(141 days)
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 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 were validated for a maximum load of 8.5 lbs (tray + instruments).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Prevacuum
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.
The subject CrossRoads Tray System is a reusable sterilization tray or organizing tray 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 the interior components during sterilization. All components are perforated for steam penetration. The tray can hold implants and instruments such as inserters, K-wire guides, fixation pins, reamers and ratcheting handles.
The tray is 20.60" length x 9.80" width x 2.00" depth.
The CrossRoads Tray System tray is manufactured from aluminum conforming to ASTM B029, silicone, 304 stainless steel conforming to ASTM A240 and ASTM A313, 18-8 stainless steel, 17-4 stainless steel 304 stainless steel, and 316 stainless steel.
This document pertains to the CrossRoads Tray System, a reusable sterilization tray for medical devices. The primary study presented verifies the sterilization efficacy and cleanability of the tray and its contents, along with its biocompatibility.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | No growth on half cycles. No moisture on full drying cycle. | In three pre-vacuum autoclave cycles, 2 minutes at 270°F was sufficient to sterilize the biological indicators (BI's) in the DynaBunion Non-Sterile Set, 15NS-4800, when seeded with (8) BI carriers impregnated with Geobacillus stearothermophilus and (2) SporView self-contained BI's. As this was a half-cycle validation, the 4-minute full cycle exposure time is expected to provide the required Sterility Assurance Level (SAL) of 10-6. Positive controls showed growth for all three cycles, and negative controls remained negative (no growth). There was no evidence of moisture on or within the sterilized package, wrap, and instruments, and no recorded weight gain after each pre-vacuum sterilization cycle. |
| Reprocessing (Instruments) | Meets AAMI TIR-30 guideline acceptance criteria of $\le$ 6.4µg/cm² protein residuals and $\le$ 2.2µg/cm² for hemoglobin residuals. | Three (3) cleaning cycles were performed on 5 instruments and met the acceptance criteria. |
| Reprocessing (Tray) | Meets AAMI TIR-30 guideline acceptance criteria of $\le$ 6.4µg/cm² protein residuals and $\le$ 2.2µg/cm² for hemoglobin residuals. | Three (3) cleaning cycles were performed on the tray and met the acceptance criteria. |
| Biocompatibility | Pass is a score of less than 2. | No cytotoxic reaction was observed (Grade 0) on the ratchet handle for any sample extracts at 24 and 48 hours contact. Positive controls were positive (Grade 4) at 24 and 48 hours. |
2. Sample size used for the test set and the data provenance:
- Sterilization Efficacy: The test involved Geobacillus stearothermophilus biological indicators (8 BI carriers and 2 SporView self-contained BIs) placed in areas deemed most difficult for sterilant penetration, within the CrossRoads Tray System containing a maximum load. The specific DynaBunion Non-Sterile Set, 15NS-4800, was used as the representative load. The test was performed over three pre-vacuum autoclave cycles. This appears to be a prospective test conducted specifically for this device submission. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA given the FDA submission.
- Reprocessing (Cleanability):
- Instruments: Three cleaning cycles were performed on 5 instruments.
- Tray: Three cleaning cycles were performed on the tray.
- This is a prospective test. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA.
- Biocompatibility: The test involved the ratchet handle component of the tray system. The specific number of samples tested is not explicitly stated, but "any of the sample extracts at 24 and 48hrs contact" implies multiple extracts were tested. This is a prospective test. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of study does not involve expert readers establishing ground truth in the way a medical image interpretation study would. Ground truth in these types of performance tests (sterilization, cleaning, biocompatibility) is established through standardized laboratory methods and analytical measures (e.g., assessing microbial growth, measuring residual protein/hemoglobin levels, observing cytotoxic reactions) performed by qualified laboratory personnel following established protocols (e.g., ANSI/AAMI/ISO 14937:2013, AAMI TIR12-2010, AAMI TIR30-2011, ANSI/AAMI/ISO 10993-5:2009). The "experts" are the scientists and technicians conducting these validated tests. Their qualifications are inherent in the adherence to these recognized standards.
4. Adjudication method for the test set:
Not applicable for these types of laboratory performance tests. The results are based on objective measurements against predefined acceptance criteria, not subjective human assessments requiring adjudication.
5. 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. This is not an AI-assisted device or a diagnostic device involving human readers or case interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (sterilization tray), not an algorithm or AI system. The tests evaluate the physical performance of the tray itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for these tests is based on objective laboratory measurements and adherence to established scientific and regulatory standards:
- Sterilization Efficacy: Ground truth is the observable absence of microbial growth in biological indicators after sterilization, confirming a 6-log reduction in the indicator organism as required for a Sterility Assurance Level (SAL) of 10-6.
- Reprocessing (Cleanability): Ground truth is the quantitative measurement of residual protein and hemoglobin levels on the instruments and tray, falling below the specified AAMI TIR-30 guideline acceptance criteria.
- Biocompatibility: Ground truth is the absence of a cytotoxic reaction (Grade 0 score) in in-vitro tests, indicating the material does not harm cells.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 30, 2020
CrossRoads Extremity Systems, LLC Kim Strohkirch Sr. Director, QA/RA/Compliance 6055 Primacy Pkwy, Suite 140 Memphis, Tennessee 38119
Re: K202268
Trade/Device Name: CrossRoads Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: December 1, 2020 Received: December 2, 2020
Dear Kim Strohkirch:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
For Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K202268
Device Name CrossRoads Tray System
Indications for Use (Describe)
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 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 were validated for a maximum load of 8.5 lbs (tray + instruments).
| Method: | Steam Sterilization (Moist Heat Sterilization) Cycle Prevacuum |
|---|---|
| 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for CrossRoads Extremity Systems. The logo consists of a grid 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.
510(k) Summary K202268
| Date: | December 27, 2020 |
|---|---|
| Device Name: | CrossRoads Tray System |
| EstablishmentRegistration: | 3011421599 |
| Company: | CrossRoads Extremity Systems6055 Primacy Parkway, Suite 140Memphis, TN 38119 USA |
| Contact Person: | Kim StrohkirchSr. Director, QA/RA/ComplianceCrossRoads Extremity Systems901.221.8406kstrohkirch@crextremity.com |
| Trade Name: | CrossRoads Tray System |
| Common Name: | Sterilization Tray |
| Classification: | Class II |
| Regulation Number: | 21 CFR 880.6850 Sterilization Wrap Containers, Trays,Cassettes & other Accessories |
| Panel: | General Hospital |
| Product Code: | KCT |
| Predicate Devices: | K200632 TCAT TKA Instrument Tray Set |
| Device Description: | The subject CrossRoads Tray System is a reusablesterilization tray or organizing tray intended for use inhealth care facilities for the purpose of containing reusablemedical devices for sterilization. It is composed of multiplepieces, designed to be integrated into a single unit whichcontains and protects the interior components duringsterilization. All components are perforated for steampenetration. The tray can hold implants and instrumentssuch as inserters, K-wire guides, fixation pins, reamers andratcheting handles. |
The tray is 20.60" length x 9.80" width x 2.00" depth.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for "CrossRoads Extremity Systems". The logo consists of four squares in the colors blue and green, arranged in a 2x2 grid. To the right of the squares is the text "CrossRoads" in a gray, sans-serif font, with the trademark symbol. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller, gray, sans-serif font.
The CrossRoads Tray System is used in healthcare Indications for Use: 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 were validated for a maximum load of 8.5 lbs (tray + instruments).
| Method | Steam Sterilization (Moist Heat Sterilization) |
|---|---|
| Cycle | Prevacuum |
| 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.
The CrossRoads Tray System tray is manufactured from Materials: aluminum conforming to ASTM B029, silicone, 304 stainless steel conforming to ASTM A240 and ASTM A313, 18-8 stainless steel, 17-4 stainless steel 304 stainless steel, and 316 stainless steel.
Technology Characteristics:
Shown below is a Technological Characteristics Comparison Table that compares the subject device and the predicate device in this submission:
{5}------------------------------------------------
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 text "CrossRoads" in a gray sans-serif font. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller, lighter gray font. The logo is simple and modern, and the colors are calming and professional.
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| 510(k) | K202268 | K200632 | Different |
| Name | CrossRoads Tray System | THINK Surgical TCAT TKAInstrument | Different |
| Product Code | KCT | KCT | Same |
| Intended Use | The CrossRoads Tray Systemis designed to hold varioussurgical instruments in order toorganize, steam sterilize, andtransport the instrumentsbetween uses. The trays arewrapped with an FDA- clearedsterilization wrap during thepre- vacuum autoclavesterilization process. | The THINK Surgical TCAT® TKAInstrument Tray Set is intended toprotect, organize and deliver to thesurgical field TCAT® tools, instrumentsand accessories. The trays allowaccessories, and maintain sterility of theenclosed devices until used. The traysare wrapped with an FDA-clearedsterilization wrap during the pre-vacuum autoclave sterilizationprocess. | Similar |
| IntendedInstrumentTray SetContentMaximumLoad | Medical devices/ instrumentsweighing no more than 8.5 lbs(tray+ instruments). | Medical devices/ instruments weighing noless than 7.5lbs-18.0lbs. total includingthe weight of the trays. | Different |
| Material | Lid/base/Lift out tray -Aluminum Inserts - Silicone,aluminum, stainless steelLatch - Stainless steel | Lid/base/Lift out tray - AluminumInserts - Silicone, aluminum,stainless steel, nylonLatch - Stainless steel | Similar |
| Design | Base and lid | Base, lift out tray, lid | Similar |
| Insert | Yes | Yes | Same |
| Dimensions | 20.60 length x 9.80 width x2.00 inches depth | 20 length x 9.8 width x 4.5 inchesdepth | Similar |
| Sterilization | |||
| SterilizationMethod | Pre-vacuum (Steam) | Pre-vacuum (Steam) | Same |
| CycleTemperature | 270 °F (132 °C) | 270 °F (132 °C) | Same |
| Cycle Time | 4 minutes | 4 minutes | Same |
| Drying Time | 20 minutes | 45 minutes | Different |
| Non-ClinicalPerformanceTest | • Sterilization Efficacy• Cleaning• Biocompatibility | • Sterilization Efficacy• Packaging• Cleaning• Biocompatibility• Use and Sterile Processing• Guide | Similar |
{6}------------------------------------------------
Image /page/6/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, also in gray. The logo is simple and modern, with a focus on the company name.
Performance Testing:
| Name of Testing | Purpose of Testing | Acceptance Criteria | Results |
|---|---|---|---|
| ER20-0010Sterilization Efficacy(ANSI/AAMI/ISO14937:2013 –Sterilization ofHealthcare Product –General Requirementsfor Characterization of aSterilizing Agent and theDevelopment, Validationand Routine Control of aSterilization Process forMedical Devices) | To verify theCrossRoads TraySystem containing themaximum load wereinoculated withbiological indicatorsplaced in areas of thetrays deemed to bemost difficult for sterilant(steam) to penetrate.Following inoculation,the trays were wrappedin FDA-clearedsterilization wraps. Thetrays indicated that thebiological indicators (BI)Overkill methodprovided a six-logreduction of theindicator organism. | No growth on halfcycles. No moistureon full drying cycle. | In the three pre-vacuumautoclave cycles, 2 minutesat 270°F was sufficient tosterilize the BI's in theDynaBunion Non-Sterile Set,15NS-4800, when seededwith (8) BI carriersimpregnated withGeobacillusstearothermophilus and (2)SporView self-containedBI's. Since this is a half-cycle validation, the 4-minute full cycle exposuretime will provide the requiredSterility Assurance Level(SAL) of 10-6. Positivecontrols showed growth forall three cycles. Negativecontrols remained negative(no growth) for all threecycles.There was no evidence ofmoisture on or within thesterilized package, wrap,and instruments. There wasno recorded weight gainafter each of the pre-vacuumsterilization cycles. |
| 20-0963 CREXReprocessing(AAMI TIR12-2010Designing, testing andlabeling reusablemedical devices forreprocessing in healthcare facilities: A guidefor medical devicemanufacturers andAAMI TIR30-2011 Acompendium ofprocesses, materials,test methods andacceptance criteria forcleaning reusablemedical devices) | To verify theinstruments in theCrossRoads TraySystem for cleanabilityaccording to the userinstructions. | Meets the AAMI TIR-30 guidelineacceptance criteria of$\le$ 6.4µg/cm² proteinresiduals and $\le$2.2µg/cm² forhemoglobinresiduals. | Three (3) cleaning cycleswere performed on 5instruments and meet theacceptance criteria. |
| 20-2723 CREX(AAMI TIR12-2010Designing, testing andlabeling reusable | CrossRoads TraySystem for cleanabilityaccording to the user | Meets the AAMI TIR-30 guidelineacceptance criteria of$\le$ 6.4µg/cm² proteinresiduals and $\le$2.2µg/cm² forhemoglobinresiduals. | Three (3) cleaning cycleswere performed on the trayand meet the acceptancecriteria. |
| Name of Testing | Purpose of Testing | Acceptance Criteria | Results |
| medical devices forreprocessing in healthcare facilities: A guidefor medical devicemanufacturers andAAMI TIR30-2011 Acompendium ofprocesses, materials,test methods andacceptance criteria forcleaning reusablemedical devices) | instructions | residuals and ≤$2.2µg/cm²$ forhemoglobinresiduals. | |
| ER20-0010Biocompatibility(ANSI/AAMI/ISO 10993-5:2009 - BiologicalEvaluation of MedicalDevices - Part 5: Testsfor In Vitro Cytotoxicity) | To verify theCrossRoads TraySystem wereevaluated forbiocompatibilityaccording to ISO 10993-1. The results indicatedbiocompatibilityrequirements were met | Pass is a score ofless than 2. | There was no cytotoxicreaction observed (Grade 0)on the ratchet handle, forany of the sample extracts at24 and 48hrs contact.Positive controls werepositive (Grade 4) at 24 and48hrs. |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for "CrossRoads Extremity Systems". The logo consists of four squares arranged in a 2x2 grid on the left side. The top left square is dark blue, the top right square is green, the bottom left square is light green, and the bottom right square is light blue. To the right of the squares is the text "CrossRoads" in gray, with "Extremity Systems" in a smaller font below it.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).