Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization efficacy of a reusable container system, with no mention of AI or ML technologies.

Therapeutic

No.
The device is described as a "reusable sterilization container system" designed to sterilize other medical devices and maintain their sterility, not to treat or diagnose patients itself.

Diagnostic

No

The device is a sterilization container system designed to enclose and maintain the sterility of other medical devices, not to diagnose a medical condition. Its function is to facilitate the sterilization process and ensure sterility until use.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a lid with gasket, base, filter, tamper evident arrows, data cards, and a lifting platform. It is a physical container system for sterilization.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
Device Description: The description focuses on the physical components of a container system designed for sterilization and storage.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on sterilization efficacy, dry time, shelf life, and microbial challenge – all related to the sterilization and storage function.

IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

KCT

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.
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 provider

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: 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: Dry time studies establish minimum dry time of 30 minutes for pre-vacuum steam sterilization modality.
180 Day Event Related Shelf Life: 180 Day Event Related Shelf life studies demonstrated sterility maintenance for the recommended pre-vacuum steam sterilization modality.
Microbial 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sterility Assurance Level (SAL) of 10^-6
100% negative growth on microbial challenge test

Predicate Device(s)

Genesis Reusable Rigid Sterilization Container System (K112535)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

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.

1

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely 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.

3

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
(Pre-Vacuum) Steam	Exposure Temperature: 270°F
(132°C)

Pre-Conditioning Pulses: 3

Exposure Time: 4 Minutes

Dry Time Cycle: 30 Minutes

Minimum Cool Time: 60 minutes (may vary according to load contents)

Stacking Not Permitted | 25 lbs. | Solid Bottom Containers;
Perforated Bottom
Containers; Lifting Platforms.

Lumen (Cannulated) Devices.
Devices or Device
Configurations with
conjoined surfaces which
meet, touch or unite. Mated
surfaces.

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.

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

Validation Data
Modality
Type of Container	Dynamic Air Removal (Pre-Vacuum) Steam
Contents / Configuration	Validation Details
Perforated Bottom
Container and Solid
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.
Composites, thermoplastics and
thermosetting polymers with constant use
temperatures above 135°C.	Yes
	Filter	NST Series
	Data Card	MD1-1
	Tamper Evident Arrow	AS2-3
	Maximum Total Weight
(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
Number | Synthes Part
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 | Not Applicable | 2.6 | 20.5 x 10.6 x 1.3 | Not Applicable |
| 62.009.010 | Lifting Platform for
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
Graphic Case
Footprint | Graphic Case
Dimensions
(L x W x H), in. | Contents | Required
Accessories | Max.
Weight
(loaded) |
|-------------------------------------------------|-----------|-----------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------|
| ull-One Level,
erforated or Solid Base | Full Size | Half length,
1 high | 10.5 x 9.8 x 2.0 | Materials: Intrinsically stable metals. Composites,
thermoplastics and thermosetting polymers with constant use
temperatures above 135°C.
Devices: Graphic Cases, Orthopedic Surgical Instruments,
Implants | 2 Filters (Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow | 25 lb.
(11.3 kg) |
| ull-Two Level,
erforated or Solid Base | Full Size | 2/3 length,
1 high

Full length,
1 high | 13.9 x 9.8 x 2.0

20.7 x 9.8 x 2.0 | Device Design Features: Mated Surfaces; Dead end lumen
(Ø2.1mm x 330mm); Open end lumens ( $(Ø0.9mm x 278mm)$
(Ø1.1mm x 285mm), (Ø1.35mm x 278mm), (Ø3.65mm x
465mm), (Ø4.5mm x 438mm) | 2 Filters (Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow | 25 lb.
(11.3 kg) |
| ull-Two Level,
erforated or Solid Base | Full Size | Half length,
2 high

2/3 length,
2 high

Full length,
2 high | 10.5 x 9.8 x 3.4

13.9 x 9.8 x 3.4

20.7 x 9.8 x 3.4 | Materials: Intrinsically stable metals. Composites,
thermoplastics and thermosetting polymers with constant use
temperatures above 135°C.
Devices: Graphic Cases, Orthopedic Surgical Instruments,
Implants | 2 Filters (Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow | 25 lb.
(11.3 kg) |
| ull-Three Level,
erforated or Solid Base | Full Size | Half length,
3 high

2/3 length,
3 high

Full length,
3 high | 10.5 x 9.8 x 4.9

13.9 x 9.8 x 4.9

8

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

9

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.
The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container.

10

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

11

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

12

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
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. | The Genesis Reusable Rigid Sterilization Container System
is a device intended to be used to enclose another medical
device that is to be sterilized by a healthcare provider. It
allows sterilization of the enclosed medical device and
maintains sterility of the enclosed device until used for a
maximum of 180 days.

Containers are suitable for dynamic air removal (pre-
vacuum) steam sterilization, immediate use pre-vacuum
steam sterilization and 100% ethylene oxide sterilization
when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats,
etc.) are intended to organize and secure enclosed medical
devices 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
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. |
| Material
Composition | Stainless Steel, Aluminum, Silicone (Gasket), SMS
Polypropylene (Filter). All components in the subject
system are identical in material composition to the
predicate. The subject system does not contain polymeric
components to hold devices within the container. | Stainless Steel, Aluminum, Silicone (Gasket), Silicone
Elastomer (Bars, Mats, Instrument Holders), SMS
Polypropylene (Filter), Radel/Polyphenysulfone/Aluminum/
Silicone Elastomer/Stainless (Laproscopic Instrument
Racks) |
| Element | K130720 - Subject Device
Synthes Reusable Sterilization Container System | K112535 - Predicate
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
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/
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
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
Sterilant
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 | Lethality testing via over-challenge half-cycle lethality validation demonstrated all test samples were negative for growth following the seven (7) day incubation period |
| | K130720 - Subject Device | K112535 - Predicate |
| Element | Synthes Reusable Sterilization Container System | Genesis Reusable Rigid Sterilization Container System |
| | identical to the predicate. | |
| Microbial Barrier | Whole package integrity/microbial barrier aerosol challenge | Whole package integrity/microbial barrier aerosol challenge |
| Properties (Package | demonstrated all containers tested passed and were 100% | demonstrated all containers tested passed and were 100% |
| Integrity) | negative for growth when subjected to aerosol challenge
testing. Identical to the predicate. | negative for growth when subjected to aerosol challenge
testing. |
| Material | The subject container system is manufactured from the | The materials used in the construction of the containers do |
| Compatibility | same materials as the predicate device and it's compatibility | not degrade and have proven compatibility with the |
| | with the sterilization process is identical to the predicate. | sterilization process and sterilants for which the system is |
| | | indicated. |
| Toxicological | No patient contact, contact with devices that will have | No patient contact, contact with devices that will have |
| Properties | external communicating, tissue/bone/dentin contact (limited | external communicating, tissue/bone/dentin contact (limited |
| (Biocompatibility. | exposure). The subject Container System will include a | exposure). Primary dermal irritation testing was performed |
| including Sterilant | stainless steel lifting platform that represents the only | on polymeric components of the container system. All |
| Residue Limits) | internal component to hold devices within the container. | samples were subjected to ISO Skin Irritation Testing (2 |
| | The lifting platform is manufactured from type 304 stainless | extracts - 0.9% Sodium Chloride and Sesame Oil Extracts) |
| | steel that conforms to ASTM Standard F899 and has an | in compliance with the requirements noted in ISO 10993- |
| | established biocompatibility profile. The system will not | 10. These polymeric components were evaluated for |
| | include the polymeric components, such as silicone bars or | biocompatibility and are considered to be toxicologically |
| | brackets that are included in the predicate system. The | acceptable for their intended use. |
| | proposed system is indicated for prevacuum steam | |
| | sterilization only therefore sterilant residues will not pose | |
| | any risk to the patient. The material formulation, | |
| | manufacturing process, chemical composition, body | |
| | contact, and steam sterilization modality of the proposed | |
| | device is equivalent to the predicate device. | |
| Shelf Life | 180 Day shelf life identical to the 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 | 30 Minute Minimum Dry Time supported by validation |
| | study utilizing worst case device challenge identical to the | study utilizing worst case instrument challenge. |
| | predicate. | |
| Aeration Time | N/A - System not indicated for EO Sterilization | 8 hours at 109.4°F (43°C) supported by 100% Ethylene |
| | | Oxide Aeration Residual validation study |

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Image /page/13/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo features a stylized graphic of interlocking circles in a gold color, followed by the company name "DePuy Synthes" in a dark blue, sans-serif font. Below the company name, the text "COMPANIES of Johnson & Johnson" is displayed, with "COMPANIES of" in gray and "Johnson & Johnson" in a red, script-like font.

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Image /page/14/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular graphic to the left of the company name, "DePuy Synthes," which is written in a dark blue, sans-serif font. Below the company name, in smaller letters, is the text "COMPANIES OF" in gray, followed by "Johnson & Johnson" in a red, cursive font.

15

Image /page/15/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 smaller letters, it says "COMPANIES OF Johnson & Johnson", with "Johnson & Johnson" in a red script font.

Summary of Technological Characteristics of the Subject Device
Characteristic	Proposed Device
Synthes Reusable Sterilization Container	Predicate
Genesis Reusable Rigid
Sterilization Container System
(K112535)
Container	Anodized Aluminum	Anodized Aluminum 5000 and
1100 Series; Stainless Steel 300
Series
Gasket	Closed Cell Silicone Foam	Closed Cell Silicone Foam
Filter Material	SMS Polypropylene for Pre-
Vacuum Steam modality	SMS Polypropylene for all
modalities
Lifting
Platform/Basket	Lifting Platform 304 Stainless
Steel Electropolished	Basket 304 Stainless Steel
Electropolished
Dividers Brackets	N/A	Aluminum 5000 Series
Clips, Posts, Pins	N/A	300 & 400 Series Stainless
Silicone Bars, Mats	N/A	Silicone Elastomer
Performance Data
Summary of Non-Clinical Testing Conducted for Determination of Substantial Equivalence
Performance Test Summary - Proposed Device
Characteristic	Standard/Test/
FDA Guidance	Results Summary
Sterilization Efficacy:
Pre-Vacuum Steam	ANSI/AAMI ST77:2006
Containment Devices for
Reusable Medical Device
Sterilization.	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.	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.	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.	Whole package microbial challenge test,
exposing a container to a minimum of 1 x
106 Bacillus atrophaeus colony forming
units (CFU) via an aerosol challenge
demonstrating 100% negative growth.

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Image /page/16/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo features a geometric symbol 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.

Summary of Clinical Tests Conducted for Determination of Substantial Equivalence

N/A - No clinical tests were conducted for this submission.

Conclusion

Information presented supports substantial equivalence of the Synthes Reusable Sterilization Container System to the predicate device based on similarities in intended use, design, principles of operation, and performance specifications.

Sterilization Efficacy / Lethality testing was conducted on the proposed sterilization container system to support substantial equivalence to the predicate device and demonstrate effectiveness when used with Synthes orthopedic medical devices.

Filter material properties, package integrity testing and 180 day shelf life validation are exactly the same as the predicate device.

The performance testing data demonstrates that the Synthes Reusable Sterilization Container meet the same criteria as the predicate device is substantial equivalent.

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Image /page/17/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular graphic on the left, followed by the company name in bold, blue font. Below the company name, in smaller font, is the text "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red.

| Sterilization Parameters for the Synthes Reusable Sterilization Container

Applicable to both Solid Bottom and Perforated Bottom Containers with Lifting Platforms
Sterilization
Method	Cycle Parameters	Total
System
Weight	Types of Medical Devices
& Materials Validated
for Use
Dynamic Air
Removal (Pre-
Vacuum) Steam	Exposure Temperature:
270°F (132°C)
Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Dry Time Cycle: 30
Minutes
Minimum Cool Time: 60
minutes (may vary
according to load contents)
Stacking Not Permitted	25 lbs.
(Container
plus
contents)	Orthopedic Medical
Devices including Lumen
(Cannulated) Devices.
Devices or Device
Configurations with
conjoined surfaces which
meet, touch or unite.
Mated Surfaces.
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.

Examples of intrinsically stable metals include stainless steel, titanium (CP and alloys) and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/Styrene) and POM (Polyoxymethylene).

Examples of thermosetting polymers are Phenolic and Silicone.

Examples of composites include carbon fiber reinforced epoxy (CFRE).

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Image /page/18/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular graphic on the left, followed by the company name in a bold, sans-serif font. Below the company name, in a smaller font, it says "COMPANIES of Johnson & Johnson".

Synthes Reusable Sterilization Container System & Accessories
Supported by Validation Data
Modality	Dynamic Air Removal (Pre-Vacuum) Steam
Type of Container	Contents / Configuration	Validation Details
Perforated Bottom
Container and Solid
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.
Composites, thermoplastics and
thermosetting polymers with constant
use temperatures above 135°C.	Yes
	Filter	NST Series
(SMS Polypropylene)
	Data Card	MD1-1
	Tamper Evident Arrow	AS2-3
	Maximum Total Weight
(Container plus Contents)	25 lbs.
	Stacking	Not permitted

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Container Compatibility, Contents, Accessories, Maximum Allowable Weight
Container	Lid	Compatible
Graphic Case
Footprint	Graphic Case
Dimensions
(L x W x H), in.	Contents	Required
Accessories	Max.
Weight
(loaded)
Full-One Level.
Perforated or Solid Base	Full Size	Half length,
1 high	10.5 x 9.8 x 2.0	Materials: Intrinsically stable metals.
Composites, thermoplastics and thermosetting
polymers with constant use temperatures
above 135°C.
Devices: Graphic Cases, Orthopedic Surgical
Instruments, Implants
Device Design Features: Mated Surfaces;
Dead end lumen (Ø2.1mm x 330mm); Open
end lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x
285mm), (Ø1.35mm x 278mm), (Ø3.65mm x
465mm), (Ø4.5mm x 438mm)	2 Filters( Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow	25 lb.
(11.3 kg)
		2/3 length,
1 high	13.9 x 9.8 x 2.0
		Full length,
1 high	20.7 x 9.8 x 2.0
Full-Two Level,
Perforated or Solid Base	Full Size	Half length,
2 high	10.5 x 9.8 x 3.4	Materials: Intrinsically stable metals.
Composites, thermoplastics and thermosetting
polymers with constant use temperatures
above 135°C.
Devices: Graphic Cases, Orthopedic Surgical
Instruments, Implants
Device Design Features: Mated Surfaces;
Dead end lumen (Ø2.1mm x 330mm); Open
end lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x
285mm), (Ø1.35mm x 278mm), (Ø3.65mm x
465mm), (Ø4.5mm x 438mm)	2 Filters( Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow	25 lb.
(11.3 kg)
		2/3 length,
2 high	13.9 x 9.8 x 3.4
		Full length.
2 high	20.7 x 9.8 x 3.4
Full-Three Level,
Perforated or Solid Base	Full Size	Half length,
3 high	10.5 x 9.8 x 4.9	Materials: Intrinsically stable metals.
Composites, thermoplastics and thermosetting
polymers with constant use temperatures	2 Filters( Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow	25 lb.
(11.3 kg)
		2/3 length,
3 high	13.9 x 9.8 x 4.9	above 135°C.
Devices: Graphic Cases, Orthopedic Surgical
Instruments, Implants
		Full length,
3 high	20.7 x 9.8 x 4.9	Device Design Features: Mated Surfaces;
Dead end lumen (Ø2.1mm x 330mm); Open
end lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x
285mm), (Ø1.35mm x 278mm), (Ø3.65mm x
465mm), (Ø4.5mm x 438mm)
Container Compatibility, Contents, Accessories, Maximum Allowable Weight
Container	Lid	Compatible
Graphic Case
Footprint	Graphic Case
Dimensions
(L x W x H), in.	Contents	Required
Accessories	Max.
Weight
(loaded)
Extended-Four Level,
Perforated or Solid Base	Extended	Half length,
4 high	10.5 x 9.8 x 6.3	Materials: Intrinsically stable metals.
Composites, thermoplastics and thermosetting
polymers with constant use temperatures	2 Filters( Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow	25 lb.
(11.3 kg)
		2/3 length,
4 high	13.9 x 9.8 x 6.3	above 135°C.
Devices: Graphic Cases, Orthopedic Surgical
Instruments, Implants
		Full length,
4 high	20.7 x 9.8 x 6.3	Device Design Features: Mated Surfaces;
Dead end lumen (Ø2.1mm x 330mm); Open
end lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x
285mm), (Ø1.35mm x 278mm), (Ø3.65mm x
465mm), (Ø4.5mm x 438mm)
Extended-Five Level,
Perforated or Solid Base	Extended	Half length,
5 high	10.5 x 9.8 x 7.8	Materials: Intrinsically stable metals.
Composites, thermoplastics and thermosetting
polymers with constant use temperatures	2 Filters( Solid Base)
4 Filters (Perf. Base)
Lifting Platform
Tamper Evident
Arrow	25 lb.
(11.3 kg)
		2/3 length,
5 high	13.9 x 9.8 x 7.8	above 135°C.
Devices: Graphic Cases, Orthopedic Surgical
Instruments, Implants
Device Design Features: Mated Surfaces;
		Full length,
5 high	20.7 x 9.8 x 7.8	Dead end lumen (Ø2.1mm x 330mm); Open
end lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x
285mm), (Ø1.35mm x 278mm), (Ø3.65mm x
465mm), (Ø4.5mm x 438mm)

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Image /page/20/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a symbol of two overlapping circles in gold, followed by the company name in blue. Below the company name, it says "COMPANIES OF" in gray, followed by "Johnson & Johnson" in red script.