(69 days)
The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as part of their treatment plan.
The X-Guide® Surgical Navigation System is an electro-optical dental implantation procedures by providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data.
The X-Guide® Surgical Navigation System is currently cleared (K150222) with Bone Screws which are intended to affix an Edentulous Clin to an edentulous patients anatomy. The Edentulous clip is necessary to attach tracking patterns to facilitate the navigation and tracking process, and is calibrated to the patient anatomy and CT.
As an alternative, the proposed EDX Bone Screws and EDX Nut may be used to secure tracking patterns to edentulous patient anatomy.
The proposed EDX Bone Screws are a titanium screws which are tapered and vary in diameters of 2.7 mm and 3.2 mm wth thread lengths of 7mm and stud lengths of 4 mm, and 16 mm. In addition to the dimensional design changes, the screws have been modified with an M5 threading to accept the EDX Nut. The addition of M5 the Bone Screw is necessary to secure the tracking patterns to the patient.
The 2.7 mm diameter EDX Bone Screws are typically placed to secure the EDX Tracker Arm. Should the bone be too soft resulting in a loose Bone Screw, a large diameter "rescue" EDX Bone Screw (3.2 mm diameter) can be placed.
All of the EDX Bone Screws and EDX Bone Nuts are manufactured using a Ti6AL4V (Grade 5) alloy per ASTM F136 and adhere to the requirements of ASTM F543.
The EDX Bone Screws are intended to be removed from the conclusion of the surgical implant procedure. The EDX Bone Screws are single use devices, sold in a non-sterile state and intended to be sterilized by the end user prior to use.
The body of the proposed EDX Tracker Arms a stanless steel, which is a harder material providing more stability / rigidity in the Tracker Arm. A passivation coating is added to prevent oxidation of the during steam sterilization.
The EDX Tracker Arms include a spike intended to added stability in EDX Tracker Arm registration.
The body of the proposed EDX Tracker Arms are contoured in a variety of geometric shapes intended to minimize interferences with patient soft tissue by positioning on the Mandible and Maxilla in the posterior positions of the oral cavity.
The EDX Tracker Arms are distributed in a non-sterile state, and intended to be sterilized by the end user prior to use.
This is an FDA 510(k) Premarket Notification for the X-Guide® Surgical Navigation System, specifically addressing new components (EDX Bone Screws, EDX Nut, and EDX Tracker Arms). The document details the device description, comparison to predicate and reference devices, and non-clinical performance testing.
Here's the breakdown of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance numbers for the new components in terms of clinical accuracy or effectiveness. Instead, the "Performance Testing - Non-Clinical" section describes various tests performed and their conclusions, primarily focusing on demonstrating equivalence to the predicate device or adherence to existing standards.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Mechanical Properties | The predicate device's bone screws were tested per ASTM E543-17. The new EDX Bone Screws should be substantially equivalent in mechanical properties. | A review of test results and comparison demonstrated that the EDX Bone Screws are substantially equivalent to the predicate device Bone Screws. Additional mechanical testing was conducted to assess comparative deflection and stability of the EDX assembly under load conditions (specific results not detailed). |
| Biocompatibility | Per FDA Guidance document 1811, "Use of International Standard ISO 10993-1," biocompatibility testing is not necessary if the material, process, and tissue contact are comparable to a legally marketed predicate device, and manufacturing does not adversely impact biocompatibility. Otherwise, cytotoxicity, sensitization, and irritation testing are required. | The EDX Bone Screws, EDX Bone Screw Nut, and EDX Tracker Arms were deemed equivalent in material, process, and tissue contact to the predicate device. Therefore, biocompatibility results from the predicate device (K150222) were used to demonstrate compliance. |
| Sterilization | The new components (EDX Bone Screws) should meet a sterility assurance level (SAL) of ≤10-6 using the biological indicator (BI) overkill method. Cleaning and sterilization validation per ISO 17665-1 and FDA Reprocessing Guidance Document. | The EDX Bone Screws are considered geometrically similar to the predicate system, which successfully met a SAL of ≤10-6. Cleaning and sterilization validation conducted per ISO 17665-1 and FDA Reprocessing Guidance Document were provided. |
| Effect on Navigation | The changes in the EDX components (bone screws, nut, tracker arms) should not raise new issues of substantial equivalence, implying that the navigational accuracy and performance of the X-Guide® system should remain consistent with the cleared predicate. | "(S)ubstantial equivalence between the predicate and the proposed EDX Bone Screw, EDX Tracker Arms, and EDX Bone Screw Nut has been demonstrated throughout this submission by performance and bench testing, comparison of intended clinical and similarity in materials." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each specific test mentioned (e.g., mechanical testing, sterilization validation). The document uses a comparative approach, relying on the substantial equivalence to previous tests or established standards.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or conducted by the manufacturer based on regulatory standards. The studies referred to are "performance and bench testing." The phrase "Additional mechanical testing was conducted on the subject device" suggests this was done for the current submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The provided document details non-clinical performance testing and a comparison to a predicate device for regulatory clearance. It does not describe a study involving human experts to establish ground truth for a test set in the context of diagnostic accuracy or clinical decision-making.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a test set requiring adjudication in the context of expert review or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this submission. The document explicitly states: "Clinical testing was not necessary for the substantial equivalence determination."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a surgical navigation system, which inherently involves a human (the surgeon) in the loop. The "performance and bench testing" described are non-clinical and focus on the physical components and their properties, not a standalone algorithmic performance in the absence of human interaction.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by:
- Established Standards: e.g., ASTM E543-17 for mechanical properties, ISO 10993-1 for biocompatibility, ISO 17665-1 for sterilization.
- Predicate Device Data: Performance characteristics of the previously cleared X-Guide® Surgical Navigation System (K150222) serve as a baseline for demonstrating substantial equivalence of the new components.
8. The Sample Size for the Training Set
Not applicable. This document is not describing an AI/algorithm where a "training set" would be used in the traditional sense. The X-Guide® system is a navigation system that uses CT scan data for preoperative planning and intra-operative guidance, not a machine learning model that requires a training set for its development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/algorithm described in this document.
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May 21, 2020
X-NAV Technologies, LLC. Fred Cowdery VP- Regulatory and Ouality Compliance 1555 Bustard Road, Suite 75 Lansdale, Pennsylvania 19446
Re: K200662
Trade/Device Name: X-Guide® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: April 20, 2020 Received: April 24, 2020
Dear Fred Cowdery:
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
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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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200662
Device Name
X-Guide® Surgical Navigation System
Indications for Use (Describe)
The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as part of their treatment plan.
| 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 is a logo for X-NAV Technologies. The "X" in X-NAV is stylized with green, blue, and gray horizontal lines. The rest of the text is in a dark blue color, and the word "TECHNOLOGIES" is in gray and located below the X-NAV text.
510(k) Summary (As required by Section 807.92)
| Date Prepared: | May 20, 2020 |
|---|---|
| Applicant: | X-NAV Technologies, LLC1555 Bustard Road, Suite 75Lansdale, PA. 19446 |
| Contact Person: | Fred CowderyVice President - Regulatory and Quality CompliancePh 267.436.0414Email: fred.cowdery@x-navtech.com |
| Device Trade/Proprietary Name: | X-Guide® Surgical Navigation System |
Device Name: Common / Usual: Surgical Navigation System
| ClassificationName: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories) |
|---|---|
| Regulatory Class: | II |
| Product Code: | PLV |
| Primary Predicate Device: | X-Guide® Surgical Navigation System (K150222) |
| Reference Device: | KLS Martin Individual Patient Solutions (K163579) |
Indications for Use:
The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures.
The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as part of their treatment plan.
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Image /page/4/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of green, blue, and gray bars. To the right of the "X" is the word "-NAV" in blue, and below the entire logo is the word "TECHNOLOGIES" in gray.
Device Description:
The X-Guide® Surgical Navigation Systemis anelectro-optical dental implantation procedures by providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data.
The X-Guide® Surgical Navigation System is currently cleared (K150222) with Bone Screws which are intended to affix an Edentulous Clin to an edentulous patients anatomy. The Edentulous clip is necessary to attach tracking patterns to facilitate the navigation and tracking process, and is calibrated to the patient anatomy and CT.
As an alternative, the proposed EDX Bone Screws and EDX Nut may be used to secure tracking patterns to edentulous patient anatomy.
The proposed EDX Bone Screws are a titanium screws which are tapered and vary in diameters of 2.7 mm and 3.2 mm wth thread lengths of 7mm and stud lengths of 4 mm, and 16 mm. In addition to the dimensional design changes, the screws have been modified with an M5 threading to accept the EDX Nut. The addition of M5 the Bone Screw is necessary to secure the tracking patterns to the patient.
The 2.7 mm diameter EDX Bone Screws are typically placed to secure the EDX Tracker Arm. Should the bone be too soft resulting in a loose Bone Screw, a large diameter "rescue" EDX Bone Screw (3.2 mm diameter) can be placed.
All of the EDX Bone Screws and EDX Bone Nuts are manufactured using a Ti6AL4V (Grade 5) alloy per ASTM F136 and adhere to the requirements of ASTM F543.
The EDX Bone Screws are intended to be removed from the conclusion of the surgical implant procedure. The EDX Bone Screws are single use devices, sold in a non-sterile state and intended to be sterilized by the end user prior to use.
The body of the proposed EDX Tracker Arms a stanless steel, which is a harder material providing more stability / rigidity in the Tracker Arm. A passivation coating is added to prevent oxidation of the during steam sterilization.
The EDX Tracker Arms include a spike intended to added stability in EDX Tracker Arm registration.
The body of the proposed EDX Tracker Arms are contoured in a variety of geometric shapes intended to minimize interferences with patient soft tissue by positioning on the Mandible and Maxilla in the posterior positions of the oral cavity.
The EDX Tracker Arms are distributed in a non-sterile state, and intended to be sterilized by the end user prior to use.
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Proposed Components:
| X-Nav Part Number | Description |
|---|---|
| P010303 | Bone Screw, Length: 4mm; Diameter: 2.7mm |
| P010304 | Bone Screw, Length: 8mm; Diameter: 2.7mm |
| P010305 | Bone Screw, Length: 16mm; Diameter: 2.7mm |
| P010306 | Bone Screw, Length: 4mm; Diameter: 3.2mm |
| P010307 | Bone Screw, Length: 8mm; Diameter: 3.2mm |
| P010308 | Bone Screw, Length: 16mm; Diameter: 3.2mm |
| P010869 | Tracker Arm Assembly; EDX, Posterior Upper Right |
| P010870 | Tracker Arm Assembly; EDX, Posterior Upper Left |
| P010871 | Tracker Arm Assembly; EDX, Anterior Upper Right |
| P010872 | Tracker Arm Assembly; EDX, Anterior Upper Left |
| P010873 | Tracker Arm Assembly; EDX, Posterior Lower Right |
| P010874 | Tracker Arm Assembly; EDX, Posterior Lower Left |
| P010875 | Tracker Arm Assembly; EDX, Anterior Lower Right |
| P010876 | Tracker Arm Assembly; EDX, Anterior Lower Left |
| P010660 | Bone Screw Nut, EDX |
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Image /page/6/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of green, blue, and gray bars, followed by the text "-NAV" in large, bold, blue letters. Below the main logo is the word "TECHNOLOGIES" in smaller, gray letters.
Comparison to Predicate and Reference Devices:
As described in the tables below, the application System is substantially equivalent in intended use, design and physician use to the predicate device X-Guide® System (K15022). The application device is substantially equivalent in scientific technology to the reference device KLS Martin Drill Free® MMF Screw.
| Application Device | Primary Predicate Device | Reference Device | ||
|---|---|---|---|---|
| UseSpecifications | X-Guide® SurgicalNavigation System | X-Guide® SurgicalNavigation System(K150222) | KLS MartinIndividual PatientSolutions (K163579) | Justification ofDifferences |
| Indications forUse | The X-Guide® Surgical NavigationSystem is a computerizednavigational system intended toprovide assistance in both thepreoperative planning phase and theintra- operative surgical phase ofdental implantation procedures.The system provides software topreoperatively plan dentalsurgical procedures and providesnavigational guidance of thesurgical instruments. The deviceis intended for use for partiallyedentulous and edentulous adultand geriatricpatients who need dentalimplants as part of theirtreatment plan. | The X-Guide® Surgical NavigationSystem is a computerized navigationalsystem intended to provide assistance inboth the preoperative planning phase andthe intra-operative surgical phase ofdental implantation procedures.The system provides software topreoperatively plan dental surgicalprocedures and provides navigationalguidance of the surgical instruments. Thedevice is intended for use for partiallyedentulous and edentulous adult andgeriatricpatients who need dental implants aspart of their treatment plan. | KLS Martin Individual Patient Solutionsimplant devices are intended for use inthe stabilization and fixation ofmandibular fractures and mandibularreconstruction. | The proposed device and Predicatedevice share the same intended use.Although the reference device has adifferent intended use, it was chosen toshow there are cleared devices of thesame diameter. |
| Product Code | PLV | PLV | DZL | |
| Application Device | Primary Predicate Device | Reference Device | ||
| Technology / PerformanceCharacteristics - Bone Screws | X-Guide® SurgicalNavigation System (K200662) | X-Guide® SurgicalNavigation System (K150222) | KLS Martin IndividualPatient Solutions (K163579) | Justification of Differences |
| Material | Titanium Ti-6AL-4V (Grade 5) | Titanium Ti-6AL-4V (Grade 5) | Titanium Ti-6AL-4V | No Difference |
| Screw Type | Self- DrillingSelf-Tapping | Self- DrillingSelf-Tapping | Self- DrillingSelf-Tapping | No Difference |
| Manufacturing Method | Traditional (Subtractive) | Traditional (Subtractive) | Traditional (Subtractive) | No Difference |
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | No Difference |
| Anatomical Sites | Mandible and Maxilla | Mandible and Maxilla | Mandible and Maxilla | No Difference |
| Diameter | 2.7 mm, 3.2 mm | 2.0 mm, 2.7 mm | 2.0 mm – 3.2mm | No Difference |
| Thread Length | 7 mm | 4, 6, 8, 10, mm | 5 mm – 22 mm | Application Device Thread Length iswithin range of Predicate andReference devices. |
| Thread Pitch | 2.7mm diameter: 1.20 mm3.2mm diameter: 1.23 mm | 2.0mm Diameter: 0.80 mm2.7 mm Diameter: 1.20 mm | Documentation does not listthread pitch | 2.7mm pitch is based off ofpredicate. 3.2 pitch is derived fromTable A5.2 listed in ASME F543-17,Metallic Medical Bone Screws. |
| Stud (Shaft) Length | 4,8 16 mm | N/A | N/A | Stud offsets EDX Tracker Arm frombone and tissue, allowing the trackerarm to be clamped between the EDXNut and Bone Screw providingincreased mounting stability.Predicate and reference devicesclamp Edentulous Clip or Bone Platedirectly to the bone which may havecurvatures. |
| Biocompatibility | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | No Difference |
| Single Use | Yes | Yes | Yes | No Difference |
| Shelf Life | None | None | Unknown | No Difference |
| Surface Casting | Anodizing | Anodizing | Anodizing | No Difference |
| Application Device (K200662) | Primary Predicate Device | |||
| Technology / PerformanceCharacteristics - Tracker Arm | X-Guide® Surgical NavigationSystem(EDX Tracker Arms) | X-Guide® SurgicalNavigation System(K150222)(Predicate Tracker Arms) | Justification of Differences | |
| Material | Stainless Steel (316L) | Aluminum 6061-T6 (Grade 5),316L, | Stainless Steel has stronger material properties and is therefore a morerigid material than Aluminum. | |
| Manufacturing Method | Traditional (Subtractive) | Traditional (Subtractive) | No Difference | |
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | No Difference | |
| Anatomical Sites | Mandible and Maxilla (8Versions) | Mandible and Maxilla (3Versions) | Additional arm shapes to avoid interference with patient soft tissueand surgical instruments. | |
| Spikes | Spike is between mounting holeson tracker arm to provide stability | Spikes are underneath E-Clipto provide stability | No Difference | |
| Attachment Method | Clamped between EDX Nut andEDX Bone Screw | Tracker arm is attached to E-clip via tracker arm screw. E-Clip is clamped between bonescrew and patient bone. | EDX mounting technique provides improved mounting stability,allowing the tracker arm to be clamped between the EDX Nut and bonescrew and offset from soft tissue. | |
| Stud (Shaft) Length | 4, 8, 16 mm | Not Applicable | EDX Bone Screw shaft offsets Tracker Arm above bone and tissue,allowing the tracker arm to be clamped between the EDX Nut and bonescrew. | |
| Biocompatibility | Biocompatible in accordance withISO 10993-1 | Biocompatible in accordance with ISO 10993-1 | No Difference | |
| Single Use | No | No | No Difference | |
| Shelf Life | None | None | Similar | |
| Surface Casting | Passivation | Anodizing/Passivation | Predicate Device is Anodized. Application Device is passivated. Bothmethods are acceptable industry standards to prevent corrosion. |
Table 1: Summary of Technological Characteristics Comparison
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Image /page/9/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of blue, green, and gray horizontal bars. To the right of the "X" is the word "NAV" in large, bold, dark blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, light gray letters.
Risk Management was performed in compliance with ISO 14971:2012 and includes FMEA analysis to review the following:
- risks associated with the use, usability and performance of the device (HFFMEA and Risk Analysis) .
- the risks associated with and specific to the design aspects of the device (Risk Analysis) .
- Risks associated with biocompatibility, cleaning and sterilization
Additional warning information was added to the product labeling to mitigate any residual risks.
Performance Testing - Non-Clinical:
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Dental Stereotaxic Instruments.
-
- Mechanical Properties:
The predicate devices Bone Screws were tested in a STM E543-17. A review of the test results and comparison of the mechanical properties of the predicate device Bone Screws and the EDX Bone Screws are substantialy equival are substantially equivalent to the predicate device Bone Screws.
- Mechanical Properties:
Additional mechanical testing was conducted on the subject device to assess comparative deflection and stability of the EDX assembly under load conditions.
-
- Biocompatibility:
Per FDA Guidance document 1811, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", section IV.A, biocompatibility testing is not necessary 'if the sponsor is able to document the use of a particular material in a legally-marketed predicate device with comparable tissue exposure, and is able to explain why manufacturing is not expected to adversely impact biocompatibility."
- Biocompatibility:
The EDS Bone Screws, EDX Bone Screw Nut, and EDX Tracker Arms were deemed to be equivalent in material, process, and tissue contact to the predicate device. Therefore, this submission is results of Biocompatibility Testing (Cytotoxicity, Sensitization, and Irritation) conducted on our predicate device (K150222) to demonstrate biocompatibility compliance for the proposed components.
-
- Sterilization Testing:
The EDX Bone Screws are considered geometrically similar to the predicate X-Guide® Surgical Navigation Systems, which were successfully tested and determined to meet a sterility assurance level (SAL) of ≤10-6 using the biological indicator (BI) overkill method. Therefore, this submission is results of cleaning and sterliization validation conducted per ISO 17665-1 and FDA Reprocessing Guidance Document to demonstrate compliance for the subject components.
- Sterilization Testing:
Performance Testing - Clinical Testing:
Clinical testing was not necessary for the substantial equivalence determination.
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Image /page/10/Picture/0 description: The image shows the logo for X-NAV Technologies. The X is made up of green, blue, and gray horizontal lines. The NAV is in large, bold, blue letters. The word TECHNOLOGIES is in smaller, gray letters below the X-NAV.
Substantial Equivalence Conclusion:
Substantial equivalence between the predicate and the proposed EDX Bone Screw, EDX Tracker Arms, and EDX Bone Screw Nut has been demonstrated throughout this submission by performance and bench testing, companson of intended clinical and similarity in materials.
This submission has demonstrated that differences in materials, geometry, or application methods between the predicate and reference devices do not raise any new issues of substantial equivalence.
Additionally, the proposed changes within this Special 510(k) are substantially equivalent to the following:
- Same indications for Use .
- Sterilized in accordance with validated methods ●
- Biocompatibility ●
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.