(294 days)
Not Found
No
The document describes a physical sterilization container and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a sterilization container system, which is used to sterilize and maintain the sterility of other medical devices. It does not directly provide a therapeutic effect on a patient.
No
Explanation: The device is a sterilization container system, not a diagnostic device. Its purpose is to sterilize and maintain sterility of other medical devices, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines a physical, reusable container system with components like a lid, base, filter, and lifting platform, intended for sterilizing other medical devices. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "enclose other medical devices to be sterilized by healthcare facilities." It facilitates the sterilization process and maintains sterility.
- Device Description: The description reinforces this by detailing its components and function in sterilizing and storing other medical devices.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with human specimens in this way.
The device is a sterilization container, which is a type of medical device used in the processing of other medical devices.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization Efficacy: Pre-Vacuum Steam
- Study Type: Performed according to ANSI/AAMI ST77:2006 Containment Devices for Reusable Medical Device Sterilization.
- 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.
- Key Results: 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
- Study Type: Performed according to ANSI/AAMI ST77:2006 Containment Devices for Reusable Medical Device Sterilization. ANSI/AAMI ST79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
- 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.
- Key Results: Dry time studies establish minimum dry time of 30 minutes for pre-vacuum steam sterilization modality.
180 Day Event Related Shelf Life
- Study Type: Performed according to ANSI/AAMI ST77:2006 Containment Devices for Reusable Medical Device Sterilization.
- 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).
- Key Results: 180 Day Event Related Shelf life studies demonstrated sterility maintenance for the recommended pre-vacuum steam sterilization modality.
Microbial Challenge
- Study Type: Performed according to ANSI/AAMI ST77:2006 Containment Devices for Reusable Medical Device Sterilization.
- 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.
- Key Results: Whole package microbial challenge test, exposing a container to a minimum of 1 x 10^-6 Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth.
Limits of Reuse
- Study Type: Performed according to Premarket Notification 510(k) Submissions for Medical Device Sterilization Systems in Health Care Facilities.
- 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.
- Key Results: After 100 cycles of processing samples showed no signs of physical or mechanical degradation and continued to function as intended.
Biocompatibility
- Study Type: Performed according to USP General Chapter Heavy Metals, Method I and Cytotoxicity according to ISO 10993-5, 2009.
- 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.
- Key Results: Results showed no heavy metal leaching or cytotoxicity at detectable levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/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
1
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
2
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
| Applicable to both Solid and Perforated Base Containers with Lifting Platforms | |||
|---|---|---|---|
| Sterilization | |||
| Method | Cycle Parameters | Total System | |
| Weight | Devices and Materials | ||
| Validated for Use with | |||
| DePuy Synthes Containers | |||
| Dynamic Air | |||
| Removal (Pre- | |||
| Vacuum) Steam | Exposure Temperature: | ||
| 270°F (132°C) |
Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Minimum Dry Time Cycle:
30 Minutes
Minimum Cool Time: 60
minutes (may vary according
to load contents)
Stacking Containers During
Sterile Processing Not
Permitted. | Maximum 25
lbs.
(Container
plus
contents) | Orthopaedic Medical
Devices including Lumen
(Cannulated) Devices.
Mated Surface Devices
(Devices or Device
Configurations with
conjoined surfaces which
meet, touch or unite).
Instrument and implant
Materials: Intrinsically
stable metals. Composites,
thermoplastics and
thermosetting polymers
with constant use
temperatures above 135°C. |
3
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
| Validation Data | ||
|---|---|---|
| Modality | Dynamic Air Removal (Pre-Vacuum) Steam | |
| Type of Container | Contents / Configuration | Validation Details |
| Perforated Base | ||
| Container and Solid | ||
| 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. | ||
| Composites, thermoplastics and | ||
| thermosetting polymers with constant use | ||
| temperatures 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 Sterile | ||
| Processing | Not permitted | |
| NOTE: This list refers to parameters of validated devices only. Please refer to the DePuy | ||
| Synthes Sterilization Container System User Manual for further details on the validated and | ||
| compatible products. |
4
Device Models and Accessories:
| Container Descriptions and Dimensions | |||||
|---|---|---|---|---|---|
| Part | |||||
| Number | Description | Volume to | |||
| Vent Ratio | |||||
| (in³/in²) | Weight | ||||
| (lbs.) | Outer | ||||
| Dimensions (L x | |||||
| W 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, Solid | ||||
| 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 | ||||
| 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, | ||||
| 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 for | ||||
| Full Container | N/A | 2.6 | 20.5 x 10.6 x 1.3 | N/A | |
| 62.009.010 | Lifting Platform for | ||||
| Extended Container | N/A | 2.9 | 22.5 x 10.6 x 1.3 | N/A |
5
| 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)
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."
FORM FDA 3881 (7/17)
6
K181933 510(k) Summary
| Sponsor | DePuy Synthes
Thomas Shea
1301 Goshen Parkway
West Chester, PA USA
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
Regulation Number: 21 CFR 880.6850
Product Code: KCT |
| Predicate Device | Synthes Reusable Sterilization Container System (K130720) |
| Reason for Submission | To support compatibility of the system with DePuy Synthes Joint
Reconstruction Devices. |
| Device Description | 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. |
| 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
| Applicable to both Solid and Perforated Base Containers with Lifting Platforms | |||
|---|---|---|---|
| Sterilization | |||
| Method | Cycle Parameters | Total System | |
| Weight | Devices and Materials | ||
| Validated for Use with | |||
| DePuy Synthes Containers | |||
| Dynamic Air | |||
| Removal (Pre- | |||
| Vacuum) Steam | Exposure Temperature: | ||
| 270°F (132°C) | |||
| Pre-Conditioning Pulses: 3 | |||
| Exposure Time: 4 Minutes | |||
| Minimum Dry Time Cycle: | |||
| 30 Minutes | |||
| Minimum Cool Time: 60 | |||
| minutes (may vary according | |||
| to load contents) | |||
| Stacking Containers During | |||
| Sterile Processing Not | |||
| Permitted. | Maximum 25 | ||
| lbs. | |||
| (Container | |||
| plus | |||
| contents) | Orthopaedic Medical | ||
| Devices including Lumen | |||
| (Cannulated) Devices. | |||
| Mated Surface Devices | |||
| (Devices or Device | |||
| Configurations with | |||
| conjoined surfaces which | |||
| meet, touch or unite). | |||
| Instrument and implant | |||
| Materials: Intrinsically | |||
| stable metals. Composites, | |||
| thermoplastics and | |||
| thermosetting polymers | |||
| with constant use | |||
| 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 | ||
| Container and Solid | ||
| 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. | ||
| Composites, thermoplastics and | ||
| thermosetting polymers with constant use | ||
| temperatures 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. |
9
Device Models and Accessories
| Container Descriptions and Dimensions | |||||
|---|---|---|---|---|---|
| Part | |||||
| Number | Description | Volume to | |||
| Vent Ratio | |||||
| (in³/in²) | Weight | ||||
| (lbs.) | Outer | ||||
| Dimensions (L x | |||||
| W 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, Solid | ||||
| 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 | ||||
| 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, | ||||
| 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 for | ||||
| Full Container | N/A | 2.6 | 20.5 x 10.6 x 1.3 | N/A | |
| 62.009.010 | Lifting Platform for | ||||
| 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
DePuy Synthes Sterilization Container System | K130720 - Predicate Device
Synthes Reusable Sterilization Container System |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulation Class; II
Product Code: KCT | Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulation Class; II
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.
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 Device
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
Sterilization Cycle | Identical to predicate. | Pre-vacuum Steam:
Exposure Temperature: 270°F (132°C)
Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes |
| Maximum Load
Weight | Identical to predicate. | 25 lbs. (Container plus Contents) |
| Material
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
Properties | 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 and
employ an SMS Polypropylene filter to allow ingress of
sterilant. |
| Percent of Surface
Perforations | Identical to predicate. | The volume to vent ratio (V:V, in³/in²) represents the total
container volume divided by the total vent area. The V:V ratios
for the proposed Synthes containers range from 26 - 126
in³/in². |
| Sterilant
Penetration | Lethality testing using worst case configuration of
Joint Reconstruction devices for half-cycle lethality
validation demonstrated all test samples were
negative for growth. Identical to the predicate. | Lethality testing using over-challenge half-cycle lethality
validation demonstrated all test samples were negative for
growth. |
| Microbial Barrier
Properties
(Package Integrity) | Identical to predicate. | Whole package integrity/microbial barrier aerosol challenge
demonstrated all containers tested passed and were 100%
negative for growth when subjected to aerosol challenge
testing. |
| Biocompatibility | Identical to predicate. | Biocompatibility testing of the materials of construction and
colorants consisted of skin sensitivity, cytotoxicity and heavy
metals leaching and determined the containers to be
toxicologically acceptable for their intended use. |
| Shelf Life | Identical to predicate. | 180 Day shelf life demonstrated by real time event related
Shelf Life/Package Integrity testing. |
| Drying Time | 30 Minute Minimum Dry Time supported by
validation study utilizing worst case configuration of
Joint Reconstruction devices and standard pre-
vacuum steam cycle. Identical to the predicate. | 30 Minute Minimum Dry Time supported by validation study
utilizing 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 |
12
13
14
| Non-Clinical Testing Summary | |||
|---|---|---|---|
| Properties | Standard/Test/FDA Guidance | Objective | Results Summary |
| Sterilization | |||
| Efficacy: Pre- | |||
| Vacuum Steam | ANSI/AAMI ST77:2006 Containment | ||
| Devices for Reusable Medical Device | |||
| Sterilization. | 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. | 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 | ANSI/AAMI ST77:2006 Containment | ||
| Devices for Reusable Medical Device | |||
| Sterilization. | |||
| ANSI/AAMI ST79:2010 | |||
| Comprehensive guide to steam | |||
| sterilization and sterility assurance in | |||
| health care facilities. | 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. | Dry time studies establish minimum | ||
| dry time of 30 minutes for pre-vacuum | |||
| steam sterilization modality. | |||
| 180 Day Event | |||
| Related Shelf | |||
| Life | ANSI/AAMI ST77:2006 Containment | ||
| Devices for Reusable Medical Device | |||
| Sterilization. | 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). | 180 Day Event Related Shelf life | ||
| studies demonstrated sterility | |||
| maintenance for the recommended | |||
| pre-vacuum steam sterilization | |||
| modality. | |||
| Microbial | |||
| Challenge | ANSI/AAMI ST77:2006 Containment | ||
| Devices for Reusable Medical Device | |||
| Sterilization. | 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. | Whole package microbial challenge | ||
| test, exposing a container to a | |||
| minimum of 1 x $10^{-6}$ Bacillus | |||
| atrophaeus colony forming units (CFU) | |||
| via an aerosol challenge | |||
| demonstrating 100% negative growth. | |||
| Limits of Reuse | Premarket Notification 510(k) | ||
| Submissions for Medical Device | |||
| Sterilization Systems in Health Care | |||
| Facilities | 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. | After 100 cycles of processing samples | ||
| showed no signs of physical or | |||
| mechanical degradation and | |||
| continued to function as intended. | |||
| Biocompatibility | USP General Chapter Heavy | ||
| Metals, Method I and Cytotoxicity | |||
| according to ISO 10993-5, 2009 | 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 | Results showed no heavy metal | ||
| leaching or cytotoxicity at detectable | |||
| levels. |
15
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).