(294 days)
The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
The DePuy Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid with gasket, base, filter, tamper evident arrows, and data cards. The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container.
The DePuy Synthes Sterilization Container System (K181933) is intended to enclose medical devices for sterilization and maintain their sterility for up to 180 days. The device uses dynamic air removal (pre-vacuum) steam sterilization. No clinical tests were performed, but extensive non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device, Synthes Reusable Sterilization Container System (K130720).
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Efficacy: Pre-Vacuum Steam | Objective: To validate the efficacy of the DePuy Synthes Sterilization Container System using pre-vacuum sterilization cycle of 270°F (132°C) with 4 minutes of exposure. |
| Result: | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10⁻⁶ using the biological (BI) overkill method and half-cycle validation. |
| Dry Time | Objective: To determine the drying time for the DePuy Synthes Sterilization Container System following a steam pre-vacuum cycle of 270°F (132°C) with 4 minutes of exposure. |
| Result: | Dry time studies establish minimum dry time of 30 minutes for pre-vacuum steam sterilization modality. |
| 180 Day Event Related Shelf Life | Objective: To validate the 180-day event related shelf life evaluation of the DePuy Synthes Sterilization Container System following exposure to a full pre-vacuum sterilization cycle (lethality plus dry time). |
| Result: | 180 Day Event Related Shelf life studies demonstrated sterility maintenance for the recommended pre-vacuum steam sterilization modality. The device maintains sterility for a maximum of 180 days. |
| Microbial Challenge | Objective: To demonstrate the DePuy Synthes Sterilization Container System can maintain package integrity/microbial barrier after being subjected to sterilization processing and a whole package microbial (aerosol) challenge. |
| Result: | Whole package microbial challenge test, exposing a container to a minimum of 1 x 10⁶ Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth. |
| Limits of Reuse | Objective: To verify the limits of reuse of the DePuy Synthes Sterilization Container System when processed in repetitive pre-cleanings, mechanical washer cycles and steam pre-vacuum cycles. |
| Result: | After 100 cycles of processing samples showed no signs of physical or mechanical degradation and continued to function as intended. |
| Biocompatibility | Objective: To evaluate the biocompatibility of the DePuy Synthes Sterilization Container System for cytotoxicity to mammalian cells in culture by a method compliant with the requirements specified in ISO 10993-5:2009. |
| Result: | Results showed no heavy metal leaching or cytotoxicity at detectable levels. The device materials are toxicologically acceptable for their intended use. For specific materials, stainless steel, aluminum, silicone (gasket), SMS polypropylene (filter) were used in the construction and were demonstrated to withstand repeated processing with proven compatibility with the sterilization process and sterilants. Examples of intrinsically stable metals: stainless steel, titanium (CP and alloys), aluminum. Thermoplastic polymers: PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile Butadiene Styrene), POM (Polyoxymethylene). Thermosetting polymers: Phenolic, Silicone. Composites: carbon fiber reinforced epoxy (CFRE). The materials are all compliant with the criteria for the stated materials. |
2. Sample size used for the test set and the data provenance
The document indicates that testing was performed on "samples" of the device, container models, and worst-case configurations of joint reconstruction devices. Specific numerical sample sizes for each test are not explicitly provided. The data provenance is described as non-clinical testing performed by the manufacturer, DePuy Synthes. The studies are retrospective as they summarize verification and validation testing results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This submission is for a sterilization container system, and the evaluation is based on engineering and microbiological performance studies (non-clinical testing). Therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiologist for imaging) is not directly applicable. The "truth" is established by adherence to recognized standards (e.g., ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010, ISO 10993-5:2009, USP General Chapter <231> Heavy Metals) and objective measurements performed by qualified personnel in laboratories following Good Laboratory Practices (GLP), implied by the regulatory context.
4. Adjudication method for the test set
Not applicable, as this is a non-clinical device performance study based on objective measurements against scientific standards, not a diagnostic or interpretative study requiring expert adjudication.
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
Not applicable. This device is a medical device sterilization container, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device sterilization container, not an AI-based algorithm.
7. The type of ground truth used
The ground truth for the non-clinical tests is based on:
- Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10⁻⁶ and 12 log reduction via biological indicators (BIs) (for sterilization efficacy and microbial challenge).
- Physical and Chemical Measurement Standards: Adherence to established standards for dry time, material properties (e.g., heavy metals leaching, cytotoxicity), and physical integrity (e.g., limits of reuse, package integrity).
- Industry and Regulatory Standards: Compliance with ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010, ISO 10993-5:2009, and USP General Chapter <231> Heavy Metals.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 9, 2019
Synthes (USA) Products LLC / DePuy Orthopaedics Inc. Thomas Shea Manager Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K181933
Trade/Device Name: DePuy Synthes Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 8, 2019 Received: April 9, 2019
Dear Thomas Shea:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
INDICATIONS FOR USE
FORM APPROVED: OMB NO. 0910-0120 EXPIRATION DATE: 06/30/2020
510(k) Number (if known)
K181933
Device Name DePuy Synthes Sterilization Container System
Indications for Use (Describe)
The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
Sterilization Parameters and Devices Recommended for Use with System
| Sterilization Parameters for the DePuy Synthes Sterilization ContainerApplicable to both Solid and Perforated Base Containers with Lifting Platforms | |||
|---|---|---|---|
| SterilizationMethod | Cycle Parameters | Total SystemWeight | Devices and MaterialsValidated for Use withDePuy Synthes Containers |
| Dynamic AirRemoval (Pre-Vacuum) Steam | Exposure Temperature:270°F (132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesMinimum Dry Time Cycle:30 MinutesMinimum Cool Time: 60minutes (may vary accordingto load contents)Stacking Containers DuringSterile Processing NotPermitted. | Maximum 25lbs.(Containerpluscontents) | Orthopaedic MedicalDevices including Lumen(Cannulated) Devices.Mated Surface Devices(Devices or DeviceConfigurations withconjoined surfaces whichmeet, touch or unite).Instrument and implantMaterials: Intrinsicallystable metals. Composites,thermoplastics andthermosetting polymerswith constant usetemperatures above 135°C. |
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Examples of intrinsically stable metals include stainless steel, titanium (CP and alloys) and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile Butadiene Styrene) and POM (Polyoxymethylene).
Examples of thermosetting polymers are Phenolic and Silicone.
Examples of composites include carbon fiber reinforced epoxy (CFRE).
| DePuy Synthes Sterilization Container and Accessory Configurations Supported byValidation Data | ||
|---|---|---|
| Modality | Dynamic Air Removal (Pre-Vacuum) Steam | |
| Type of Container | Contents / Configuration | Validation Details |
| Perforated BaseContainer and SolidBase Container | Lifting Platform | Yes |
| Dead end lumen: $Ø$ 1.13mm x 50mm | Yes | |
| Dead end lumen: $Ø$ 2.1mm x 330mm | Yes | |
| Open end lumen: $Ø$ 0.3048mm x 5.5626mm | Yes | |
| Open end lumen: $Ø$ 0.9mm x 278mm | Yes | |
| Open end lumen: $Ø$ 1.1mm x 285mm | Yes | |
| Open end lumen: $Ø$ 3.65mm x 465mm | Yes | |
| Open end lumen: $Ø$ 4.5mm x 438mm | Yes | |
| Mated Surfaces | Yes | |
| Materials: Intrinsically stable metals.Composites, thermoplastics andthermosetting polymers with constant usetemperatures above 135°C. | Yes | |
| Filter | 62.010.002 | |
| Data Card | 62.010.005 | |
| Tamper Evident Arrow | 62.010.004 | |
| Maximum Total Weight(Container plus Contents) | 25 lbs. | |
| Stacking Containers During SterileProcessing | Not permitted | |
| NOTE: This list refers to parameters of validated devices only. Please refer to the DePuySynthes Sterilization Container System User Manual for further details on the validated andcompatible products. |
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Device Models and Accessories:
| Container Descriptions and Dimensions | |||||
|---|---|---|---|---|---|
| PartNumber | Description | Volume toVent Ratio(in³/in²) | Weight(lbs.) | OuterDimensions (L xW x H), in. | Inner Dimensions(L x W x H), in. |
| Perforated Bottom Containers | |||||
| 62.006.001 | Full-One Level,Perforated Base | 26 | 8.5 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.006.002 | Full-Two Level,Perforated Base | 31 | 8.8 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.006.003 | Full-Three Level,Perforated Base | 42 | 9.4 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.009.004 | Extended-Four Level,Perforated Base | 56 | 9.7 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.009.005 | Extended-Five Level,Perforated Base | 63 | 10.3 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Solid Bottom Containers | |||||
| 62.016.001 | Full-One Level, SolidBase | 52 | 7.8 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.016.002 | Full-Two Level, SolidBase | 62 | 7.9 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.016.003 | Full-Three Level,Solid Base | 83 | 8.5 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.019.004 | Extended-Four Level,Solid Base | 112 | 9.1 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.019.005 | Extended-Five Level,Solid Base | 126 | 10.0 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Lifting Platforms | |||||
| 62.006.010 | Lifting Platform forFull Container | N/A | 2.6 | 20.5 x 10.6 x 1.3 | N/A |
| 62.009.010 | Lifting Platform forExtended Container | N/A | 2.9 | 22.5 x 10.6 x 1.3 | N/A |
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| Additional Items in DePuy Synthes Sterilization Container System | |
|---|---|
| Part Number | Description |
| Consumables | |
| 62.010.002 | Filters (1,000 pcs) |
| 62.010.004 | Tamper Evident Arrows (1,000 pcs) |
| 62.010.005 | Data Cards (500 pcs) |
| Replacement Parts | |
| Lids | |
| 62.006.020 | Lid for Full Sterilization Container |
| 62.009.021 | Lid for Extended Sterilization Container |
| Bases | |
| 62.006.031 | Perforated Base for Full-One Level Container |
| 62.006.032 | Perforated Base for Full-Two Level Container |
| 62.006.033 | Perforated Base for Full-Three Level Container |
| 62.009.034 | Perforated Base for Extended-Four Level Container |
| 62.009.035 | Perforated Base for Extended-Five Level Container |
| 62.016.031 | Solid Base for Full-One Level Container |
| 62.016.032 | Solid Base for Full-Two Level Container |
| 62.016.033 | Solid Base for Full-Three Level Container |
| 62.019.034 | Solid Base for Extended-Four Level Container |
| 62.019.035 | Solid Base for Extended-Five Level Container |
| Filter Retention Plates | |
| 62.010.001 | Optional Protective Plate |
| 62.010.003 | Filter Retention Plate, Top |
| 62.010.006 | Filter Retention Plate, Bottom |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over The-Counter Use (21 CFR 801 Subpart C)
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K181933 510(k) Summary
| Sponsor | DePuy SynthesThomas Shea1301 Goshen ParkwayWest Chester, PA USAPhone: 610-719-5679 |
|---|---|
| 510(k) Number | K181933 |
| Date Prepared | May 3, 2019 |
| Proprietary Name | DePuy Synthes Sterilization Container System |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification | Class IIRegulation Number: 21 CFR 880.6850Product Code: KCT |
| Predicate Device | Synthes Reusable Sterilization Container System (K130720) |
| Reason for Submission | To support compatibility of the system with DePuy Synthes JointReconstruction Devices. |
| Device Description | The DePuy Synthes Reusable Sterilization Container System is arigid, reusable, container intended to be used to sterilize othermedical devices and maintain sterility of these devices until used.The container system is comprised of a lid with gasket, base, filter,tamper evident arrows, and data cards.The container system includes a lifting platform to hold Synthesgraphic cases containing orthopedic medical devices (instrumentsand implants) within the container. |
| Indications for use | See below for the complete indications for use. |
Indications for Use
The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
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Sterilization Parameters and Devices Recommended for Use with System
| Sterilization Parameters for the DePuy Synthes Sterilization ContainerApplicable to both Solid and Perforated Base Containers with Lifting Platforms | |||
|---|---|---|---|
| SterilizationMethod | Cycle Parameters | Total SystemWeight | Devices and MaterialsValidated for Use withDePuy Synthes Containers |
| Dynamic AirRemoval (Pre-Vacuum) Steam | Exposure Temperature:270°F (132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesMinimum Dry Time Cycle:30 MinutesMinimum Cool Time: 60minutes (may vary accordingto load contents)Stacking Containers DuringSterile Processing NotPermitted. | Maximum 25lbs.(Containerpluscontents) | Orthopaedic MedicalDevices including Lumen(Cannulated) Devices.Mated Surface Devices(Devices or DeviceConfigurations withconjoined surfaces whichmeet, touch or unite).Instrument and implantMaterials: Intrinsicallystable metals. Composites,thermoplastics andthermosetting polymerswith constant usetemperatures above 135°C. |
Examples of device types with conjoined or mated surfaces include: forceps, clamps, bending pliers, and cable or plate cutters. Lumen devices include cannulated drill bits, guides, screwdrivers and cannulated screws; dead end lumen (Ø1.13mm x 50mm, Ø2.1mm x 330mm); Open end lumen (Ø0.3048mm x 5.5626mm, Ø0.9mm x 278mm, Ø1.1mm x 285mm, Ø3.65mm x 465mm, Ø4.5mm x 438mm).
Examples of intrinsically stable metals include stainless steel, titanium (CP and alloys) and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile Butadiene Styrene) and POM (Polyoxymethylene).
Examples of thermosetting polymers are Phenolic and Silicone.
Examples of composites include carbon fiber reinforced epoxy (CFRE).
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| Modality | Dynamic Air Removal (Pre-Vacuum) Steam | |
|---|---|---|
| Type of Container | Contents / Configuration | Validation Details |
| Perforated BaseContainer and SolidBase Containers | Lifting Platform | Yes |
| Dead end lumen: Ø1.13mm x 50mm | Yes | |
| Dead end lumen: Ø2.1mm x 330mm | Yes | |
| Open end lumen: Ø0.3048mm x 5.5626mm | Yes | |
| Open end lumen: Ø0.9mm x 278mm | Yes | |
| Open end lumen: Ø1.1mm x 285mm | Yes | |
| Open end lumen: Ø3.65mm x 465mm | Yes | |
| Open end lumen: Ø4.5mm x 438mm | Yes | |
| Mated Surfaces | Yes | |
| Materials: Intrinsically stable metals.Composites, thermoplastics andthermosetting polymers with constant usetemperatures above 135°C. | Yes | |
| Filter | 62.010.002 | |
| Data Card | 62.010.005 | |
| Tamper Evident Arrow | 62.010.004 | |
| Maximum Total Weight(Container plus Contents) | 25 lbs. |
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Device Models and Accessories
| Container Descriptions and Dimensions | |||||
|---|---|---|---|---|---|
| PartNumber | Description | Volume toVent Ratio(in³/in²) | Weight(lbs.) | OuterDimensions (L xW x H), in. | Inner Dimensions(L x W x H), in. |
| Perforated Bottom Containers | |||||
| 62.006.001 | Full-One Level,Perforated Base | 26 | 8.5 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.006.002 | Full-Two Level,Perforated Base | 31 | 8.8 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.006.003 | Full-Three Level,Perforated Base | 42 | 9.4 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.009.004 | Extended-Four Level,Perforated Base | 56 | 9.7 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.009.005 | Extended-Five Level,Perforated Base | 63 | 10.3 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Solid Bottom Containers | |||||
| 62.016.001 | Full-One Level, SolidBase | 52 | 7.8 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.016.002 | Full-Two Level, SolidBase | 62 | 7.9 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.016.003 | Full-Three Level,Solid Base | 83 | 8.5 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.019.004 | Extended-Four Level,Solid Base | 112 | 9.1 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.019.005 | Extended-Five Level,Solid Base | 126 | 10.0 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Lifting Platforms | |||||
| 62.006.010 | Lifting Platform forFull Container | N/A | 2.6 | 20.5 x 10.6 x 1.3 | N/A |
| 62.009.010 | Lifting Platform forExtended Container | N/A | 2.9 | 22.5 x 10.6 x 1.3 | N/A |
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| Additional Items in DePuy Synthes Sterilization Container System | |
|---|---|
| Part Number | Description |
| Consumables | |
| 62.010.002 | Filters (1,000 pcs) |
| 62.010.004 | Tamper Evident Arrows (1,000 pcs) |
| 62.010.005 | Data Cards (500 pcs) |
| Replacement Parts | |
| Lids | |
| 62.006.020 | Lid for Full Sterilization Container |
| 62.009.021 | Lid for Extended Sterilization Container |
| Bases | |
| 62.006.031 | Perforated Base for Full-One Level Container |
| 62.006.032 | Perforated Base for Full-Two Level Container |
| 62.006.033 | Perforated Base for Full-Three Level Container |
| 62.009.034 | Perforated Base for Extended-Four Level Container |
| 62.009.035 | Perforated Base for Extended-Five Level Container |
| 62.016.031 | Solid Base for Full-One Level Container |
| 62.016.032 | Solid Base for Full-Two Level Container |
| 62.016.033 | Solid Base for Full-Three Level Container |
| 62.019.034 | Solid Base for Extended-Four Level Container |
| 62.019.035 | Solid Base for Extended-Five Level Container |
| Filter Retention Plates | |
| 62.010.001 | Optional Protective Plate |
| 62.010.003 | Filter Retention Plate, Top |
| 62.010.006 | Filter Retention Plate, Bottom |
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Technological Characteristics Comparison
| Element | K181933 - Subject DeviceDePuy Synthes Sterilization Container System | K130720 - Predicate DeviceSynthes Reusable Sterilization Container System |
|---|---|---|
| Regulation | Regulation Number: 21 CFR 880.6850Regulation Name: Sterilization WrapRegulation Class; IIProduct Code: KCT | Regulation Number: 21 CFR 880.6850Regulation Name: Sterilization WrapRegulation Class; IIProduct Code: KCT |
| Intended Use | The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use. | The Synthes Reusable Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.Reusable lifting platforms are intended to hold enclosed medical devices above the filter areas of a perforated bottom container during sterilization and storage of the container.Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific (pre-vacuum steam) external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only. |
| General DeviceDescription | Identical to predicate. | The Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other |
| Element | K181933 - Subject Device | K130720 - Predicate Device |
| DePuy Synthes Sterilization Container System | Synthes Reusable Sterilization Container System | |
| Synthes medical devices and maintain sterility of these devices until used. The container system is comprised of a lid with gasket, base, filter, tamper evident arrows, and data cards. The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container. | ||
| IntendedSterilization Cycle | Identical to predicate. | Pre-vacuum Steam:Exposure Temperature: 270°F (132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 Minutes |
| Maximum LoadWeight | Identical to predicate. | 25 lbs. (Container plus Contents) |
| MaterialComposition | Identical to predicate. | Stainless Steel, Aluminum, Silicone (Gasket), SMS Polypropylene (Filter). The materials used in the construction of the containers do not degrade and have proven compatibility with the sterilization process and sterilants for which the system is indicated. |
| Physical Properties | Identical to predicate. | Anodized aluminum container with a secure latching system that seals the lid to the base with a gasket running along the perimeter. Aluminum retention plates secure single use SMS Polypropylene filters in place over ventilation holes in the lid and/or base of the container. The materials of construction have been demonstrated to withstand repeated processing according to reuse and sterilization modality parameters described in the IFU. |
| ChemicalProperties | Identical to predicate. | Manufactured from aluminum, stainless steel, closed cell silicone foam, SMS polypropylene. |
| Configurations/Dimensions | Identical to the predicate. Refer to the table on page 4 for the dimensions of all subject container models offered. | Solid or perforated base with perforated lid. Container sizes range from 23.1 x 12.4 x 4.5 to 25.2 x 12.4 x 9.5. |
| K181933 - Subject Device | K130720 - Predicate Device | |
| Element | DePuy Synthes Sterilization Container System | Synthes Reusable Sterilization Container System |
| Air Permeance | Identical to predicate. | The predicate devices have perforated lids and bottoms andemploy an SMS Polypropylene filter to allow ingress ofsterilant. |
| Percent of SurfacePerforations | Identical to predicate. | The volume to vent ratio (V:V, in³/in²) represents the totalcontainer volume divided by the total vent area. The V:V ratiosfor the proposed Synthes containers range from 26 - 126in³/in². |
| SterilantPenetration | Lethality testing using worst case configuration ofJoint Reconstruction devices for half-cycle lethalityvalidation demonstrated all test samples werenegative for growth. Identical to the predicate. | Lethality testing using over-challenge half-cycle lethalityvalidation demonstrated all test samples were negative forgrowth. |
| Microbial BarrierProperties(Package Integrity) | Identical to predicate. | Whole package integrity/microbial barrier aerosol challengedemonstrated all containers tested passed and were 100%negative for growth when subjected to aerosol challengetesting. |
| Biocompatibility | Identical to predicate. | Biocompatibility testing of the materials of construction andcolorants consisted of skin sensitivity, cytotoxicity and heavymetals leaching and determined the containers to betoxicologically acceptable for their intended use. |
| Shelf Life | Identical to predicate. | 180 Day shelf life demonstrated by real time event relatedShelf Life/Package Integrity testing. |
| Drying Time | 30 Minute Minimum Dry Time supported byvalidation study utilizing worst case configuration ofJoint Reconstruction devices and standard pre-vacuum steam cycle. Identical to the predicate. | 30 Minute Minimum Dry Time supported by validation studyutilizing worst case instrument challenge and standard pre-vacuum steam cycle. |
| Aeration Time | N/A – System not indicated for EO Sterilization | N/A - System not indicated for EO Sterilization |
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| Non-Clinical Testing Summary | |||
|---|---|---|---|
| Properties | Standard/Test/FDA Guidance | Objective | Results Summary |
| SterilizationEfficacy: Pre-Vacuum Steam | ANSI/AAMI ST77:2006 ContainmentDevices for Reusable Medical DeviceSterilization. | To validate the efficacy of the DePuySynthes Sterilization Container Systemusing pre-vacuum sterilization cycle of270°F (132°C) with 4 minutes of exposure. | Testing demonstrated a 12 logreduction and a sterility assurancelevel (SAL) of $10^{-6}$ using the biological(BI) overkill method and half-cyclevalidation. |
| Dry Time | ANSI/AAMI ST77:2006 ContainmentDevices for Reusable Medical DeviceSterilization.ANSI/AAMI ST79:2010Comprehensive guide to steamsterilization and sterility assurance inhealth care facilities. | To determine the drying time for theDePuy Synthes Sterilization ContainerSystem following a steam pre-vacuum cycleof 270°F (132°C) with 4 minutes ofexposure. | Dry time studies establish minimumdry time of 30 minutes for pre-vacuumsteam sterilization modality. |
| 180 Day EventRelated ShelfLife | ANSI/AAMI ST77:2006 ContainmentDevices for Reusable Medical DeviceSterilization. | To validate the 180-day event related shelflife evaluation of the DePuy SynthesSterilization Container System followingexposure to a full pre-vacuum sterilizationcycle (lethality plus dry time). | 180 Day Event Related Shelf lifestudies demonstrated sterilitymaintenance for the recommendedpre-vacuum steam sterilizationmodality. |
| MicrobialChallenge | ANSI/AAMI ST77:2006 ContainmentDevices for Reusable Medical DeviceSterilization. | To demonstrate the DePuy SynthesSterilization Container System can maintainpackage integrity/microbial barrier afterbeing subjected to sterilization processingand a whole package microbial (aerosol)challenge. | Whole package microbial challengetest, exposing a container to aminimum of 1 x $10^{-6}$ Bacillusatrophaeus colony forming units (CFU)via an aerosol challengedemonstrating 100% negative growth. |
| Limits of Reuse | Premarket Notification 510(k)Submissions for Medical DeviceSterilization Systems in Health CareFacilities | To verify the limits of reuse of the DePuySynthes Sterilization Container Systemwhen processed in repetitive pre-cleanings,mechanical washer cycles and steam pre-vacuum cycles. | After 100 cycles of processing samplesshowed no signs of physical ormechanical degradation andcontinued to function as intended. |
| Biocompatibility | USP General Chapter <231> HeavyMetals, Method I and Cytotoxicityaccording to ISO 10993-5, 2009 | To evaluate the biocompatibility of theDePuy SynthesSterilization ContainerSystem for cytotoxicity to mammalian cellsin culture by a method compliant with therequirements specified in ISO 10993-5:2009 | Results showed no heavy metalleaching or cytotoxicity at detectablelevels. |
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Summary of Clinical Tests Conducted for Determination of Substantial Equivalence
N/A – No clinical tests were conducted for this submission.
Conclusion
The nonclinical testing performed demonstrates that the DePuy Synther System is as safe, as effective, and performs as well as or better than the legally marketed device the Synthes Reusable Sterilization Container System (K130720).
§ 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).