SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM

K130720 · Synthes (USA) Products, LLC · KCT · Aug 14, 2014 · General Hospital

Device Facts

• Record ID: K130720
• Device Name: SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
• Applicant: Synthes (USA) Products, LLC
• Product Code: KCT · General Hospital
• Decision Date: Aug 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

Rigid, reusable container system for sterilization and storage of orthopedic medical devices; includes lid with gasket, base, filter, tamper-evident arrows, data cards, and lifting platform. Used in clinical settings by healthcare providers. Input: medical devices (instruments/implants) 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. Tamper-evident arrows provide visual confirmation of cycle exposure and container integrity. Benefits: maintains sterility for up to 180 days; protects instruments during transport and storage.

Clinical Evidence

No clinical data. Bench testing only. Validated via biological overkill method (12-log reduction, SAL 10^-6), dry time studies (30 min), 180-day event-related shelf life, and whole-package microbial aerosol challenge (100% negative growth).

Technological Characteristics

Anodized aluminum container; closed-cell silicone foam gasket; SMS polypropylene filter; 304 stainless steel electropolished lifting platform. Dimensions: 23.1"-25.2" L x 12.4" W x 4.5"-9.5" H. Sterilization: dynamic air removal (pre-vacuum) steam. No software or electronic components.

Indications for Use

Indicated for healthcare providers to enclose and sterilize medical devices, including orthopedic surgical instruments and implants, via dynamic air removal (pre-vacuum) steam sterilization. Suitable for devices with mated surfaces and lumens (cannulated drill bits, guides, screwdrivers, screws).

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

• Genesis Reusable Rigid Sterilization Container System (K112535)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, representing the department's focus on people and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 14, 2014

Synthes USA Mr. Thomas Shea Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, PA 19380

Re: K130720

Trade/Device Name: Synthes Reusable Sterilization Container Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Container Regulatory Class: II Product Code: KCT Dated: July 16, 2014 Received: July 17, 2014

Dear Mr. 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. 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.

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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular symbol with intersecting lines, followed by the company name in bold, dark blue letters. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.

#### 4.0 Indications for Use Statement

## 510(k): K130720

Device Name: Synthes Reusable Sterilization Container System

Indications 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.

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Image /page/3/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interconnected circles in a gold color. To the right of the symbol is the company name, "DePuy Synthes," written in a bold, dark blue font. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.

| Sterilization Method | Cycle Parameters | Total System Weight | Containers, Accessories & Validated Contents |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dynamic Air Removal<br>(Pre-Vacuum) Steam | Exposure Temperature: 270°F<br>(132°C)<br><br>Pre-Conditioning Pulses: 3<br><br>Exposure Time: 4 Minutes<br><br>Dry Time Cycle: 30 Minutes<br><br>Minimum Cool Time: 60 minutes (may vary according to load contents)<br><br>Stacking Not Permitted | 25 lbs. | Solid Bottom Containers;<br>Perforated Bottom<br>Containers; Lifting Platforms.<br><br>Lumen (Cannulated) Devices.<br>Devices or Device<br>Configurations with<br>conjoined surfaces which<br>meet, touch or unite. Mated<br>surfaces.<br><br>Materials: Intrinsically stable<br>metals. Composites,<br>thermoplastics and<br>thermosetting polymers with<br>constant use temperatures<br>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.

Examples of intrinsically stable metals include stainless steel, titanium (CP and alloys) and aluminum. Examples of thermoplastic polymers are PEEK, PEKK, 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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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interconnected circles in a light brown color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.

| Synthes Reusable Sterilization Container and Accessory Configurations Supported by<br>Validation Data | | |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Modality<br>Type of Container | Dynamic Air Removal (Pre-Vacuum) Steam<br>Contents / Configuration | Validation Details |
| Perforated Bottom<br>Container and Solid<br>Bottom Container | Lifting Platform | Yes |
| | Dead end lumen: Ø2.1mm x 330mm | Yes |
| | Open end lumens: Ø0.9mm x 278mm | Yes |
| | Open end lumens: Ø1.1mm x 285mm | Yes |
| | Open end lumens: Ø1.35mm x 278mm | Yes |
| | Open end lumens: Ø3.65mm x 465mm | Yes |
| | Open end lumens: 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 | NST Series |
| | Data Card | MD1-1 |
| | Tamper Evident Arrow | AS2-3 |
| | Maximum Total Weight<br>(Container plus Contents) | 25 lbs. |
| | Stacking | Not permitted |

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Image /page/5/Picture/0 description: The image shows the logo for DePuy Synthes, a company that is part of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interlocking circles in a gold color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.

| Synthes Part<br>Number | Synthes Part<br>Description | Volume to Vent<br>Ratio (in³/in²) | Weight<br>(lbs.) | Outer Dimensions<br>(L x 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, Solid<br>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 | Not Applicable | 2.6 | 20.5 x 10.6 x 1.3 | Not Applicable |
| 62.009.010 | Lifting Platform for<br>Extended Container | Not Applicable | 2.9 | 22.5 x 10.6 x 1.3 | Not Applicable |

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Image /page/6/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol resembling interlocking circles in a gold color, followed by the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, the text "COMPANIES of Johnson & Johnson" is written, with "Johnson & Johnson" in a red script font.

| Additional Items in System | |
|----------------------------|---------------------------------------------------|
| Part Number | Description |
| Consumables | |
| DST-3 | Filters (1,000/Box) |
| AS2-3 | Tamper Evident Arrows (1,000/Box) |
| MD1-1 | Data Cards (500/Box) |
| 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 |
| Additional Parts | |
| 62.010.100 | Identification Tag |

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Image /page/7/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The DePuy Synthes logo is in blue and is oriented vertically. Below the logo is a circular design in gold. The Johnson & Johnson logo is in red and is oriented horizontally.

| Container | Lid | Compatible<br>Graphic Case<br>Footprint | Graphic Case<br>Dimensions<br>(L x W x H), in. | Contents | Required<br>Accessories | Max.<br>Weight<br>(loaded) |
|-------------------------------------------------|-----------|-----------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------|
| ull-One Level,<br>erforated or Solid Base | Full Size | Half length,<br>1 high | 10.5 x 9.8 x 2.0 | Materials: Intrinsically stable metals. Composites,<br>thermoplastics and thermosetting polymers with constant use<br>temperatures above 135°C.<br>Devices: Graphic Cases, Orthopedic Surgical Instruments,<br>Implants | 2 Filters (Solid Base)<br>4 Filters (Perf. Base)<br>Lifting Platform<br>Tamper Evident<br>Arrow | 25 lb.<br>(11.3 kg) |
| ull-Two Level,<br>erforated or Solid Base | Full Size | 2/3 length,<br>1 high<br><br>Full length,<br>1 high | 13.9 x 9.8 x 2.0<br><br>20.7 x 9.8 x 2.0 | Device Design Features: Mated Surfaces; Dead end lumen<br>(Ø2.1mm x 330mm); Open end lumens ( $(Ø0.9mm x 278mm)$<br>(Ø1.1mm x 285mm), (Ø1.35mm x 278mm), (Ø3.65mm x<br>465mm), (Ø4.5mm x 438mm) | 2 Filters (Solid Base)<br>4 Filters (Perf. Base)<br>Lifting Platform<br>Tamper Evident<br>Arrow | 25 lb.<br>(11.3 kg) |
| ull-Two Level,<br>erforated or Solid Base | Full Size | Half length,<br>2 high<br><br>2/3 length,<br>2 high<br><br>Full length,<br>2 high | 10.5 x 9.8 x 3.4<br><br>13.9 x 9.8 x 3.4<br><br>20.7 x 9.8 x 3.4 | Materials: Intrinsically stable metals. Composites,<br>thermoplastics and thermosetting polymers with constant use<br>temperatures above 135°C.<br>Devices: Graphic Cases, Orthopedic Surgical Instruments,<br>Implants | 2 Filters (Solid Base)<br>4 Filters (Perf. Base)<br>Lifting Platform<br>Tamper Evident<br>Arrow | 25 lb.<br>(11.3 kg) |
| ull-Three Level,<br>erforated or Solid Base | Full Size | Half length,<br>3 high<br><br>2/3 length,<br>3 high<br><br>Full length,<br>3 high | 10.5 x 9.8 x 4.9<br><br>13.9 x 9.8 x 4.9<br><br>20.7 x 9.8 x 4.9 | Device Design Features: Mated Surfaces; Dead end lumen<br>(Ø2.1mm x 330mm); Open end lumens ((Ø0.9mm x 278mm)<br>(Ø1.1mm x 285mm), (Ø1.35mm x 278mm), (Ø3.65mm x<br>465mm), (Ø4.5mm x 438mm) | 2 Filters (Solid Base)<br>4 Filters (Perf. Base)<br>Lifting Platform<br>Tamper Evident<br>Arrow | 25 lb.<br>(11.3 kg) |
| Extended-Four Level,<br>erforated or Solid Base | Extended | Half length,<br>4 high | 10.5 x 9.8 x 6.3 | Materials: Intrinsically stable metals. Composites,<br>thermoplastics and thermosetting polymers with constant use | 2 Filters (Solid Base)<br>4 Filters (Perf. Base) | 25 lb.<br>(11.3 kg) |
| | | | | es Reusable Sterilization Container Compatibility, Contents, Accessories and Maximum Allowable Wei | | |
| Container | Lid | Compatible Footprint | Graphic Case Dimensions (L x W x H), in | Contents | Accessories<br>Required | มอลิก |
| | | 2/3 length | 3.9 x 9.8 x 6.3 | eratures above 135°C. es: Graphic Cases, Orthopedic Surgical Instr<br>mplants | amper Evider<br>Arrow | |
| | | Full length 4 high | 20.7 x 9.8 x 6.3 | ce Design Features: Mated Surfaces; Dead end lumen Imm x 330mm); Open end lumens (Ø0.9mm x 278mm Imm x 285mm), (Ø1.35mm x 278mm), (Ø3.65mm x mm), (Ø4.5mm x 438mm) | | |
| | | Half length 5 high | 10.5 x 9.8 x 7.8 | terials: Intrinsically stable metals. Composites, rmoplastics and thermosetting polymers with constant speratures above 135°C. wices: Graphic Cases, Orthopedic Surgical Instr | | |
| tended-Five Level, rforated or Solid Bas | Extended | 2/3 length | 3 .9 x 9.8 x 7.8 | mplants | lters (Solid Base) | 25 lb. (11.3 kg) |
| | | Full length 5 high | 20.7 x 9.8 x 7.8 | ce Design Features: Mated Surfaces; Dead end lumen Imm x 330mm); Open end lumens (Ø0.9mm x 278mm Imm x 285mm); (Ø1.35mm x 278mm), (Ø3.65mm x mm), (Ø4.5mm x 438mm) | | |
| | | | | | | |

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Image /page/8/Picture/9 description: The image shows the logo for DePuy Synthes, a company that is part of Johnson & Johnson. The logo consists of the company name, "DePuy Synthes," written vertically in a dark blue sans-serif font. Below the name is a golden-colored abstract symbol. To the right of the name, the text "COMPANIES OF Johnson & Johnson" is written in a smaller, red font.

Prescription Use

(Per 21 CFR 801.109

lver-The-Counter Use AND/OR

X

21 CFR 807 Subpart

LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEL

ncurrence of CDRH, Office of Device Evaluation (OD)

720 – Synthes Reusable Sterilization Container Sys

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Image /page/9/Picture/0 description: The image is the logo for DePuy Synthes, a Johnson & Johnson company. The logo features a geometric symbol resembling interconnected circles in a tan color on the left. To the right of the symbol is the company name "DePuy Synthes" in a dark blue, sans-serif font. Below the company name, in smaller fonts, it says "COMPANIES of Johnson & Johnson" with "Johnson & Johnson" in a red script font.

#### 5.0 510(k) Summary – K130720

The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

| Sponsor Information | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Synthes |
| Address | 1302 Wrights Lane East, West Chester, PA 19380 |
| Phone | 610-719-5679 |
| FAX | 484-356-9682 |
| Establishment Registration | 3008812563 |
| Contact Person | Thomas N. Shea |
| Date Prepared | August 1, 2014 |
| Device Information | |
| Proprietary Name | Synthes Reusable Sterilization Container System |
| Common Name | Sterilization Container |
| Device | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulation Description | Sterilization Wrap |
| Classification/Review Panel | 80 General Hospital |
| Product Code | KCT |
| Submission Type | Traditional 510(k) |
| Regulation | 880.6850 |
| Device Class | Class II |
| Predicate Device | Genesis Reusable Rigid Sterilization Container System (K112535) |
| Reason for Submission | Introduction of a Synthes sterilization container for use with Synthes orthopedic medical devices. |
| Device Description | The Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other 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.<br>The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container. |

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Image /page/10/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol resembling interconnected circles in a gold color, followed by the company name "DePuy Synthes" in a dark blue sans-serif font. Below the company name, in smaller letters, it says "COMPANIES OF" followed by the Johnson & Johnson logo in red.

# 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 |

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Image /page/11/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interconnected circles in a gold color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in a smaller font, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.

| Additional Items in System | |
|----------------------------|---------------------------------------------------|
| Part Number | Description |
| Consumables | |
| DST-3 | Filters (1,000/Box) |
| AS2-3 | Tamper Evident Arrows (1,000/Box) |
| MD1-1 | Data Cards (500/Box) |
| 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 |
| Additional Parts | |
| 62.010.100 | Identification Tag |

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Image /page/12/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, followed by the company name in blue. Below the company name, the text "COMPANIES OF Johnson&Johnson" is written in a smaller font size, with "Johnson&Johnson" in red script.

# Comparison with Predicate Device:

| Element | K130720 - Subject Device | K112535 - Predicate |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Synthes Reusable Sterilization Container System | Genesis Reusable Rigid Sterilization Container System |
| Intended Use | The Synthes Reusable Sterilization Container System is a<br>device intended to be used to enclose other medical devices<br>to be sterilized by a healthcare provider. It allows<br>sterilization of the enclosed medical devices and maintains<br>sterility of the devices until used for a maximum of 180<br>days.<br><br>Synthes containers are suitable for dynamic air removal<br>(pre-vacuum) steam sterilization when used according to<br>the instructions for use.<br><br>Reusable lifting platforms are intended to hold enclosed<br>medical devices above the filter areas of a perforated<br>bottom container during sterilization and storage of the<br>container.<br><br>Data cards are used to record information regarding a<br>specific sterilization process load. Filter media allows<br>ingress and egress of sterilant while providing a microbial<br>barrier. Tamper evident arrows provide a visual indication<br>that the container system has not been inadvertently opened<br>prior to use. Each arrow contains a modality-specific (pre-<br>vacuum steam) external process indicator that serves as a<br>visual indication that the system has been exposed to a<br>specific sterilization cycle parameter. Data cards, filters and<br>tamper evident arrows are single use only. | The Genesis Reusable Rigid Sterilization Container System<br>is a device intended to be used to enclose another medical<br>device that is to be sterilized by a healthcare provider. It<br>allows sterilization of the enclosed medical device and<br>maintains sterility of the enclosed device until used for a<br>maximum of 180 days.<br><br>Containers are suitable for dynamic air removal (pre-<br>vacuum) steam sterilization, immediate use pre-vacuum<br>steam sterilization and 100% ethylene oxide sterilization<br>when used as described in the instructions for use.<br><br>Reusable baskets and accessory items (pins, dividers, mats,<br>etc.) are intended to organize and secure enclosed medical<br>devices during sterilization and storage of the container.<br><br>Data cards are used to record information regarding a<br>specific sterilization process load. Filter media allows<br>ingress and egress of sterilant while providing a microbial<br>barrier. Tamper evident arrows provide a visual indication<br>that the container system has not been inadvertently opened<br>prior to use. Each arrow contains a modality-specific<br>external process indicator that serves as a visual indication<br>that the system has been exposed to a specific sterilization<br>cycle parameter. Data cards, filters and tamper evident<br>arrows are single use only. |
| Material<br>Composition | Stainless Steel, Aluminum, Silicone (Gasket), SMS<br>Polypropylene (Filter). All components in the subject<br>system are identical in material composition to the<br>predicate. The subject system does not contain polymeric<br>components to hold devices within the container. | Stainless Steel, Aluminum, Silicone (Gasket), Silicone<br>Elastomer (Bars, Mats, Instrument Holders), SMS<br>Polypropylene (Filter), Radel/Polyphenysulfone/Aluminum/<br>Silicone Elastomer/Stainless (Laproscopic Instrument<br>Racks) |
| Element | K130720 - Subject Device<br>Synthes Reusable Sterilization Container System | K112535 - Predicate<br>Genesis Reusable Rigid Sterilization Container System |
| Physical Properties | Physical properties of the subject container system are identical to the predicated. The sole difference is the color of the lid and branding. The colorization is done according to the same process as the predicate device. | The predicate consists of an 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 | The material formulation, manufacturing process, chemical composition and steam sterilization modality for the proposed device is identical to the predicate device. The subject system does not include the polymeric components used to organize devices within the predicate container. | The predicate system is manufactured from aluminum, stainless steel, closed cell silicone foam, SMS polypropylene, and silicone polymeric components. |
| Configurations/<br>Dimensions | 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, please see the table on the previous page for the dimensions of all subject container models offered. | Solid or perforated base with perforated lid. Container sizes cleared under K112535 range from 10.2 x 7.2 x 3.2 (smallest) to 28.1 x 11.2 x 6.4 (max length) 26.5 x 17.0 x 6.9 (max width) 19.2 x 12.5 x 9.4 (max depth). |
| Air Permeance | The subject container also has perforated lids and bottoms that feature the same size and amount of vent holes and makes use of the same filter as the predicate device (SMS Polypropylene) and will have the same permeability to allow ingress of sterilant. | The predicate container has perforated lids and bottoms and employs an SMS Polypropylene filter to allow ingress of sterilant. |
| Percent of Surface<br>Perforations | 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. All of the proposed containers fall within the range of volume to vent ratios for the predicate device. | 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 predicate containers (K120535) range from 24 – 182 in3/in2. |
| Performance<br>Sterilant<br>Penetration | Lethality testing via over-challenge half-cycle lethality validation demonstrated all test samples were negative for growth following the seven (7) day incubation period…