| SterilizationModality | Cycle Type | Cycle Parameters | Instrument Type | QualifiedLumenSize/MaximumQuantity | LoadRequirements(MaximumWeight) |
| STERRAD 100S | Standard | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:3mm x 400mmThree Quarter andHalf Size: 2mm x250mm5 Lumen percontainer | Full, ThreeQuarter, and HalfSizes:18.2 lbs |
| STERISV-PRO™ 1 PLUS | Lumen orNo Lumen | Cycle time = 55minutesStackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:3mm x 400mmThree Quarter andHalf Sizes: 2mm x250mm10 lumen percontainer | Full, ThreeQuarter, and HalfSizes: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 2Container System Compatibility by Cycle Type | |||||
|---|---|---|---|---|---|
| Product Code | Size | Pre-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen |
| 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-QuarterLength | |||||
| 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 2Container System Compatibility by Cycle Type | |||||
| Product Code | Size | Pre-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen |
| Container Component Compatibility | |||||
| 508742 | 200mm (8 inch) | YES | YES | NO | NO |
| 508743 | 260mm (10 inch) | YES | YES | NO | NO |
| Three-QuarterLength | |||||
| 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-QuarterLength | |||||
| 508956 | Grey | YES | YES | YES | YES |
| 508957 | Yellow | YES | NO | NO | NO |
| Table 2Container System Compatibility by Cycle Type | |||||
| Product Code | Size | Pre-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen |
| 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-QuarterLength | |||||
| 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 2Container System Compatibility by Cycle Type | |||||
| Product Code | Size | Pre-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen |
| 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-QuarterLength | |||||
| 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}------------------------------------------------
{10}------------------------------------------------
| Table 2 | |||||||
|---|---|---|---|---|---|---|---|
| Product Code | Size | Pre-VacuumSteam | 100%EthyleneOxide | Container System Compatibility by Cycle Type | |||
| STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen | ||||||
| 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 (1inch) | YES | YES | YES | YES | |
| 508513 | Three-Quarter | 26mm (1inch) | YES | YES | YES | YES | |
| 508514 | Full | 26mm (1inch) | 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 370131-800-251-30001-615-964-5567 (fax) |
| Contact Person | Michele LuceyLakeshore Medical Device Consulting LLC128 Blye Hill LandingNewbury NH603-763-3455Lucey_m@msn.com |
| Device Proprietary Name:Container System Device Common Name: | Symmetry Surgical Quad-Lock® Container SystemContainer 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 1Sterilization Parameters | |||||
|---|---|---|---|---|---|
| SterilizationModality | Cycle Type | CycleParameters* | InstrumentType | QualifiedLumenSize/MaximumQuantity | LoadRequirements(MaximumWeight) |
| Steam | Prevacuum | Temperature:132°CExposureTime: 4minutesDrying Time:30 minutesStackable –Yes, up to threecontainers | stainless steel,aluminum,titanium, plastic*and siliconesurgicalinstruments | Full and ThreeQuarter Sizes :3 mm x 400mmHalf Size:3mm x 250mmsize4 lumen percontainer | Full, ThreeQuarter and HalfSizes:25 lbs |
| Ethylene Oxide | 100% ETO | Concentration:725mg/LTemperature:55°CExposureTime: 60minutesHumidity: 50-70%Aeration time 8 | stainless steel,aluminum,titanium, andsilicone surgicalinstruments | Full and ThreeQuarter Sizes:3 mm x 400mmHalf Size:2mm x 250mm4 Lumen percontainer | Full, ThreeQuarter and HalfSizes:25 lbs |
| SterilizationModality | Cycle Type | CycleParameters* | InstrumentType | QualifiedLumenSize/MaximumQuantity | LoadRequirements(MaximumWeight) |
| Table 1Sterilization Parameters | |||||
| hours at 110°F(43°C)Stackable - No | |||||
| Low Temperature H2O2 Sterilizers by Model Name/Cycle TypeSterilization Parameters for each cycle type are set by the manufacturer | |||||
| STERRAD100NX | Standard | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:2mm x 400mmThree Quarter andHalf Sizes:2mm x 250mm5 Lumen percontainer | Full Size:21.4 lbThree Quarterand Half Sizes:13.85 lbs |
| DUO | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:2mm x 400mmThree Quarter andHalf Sizes:2mm x 250mm5 Lumen percontainer | Full Size:21.4 lbsThree Quarterand Half Sizes:13.2 lbs | |
| STERRAD100NX | FLEX | Fixed CycleType**Stackable - No | Porous Lumens | Full, ThreeQuarter and HalfSizes:One 1mm x 850mmFlexible Endoscopeper container | Full Size:16.65 lbsThree QuarterSize : 12.40 lbsHalf Size:10.75 lbs |
| STERRAD NX | Standard | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:1mm x 400mmThree Quarter andHalf Size:2mm x 250mm | Full Size:21.4 lbsThree Quarterand Half Sizes:13.85 lbs |
| Table 1Sterilization Parameters | |||||
| SterilizationModality | Cycle Type | CycleParameters* | InstrumentType | QualifiedLumenSize/MaximumQuantity | LoadRequirements(MaximumWeight) |
| 5 Lumen percontainer | |||||
| Advanced | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full, ThreeQuarter, and HalfSizes:2mm x 250mm5 Lumen percontainer | Full Size:21.4 lbsThree Quarterand Half Sizes:13.85 lbs | |
| STERRAD 100S | Standard | Fixed CycleType**Stackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:3mm x 400mmThree Quarter andHalf Size: 2mm x250mm5 Lumen percontainer | Full, ThreeQuarter, and HalfSizes:18.2 lbs |
| STERISV-PRO™ 1 PLUS | Lumen or NoLumen | Cycle time =55 minutesStackable - No | stainless steel,aluminum,titanium, and,silicone surgicalinstruments | Full Size:3mm x 400mmThree Quarter andHalf Sizes: 2mm x250mm10 lumen percontainer | Full, ThreeQuarter, and HalfSizes: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-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen | |
| 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-QuarterLength | ||||||
| 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-QuarterLength | ||||||
| 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-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen | |
| 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-QuarterLength | ||||||
| 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-QuarterLength | ||||||
| 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 2Container System Compatibility by Cycle Type | ||||||
| Product Code | Size | Pre-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen | |
| 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-QuarterLength | ||||||
| 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-VacuumSteam | 100%EthyleneOxide | STERRAD100SNX StandardNX Advanced100NX Standard100NX FLEX100NX DUO | STERISV-Pro 1PlusLumen | |
| 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 andDifferences | PredicateSymmetry Surgical Quad-Lock® Container Systems(Previously Codman) | PredicateSymmetry SurgicalQuad-Lock® ContainerSystems(Previously Codman) | ProposedSymmetry Surgical Quad-Lock® Container Systems |
|---|---|---|---|
| Table 3 | |||
| Substantial Equivalence Comparison | |||
| 510(k) Number | K092437 | K120117 | This Submission |
| Trade Name | Codman SterilizationContainers | Codman® SterilizationContainers | Symmetry Surgical Quad-Lock® Container Systems |
| 510(k) DecisionDate | March 25, 2010 | April 16, 2012 | NA |
| FDA ProductCode | KCT | Same | Same |
| ClassificationSection | 21CFR880.6850 | Same | Same |
| ClassificationName | Sterilization wrap containers,trays, cassettes & otheraccessories | Same | Same |
| Use Description | Means to organize and protectinstruments during sterilizationand storage | Same | Same |
| Materials | Aluminum alloy, StainlessSteel & Silicone | Same | Same |
| Indications forUse | The Symmetry Surgical Quad-Lock® Sterilization ContainerSystem is indicated for use byhospitals and by health carefacilities to:organize and protectstainless steel,aluminum, and titaniumgeneral surgicalinstruments that will besterilized allow sterilization of thecontained instruments byprevacuum steamsterilization maintain the sterility of thecontents for up to 180 daysduring storage and transportwithin the health care facility,as long as the integrity of thecontainer has not beencompromised | The Symmetry SurgicalQuad-Lock® SterilizationContainer System isindicated for use byhospitals and by healthcare facilities to:organize and protectstainless steel,aluminum, titanium,plastic and siliconesurgical instrumentsthat will besterilized allow sterilizationof the containedinstruments byprevacuum steamsterilization maintain the sterility ofthe contents for up to 180days during storage andtransport within the healthcare facility, as long asthe integrity of thecontainer has not beencompromised | The Symmetry Surgical Quad-Lock® is indicated for useby hospitals and by health care facilities to:organize and protect stainless steel, aluminum,titanium, plastic* and silicone surgical instrumentsthat will be sterilized allow sterilization of the contained instruments byprevacuum steam, ethylene oxide, and lowtemperature hydrogen peroxide sterilization cycles(validated parameters shown in Table 1) When sterilized by prevacuum steam sterilization,the Quad-Lock® Containers maintain the sterilityof the contents for up to 180 days during storageand transport within the healthcare facility, as longas the integrity of the container has not beencompromised When sterilized by ethylene oxide or lowtemperature hydrogen peroxide cycle types theQuad-Lock® Containers maintain the sterility ofthe contents when sterilized by any of the abovefor up to 30 days during storage and transportwithin the healthcare facility, as long as theintegrity of the container has not beencompromised New modalities have been validated to demonstrate |
{20}------------------------------------------------
| Table 3 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Substantial Equivalence Comparison | ||||||||||||
| Similarities andDifferences | PredicateSymmetry Surgical Quad-Lock® Container Systems(Previously Codman) | PredicateSymmetry SurgicalQuad-Lock® ContainerSystems(Previously Codman) | ProposedSymmetry Surgical Quad-Lock® Container Systems | |||||||||
| compromised | differences.*The inclusion of plastic instruments applies only tosteam sterilization. | |||||||||||
| Materials | Aluminum, stainless steel,polycarbonate, silicone, nylon | Same | Same | |||||||||
| Stacking | Caution: Do not stack thecontainers in the sterilizer | The Symmetry SurgicalQuad-Lock® ContainerSystems can be stackedduring sterilization withup to three containers. | Same as K120117 | |||||||||
| Volume to VentRatiomm³/mm² | 1004-5316 | Same | Same | |||||||||
| Energy modality | None | Same | Same | |||||||||
| Maximum Weightof Container | For effective sterilization anddrying of any size SymmetrySurgical Quad-Lock®Container Systems, therecommended maximumcombined weight of the singlecontainer, lid, basket andbasket contents is 25 lb. (11.3kg). | Same | For effective sterilization and drying of any sizeSymmetry Surgical Quad-Lock® Container Systems, therecommended maximum combined weight of the singlecontainer, lid, basket and basket contents is defined foreach container type. The weights are similar to thepredicate.Container weights are specified in the labeling. No newissues are raised due to these differences. | |||||||||
| Sterilization Parameters | ||||||||||||
| SterilizationParameters | Cycle Type - Pre-vacuumTemperature - 132°CExposure Time – 4 minutesDrying Time - 30 minutes | Same | SterilizationModality Cycle Type CycleParameters Steam Prevacuum Temperature:132°CExposure Time: 4minutesDrying Time: 30minutesStackable - Yes,up to threecontainers EthyleneOxide 100% ETO Concentration:725mg/LTemperature:55°CExposure Time:60 minutesHumidity: 50-70%Stackable - No |
{21}------------------------------------------------
| Table 3Substantial Equivalence Comparison | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Similarities andDifferences | PredicateSymmetry Surgical Quad-Lock® Container Systems(Previously Codman) | PredicateProposedSymmetry Surgical Quad-Lock® Container Systems | ||||||||
| Low Temperature H2O2 Sterilizers by ModelName/Cycle TypeSterilization Parameters for each cycle typeare set by the manufacturerStackable - NoSilicone Mat - Not compatible with LowTemperature H2O2 sterilization cyclesSTERRAD 100NX StandardDUOFLEX STERRAD NX StandardAdvanced STERRAD 100S Standard V-PRO™ 1 PLUS LumenNo Lumen New modalities have been validated to demonstrateefficacy. No new issues are raised due to thesedifferences. | ||||||||||
| Storage | The contents of the unopenedcontainers will maintainsterility for 180 days. | When sterilized by prevacuum steam sterilization,the Quad-Lock® Containers maintain the sterilityof the contents for up to 180 days during storageand transport within the healthcare facility, as longas the integrity of the container has not beencompromised When sterilized by ethylene oxide or lowtemperature hydrogen peroxide cycle types theQuad-Lock® Containers maintain the sterility ofthe contents when sterilized by any of the abovefor up to 30 days during storage and transportwithin the healthcare facility, as long as theintegrity of the container has not beencompromised New modalities have been validated to demonstrateefficacy. No new issues are raised due to thesedifferences. | ||||||||
| Reuse | The container may be used upto 100 sterilization cycles | Same | ||||||||
| SterilizationModality | Steam | Steam, Ethylene Oxide, and Low TemperatureHydrogen Peroxide.New modalities have been validated to demonstrateefficacy. No new issues are raised due to these |
{22}------------------------------------------------
| Table 3 | |||
|---|---|---|---|
| Substantial Equivalence Comparison | |||
| Similarities andDifferences | PredicateSymmetry Surgical Quad-Lock® Container Systems(Previously Codman) | PredicateSymmetry SurgicalQuad-Lock® ContainerSystems(Previously Codman) | ProposedSymmetry 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 andsimulated use testing | Validated sterility assurance level of $10^{-6}$ | Pass |
| Shelf life of sterile container | Maintenance of sterility after 30 days ofstorage | Pass |
| Reuse Testing | Microbial Challenge following multiplesterilization cycles verified for up to100sterilization cycles | Pass |
| Biocompatibility, extractables,and leachables | In vitro evaluations for these tests hadacceptable results | Pass |
| Functional strength of handles | Testing performed in accordance with ST77had 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).
§ 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).