(90 days)
Not Found
No
The device description and intended use are focused on a physical sterilization tray system and its validation for steam sterilization. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a reusable sterilization case with organizing trays intended for use in healthcare facilities for the purpose of containing reusable medical devices for sterilization. It does not directly provide therapy or treatment to a patient.
No
The device is described as a reusable sterilization case with organizing trays for containing surgical instruments during sterilization, not for diagnostic purposes.
No
The device description clearly states it is a "reusable sterilization case with organizing trays," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as storing and organizing surgical instruments during sterilization and implant/prosthetic treatment. This is a function related to the handling and sterilization of surgical tools, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details a reusable sterilization case with organizing trays for containing reusable medical devices for sterilization. This aligns with the intended use and does not involve any diagnostic processes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the CrossRoads Modular Tray System falls under the category of a medical device used for the sterilization and organization of surgical instruments, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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
Product codes
KCT
Device Description
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.
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, Cleaning Validation, Biocompatibility, and Handle Strength Assessment. The data was used for the determination of substantial equivalence. Testing demonstrates that the CrossRoads Modular Tray System is as safe and effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterilization Validation: All Bl's processed in each half-cycle must be negative for microbial growth of the indicator organism after 7 days for the overkill method to be validated. Positive controls must show growth of the indicator organism. Negative controls must remain negative (no growth). Dry Time Validation: The dry time validation is successful if the weight differential of the wrapped case after sterilization does not increase by 0.2% of the pre-sterilization weight, and there is no evidence of moisture on or within the sterilized package, wrap, and instruments.
Cleaning Validation: Acceptance Criteria 1: Visual Inspection - Visibly clean without evidence of discoloration, residue or particulate to the unaided eye without magnification under normal task lighting. Acceptance Criteria 2: Protein
§ 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).
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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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
| Sincerely, | |
|---|---|
| Stephen A. Anisko -S | Digitally signed by Stephen A. Anisko -S |
| Date: 2024.07.16 17:47:19 -04'00' | |
| for: Christopher K. Dugard, MS | |
| Assistant Director | DHT4B: Division of Infection Control |
| and Plastic and Reconstructive Surgery Devices | |
| OHT4: Office of Surgical and Infection Control Devices | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health |
2
Enclosure
3
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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: (267) 885-9690 Applicant Contact: Ms. Jacqueline Gorberg Applicant Contact Email: jgorberg@its.jnj.com 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
(subject vs
predicate
device) | Subject Device (K241050) | Predicate Device (K202268) | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Device Name | Different, name
change | CrossRoads Modular Tray System | CrossRoads Tray System | | | |
| Device Image | Different, new
tray design | Image: CrossRoads Modular Tray System | Image: CrossRoads Tray System | | | |
| Product Code | Same | KCT | KCT | | | |
| Intended Use | Similar, name
change only | 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. | 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. | | | |
| Indications for
Use | Different,
updated name,
weight, and
dimensions | 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 | 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 | | | |
| | | 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" | | The tray is 20.60" length x 9.80" width x | | |
| | | depth | | 2.00" depth. | | |
| System
Features | Different,
design change
to include lift
out trays | Basic lid/base design
Inserts
Perforated
Handles
Latches
Lift out trays | | Basic lid/base design
Inserts
Perforated
Handles
Latches | | |
| Material | Different, new
materials
included | Lid/base— Aluminum
Inserts - Silicone, Aluminum, Stainless
Steel, Nylon-coating
Latch - Stainless Steel
Lift out trays – Aluminum, Stainless Steel,
PROPYLUX, Radel | | Lid/base - Aluminum
Inserts - Silicone, Aluminum, Stainless
Steel, Nylon-coating
Latch - Stainless Steel | | |
| Dimensions
(inches) | Different,
change to
dimensions | Part Number | Dimensions | 20.60" length x 9.80" width x 2.00" depth | | |
| | | 28060CPKG | 20.08" length x
9.84" width x
3.978" depth | | | |
| | | 28061LPKG | 9.824" length x
6.594" width x
0.716" depth | | | |
| | | 28062LPKG | 13.260" length x
9.626" width x
0.749" depth | | | |
| | | | | | | |
| | | 2806PIPKG | 9.213" length x
6.299" width x
1.772" depth | | | |
| | | 2806SIPKG | 12.756" length x
9.213" width x
1.772" depth | | | |
| | | 28061EPKG | 9.213" length x
6.299" width x
1.772" depth | | | |
| | | 28062EPKG | 12.756" length x
9.213" width x
1.772" depth | | | |
| | | 2806DBPKG | 12.756" length x
9.213" width x
1.772" depth | | | |
| | | 2806MPPKG | 9.213" length x
6.299" width x
1.772" depth | | | |
| | | 2806KLPKG | 4.862" length x
2.832" width x
1.225" depth | | | |
| | | 2806OLPKG | 20.546" length x
10.022" width x
1.5" depth | | | |
| System Content | Similar, predicate already included instruments as system content | Instruments | | Implants and instruments | | |
| Intended Maximum Load | Different, updated system load | | Tray + system content weighing no more than 18.7 lbs | Tray + system content weighing no more than 8.5 lbs | | |
| Sterilization Parameters | Same | | Sterilization method: Pre-vacuum (steam)
Cycle Temperature: 270°F (132°C)
Cycle Time: 4 minutes
Drying Time: 20 minutes | Sterilization method: Pre-vacuum (steam)
Cycle Temperature: 270°F (132°C)
Cycle Time: 4 minutes
Drying Time: 20 minutes | | |
| Sterile Barrier | Similar, predicate already included FDA cleared sterilization | | FDA cleared sterilization wrap | FDA cleared sterilization wrap or pouch | | |
| | wrap as the
sterile barrier | | | | | |
| Cleaning
Methods | Different,
change to
cleaning
methods | 1. Disassemble all components as per
manufacturer instructions (if
appropriate). Open all hinged
instruments. *
2. Rinse*
3. Bathe in an enzymatic detergent
solution prepared per manufacturer
directions for 10 minutes. *
4. Scrub*
5. Rinse with cold tap water for a
minimum of two minutes; use a
syringe to repeatedly flush any very
narrow lumens. *
6. Rinse*
7. Sonicate for a minimum of 15 minutes
in an enzymatic detergent solution
prepared per manufacturer
directions. *
8. Rinse thoroughly /flush with RO/DI
water for a minimum of two minutes.*
9. Dry*
10. Visually inspect for cleanliness. All
visible surfaces, internal and external,
should be visually inspected. If
necessary reclean until it is visibly
clean. Visually inspect each instrument
for deterioration such as corrosion and
worn components; ensure that the
laser markings are legible. Visual
inspection must be performed at each
cleaning to determine if an instrument
is acceptable for use. If an instrument
is not acceptable for use, return to the
manufacturer.*
*Cleaning methods are the same to those
of the reference device
NOTE: Steps have been truncated if there
is no difference in cleaning method to that
of the predicate device (i.e. Steps 2, 4, 6,
and 9) | 1. Disassemble all components as per
manufacturer instructions (if
appropriate).
2. Rinse
3. Bathe in an enzymatic detergent
solution prepared per manufacturer
instructions for 5 minutes.
4. Scrub
5. Rinse with cold tap water for a
minimum of one minute; use a
syringe to repeatedly flush any very
narrow lumens.
6. Bathe in a detergent solution
prepared per manufacturer
directions for 5 minutes.
7. Scrub thoroughly with a soft brush
and/or pipe cleaner; repeatedly
flush any very narrow lumens with
detergent solution using a syringe.
8. Rinse
9. Sonicate for a minimum of 10
minutes in an enzymatic detergent
solution prepared per manufacturer
directions.
10. Rinse thoroughly/flush with RO/DI
water.
11. Dry
12. Visually inspect for cleanliness. All
visible surfaces, internal and
external, should be visually
inspected. If necessary reclean until
it is visibly clean.
NOTE: Steps 2, 4, 8, and 11 are comparable to
the subject device; thus, steps have been
truncated. | | | |
| Non-clinical
Data | Same | • Sterilization Efficacy
• Cleaning
• Biocompatibility
• Handle Strength Assessment | • Sterilization Efficacy
• Cleaning
• Biocompatibility
• Tolerance and handle strength analysis | | | |
| Test | Standard / Method | Acceptance Criteria | Results | | | |
| Sterilization Efficacy | ISO 17665-
1:2006(R)20013
ISO11138-1:2017
AAMI ST79:2017
AAMI TIR12:2020 | Sterilization Validation:
All Bl's processed in each
half-cycle must be
negative for microbial
growth of the indicator
organism after 7 days for
the overkill method to be
validated. Positive
controls must show
growth of the indicator
organism. Negative
controls must remain
negative (no growth).
Dry Time Validation:
The dry time validation is
successful if the weight
differential of the
wrapped case after
sterilization does not
increase by 0.2% of the
pre-sterilization weight,
and there is no evidence
of moisture on or within
the sterilized package,
wrap, and instruments. | Pass | | | |
| Cleaning Validation | AAMI TIR30:2011
ISO19227
AAMI TIR12:2020
AAMI ST98:2022
ASTM F2459 (2018)
ASTM D4839-03 (2017) | Acceptance Criteria 1:
Visual Inspection - Visibly
clean without evidence of
discoloration, residue or
particulate to the unaided
eye without magnification
under normal task
lighting. | Pass | | | |
| | | Acceptance Criteria 2:
Protein $\le$ 6.4 µg/cm2
Acceptance Criteria 3:
Hemoglobin $\le$ 2.2 µg/cm2
Acceptance Criteria 4:
TOC $\le$ 1000 mg/device (or
100 mg/cm2 for devices
larger than 50cm2) | | | | |
| | | Biocompatibility | | ISO 10993-1:2018 | The materials are
biocompatible | Pass |
| | | Handle Strength
Assessment | | Shear and Tensile
Strength Analysis -
501913762 | The lowest failure force
determined in the
assessment of handle
assembly components
must be greater than the
maximum load of
18.7lbs. | Pass |
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Image /page/6/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, followed by the text "CrossRoads" in gray. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller font, also in gray.
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Image /page/7/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 blue and green, followed by the word "CrossRoads" in gray. Below "CrossRoads" is the phrase "Extremity Systems" in a smaller, lighter gray font.
8
Image /page/8/Picture/0 description: The image shows the logo for CrossRoads Extremity Systems. The logo consists of a series of colored squares on the left, followed by the text "CrossRoads" in a gray, sans-serif font. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller font. The squares are arranged in a 2x2 grid, with the top left square being blue, the top right square being green, the bottom left square being green, and the bottom right square being blue.
9
Image /page/9/Picture/0 description: The image shows the logo for CrossRoads Extremity Systems. The logo consists of a square grid of four squares in the colors blue and green, followed by the company name in gray, with the trademark symbol next to it. Below the company name, the words "Extremity Systems" are written in a smaller font.
Non-Clinical and/or Clinical Tests Summary
Nonclinical testing included Sterilization Efficacy, Cleaning Validation, Biocompatibility, and Handle Strength Assessment. The data was used for the determination of substantial equivalence. Testing demonstrates that the CrossRoads Modular Tray System is as safe and effective as its predicate device.
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Image /page/10/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 text "CrossRoads" in gray. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller font size, also in gray. The logo is simple and modern, and the colors are calming and professional.
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusions
The conclusions drawn from the nonclinical tests demonstrates that the subject device, K241050, CrossRoads Modular Tray System, is as safe, as effective, and performs as well as or better than the legally marketed device, cleared under K202268.