(141 days)
Not Found
No
The device is a physical tray system for organizing and sterilizing surgical instruments. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a sterilization tray system designed to hold instruments for sterilization and storage, not to diagnose, treat, or prevent disease.
No
The device is a sterilization tray system used to store and organize surgical instruments for cleaning and sterilization, not for diagnostic purposes.
No
The device description clearly states it is a reusable sterilization tray made of physical materials (aluminum, silicone, stainless steel) and is intended for containing and protecting physical medical devices during sterilization. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CrossRoads Tray System is used for storing and organizing surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. This is a function related to the preparation and handling of surgical tools, not for performing diagnostic tests on samples taken from the human body.
- Device Description: The description reinforces its purpose as a reusable sterilization tray or organizing tray for containing reusable medical devices for sterilization.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on sterilization efficacy, reprocessing (cleanability), and biocompatibility, which are all relevant to surgical instrument trays but not to IVD devices.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The CrossRoads Tray System does not fit this definition.
N/A
Intended Use / Indications for Use
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.
Product codes
KCT
Device Description
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.
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)
ER20-0010 Sterilization Efficacy
- Purpose of Testing: To verify the CrossRoads Tray System containing the maximum load were inoculated with biological indicators placed in areas of the trays deemed to be most difficult for sterilant (steam) to penetrate. Following inoculation, the trays were wrapped in FDA-cleared sterilization wraps. The trays indicated that the biological indicators (BI) Overkill method provided a six-log reduction of the indicator organism.
- Acceptance Criteria: No growth on half cycles. No moisture on full drying cycle.
- Results: In the three pre-vacuum autoclave cycles, 2 minutes at 270°F was sufficient to sterilize the 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. Since this is a half-cycle validation, the 4-minute full cycle exposure time will provide the required Sterility Assurance Level (SAL) of 10-6. Positive controls showed growth for all three cycles. Negative controls remained negative (no growth) for all three cycles. There was no evidence of moisture on or within the sterilized package, wrap, and instruments. There was no recorded weight gain after each of the pre-vacuum sterilization cycles.
20-0963 CREX Reprocessing
- Purpose of Testing: To verify the instruments in the CrossRoads Tray System for cleanability according to the user instructions.
- Acceptance Criteria: Meets the AAMI TIR-30 guideline acceptance criteria of
§ 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).
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) |
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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 |
| Establishment | |
| Registration: | 3011421599 |
| Company: | CrossRoads Extremity Systems |
| 6055 Primacy Parkway, Suite 140 | |
| Memphis, TN 38119 USA | |
| Contact Person: | Kim Strohkirch |
| Sr. Director, QA/RA/Compliance | |
| CrossRoads Extremity Systems | |
| 901.221.8406 | |
| kstrohkirch@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 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.
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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 TKA | |
| Instrument | Different | ||
| Product Code | KCT | KCT | Same |
| Intended Use | 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. | The THINK Surgical TCAT® TKA | ||
| Instrument Tray Set is intended to | |||
| protect, organize and deliver to the | |||
| surgical field TCAT® tools, instruments | |||
| and accessories. The trays allowaccessories, and maintain sterility of the | |||
| enclosed devices until used. The trays | |||
| are wrapped with an FDA-cleared | |||
| sterilization wrap during the pre- | |||
| vacuum autoclave sterilization | |||
| process. | Similar | ||
| Intended | |||
| Instrument | |||
| Tray Set | |||
| Content | |||
| Maximum | |||
| Load | Medical devices/ instruments | ||
| weighing no more than 8.5 lbs | |||
| (tray |
- instruments). | Medical devices/ instruments weighing no
less than 7.5lbs-18.0lbs. total including
the weight of the trays. | Different |
| Material | Lid/base/Lift out tray -
Aluminum Inserts - Silicone,
aluminum, stainless steel
Latch - Stainless steel | Lid/base/Lift out tray - Aluminum
Inserts - Silicone, aluminum,
stainless steel, nylon
Latch - 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 x
2.00 inches depth | 20 length x 9.8 width x 4.5 inches
depth | Similar |
| | Sterilization | | |
| Sterilization
Method | Pre-vacuum (Steam) | Pre-vacuum (Steam) | Same |
| Cycle
Temperature | 270 °F (132 °C) | 270 °F (132 °C) | Same |
| Cycle Time | 4 minutes | 4 minutes | Same |
| Drying Time | 20 minutes | 45 minutes | Different |
| Non-Clinical
Performance
Test | • 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 |
|---|---|---|---|
| ER20-0010 | |||
| Sterilization Efficacy | |||
| (ANSI/AAMI/ISO | |||
| 14937:2013 – | |||
| Sterilization of | |||
| Healthcare Product – | |||
| General Requirements | |||
| for Characterization of a | |||
| Sterilizing Agent and the | |||
| Development, Validation | |||
| and Routine Control of a | |||
| Sterilization Process for | |||
| Medical Devices) | To verify the | ||
| CrossRoads Tray | |||
| System containing the | |||
| maximum load were | |||
| inoculated with | |||
| biological indicators | |||
| placed in areas of the | |||
| trays deemed to be | |||
| most difficult for sterilant | |||
| (steam) to penetrate. | |||
| Following inoculation, | |||
| the trays were wrapped | |||
| in FDA-cleared | |||
| sterilization wraps. The | |||
| trays indicated that the | |||
| biological indicators (BI) | |||
| Overkill method | |||
| provided a six-log | |||
| reduction of the | |||
| indicator organism. | No growth on half | ||
| cycles. No moisture | |||
| on full drying cycle. | In the three pre-vacuum | ||
| autoclave cycles, 2 minutes | |||
| at 270°F was sufficient to | |||
| sterilize the 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. Since this is a half- | |||
| cycle validation, the 4- | |||
| minute full cycle exposure | |||
| time will provide the required | |||
| Sterility Assurance Level | |||
| (SAL) of 10-6. Positive | |||
| controls showed growth for | |||
| all three cycles. Negative | |||
| controls remained negative | |||
| (no growth) for all three | |||
| cycles. | |||
| There was no evidence of | |||
| moisture on or within the | |||
| sterilized package, wrap, | |||
| and instruments. There was | |||
| no recorded weight gain | |||
| after each of the pre-vacuum | |||
| sterilization cycles. | |||
| 20-0963 CREX | |||
| Reprocessing | |||
| (AAMI TIR12-2010 | |||
| Designing, testing and | |||
| labeling reusable | |||
| medical devices for | |||
| reprocessing in health | |||
| care facilities: A guide | |||
| for medical device | |||
| manufacturers and | |||
| AAMI TIR30-2011 A | |||
| compendium of | |||
| processes, materials, | |||
| test methods and | |||
| acceptance criteria for | |||
| cleaning reusable | |||
| medical devices) | To verify the | ||
| instruments in the | |||
| CrossRoads Tray | |||
| System for cleanability | |||
| according to the user | |||
| instructions. | Meets the 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 meet the | |||
| acceptance criteria. | |||
| 20-2723 CREX | |||
| (AAMI TIR12-2010 | |||
| Designing, testing and | |||
| labeling reusable | CrossRoads Tray | ||
| System for cleanability | |||
| according to the user | Meets the 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 meet the acceptance | |||
| criteria. | |||
| Name of Testing | Purpose of Testing | Acceptance Criteria | Results |
| medical devices for | |||
| reprocessing in health | |||
| care facilities: A guide | |||
| for medical device | |||
| manufacturers and | |||
| AAMI TIR30-2011 A | |||
| compendium of | |||
| processes, materials, | |||
| test methods and | |||
| acceptance criteria for | |||
| cleaning reusable | |||
| medical devices) | instructions | residuals and ≤ | |
| $2.2µg/cm²$ for | |||
| hemoglobin | |||
| residuals. | |||
| ER20-0010 | |||
| Biocompatibility | |||
| (ANSI/AAMI/ISO 10993- | |||
| 5:2009 - Biological | |||
| Evaluation of Medical | |||
| Devices - Part 5: Tests | |||
| for In Vitro Cytotoxicity) | To verify the | ||
| CrossRoads Tray | |||
| System were | |||
| evaluated for | |||
| biocompatibility | |||
| according to ISO 10993- |
- The results indicated
biocompatibility
requirements were met | Pass is a score of
less than 2. | There was no cytotoxic
reaction observed (Grade 0)
on the ratchet handle, for
any of the sample extracts at
24 and 48hrs contact.
Positive controls were
positive (Grade 4) at 24 and
48hrs. |
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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.