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 case and tray system, with no mention of AI or ML.

Therapeutic

No
The device is described as a system for containing and protecting orthopedic instruments and implants during sterilization and transport, not for treatment.

Diagnostic

No

Explanation: The device is described as a system for storing, organizing, and transporting orthopedic instruments and implants for sterilization and surgical procedures. It is not used to diagnose any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "modular, reusable case and tray system" composed of "multiple pieces" and "components," indicating a physical hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the system is used to "store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures." This is a function related to the handling and sterilization of surgical tools, not the in vitro examination of specimens derived from the human body.
Device Description: The description reinforces this by stating it's a "modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization."
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on in vitro testing.

Therefore, the Synthes Graphic Case & Tray System falls under the category of a medical device used for the sterilization and handling of surgical instruments, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).

The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.

The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).

Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Minimum Drying time: 20 minutes

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.

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)

Nonclinical testing included Sterilization Efficacy, Dry Time and Thermal Profiling, Manual and Automated Cleaning Validation, Biocompatibility, and Durability (Limits of Reuse). Testing demonstrates that the Synthes Graphic Case and Tray System is summarized in the table below.

Sterilization Efficacy with FDA cleared sterilization wrap:
Purpose: Validation for the efficacy of the dynamic air removal steam sterilization process in attaining a sterility assurance level (SAL) of 10-6 via the overkill method using a half cycle for the Synthes Graphic Case and Tray System when processed in two layers of blue sterilization wrap.
Results: Pass, all acceptance criteria met. Each product BI test location was negative for growth Each positive control BI type was positive for growth Each negative and environmental control BI type was negative for growth All integrators demonstrated steam penetration The sterilizer cycle tapes verified that the cycle parameters were achieved.

Sterilization Efficacy with FDA cleared rigid sterilization container:
Purpose: Validation for the efficacy of the dynamic air removal steam sterilization process in attaining a sterility assurance level (SAL) of 10-6 via the overkill method using a half cycle for the Synthes Graphic Case and Tray System when processed in a rigid sterilization container.
Results: Pass, all acceptance criteria met. Each product BI test location was negative for growth Each positive control BI type was positive for growth Each negative and environmental control BI type was negative for growth All integrators demonstrated steam penetration The sterilizer cycle tapes verified that the cycle parameters were achieved.

Dry Time and Thermal Profiling with FDA cleared sterilization wrap:
Purpose: Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in a two layers of blue sterilization wrap.
Results: Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: -0.085% Cycle 2: 0.093% Cycle 3: 0.062% For Autoclave Parameter of 20 Minute Dry Time: No Visible Moisture At the end of the cycle, the temperature sensors were found to have remained in position. F0 results of >12.0 achieved for Cycle 1,2 and 3 for all locations All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved.

Dry Time and Thermal Profiling with FDA cleared rigid sterilization container:
Purpose: Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in a rigid sterilization container.
Results: Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: 0.00% Cycle 2: 0.00% Cycle 3: 0.00% Cycle 4: 0.00% Cycle 5: 0.00% Cycle 6: 0.00% For Autoclave Parameter of 20 Minute Dry Time: No Visible Moisture At the end of the cycle, the temperature sensors were found to have remained in position. F0 results of >12.0 achieved for all cycles and for all locations All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved.

Cleaning (Manual):
Purpose: To validate the manual cleaning method, the device challenge features present in the Case and Tray System were soiled with a clinically relevant soil for orthopedic surgery, cleaned using worst case process parameters (e.g. times, water temperature, and/or cleaning solution concentration) and analyzed for the presence of two clinically relevant analytes, protein and hemoglobin.
Results: The extraction efficiency was greater than or equal to 70% at each sample location. There was no visible soil after cleaning. For all cycles the acceptance criteria were met with an observed protein analyte level of

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.

March 28, 2025

Synthes GmbH Thomas Shea Manger, Regulatory Affiars Luzernstrasse 21 Zuchwil, SO 4528 Switzerland

Re: K241927

Trade/Device Name: Synthes Graphic Case & Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 26, 2025 Received: February 26, 2025

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

2

Sincerely,

Digitally signed by Stephen A. Digitally signed by
Stephen A. Anisko -S Anisko -S Date: 2025.03.28 16:08:45 -04'00'

for: Christopher Dugard Director DHT4C: Division of Infection Control OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K241927

Device Name Synthes Graphic Case & Tray System

Indications for Use (Describe)

The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterlity; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).

The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.

The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).

Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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4

Synthes Graphic Case & Tray System - Description and Dimensions
Part Number	Part Description	Volume to Vent
Ratio (in³/in²)
(with Lid)	Weight
(lbs.)	Dimensions (in)
(L x W x H) Case/Tray
(L x W) Lids
Outer Cases
60.133.181	1 High, 1/3 width outer case	5.62	1.62	7.1 x 9.7 x 1.9
60.133.182	1 High, 2/3 width outer case	4.84	2.19	13.6 x 9.7 x 1.9
60.133.183	1 High, 3/3 width outer case	4.72	2.73	20 x 9.7 x 1.9
60.133.213	2 High, 1/3 width outer case	8.11	2.10	7.1 x 9.7 x 3.4
60.133.223	2 High, 2/3 width outer case	7.35	2.78	13.6 x 9.7 x 3.4
60.133.200	2 High, 3/3 width outer case	6.12	3.41	20 x 9.7 x 3.4
60.133.313	3 High, 1/3 width outer case	9.34	2.51	7.1 x 9.7 x 5
60.133.323	3 High, 2/3 width outer case	8.81	3.31	13.6 x 9.7 x 5
60.133.300	3 High, 3/3 width outer case	8.30	4.04	20 x 9.7 x 5
60.133.413	4 High, 1/3 width outer case	10.05	2.92	7.1 x 9.7 x 6.6
60.133.423	4 High, 2/3 width outer case	9.69	3.83	13.6 x 9.7 x 6.6
60.133.400	4 High, 3/3 width outer case	9.19	4.65	20 x 9.7 x 6.6
Case Lids
Synthes Graphic Case & Tray System - Description and Dimensions
Part Number	Part Description	Volume to Vent
Ratio (in³/in²)
(with Lid)	Weight
(lbs.)	Dimensions (in)
(L x W x H) Case/Tray
(L x W) Lids
60.133.013	1/3 width lid	n/a	.60	7.1 x 9.7
60.133.023	2/3 width lid	n/a	1.01	13.6 x 9.7
60.133.000	3/3 width lid	n/a	1.59	20 x 9.7
Auxiliary Trays * Representative for all 1 high Tray size
60.133.103	Auxiliary Tray 1/3 width	5.62	0.89	6.34 x 9.25 x 1.77
60.133.169	Auxiliary Tray, 1 High, 2/3 Width	4.84	1.80	12.80 x 9.25 x 1.77
60.133.171	Auxiliary Tray, 1 High, 3/3 Width	4.72	2.70	19.25 x 9.25 x 1.77
Auxiliary Tray Lids
60.133.111	Lid (1/3 Width), Aluminium Tray	n/a	0.81	6.61 x 9.65
60.133.110	Lid (2/3 Width), Aluminium Tray	n/a	1.33	13.07 x 9.65
60.133.109	Lid 3/3 Aluminium Tray	n/a	1.79	19.53 x 9.65

5

510(k) Summary K241927

| Sponsor | Synthes GmbH
Luzernstrasse 21
4528 Zuchwil, Switzerland |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Thomas Shea
Manager, Regulatory Affairs
T: +1 610-719-5679
E: tshea@its.jnj.com |
| Alternate Contact | Damon Lees
Director, Regulatory Affairs
T: +1 610-719-5608
E: dlees@its.jnj.com |
| Date Prepared | March 25, 2025 |
| Proprietary Name | Synthes Graphic Case & Tray System |
| Classification
Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification | Class II
Regulation Number: 21 CFR 880.6850
Product Code: KCT |
| Predicate /
Reference
devices | Predicate Device: CrossRoads Tray System (K202268)
Reference Device: DePuy Synthes Sterilization Container System (K181933) |
| Device
Description | The Synthes Graphic Case and Tray System is a modular, reusable case and tray
system intended for use in health care facilities for the purpose of containing
medical devices for sterilization. It is composed of multiple pieces, designed to be
integrated into a single unit that contains and protects instruments and implants
during sterilization and transport. All components are perforated for steam
penetration. |
| Indications for
Use | The Synthes Graphic Case & Tray System are used in healthcare facilities to
store, organize, and transport DePuy Synthes orthopedic instruments and
implants during sterilization and surgical procedures. The Synthes Graphic Case
& Tray System are not intended on their own to maintain sterility; they are intended
to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g.,
wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic
medical devices including lumen (cannulated) devices and mated surface devices
(devices or device configurations with conjoined surfaces which meet, touch or
unite). Compatible instrument and implant materials include intrinsically stable
metals, composites, thermoplastics and thermosetting polymers with constant use
temperatures above 135°C. |
| | The Synthes Graphic Case & Tray System were validated for a maximum load of
25 lbs (case + contents+ lid+ weight of sterile barrier wrap). |
| | Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Minimum Drying time: 20 minutes |

6

Part Number	Part Description	Volume to Vent Ratio (in³/in²) (with Lid)	Weight (lbs.)	Dimensions (in) (L x W x H) Case/Tray (L x W) Lids
Outer Cases
60.133.181	1 High, 1/3 width outer case	5.62	1.62	7.1 x 9.7 x 1.9
60.133.182	1 High, 2/3 width outer case	4.84	2.19	13.6 x 9.7 x 1.9
60.133.183	1 High, 3/3 width outer case	4.72	2.73	20 x 9.7 x 1.9
60.133.213	2 High, 1/3 width outer case	8.11	2.10	7.1 x 9.7 x 3.4
60.133.223	2 High, 2/3 width outer case	7.35	2.78	13.6 x 9.7 x 3.4
60.133.200	2 High, 3/3 width outer case	6.12	3.41	20 x 9.7 x 3.4
60.133.313	3 High, 1/3 width outer case	9.34	2.51	7.1 x 9.7 x 5
60.133.323	3 High, 2/3 width outer case	8.81	3.31	13.6 x 9.7 x 5
60.133.300	3 High, 3/3 width outer case	8.30	4.04	20 x 9.7 x 5
60.133.413	4 High, 1/3 width outer case	10.05	2.92	7.1 x 9.7 x 6.6
60.133.423	4 High, 2/3 width outer case	9.69	3.83	13.6 x 9.7 x 6.6
60.133.400	4 High, 3/3 width outer case	9.19	4.65	20 x 9.7 x 6.6
Case Lids
Part Number	Part Description	Volume to Vent Ratio (in³/in²) (with Lid)	Weight (lbs.)	Dimensions (in) (L x W x H) Case/Tray (L x W) Lids
60.133.013	1/3 width lid	n/a	.60	7.1 x 9.7
60.133.023	2/3 width lid	n/a	1.01	13.6 x 9.7
60.133.000	3/3 width lid	n/a	1.59	20 x 9.7
Auxiliary Trays * Representative for all 1 high Tray size
60.133.103	Auxiliary Tray 1/3 width	5.62	.89	6.34 x 9.25 x 1.77
60.133.169	Auxiliary Tray, 1 High, 2/3 Width	4.84	1.80	12.80 x 9.25 x 1.77
60.133.171	Auxiliary Tray, 1 High, 3/3 Width	4.72	2.70	19.25 x 9.25 x 1.77
Auxiliary Tray Lids
60.133.111	Lid (1/3 Width), Aluminium Tray	n/a	0.81	6.61 x 9.65
60.133.110	Lid (2/3 Width), Aluminium Tray	n/a	1.33	13.07 x 9.65
60.133.109	Lid 3/3 Aluminium Tray	n/a	1.79	19.53 x 9.65'

7

Technological Comparison

Presented below is a Technological Comparison covering the design and performance specifications of the subject device and the predicate.

Comparator	Subject Device (K241927)	Predicate Device (K202268)	Comparison
Device Name	Synthes Graphic Case and Tray
System	CrossRoads Tray System
Device Image	Image: Synthes Graphic Case and Tray System	Image: CrossRoads Tray System
Product Code	KCT	KCT	Same
Intended Use	The Synthes Graphic Case and
Tray System is designed to
hold surgical implants and
instruments in order to
organize, steam sterilize and
transport the devices between
uses. The cases and trays are
intended to be wrapped with an
FDA-cleared sterilization wrap
or placed within a reusable
sterilization container during the
pre-vacuum autoclave
sterilization process.	The CrossRoads Tray System
is designed to hold various
surgical instruments in order to
organize, steam sterilize and
transport the instruments
between uses. The trays are
wrapped with an FDA-cleared
sterilization wrap during the
pre-vacuum autoclave
sterilization process.	Similar
Comparator	Subject Device (K241927)	Predicate Device (K202268)	Comparison
Indications for
Use	The Synthes Graphic Case &
Tray System is used in
healthcare facilities to store,
organize, and transport DePuy
Synthes orthopedic instruments
and implants during sterilization
and surgical procedures. The
Synthes Graphic Case & Tray
System are not intended on
their own to maintain sterility;
they are intended to be used in
conjunction with a legally
marketed, FDA-cleared sterile
barrier (e.g., wraps or reusable
rigid sterilization containers).
The Synthes Graphic Case &
Tray System is validated for
use with orthopedic medical
devices including lumen
(cannulated) devices and
mated surface devices (devices
or device configurations with
conjoined surfaces which meet,
touch or unite). Compatible
instrument and implant
materials include intrinsically
stable metals, composites,
thermoplastics and
thermosetting polymers with
constant use temperatures
above 135°C.
The Synthes Graphic Case &
Tray System were validated for	The CrossRoads Tray System
is used in healthcare facilities to
store and organize CrossRoads
surgical instruments and
components during
cleaning/sterilization and during
implant/prosthetic treatment.
The CrossRoads Tray System
are not intended on their own to
maintain sterility; it is intended
to be used in conjunction with a
legally marketed, validated,
FDA-cleared sterilization pouch
or sterilization wrap.
Sterilization validations for the
worst-case CrossRoads Tray
System included surgical
instruments such as drills,
inserters, reamers, fixation pin,
benders, and ratcheting
handles. The CrossRoads Tray
System is validated for a
maximum load of 8.5 lbs (tray +
instruments).
Method: Steam Sterilization
(Moist Heat Sterilization) Cycle
Pre-vacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Drying time: 20 minutes
The tray is 20.60" length x 9.80"
width x 2.00" depth.	Different,
subject
device
includes
indications
for device
types and
materials
validated for
use with the
system.
	a maximum load of 25 lbs (case

contents+ lid+ weight of
sterile barrier wrap).
Method: Steam Sterilization
(Moist Heat Sterilization) Cycle
Pre-vacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Minimum Drying time: 20 | | |
| Intended
Device Load | minutes
Implants and instruments | Implants and instruments | Same |
| Max Weight | 25 lbs (case + contents+ lid +
weight of sterile barrier) | 8.5 lbs (tray + instruments) | Different,
subject
system is
validated for
a greater
max load |
| Materials | Lid/base— Aluminum
Inserts - Silicone, Aluminum,
Stainless Steel
Latch - Stainless Steel | Lid/base/Lift out tray -
Aluminum Inserts - Silicone,
aluminum, stainless steel
Latch - Stainless steel | Similar |
| Design | Outer case, inner tray, lids | Base and lid | Similar |
| Comparator | Subject Device (K241927) | Predicate Device (K202268) | Comparison |
| Dimensions | Cases and trays ranging in size
from 7.2 – 20.1 length x 9.8
width x 1.8 – 6.5 inches depth
See Table in IFU for complete
list of cases and trays with
dimensions. | 20.60 length x 9.80 width x
2.00 inches depth | Different,
subject
system offers
a range of
sizes |
| Sterilization Parameters | | | |
| Sterilization
Method | Pre-vacuum (steam) | Pre-vacuum (steam) | Same |
| Cycle
Temperature | 270°F (132°C) | 270°F (132°C) | Same |
| Cycle Time | 4 minutes | 4 minutes | Same |
| Dry Time | 20 minutes | 20 minutes | Same |
| Sterile Barrier | FDA cleared sterilization wrap or
rigid container | FDA cleared sterilization wrap
or pouch | Similar |
| Performance Testing | | | |
| Non-clinical
performance
testing | Sterilization Efficacy
Dry Time
Cleaning
Biocompatibility
Durability (Limits of Reuse) | Sterilization Efficacy
Dry Time
Cleaning
Biocompatibility | Similar |

8

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Non-clinical Testing Summary

Nonclinical testing included Sterilization Efficacy, Dry Time and Thermal Profiling, Manual and Automated Cleaning Validation, Biocompatibility, and Durability (Limits of Reuse). Testing demonstrates that the Synthes Graphic Case and Tray System is summarized in the table below.

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Test	Purpose	Acceptance Criteria	Results
Sterilization
Efficacy with FDA
cleared
sterilization wrap	Validation for the efficacy of
the dynamic air removal steam
sterilization process in
attaining a sterility assurance
level (SAL) of 10-6 via the
overkill method using a half
cycle for the Synthes Graphic
Case and Tray System when
processed in two layers of
blue sterilization wrap.	All biological indicator test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved.	Pass, all acceptance criteria met.
Each product BI test location was negative for growth Each positive control BI type was positive for growth Each negative and environmental control BI type was negative for growth All integrators demonstrated steam penetration The sterilizer cycle tapes verified that the cycle parameters were achieved
Sterilization
Efficacy with FDA
cleared rigid
sterilization
container	Validation for the efficacy of
the dynamic air removal steam
sterilization process in
attaining a sterility assurance
level (SAL) of 10-6 via the
overkill method using a half
cycle for the Synthes Graphic
Case and Tray System when
processed in a rigid
sterilization container.	All biological indicator (BI) test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved.	Pass, all acceptance criteria met.
Each product BI test location was negative for growth Each positive control BI type was positive for growth Each negative and environmental control BI type was negative for growth All integrators demonstrated steam penetration The sterilizer cycle tapes verified that the cycle parameters were achieved
Test	Purpose	Acceptance Criteria	Results
Dry Time and Thermal Profiling with FDA cleared sterilization wrap	Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in a two layers of blue sterilization wrap.	The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle.	Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: -0.085% Cycle 2: 0.093% Cycle 3: 0.062% For Autoclave Parameter of 20 Minute Dry Time: No Visible Moisture At the end of the cycle, the temperature sensors were found to have remained in position. $F_0$ results of >12.0 achieved for Cycle 1,2 and 3 for all locations All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved:

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Test	Purpose	Acceptance Criteria	Results
Dry Time and
Thermal Profiling
with FDA cleared
rigid sterilization
container	Validation of the efficacy of
thermal profile and dry time for
the Synthes Graphic Case and
Tray System when processed
in a rigid sterilization
container.	The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle.	Pass, all acceptance criteria met.
Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time:
Cycle 1: 0.00%
Cycle 2: 0.00%
Cycle 3: 0.00%
Cycle 4: 0.00%
Cycle 5: 0.00%
Cycle 6: 0.00% For Autoclave Parameter of 20 Minute Dry Time: No Visible Moisture At the end of the cycle, the temperature sensors were found to have remained in position. F0 results of >12.0 achieved for all cycles and for all locations All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved
Test	Purpose	Acceptance Criteria	Results
Cleaning
(Manual)	To validate the manual
cleaning method, the device
challenge features present in
the Case and Tray System
were soiled with a clinically
relevant soil for orthopedic
surgery, cleaned using worst
case process parameters (e.g.
times, water temperature,
and/or cleaning solution
concentration) and analyzed
for the presence of two
clinically relevant analytes,
protein and hemoglobin.	● The extraction efficiency
shall be greater than or
equal to 70%.
● Test samples show no
visible soil after cleaning.
● The overall result of the
protein analyte test is a
level of