CrossRoads Modular Tray System

K241050 · Crossroads Extremity Systems · KCT · Jul 16, 2024 · General Hospital

Device Facts

• Record ID: K241050
• Device Name: CrossRoads Modular Tray System
• Applicant: Crossroads Extremity Systems
• Product Code: KCT · General Hospital
• Decision Date: Jul 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The CrossRoads Modular 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.

Device Story

Reusable sterilization case with organizing trays; contains and protects surgical instruments (e.g., inserters, reamers, ratcheting handles) during steam sterilization. Components are perforated for steam penetration. Used in healthcare facilities; operated by clinical staff. Device input: surgical instruments. Device output: organized, sterilized instrument set. Benefits: facilitates organized, effective sterilization and transport of surgical tools. Healthcare providers use the tray to ensure instruments are properly contained and sterilized before use in implant/prosthetic treatment.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing: sterilization efficacy (ISO 17665-1, AAMI ST79), cleaning validation (AAMI TIR30, ISO 19227), biocompatibility (ISO 10993-1), and handle strength assessment (shear/tensile testing).

Technological Characteristics

Materials: Aluminum (lid/base), Silicone, Stainless Steel, Nylon-coating, PROPYLUX, Radel. Sensing/Actuation: None (mechanical). Energy: Steam sterilization (moist heat). Dimensions: Max 20.546" x 10.022" x 3.978". Connectivity: None. Sterilization: Pre-vacuum steam (270°F/132°C, 4 min exposure, 20 min dry).

Indications for Use

Indicated for use in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. Not intended to maintain sterility on its own; must be used with a legally marketed, validated, FDA-cleared sterilization wrap. Validated for a maximum load of 18.7 lbs (tray + instruments).

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

• CrossRoads Tray System (K202268)

Submission Summary (Full Text)

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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 Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 16, 2024

CrossRoads Extremity Systems Jacqueline Gorberg Regulatory Affairs Specialist II 6423 Shelby View Dr., Suite 101 Memphis, Tennessee 38134

Re: K241050

Trade/Device Name: CrossRoads Modular Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 17, 2024 Received: April 17, 2024

Dear Jacqueline Gorberg:

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" (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).

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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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

| Sincerely, | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stephen A. Anisko -S | Digitally signed by Stephen A. Anisko -S<br>Date: 2024.07.16 17:47:19 -04'00' |
| for: Christopher K. Dugard, MS<br>Assistant Director | DHT4B: Division of Infection Control<br>and Plastic and Reconstructive Surgery Devices<br>OHT4: Office of Surgical and Infection Control Devices<br>Office of Product Evaluation and Quality<br>Center for Devices and Radiological Health |

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Enclosure

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#### Indications for Use

510(k) Number (if known) K241050

Device Name CrossRoads Modular Tray System

#### Indications for Use (Describe)

The CrossRoads Modular Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. The CrossRoads Modular Tray System is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterlizations for the worst-case CrossRoads Modular Tray System included surgical instruments such as inserters, reamers, and ratcheting handles. The CrossRoads Modular Tray System is validated for a maximum load of 18.7 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

Dimensions do not exceed: 20.546" length x 10.022" width x 3.978" depth

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------|-----------------------------------------|
| <span style="text-decoration: underline;"><b>Prescription Use</b></span> (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span>☐</span> |

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Image /page/4/Picture/0 description: The image shows the logo for CrossRoads Extremity Systems. The logo consists of a square made up of four smaller squares in the colors blue and green. To the right of the square is the company name, "CrossRoads" in gray, with the letters "TM" in a smaller font size in the upper right corner. Below the company name is the text "Extremity Systems" in a smaller font size.

## 510(k) Summary – K241050

Applicant Name: CrossRoads Extremity Systems Applicant Address: 6423 Shelby View Dr., Suite 101 Memphis TN 38134 United States Applicant Contact Telephone: [phone] Applicant Contact: Ms. Jacqueline Gorberg Applicant Contact Email: [e-mail] Prepared On Date: July 15, 2024 Device Name Device Trade Name: CrossRoads Modular Tray System Common Name: Sterilization Wrap Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Regulation Number: 21 CFR 880.6850 Product Code: KCT Legally Marketed Predicate Device Predicate #: K202268 Predicate Trade Name: CrossRoads Tray System

Product Code: KCT

#### Device Description Summary

The CrossRoads Modular Tray System is a reusable sterilization case with organizing trays intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects instruments during sterilization. All components are perforated for steam penetration. The tray can hold CrossRoads surgical instruments.

#### Indications for Use

The CrossRoads Modular Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. The CrossRoads Modular Tray System is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization validations for the worst-case CrossRoads Modular Tray System included surgical instruments such as inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Modular Tray System is validated for a maximum load of 18.7 lbs. (tray + instruments).

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Image /page/5/Picture/0 description: The image shows the logo for CrossRoads Extremity Systems. The logo consists of four squares in the colors blue and green, followed by the company name in gray. The words "Extremity Systems" are written in a smaller font below the company name.

Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum

Temperature: 270 °F (132 °C)

Exposure time: 4 minutes

Drying time: 20 minutes

Dimensions do not exceed:

20.546" length x 10.022" width x 3.978" depth

### Technological Comparison

The subject CrossRoads Modular Tray System is identical to the predicate CrossRoads Tray System (K202268) in terms of basic design, fundamental technology, and manufacturing and sterilization methods. Differences include a change to maximum load, size, system features, and cleaning methods.

| Comparator | Comparison<br>(subject vs<br>predicate<br>device) | Subject Device (K241050) | Predicate Device (K202268) | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Device Name | Different, name<br>change | CrossRoads Modular Tray System | CrossRoads Tray System | | | |
| Device Image | Different, new<br>tray design | Image: CrossRoads Modular Tray System | Image: CrossRoads Tray System | | | |
| Product Code | Same | KCT | KCT | | | |
| Intended Use | Similar, name<br>change only | The CrossRoads Modular Tray System is<br>designed to hold various surgical<br>instruments in order to organize, steam<br>sterilize, and transport the instruments<br>between uses. The trays are wrapped with<br>an FDA-cleared sterilization wrap during<br>the pre-vacuum autoclave sterilization<br>process. | The CrossRoads Tray System is designed to<br>hold various surgical instruments in order<br>to organize, steam sterilize, and transport<br>the instruments between uses. The trays<br>are wrapped with an FDA-cleared<br>sterilization wrap during the pre-vacuum<br>autoclave sterilization process. | | | |
| Indications for<br>Use | Different,<br>updated name,<br>weight, and<br>dimensions | The CrossRoads Modular Tray System is<br>used in healthcare facilities to store and<br>organize CrossRoads surgical instruments<br>and components during sterilization and<br>during implant/prosthetic treatment. The<br>CrossRoads Modular Tray System is not<br>intended on its own to maintain sterility; it | The CrossRoads Tray System is used in<br>healthcare facilities to store and organize<br>CrossRoads surgical instruments and<br>components during cleaning/sterilization<br>and during implant/prosthetic treatment.<br>The CrossRoads Tray System are not<br>intended on their own to maintain | | | |
| | | is intended to be used in conjunction with | | sterility; it is intended to be used in | | |
| | | a legally marketed, validated, FDA-cleared | | conjunction with a legally marketed, | | |
| | | sterilization wrap. Sterilization validations | | validated, FDA-cleared sterilization pouch | | |
| | | for the worst-case CrossRoads Modular | | or sterilization wrap. Sterilization | | |
| | | Tray System included surgical instruments | | validations for the worst-case CrossRoads | | |
| | | such as inserters, reamers, fixation pin, | | Tray System included surgical instruments | | |
| | | benders, and ratcheting handles. The | | such as drills, inserters, reamers, fixation | | |
| | | CrossRoads Modular Tray System is | | pin, benders, and ratcheting handles. The | | |
| | | validated for a maximum load of 18.7 lbs | | CrossRoads Tray System is validated for a | | |
| | | (tray + instruments). | | maximum load of 8.5 lbs (tray + | | |
| | | Method: Steam Sterilization (Moist Heat | | instruments). | | |
| | | Sterilization) Cycle Pre-vacuum | | Method: Steam Sterilization (Moist Heat | | |
| | | Temperature: 270 °F (132 °C) | | Sterilization) Cycle Pre-vacuum | | |
| | | Exposure time: 4 minutes | | Temperature: 270 °F (132 °C) | | |
| | | Drying time: 20 minutes | | Exposure time: 4 minutes | | |
| | | Dimensions do not exceed: | | Drying time: 20 minutes | | |
| | | 20.546" length x 10.022" width x 3.978"…