DePuy Synthes Sterilization Container System
Device Facts
| Record ID | K181933 |
|---|---|
| Device Name | DePuy Synthes Sterilization Container System |
| Applicant | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. |
| Product Code | KCT · General Hospital |
| Decision Date | May 9, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
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.
Device Story
Rigid, reusable sterilization container system; encloses medical devices (orthopaedic instruments/implants) for steam sterilization. Components: lid with gasket, base, filter, tamper-evident arrows, data cards, lifting platform. Used in healthcare facilities; operated by sterile processing staff. Input: medical devices placed inside container. Process: dynamic air removal (pre-vacuum) steam sterilization (270°F/132°C, 4-minute exposure, 30-minute dry time). Output: sterilized, protected medical devices. Benefits: maintains sterility of instruments for up to 180 days post-processing; provides microbial barrier; facilitates safe transport and storage of surgical instruments.
Clinical Evidence
No clinical data. Bench testing only: sterilization efficacy (BI overkill method, 12-log reduction, SAL 10^-6), dry time validation (30 min), 180-day shelf life/package integrity, microbial aerosol challenge (100% negative growth), reuse limit testing (100 cycles), and biocompatibility (cytotoxicity, heavy metals).
Technological Characteristics
Rigid container system; materials: anodized aluminum, stainless steel, silicone gasket, SMS polypropylene filter. Sensing: modality-specific external process indicator on tamper-evident arrows. Connectivity: none. Sterilization: dynamic air removal (pre-vacuum) steam. Dimensions: various sizes (23.1"x12.4"x4.5" to 25.2"x12.4"x9.5"). Standards: ANSI/AAMI ST77, ANSI/AAMI ST79, ISO 10993-5.
Indications for Use
Indicated for healthcare facilities to enclose and sterilize orthopaedic medical devices, including lumen (cannulated) devices and mated surface devices, using dynamic air removal (pre-vacuum) steam sterilization. Maintains sterility for up to 180 days.
Regulatory Classification
Identification
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Predicate Devices
- Synthes Reusable Sterilization Container System (K130720)
Related Devices
- K130720 — SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM · Synthes (USA) Products, LLC · Aug 14, 2014
- K140850 — GENESIS REUSABLE RIGID CONTAINER SYSTEM · Carefusion 2200, Inc. · Aug 27, 2014
- K091720 — SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM · Sklar Corp. · Apr 9, 2010
- K112671 — STERILCONTAINER SYSTEM · Aesculap, Ltd. · May 4, 2012
- K173259 — Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories · Case Medical, Inc. · Jun 13, 2018
Submission Summary (Full Text)
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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 Container<br>Applicable to both Solid and Perforated Base Containers with Lifting Platforms | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization<br>Method | Cycle Parameters | Total System<br>Weight | Devices and Materials<br>Validated for Use with<br>DePuy Synthes Containers |
| Dynamic Air<br>Removal (Pre-<br>Vacuum) Steam | Exposure Temperature:<br>270°F (132°C)<br><br>Pre-Conditioning Pulses: 3<br><br>Exposure Time: 4 Minutes<br><br>Minimum Dry Time Cycle:<br>30 Minutes<br><br>Minimum Cool Time: 60<br>minutes (may vary according<br>to load contents)<br><br>Stacking Containers During<br>Sterile Processing Not<br>Permitted. | Maximum 25<br>lbs.<br><br>(Container<br>plus<br>contents) | Orthopaedic Medical<br>Devices including Lumen<br>(Cannulated) Devices.<br><br>Mated Surface Devices<br>(Devices or Device<br>Configurations with<br>conjoined surfaces which<br>meet, touch or unite).<br><br>Instrument and implant<br>Materials: Intrinsically<br>stable metals. Composites,<br>thermoplastics and<br>thermosetting polymers<br>with constant use<br>temperatures 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 by<br>Validation Data | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Modality | Dynamic Air Removal (Pre-Vacuum) Steam | |
| Type of Container | Contents / Configuration | Validation Details |
| Perforated Base<br>Container and Solid<br>Base 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.<br>Composites, thermoplastics and<br>thermosetting polymers with constant use<br>temperatures above 135°C. | Yes |
| | Filter | 62.010.002 |
| | Data Card | 62.010.005 |
| | Tamper Evident Arrow | 62.010.004 |
| | Maximum Total Weight<br>(Container plus Contents) | 25 lbs. |
| | Stacking Containers During Sterile<br>Processing | Not permitted |
| NOTE: This list refers to parameters of validated devices only. Please refer to the DePuy<br>Synthes Sterilization Container System User Manual for further details on the validated and<br>compatible products. | | |
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# Device Models and Accessories:
| Container Descriptions and Dimensions | | | | | |
|---------------------------------------|--------------------------------------------|--------------------------------------|------------------|-----------------------------------------|--------------------------------------|
| Part<br>Number | Description | Volume to<br>Vent Ratio<br>(in³/in²) | Weight<br>(lbs.) | Outer<br>Dimensions (L x<br>W x H), in. | Inner Dimensions<br>(L x W x H), in. |
| | Perforated Bottom Containers | | | | |
| 62.006.001 | Full-One Level,<br>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,<br>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,<br>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,<br>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,<br>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, Solid<br>Base | 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, Solid<br>Base | 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,<br>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,<br>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,<br>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 for<br>Full Container | N/A | 2.6 | 20.5 x 10.6 x 1.3 | N/A |
| 62.009.010 | Lifting Platform for<br>Extended 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 Synthes<br>Thomas Shea<br>1301 Goshen Parkway<br>West Chester, PA USA<br>Phone: 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 II<br>Regulation Number: 21 CFR 880.6850<br>Product Code: KCT |
| Predicate Device | Synthes Reusable Sterilization Container System (K130720) |
| Reason for Submission | To support compatibility of the system with DePuy Synthes Joint<br>Reconstruction Devices. |
| Device Description | The DePuy Synthes Reusable Sterilization Container System is a<br>rigid, reusable, container intended to be used to sterilize other<br>medical devices and maintain sterility of these devices until used.<br>The container system is comprised of a lid with gasket, base, filter,<br>tamper evident arrows, and data cards.<br>The container system includes a lifting platform to hold Synthes<br>graphic cases containing orthopedic medical devices (instruments<br>and 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.
{7}------------------------------------------------
### Sterilization Parameters and Devices Recommended for Use with System
| Sterilization Parameters for the DePuy Synthes Sterilization Container<br>Applicable to both Solid and Perforated Base Containers with Lifting Platforms | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization<br>Method | Cycle Parameters | Total System<br>Weight | Devices and Materials<br>Validated for Use with<br>DePuy Synthes Containers |
| Dynamic Air<br>Removal (Pre-<br>Vacuum) Steam | Exposure Temperature:<br>270°F (132°C)<br>Pre-Conditioning Pulses: 3<br>Exposure Time: 4 Minutes<br>Minimum Dry Time Cycle:<br>30 Minutes<br>Minimum Cool Time: 60<br>minutes (may vary according<br>to load contents)<br>Stacking Containers During<br>Sterile Processing Not<br>Permitted. | Maximum 25<br>lbs.<br>(Container<br>plus<br>contents) | Orthopaedic Medical<br>Devices including Lumen<br>(Cannulated) Devices.<br>Mated Surface Devices<br>(Devices or Device<br>Configurations with<br>conjoined surfaces which<br>meet, touch or unite).<br>Instrument and implant<br>Materials: Intrinsically<br>stable metals. Composites,<br>thermoplastics and<br>thermosetting polymers<br>with constant use<br>temperatures 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).
{8}------------------------------------------------
| Modality | Dynamic Air Removal (Pre-Vacuum) Steam | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Type of Container | Contents / Configuration | Validation Details |
| Perforated Base<br>Container and Solid<br>Base 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.<br>Composites, thermoplastics and<br>thermosetting polymers with constant use<br>temperatures above 135°C. | Yes |
| | Filter | 62.010.002 |
| | Data Card | 62.010.005 |
| | Tamper Evident Arrow | 62.010.004 |
| | Maximum Total Weight<br>(Container plus Contents) | 25 lbs. |
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# Device Models and Accessories
| Container Descriptions and Dimensions | | | | | |
|---------------------------------------|--------------------------------------------|--------------------------------------|------------------|-----------------------------------------|--------------------------------------|
| Part<br>Number | Description | Volume to<br>Vent Ratio<br>(in³/in²) | Weight<br>(lbs.) | Outer<br>Dimensions (L x<br>W x H), in. | Inner Dimensions<br>(L x W x H), in. |
| Perforated Bottom Containers | | | | | |
| 62.006.001 | Full-One Level,<br>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,<br>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,<br>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,<br>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,<br>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, Solid<br>Base | 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, Solid<br>Base | 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,<br>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,<br>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,<br>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 for<br>Full Container | N/A | 2.6 | 20.5 x 10.6 x 1.3 | N/A |
| 62.009.010 | Lifting Platform for<br>Extended Container | N/A | 2.9 | 22.5 x 10.6 x 1.3 | N/A |
{10}------------------------------------------------
| 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 |
{11}------------------------------------------------
## Technological Characteristics Comparison
| Element | K181933 - Subject Device<br>DePuy Synthes Sterilization Container System | K130720 - Predicate Device<br>Synthes Reusable Sterilization Container System |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | Regulation Number: 21 CFR 880.6850<br>Regulation Name: Sterilization Wrap<br>Regulation Class; II<br>Product Code: KCT | Regulation Number: 21 CFR 880.6850<br>Regulation Name: Sterilization Wrap<br>Regulation Class; II<br>Product 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.<br>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.<br>Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.<br>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.<br>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 Device<br>Description | 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. |
| Intended<br>Sterilization Cycle | Identical to predicate. | Pre-vacuum Steam:<br>Exposure Temperature: 270°F (132°C)<br>Pre-Conditioning Pulses: 3<br>Exposure Time: 4 Minutes |
| Maximum Load<br>Weight | Identical to predicate. | 25 lbs. (Container plus Contents) |
| Material<br>Composition | 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. |
| Chemical<br>Properties | Identical to predicate. | Manufactured from aluminum, stainless steel, closed cell silicone foam, SMS polypropylene. |
| Configurations/<br>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 and<br>employ an SMS Polypropylene filter to allow ingress of<br>sterilant. |
| Percent of Surface<br>Perforations | Identical to predicate. | The volume to vent ratio (V:V, in³/in²) represents the total<br>container volume divided by the total vent area. The V:V ratios<br>for the proposed Synthes containers range from 26 - 126<br>in³/in². |
| Sterilant<br>Penetration | Lethality testing using worst case configuration of<br>Joint Reconstruction devices for half-cycle lethality<br>validation demonstrated all test samples were<br>negative for growth. Identical to the predicate. | Lethality testing using over-challenge half-cycle lethality<br>validation demonstrated all test samples were negative for<br>growth. |
| Microbial Barrier<br>Properties<br>(Package Integrity) |…
