(90 days)
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
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.
This document is a 510(k) Premarket Notification from the FDA for a medical device. It describes a sterilization wrap/case called the "CrossRoads Modular Tray System." The information pertains to the device's functional performance related to sterilization and handling, not to an AI/ML-driven diagnostic or image analysis system.
Therefore, the requested information elements such as "sample size for the test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable to this type of device and its regulatory review process. These questions are typically relevant for AI/ML-based diagnostic devices.
The document focuses on engineering and performance testing for mechanical and sterilization efficacy, not AI algorithm performance.
However, I can provide the acceptance criteria and reported device performance from the document based on the provided tables.
Acceptance Criteria and Reported Device Performance for CrossRoads Modular Tray System (K241050)
The device is a reusable sterilization case. The tests performed are standard engineering and sterilization validation tests, not AI/ML performance evaluations.
Table of Acceptance Criteria and Reported Device Performance
| Test | Standard / Method | Acceptance Criteria | Reported Performance / Results |
|---|---|---|---|
| Sterilization Efficacy | ISO 17665-1:2006(R)20013, ISO11138-1:2017, AAMI ST79:2017, AAMI TIR12:2020 | Sterilization Validation: All BIs 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. Acceptance Criteria 2 (Protein): ≤ 6.4 µg/cm² Acceptance Criteria 3 (Hemoglobin): ≤ 2.2 µg/cm² Acceptance Criteria 4 (TOC): ≤ 1000 mg/device (or 100 mg/cm² for devices larger than 50cm²) | Pass |
| 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 18.7 lbs. | Pass |
Based on the provided document, the following requested information is not applicable or not provided, as the device is a sterilization tray and not an AI/ML diagnostic system:
- Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI/ML model. The tests conducted (sterilization, cleaning, biocompatibility, handle strength) would involve specific numbers of units or samples as per the relevant standards, but this is not a "test set" for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of physical device testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is defined by physical/chemical measurements and standardized biological indicator responses, not expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for these tests is based on the results of validated physical and chemical tests (e.g., microbial growth/no growth, weight change, protein/hemoglobin/TOC levels, force measurements). Not based on expert consensus or pathology in a diagnostic sense.
- The sample size for the training set: Not applicable (no training set for a traditional engineering device).
- How the ground truth for the training set was established: Not applicable.
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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 (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 -SDate: 2024.07.16 17:47:19 -04'00' |
| for: Christopher K. Dugard, MSAssistant Director | DHT4B: Division of Infection Controland Plastic and Reconstructive Surgery DevicesOHT4: Office of Surgical and Infection Control DevicesOffice of Product Evaluation and QualityCenter 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) | |
|---|---|
| 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 vspredicatedevice) | Subject Device (K241050) | Predicate Device (K202268) | |||
|---|---|---|---|---|---|---|
| Device Name | Different, namechange | CrossRoads Modular Tray System | CrossRoads Tray System | |||
| Device Image | Different, newtray design | Image: CrossRoads Modular Tray System | Image: CrossRoads Tray System | |||
| Product Code | Same | KCT | KCT | |||
| Intended Use | Similar, namechange only | The CrossRoads Modular Tray System isdesigned to hold various surgicalinstruments in order to organize, steamsterilize, and transport the instrumentsbetween uses. The trays are wrapped withan FDA-cleared sterilization wrap duringthe pre-vacuum autoclave sterilizationprocess. | The CrossRoads Tray System is designed tohold various surgical instruments in orderto organize, steam sterilize, and transportthe instruments between uses. The traysare wrapped with an FDA-clearedsterilization wrap during the pre-vacuumautoclave sterilization process. | |||
| Indications forUse | Different,updated name,weight, anddimensions | The CrossRoads Modular Tray System isused in healthcare facilities to store andorganize CrossRoads surgical instrumentsand components during sterilization andduring implant/prosthetic treatment. TheCrossRoads Modular Tray System is notintended on its own to maintain sterility; it | The CrossRoads Tray System is used inhealthcare facilities to store and organizeCrossRoads surgical instruments andcomponents during cleaning/sterilizationand during implant/prosthetic treatment.The CrossRoads Tray System are notintended 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. | |||||
| SystemFeatures | Different,design changeto include liftout trays | Basic lid/base designInsertsPerforatedHandlesLatchesLift out trays | Basic lid/base designInsertsPerforatedHandlesLatches | |||
| Material | Different, newmaterialsincluded | Lid/base— AluminumInserts - Silicone, Aluminum, StainlessSteel, Nylon-coatingLatch - Stainless SteelLift out trays – Aluminum, Stainless Steel,PROPYLUX, Radel | Lid/base - AluminumInserts - Silicone, Aluminum, StainlessSteel, Nylon-coatingLatch - Stainless Steel | |||
| Dimensions(inches) | Different,change todimensions | Part Number | Dimensions | 20.60" length x 9.80" width x 2.00" depth | ||
| 28060CPKG | 20.08" length x9.84" width x3.978" depth | |||||
| 28061LPKG | 9.824" length x6.594" width x0.716" depth | |||||
| 28062LPKG | 13.260" length x9.626" width x0.749" depth | |||||
| 2806PIPKG | 9.213" length x6.299" width x1.772" depth | |||||
| 2806SIPKG | 12.756" length x9.213" width x1.772" depth | |||||
| 28061EPKG | 9.213" length x6.299" width x1.772" depth | |||||
| 28062EPKG | 12.756" length x9.213" width x1.772" depth | |||||
| 2806DBPKG | 12.756" length x9.213" width x1.772" depth | |||||
| 2806MPPKG | 9.213" length x6.299" width x1.772" depth | |||||
| 2806KLPKG | 4.862" length x2.832" width x1.225" depth | |||||
| 2806OLPKG | 20.546" length x10.022" width x1.5" 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 minutesDrying Time: 20 minutes | Sterilization method: Pre-vacuum (steam)Cycle Temperature: 270°F (132°C)Cycle Time: 4 minutesDrying Time: 20 minutes | |||
| Sterile Barrier | Similar, predicate already included FDA cleared sterilization | FDA cleared sterilization wrap | FDA cleared sterilization wrap or pouch | |||
| wrap as thesterile barrier | ||||||
| CleaningMethods | Different,change tocleaningmethods | 1. Disassemble all components as permanufacturer instructions (ifappropriate). Open all hingedinstruments. 2. Rinse3. Bathe in an enzymatic detergentsolution prepared per manufacturerdirections for 10 minutes. 4. Scrub5. Rinse with cold tap water for aminimum of two minutes; use asyringe to repeatedly flush any verynarrow lumens. 6. Rinse7. Sonicate for a minimum of 15 minutesin an enzymatic detergent solutionprepared per manufacturerdirections. 8. Rinse thoroughly /flush with RO/DIwater for a minimum of two minutes.9. Dry*10. Visually inspect for cleanliness. Allvisible surfaces, internal and external,should be visually inspected. Ifnecessary reclean until it is visiblyclean. Visually inspect each instrumentfor deterioration such as corrosion andworn components; ensure that thelaser markings are legible. Visualinspection must be performed at eachcleaning to determine if an instrumentis acceptable for use. If an instrumentis not acceptable for use, return to themanufacturer.**Cleaning methods are the same to thoseof the reference deviceNOTE: Steps have been truncated if thereis no difference in cleaning method to thatof the predicate device (i.e. Steps 2, 4, 6,and 9) | 1. Disassemble all components as permanufacturer instructions (ifappropriate).2. Rinse3. Bathe in an enzymatic detergentsolution prepared per manufacturerinstructions for 5 minutes.4. Scrub5. Rinse with cold tap water for aminimum of one minute; use asyringe to repeatedly flush any verynarrow lumens.6. Bathe in a detergent solutionprepared per manufacturerdirections for 5 minutes.7. Scrub thoroughly with a soft brushand/or pipe cleaner; repeatedlyflush any very narrow lumens withdetergent solution using a syringe.8. Rinse9. Sonicate for a minimum of 10minutes in an enzymatic detergentsolution prepared per manufacturerdirections.10. Rinse thoroughly/flush with RO/DIwater.11. Dry12. Visually inspect for cleanliness. Allvisible surfaces, internal andexternal, should be visuallyinspected. If necessary reclean untilit is visibly clean.NOTE: Steps 2, 4, 8, and 11 are comparable tothe subject device; thus, steps have beentruncated. | |||
| Non-clinicalData | 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)20013ISO11138-1:2017AAMI ST79:2017AAMI TIR12:2020 | Sterilization Validation:All Bl's processed in eachhalf-cycle must benegative for microbialgrowth of the indicatororganism after 7 days forthe overkill method to bevalidated. Positivecontrols must showgrowth of the indicatororganism. Negativecontrols must remainnegative (no growth).Dry Time Validation:The dry time validation issuccessful if the weightdifferential of thewrapped case aftersterilization does notincrease by 0.2% of thepre-sterilization weight,and there is no evidenceof moisture on or withinthe sterilized package,wrap, and instruments. | Pass | |||
| Cleaning Validation | AAMI TIR30:2011ISO19227AAMI TIR12:2020AAMI ST98:2022ASTM F2459 (2018)ASTM D4839-03 (2017) | Acceptance Criteria 1:Visual Inspection - Visiblyclean without evidence ofdiscoloration, residue orparticulate to the unaidedeye without magnificationunder normal tasklighting. | Pass | |||
| Acceptance Criteria 2:Protein $\le$ 6.4 µg/cm2Acceptance Criteria 3:Hemoglobin $\le$ 2.2 µg/cm2Acceptance Criteria 4:TOC $\le$ 1000 mg/device (or100 mg/cm2 for deviceslarger than 50cm2) | ||||||
| Biocompatibility | ISO 10993-1:2018 | The materials arebiocompatible | Pass | |||
| Handle StrengthAssessment | Shear and TensileStrength Analysis -501913762 | The lowest failure forcedetermined in theassessment of handleassembly componentsmust be greater than themaximum load of18.7lbs. | 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.
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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.
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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.
§ 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).