(132 days)
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an outbut data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
The TECHFIT DISRP SYSTEM is composed by Anatomic Specificx Guiding System and the Digitally Integrated Surgical Reconstruction Platform (DISRP).
- . The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows collaboration in the planning process. Detail description of the software can be found in later in this section.
- Anatomic Specificx Guiding System is a Patient-Specific single-use device designed to ● assist surgeons in transferring the pre-surgical plan to the operation room. This system includes surqical quides intended for Orthognathic and Reconstructive surgeries in adults. The surgical guides have drilling holes and slots to make osteotomies and ensure the correct positioning of bones and implants.
The Anatomic Specificx Guiding System is divided into two categories: Anatomic Specificx Orthognathic Guides and Anatomic Specificx Reconstruction Guides.
Anatomic Specificx Orthognathic Guides are classified into Titanium and Resin Surgical Guides.
Anatomic Specificx Orthognathic Titanium Guides are manufactured from Commercially Pure (CP) Titanium grade 4; they include mandibular and maxillofacial surgical guides (e.q. Le Fort, Genioplasty, etc). Palatal Splints are also part of Anatomic Specificx Orthognathic Titanium Guides, which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.
Anatomic Specificx Orthognathic Resin Guides are manufactured through rapid prototyping using the Form 3B and Form 4B printers and Biomed Clear Resin from Formlabs. These guides include Le Fort and genioplasty surgical guides. During surgery, resin surgical guides must be used with slot, drill, and screw metal sleeves. Slot sleeves are made from commercially pure grade 4 titanium, while drill and screw sleeves are made from alloyed titanium (Ti6Al4V). All sleeves are manufactured by machining. The resin quides also include splints (intermediate, final, and palatal), which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.
Anatomic Specificx Reconstruction Guides
The Anatomic Specificx Reconstruction Guides are intended for mandibular and maxillofacial surqical procedures in adults, using patient grafts/flaps for reconstruction. These guides are made from Commercially Pure (CP) grade 4 titanium, produced through machining and finished with an anodizing process. They are intended for use in the anatomical sites of the maxilla, mandible and fibula. The reconstruction guides provide transfer of the pre-surgical plan to the operating room, facilitating placement and fixation of the patient's bone grafts/flaps at the surgical site.
The TECHFIT DISRP® System is cleared based on non-clinical testing. The device is a software system and image segmentation system intended for use in maxillofacial surgery for transferring imaging information from a medical scanner (such as a CT-based system) to create digital models, or to produce physical outputs such as surgical guides and splints. It also serves as a preoperative software tool for simulating and evaluating surgical treatment options.
Here's an overview of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Assessment | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization | Validating sterilization methods | Sterilization to a Sterility Assurance Level (SAL) of 10-6 using recommended steam sterilization instructions. | The results of the steam sterilization validation show that Anatomic Specificx Reconstruction Guides and Palatal Splints were sterilized to a SAL of 10-6 using the recommended steam sterilization instructions. |
| Dimensional Accuracy | Scanning of Anatomic Specificx Reconstruction Guides | Scanning comparison between the physical guides and the existing digital files must be successful and meet all acceptance criteria. | The scanning comparison between the Anatomic Specificx Reconstruction Guides and the existing files was successful, meeting all acceptance criteria. |
| Compatibility | Compatibility testing between components: Anatomic Specificx Reconstruction Guides, Patient-specific Maxillofacial System, and TECHFIT Diagnostic Models. For palatal splints: compatibility with Anatomic Specificx Orthognathic Titanium Guides, TECHFIT Diagnostic Models, and Patient-specific Maxillofacial System. | All components must be compatible with each other as specified in their intended use. | Anatomic Specificx Reconstruction Guides were compatible with Patient-specific Maxillofacial System and TECHFIT Diagnostic Models. Palatal Splints were compatible with Anatomic Specificx Orthognathic Titanium Guides, TECHFIT Diagnostic Models and Patient-specific Maxillofacial System. |
| Mechanical Performance | Static and dynamic four-point bending mechanical tests on TECHFIT plates compared to a mandibular plate from KLS Martin. | TECHFIT plates must offer comparable or significantly greater resistance. | TECHFIT plates offer significantly greater resistance. |
| Software Verification & Validation (V&V) | Verifying the item parts for the software. | DISRP meets the Software Design Specification (SDS) and functions as intended in the intended use environment. Rigorous testing for deployment, reliability, and security. | DISRP meets the SDS and testing as intended in the intended use environment. DISRP has rigorous testing, and it is reviewing every time it is deployed working as expected. V&V includes reliability and security processes. |
| Biocompatibility | Cytotoxicity test (ISO 10993-5) | No cytotoxic effect. | No cytotoxic effect. |
| Sensitization test (ISO 10993-10) | No sensitizing properties. | No sensitizing properties. | |
| Irritation/intracutaneous reactivity test (ISO 10993-10 and ISO 10993-23) | No irritant properties. | No irritant properties. | |
| Acute systemic toxicity (ISO 10993-11) | No evidence of systemic toxicity. | No evidence of systemic toxicity. | |
| Material-Mediated Pyrogenicity (ISO 10993-11) | No pyrogenic properties. | No pyrogenic properties. | |
| Genotoxicity (ISO 10993-3) | No genotoxic potential. | No genotoxic potential. | |
| Chemical Characterization and risk assessment (ISO 10993-18 and ISO 10993-17) | Non-toxic. | Non-toxic. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for the test sets in the dimensional validation, compatibility testing, mechanical testing, or software verification and validation. It only states that these tests were conducted.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly mentioned for any of the non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For instance, in the dimensional validation, it does not state how many individuals assessed the comparisons or their qualifications. For software V&V, it does not specify who conducted the testing or their expertise.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results. The conclusions appear to be based on direct measurements and adherence to test standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, the document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies described are non-clinical hardware and software performance tests, not clinical studies involving human readers or comparative effectiveness with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The software verification and validation activities (e.g., "DISRP meets the SDS and testing as intended in the intended use environment") represent standalone algorithm performance testing to some extent. The DISRP system, as a software for planning and segmentation, operates on input data files and produces output data files, which is a core standalone function. However, the overall system still anticipates "expert clinical judgment" as stated in the Indications for Use, meaning it's intended to be used with a human in the loop for clinical application. The V&V focuses on the software's functional correctness.
7. The Type of Ground Truth Used
The type of ground truth used for the non-clinical tests can be inferred as follows:
- Sterilization: Ground truth is established by adherence to recognized international standards (AAMI/ISO 17665-1, ANSI/AAMI/ISO 14937) and demonstrating the specified SAL.
- Dimensional validation: Ground truth would be the original digital design files against which the scanned physical devices are compared. This is a direct comparison to a digital reference.
- Compatibility testing: Ground truth is defined by the functional requirement for components to work together seamlessly.
- Mechanical testing: Ground truth is established by the specified mechanical properties to be achieved or exceeded, often through direct measurement and comparison with known material properties or predicate device performance.
- Software verification and validation: Ground truth is the Software Design Specification (SDS) and the intended functional requirements of the software.
- Biocompatibility testing: Ground truth is established by the pass/fail criteria defined in the referenced ISO 10993 series standards, indicating the absence of adverse biological reactions.
8. The Sample Size for the Training Set
The document does not provide any information about a training set for an AI/ML algorithm. The device is described as a "software system and image segmentation system," but there's no explicit mention of machine learning or deep learning components requiring a dedicated training set. The development described is more akin to traditional software and CAD/CAM processes.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned or implied for an AI/ML component, this information is not applicable and not provided in the document.
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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 & 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.
December 11, 2024
TECHFIT Digital Surgery Inc. Susana Munoz Cuartas Regulatory Affairs Specialist 1511 Aviation Center Pkwy, Suite 220H Daytona Beach, Florida 32114
Re: K242263
Trade/Device Name: TECHFIT DISRP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: September 12, 2024 Received: September 13, 2024
Dear Susana Munoz Cuartas:
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.
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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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-comprehensive-regulatory
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assistance/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,
MICHAEL E. ADJODHA -S
Michael Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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
Submission Number (if known)
Device Name
TECHFIT DISRP® System
Indications for Use (Describe)
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an outbut data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
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 contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, and below that, the words "Digital Surgery" are written in a smaller font.
1. 510(k) Summary
The 510(k) summary is provided on the following page per 21 CFR 807.92(c).
Traditional 510(k): Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
1.1 Submitter information
Table 1. Submitter Information
| Company name | TECHFIT Digital Surgery Inc. |
|---|---|
| Establishment registration number | 3004187715 |
| Street Address | 1511 Aviation Center PkwySuite 220H |
| City | Daytona Beach |
| Zip code | FL 32114 |
| Country | United States |
| Phone number | +57 604 322 33 75 Ext. 165 |
| Fax number | +57 604 338 30 13 |
| Principal contact person | Susana Muñoz-Cuartas |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | susana.munoz@techfitds.com |
| Additional contact person | Angela María Lema-Pérez |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | angela.lema@techfitds.com |
1.2 Date
December 10, 2024.
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Image /page/5/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray crescent shape partially covering it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, block letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.
1.3 Submission information
Table 2. Submission Information
| Trade name | TECHFIT DISRP® SYSTEM |
|---|---|
| Common or Usual name | DISRP |
| Classification name | 21 CFR 872.4120 - Bone Cutting Instrumentand Accessories |
| Product code (classification regulation) | DZJ, LLZ |
| Classification Panel | Dental |
| Device class | Class II |
1.4 Predicate Device
Table 3. Predicate device
| Predicate Device: KLS Martin Individual Patient Solutions (IPS) Planning system | |||
|---|---|---|---|
| Trade or proprietary or model | KLS Martin Individual Patient Solutions (IPS) Planning | ||
| name | System | ||
| 510(k) number | K182789 | ||
| Decision date | 2019/03/11 | ||
| Product code | DZJ, LLZ | ||
| Manufacturer | KLS-Martin L.P. |
1.5 Reference Devices
The general information of the reference devices is the following:
Table 4. General Information of the Reference Devices
| Reference Devices | ||
|---|---|---|
| 1. | Trade or proprietary or modelname | VSP® System |
| 510 (k) number | K120956 | |
| Decision date | 2012/12/12 | |
| Product code | DZJ, LLZ | |
| Manufacturer | Medical Modeling Inc. | |
| 2. | Trade or proprietary or modelname | TECHFIT DISRP® System |
| 510 (k) number | K230276 | |
| Decision date | 2023/06/23 | |
| Product code | DZJ, LLZ | |
| Manufacturer | TECHFIT Digital Surgery, Inc. |
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Image /page/6/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape partially covering it on the left side. To the right of the sphere, the word "TECHFIT" is written in a simple, sans-serif font, with the words "Digital Surgery" written in a smaller font below it.
| 3. | Trade or proprietary or model name | TECHFIT Patient-Specific Maxillofacial System |
|---|---|---|
| 510 (k) number | K203282 | |
| Decision date | 2021/05/19 | |
| Product code | JEY | |
| Manufacturer | Techfit Digital Surgery INC. | |
| 4. | Trade or proprietary or model name | AFFINITY Proximal Tibia System |
| 510 (k) number | K220199 | |
| Decision date | 2022/03/21 | |
| Product code | HRS, HWC | |
| Manufacturer | Industrias Medicas Sampedro S.A.S |
1.6 Device Information
The following table presents the device information of the subject device and the predicate device.
Table 5. Device Information
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| should be used in conjunction with |
|---|
| expert clinical judgment. |
1.7 Device Description
The TECHFIT DISRP SYSTEM is composed by Anatomic Specificx Guiding System and the Digitally Integrated Surgical Reconstruction Platform (DISRP).
- . The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows collaboration in the planning process. Detail description of the software can be found in later in this section.
- Anatomic Specificx Guiding System is a Patient-Specific single-use device designed to ● assist surgeons in transferring the pre-surgical plan to the operation room. This system includes surqical quides intended for Orthognathic and Reconstructive surgeries in adults. The surgical guides have drilling holes and slots to make osteotomies and ensure the correct positioning of bones and implants.
The Anatomic Specificx Guiding System is divided into two categories: Anatomic Specificx Orthognathic Guides and Anatomic Specificx Reconstruction Guides.
Anatomic Specificx Orthognathic Guides
Anatomic Specificx Orthognathic Guides are classified into Titanium and Resin Surgical Guides.
Anatomic Specificx Orthognathic Titanium Guides are manufactured from Commercially Pure (CP) Titanium grade 4; they include mandibular and maxillofacial surgical guides (e.q. Le Fort, Genioplasty, etc). Palatal Splints are also part of Anatomic Specificx Orthognathic Titanium Guides, which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.
Anatomic Specificx Orthognathic Resin Guides are manufactured through rapid prototyping using the Form 3B and Form 4B printers and Biomed Clear Resin from Formlabs. These guides include Le Fort and genioplasty surgical guides. During surgery, resin surgical guides must be used with slot, drill, and screw metal sleeves. Slot sleeves are made from commercially pure grade 4 titanium, while drill and screw sleeves are made from alloyed titanium (Ti6Al4V). All sleeves are manufactured by machining. The resin quides also include splints (intermediate, final, and palatal), which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.
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Image /page/8/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray oval on top of it. To the right of the sphere is the word "TECHFIT" in gray, with the words "Digital Surgery" in a smaller font below it. The logo is simple and modern, and the colors are calming and professional.
Anatomic Specificx Reconstruction Guides
The Anatomic Specificx Reconstruction Guides are intended for mandibular and maxillofacial surqical procedures in adults, using patient grafts/flaps for reconstruction. These guides are made from Commercially Pure (CP) grade 4 titanium, produced through machining and finished with an anodizing process. They are intended for use in the anatomical sites of the maxilla, mandible and fibula. The reconstruction guides provide transfer of the pre-surgical plan to the operating room, facilitating placement and fixation of the patient's bone grafts/flaps at the surgical site.
1.8 Indications for use
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System, and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
2. Comparison to Predicate Devices
Section 12 and Table 6 presents the comparison between the subject device, the predicate device, and the reference devices.
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Table 6. Comparison Table
| Subject device | Predicate Device | Reference Devices | ||||
|---|---|---|---|---|---|---|
| Characteristic | DISRP® System(AnatomicSpecificxReconstructionGuides and PalatalSplints) | KLS MartinIndividual PatientSolutions (IPS)Planning system | VSP® System | TECHFIT DISRP®System | TECHFIT Patient-SpecificMaxillofacialsystem | AFFINITYProximal TibiaSystem |
| 510K Number | K242263 | K182789 | K120956 | K230276 | K203282 | K220199 |
| Intended use | TECHFITDigitallyIntegratedSurgicalReconstruction(DISRP)PlatformSystem isintendedfor use as a softwaresystem and imagesegmentation systemfor thetransfer ofimaginginformationmedicalfromascanner such as a CTbased system.ThefileisdataınputtheprocessedbyDISRP System andthe result is an outputdata file that maythen be provided asdigitalmodelsOlused as input to arapidprototypingportion of the systemthatproducesphysicaloutputsincludingsurgicalguides and splints foruse in maxillofaciasurgery. The DISRPSystemalsoાડintendedર્વડapreoperativeforsoftwaretool | KLSMartinThePatientIndividual(IPS)SolutionsPlanning System isintended for use as asoftware system andımagesegmentationsystemthetortransfer of imaginginformationtrom amedicalscannersuch as a CT basedsystem. The inputdata file is processedby the IPS PlanningSystemandtheresult is an outputdata file that maythen be provided asdigitalmodels or used astoınputa rapıdprototyping portion ofsystemthethatproducesphysicaloutputsincludinganatomicalmodels,guides,splints,andcasereports for use inmaxillofacial surgery.The IPS PlanningSystemalsoાડintended as a | TheMedicalModelingVSP®System is intendedfor use as a softwaresystem and imagesegmentationforthesystemtransfer of imaginginformationtrom amedicalscannersuch as a CT basedsystem. The inputdata file is processedby the VSP® Systemand the result is anoutput data file thatthenmaybeprovided as digitalmodels or used asinput toa rapıdprototyping portion ofthatthesystemproducesphysicalıncludingoutputsanatomicalmodels.templates,andguides forsurgicalmaxillofacialuse ınThe VSP®surgery.Systemalsoાટıntendedas a pre-softwareoperativetoolforsimulating/evaluatingsurgicaltreatmentoptions. | TECHFITDigitallyIntegratedSurgicalReconstruction(DISRP)PlatformSystem is intendedfor use as a softwaresystem and imagesegmentationthesystemfortransfer of imaginginformation from amedicalscannersuch as a CT basedsystem. The inputfiledataાટprocessed bytheDISRP System andthe resultanાટoutput data file thatthenmaybeprovided as digitalmodels or used asinput toa rapidprototyping portionof the system thatproducesphysicaloutputsincludingsurgical guides andsplints for use inmaxillofacialsurgery. The DISRPSystemalsoારintendedટ્રકa | TECHFITPatient-Specific MaxillofacialSystem is intendedforuseınthestabilization, fixation,and reconstruction ofthemaxillofacial/midfacemandibularandskeletal regions. | AFFINITYTibiaProximalSystemાંટintended to treatfractures,nonunions,malunions of thetibiaproximalincluding simple,comminuted,lateralwedge,depression,medialwedge,bicondylarofcombinationwedgelateraland depression,periprosthetic,andfractureswith associatedshaft fractures.-Simplemetaphysealfractures(ClassificationAO 41-A2).Multifragmentarymetaphysealfractures(ClassificationAO 41-A3). |
| simulating /evaluating surgicaltreatment options.The DISRP system iscompatible with theTECHFIT Patient-Specific MaxillofacialSystem and theTECHFIT DiagnosticModels and shouldbe used inconjunction withexpert clinicaljudgment. | pre-operativesoftware tool forsimulating/evaluatingsurgical treatmentoptions. | preoperativesoftware tool forsimulating /evaluating surgicaltreatment options.The DISRP systemis compatible withthe TECHFITPatient- SpecificMaxillofacial Systemand the TECHFITDiagnostic Modelsand should be usedin conjunction withexpert clinicaljudgment. | -Simplebicondylarfractures(ClassificationAO41-C1, 41-C2).-Multifragmentarybicondylarfractures(ClassificationAO 41-C3).-Simple joint,simplemetaphysealfractures(ClassificationAO 41-C1).-Diaphisaryfractures(ClassificationAO 42A and42B). | |||
| Indications foruse | Maxillofacial andReconstructionSurgeries | Maxillofacial andReconstructionSurgeries | Maxillofacial andReconstructionSurgeries | MaxillofacialSurgeries | OrthopedicSurgery | |
| Clinical Use | Maxillofacial | Maxillofacial | Maxillofacial | Maxillofacial /Midface & Mandible | OrthopedicProximal TibialCondyles | |
| Product Code | DZJ, LLZ | DZJ, LLZ | DZJ, LLZ | JEY | HRS, HWC |
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Image /page/10/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere and teardrop shape is the word "TECHFIT" in gray capital letters. Below "TECHFIT" are the words "Digital Surgery" in a smaller font, also in gray.
CONFIDENTIAL
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Image /page/12/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray shape partially covering it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.
| Manufacturer | TECHFIT DigitalSurgery, Inc. | KLS Martin | Medical ModelingInc. | TECHFIT DigitalSurgery, Inc. | TECHFIT DigitalSurgery, Inc. | IndustriasMedicasSampedro S.A.S |
|---|---|---|---|---|---|---|
| TargetPopulation | Adults | Pediatric & Adults | Adults | Adults | Adults | Adults |
| Patient-specificdevices? | Yes. Devices aremanufacturedpatient-specific,based on a CT scanof the patient | Yes. Devices aremanufacturedpatient-specific,based on a CT scanof the patient | Yes. Devices aremanufacturedpatient-specific,based on a CT scanof the patient | Yes. Devices aremanufacturedpatient-specific,based on a CT scanof the patient | Yes. Devices aremanufacturedpatient-specific,based on a CT scanof the patient | No. The platesare standardmanufacturedplates |
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Image /page/13/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray oval partially overlapping it on the left side. To the right of the sphere and oval are the words "TECHFIT" in gray, with the words "Digital Surgery" in a smaller font size below it.
| Material | Palatal Splints: CPTitanium.Anatomic SpecificxReconstruction: CPTitanium. | Anatomical Models:Epoxy/Resin, Acrylic.Cutting/MarkingGuides: Polyamide,Titanium Alloy (Ti-6Al-4V), CPTitanium.Splints: methacrylate | Anatomic Models,templates, andsurgical guides:Biocompatiblepolymers andsurgical instrumentgrade stainlesssteel. | Anatomic SpecificxOrthognathic ResinGuides (previouslycalled "ResinOrthognathicSurgical Guides":Biomed ClearResin.Anatomic SpecificxOrthognathicTitanium Guides(previously called"MachinedOrthognathicSurgical Guides":CP Titanium.Slot Metal sleeves:CP Titanium.Drill and ScrewMetal Sleeves: CPTitanium andAlloyed Titanium(Ti6Al4V). | Plate: CP Titanium. | Plate: CPTitanium.Screw: AlloyedTitanium(Ti6Al4V). |
|---|---|---|---|---|---|---|
| ---------- | ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------- | -------------------------------------------------------------------- |
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Image /page/14/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape partially overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.
| ManufacturingMethod | CP Titanium:Traditional(Subtractive). | Epoxy/Resin, Acrylic:Stereolithography(SLA).CP Titanium:Traditional(Subtractive).Ti-6Al-4V: 3Dprinting (Additive;Selective LaserMelting).Polyamide: 3Dprinting (Additive;Selective LaserSintering). | 3D printing | Resin: 3D printing -Stereolithography(SLA).CP Titanium andAlloyed Titanium:Traditional(Subtractive). | CP Titanium:Traditional(Subtractive). | CP Titanium andAlloyedTitanium:Traditional(Subtractive). |
|---|---|---|---|---|---|---|
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile(Steam) |
| ContactDuration | Palatal Splints:prolonged (24 h to30 days).Anatomic SpecificReconstruction:limited (≤ 24 h). | Limited (≤ 24 h). | Limited (≤ 24 h). | Limited (≤ 24 h). | Long Term (>30days). | Long Term (>30days). |
| Compatiblewith DISRPsoftware? | Yes | No | No | Yes | Yes | No |
| Softwarechanges | Palatal Splints:Include the newdevice visualization.Anatomic SpecificxReconstructionGuides: Include thereconstructionsurgical guidesvisualization, fibulagraft/flap, andmandible/maxillavisualization. | N.A. | N.A. | N.A. | N.A. | N.A. |
| Image Import | DICOM data formatfrom CT/CBCTscanner 3D modelsand surface scandata in generic openfile format (STL) | DICOM data formatfrom CT scanner 3Dmodels and surfacescan data in genericopen file format(STL). | System Inputs:Images from medicalscanners (i.e. CT) | DICOM data formatfrom CT/CBCTscanner 3D modelsand surface scandata in generic openfile format (STL) | DICOM data formatfrom CT/CBCTscanner 3D modelsand surface scandata in generic openfile format (STL) | N.A. |
| SoftwareOutput | Encrypted STL filewith design of thefinal patient specificdevice such assurgical guides,splints and casereports | N.A. | System Outputs:Physical and digitaloutputs such aspatient specificanatomical models,cutting and drillguides, templatesand splints | Encrypted STL filewith design of thefinal patient specificdevice such assurgical guides,splints and casereports | N.A. | N.A. |
| SoftwareFunctions | 3D Visualization | 2D and 3DVisualization | 3D Visualization | 3D Visualization | N.A. | N.A. |
| Distance and anglemeasurements | Distance and anglemeasurements | Distance and anglemeasurements | Distance and anglemeasurements | N.A. | N.A. | |
| SoftwareFunctions | Bone fragments canbe moved in the 3Dspace (translationsand rotations) inorder to plan theideal post-operativeposition of eachfragment. Supportedosteotomies: Le FortI, Chin, Splints, fibula | Bone fragments canbe moved in the 3Dspace (translationsand rotations) inorder to plan theideal post-operativeposition of eachfragment. Supportedosteotomies: Le FortI, Sagittal, Splint,Ramus, Chin | The system useselectronic medicalimagesof the patients'anatomy with inputfrom the physician,to manipulateoriginal patientimages for planningand executingsurgery. The systemproduces a variety ofpatientspecific outputsincluding; anatomicalmodels (physicaland digital), surgicaltemplates, guides,splints, and patientspecific casereports. | Bone fragments canbe moved in the 3Dspace (translationsand rotations) inorder to plan theideal post-operativeposition of eachfragment.Supportedosteotomies: LeFort I, Chin, Splint | N.A. | N.A. |
| 3D Surgical Modelcreation fromCBCT/CT scan dataand STL file | 3D Surgical Modelcreation from CTscan data | Commercial Off-The-Shelf (COTS) andcustomsoftware tomanipulate 3-Dmedical scan imageswhich can includeComputedTomography (CT),Cone Beam CT(CBCT), and/or 3-0scan images frompatient | 3D Surgical Modelcreation fromCBCT/CT scan dataand STL file | N.A. | N.A. | |
| SoftwareFunctions | 3D photo mapping | Soft tissuesimulation | N.A. | 3D photo mapping | N.A. | N.A. |
| SoftwareFunctions | Based on thecreated orthognathicplan the user canexport surgicalguides and splintsorder files. Thesefiles can be used tocalculate andproduce orthognathicsurgical guides andsplints in theproduction backend | Based on thecreated orthognathicplan the user canexport surgical splintorder files. Thesefiles can be used tocalculate andproduceorthognathic splintsin the productionbackend | N.A. | Based on thecreatedorthognathic planthe user can exportsurgical guides andsplints order files.These files can beused to calculateand produceorthognathicsurgical guides andsplints in theproduction backend | N.A. | N.A. |
| SoftwareFunctions | DISRP: the user cancreate a list ofrequiredosteosynthesisplates based on acreated surgicalplan. | N.A. | The system is madeup of 13 individualpieces of softwareand 9 pieces ofmanufacturingequipmentintegrated to providea range ofanatomical models | DISRP: the usercan create a list ofrequiredosteosynthesisplates based on acreated surgicalplan. | N.A. | N.A. |
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Image /page/16/Picture/0 description: The image is a logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape partially covering it on the left side. To the right of the sphere is the word "TECHFIT" in gray block letters, with the words "Digital Surgery" in a smaller font below.
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Image /page/17/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.
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Image /page/18/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray oval overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in gray, with the words "Digital Surgery" in a smaller font below.
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Image /page/19/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, with the words "Digital Surgery" written in a smaller font size below it.
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| Operatingsystemrequirements | Operating system:Windows 64-bit(Windows 7 and/orlater)Mac OS (Yosemiteor later) | Windows 64-bit(Windows 7, 8, 10)Mac OS X(Yosemite, ElCapitan) | Windows® 10 –64bit Version 1909.Windows® 11 22H2.Microsoft Edge® orequivalent.PDF viewer..NET framework4.6.1 (or higher) | Operating system:Windows 64-bit(Windows 7 and/orlater)Mac OS (Yosemiteor later) | N.A. | N.A. |
|---|---|---|---|---|---|---|
| ------------------------------------- | ----------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------- | ------ | ------ |
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Image /page/21/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere are the words TECHFIT in a simple, sans-serif font. Below TECHFIT are the words Digital Surgery in a smaller font.
3. Performance data
The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:
Performance Data ●
| Name | Test Method | Conclusion |
|---|---|---|
| Validating sterilizationmethods | AAMI/ISO 17665-1:2006/(R)2013 Sterilizationof health care products - Moistheat - Part 1 Requirements forthe development, validationand routine control of asterilization process formedical devices.ANSI/AAMI/ISO14937:2009/(R)2013Sterilization of HealthcareProducts -GeneralRequirements forCharacterization of aSterilizing Agent and theDevelopment, Validation andRoutine Control of aSterilization Process forMedical Devices. | The results of the steamsterilization validation show thatAnatomic SpecificxReconstruction Guides andPalatal Splints sterilized to a SALof 10-6 using the recommendedsteam sterilization instructions. |
| Dimensional validation | Scanning of AnatomicSpecificx ReconstructionGuides and then comparingthem versus the existing files. | The scanning comparisonbetween the Anatomic SpecificxReconstruction Guides and theexisting files was successful,meeting all acceptance criteria. |
| Compatibility testing | Verifying compatibilitybetween Anatomic SpecificxReconstruction Guides,Patient-specific MaxillofacialSystem and TECHFITDiagnostic Models.For palatal splints thecompatibility between palatalsplints, Anatomic SpecificxOrthognathic TitaniumGuides, TECHFIT DiagnosticModels and Patient-specificMaxillofacial System. | Anatomic SpecificxReconstruction Guides werecompatible with Patient-specificMaxillofacial System andTECHFIT Diagnostic Models.Palatal Splints were compatiblewith Anatomic SpecificxOrthognathic Titanium Guides,TECHFIT Diagnostic Modelsand Patient-specific MaxillofacialSystem. |
| Mechanical testing | Static and dynamic four-pointbending mechanical testswere conducted on the | TECHFIT plates offersignificantly greater resistance. |
| Table 7. Overview of the Performance Data on the Subject Device | ||||
|---|---|---|---|---|
| -- | ----------------------------------------------------------------- | -- | -- | -- |
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Section 5 Special 510(K) - Summary
| Patient-specific MaxillofacialSystem, comparing TECHFITplates to a mandibular platefrom KLS Martin | ||
|---|---|---|
| Software verification andvalidation activities | Verifying the item parts for thesoftware | DISRP meets the SDS andtesting as intended in theintended use environment.DISRP has a rigorous testing,and it is reviewing every time isdeployed working as expected.V&V includes reliability andsecurity processes. |
● Biocompatibility Testing
An overview of biocompatibility testing is shown below:
| Table 8. Biocompatibility Test Overview | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ----------------------------------------- |
| Test / Assessment Description | Test Report Conclusion |
|---|---|
| Cytotoxicity test (ISO 10993-5) | No cytotoxic effect |
| Sensitization test (ISO 10993-10) | No sensitizing properties |
| Irritation/intracutaneous reactivity test(ISO 10993-10 and ISO 10993-23) | No irritant properties |
| Acute systemic toxicity (ISO 10993-11) | No evidence of systemictoxicity |
| Material-Mediated Pyrogenicity (ISO10993-11) | No pyrogenic properties |
| Genotoxicity (ISO 10993-3) | No genotoxic potential |
| Chemical Characterization and riskassessment:ISO 10993-18 and ISO 10993-17 | Non-toxic |
4. Conclusion
Non-clinical tests demonstrate that the proposed changes to DISRP System is substantially equivalent to the predicate device.
§ 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.