tmCMF Solution

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October 2, 2023 TechMah CMF Lyndsay Bowers VP Quality 2240 Sutherland Ave. Suite 2 Knoxville, Tennessee 37919 Re: K231520 Trade/Device Name: tmCMF Solution Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: September 11, 2023 Received: September 11, 2023 Dear Lyndsay Bowers: 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. {1}------------------------------------------------ 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael E. 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231520 Device Name tmCMF Solution #### Indications for Use (Describe) The traCMF Solution 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 tmCMF Solution, 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 anatomical models, surgical guides, and dental splints for use in maxillofacial and mandibular surgery. The surgical guides and dental splints are intended to the maxillofacial and mandibular bone in mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options. Type of Use (Select one or both, as applicable) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) SUMMARY # K231520 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: Date Prepared: October 2, 2023 ## I. CONTACT DETAILS | Applicant Name: | TechMah CMF | |------------------------------|----------------------------------------------------------------------| | Applicant Contact Telephone: | +1.865.200.4376 | | Applicant Contact: | Dr. Mohamed Mahfouz | | Applicant Contact Email: | mmahfouz@tmcmf.com | | Applicant Address: | 2240 Sutherland Avenue, Suite 2<br>Knoxville, TN 37919 United States | | Correspondent Name: | TechMah CMF | |----------------------------------|----------------------------------------------------------------------| | Correspondent Contact Telephone: | +1.410.258.2770 | | Correspondent Contact: | Mrs. Lyndsay Bowers | | Correspondent Contact Email: | lbowers@tmcmf.com | | Correspondent Address: | 2240 Sutherland Avenue, Suite 2<br>Knoxville, TN 37919 United States | ## II. DEVICE NAME | Device Trade Name: | tmCMF Solution | |--------------------------|-----------------------------------------------| | Device Common Name: | Surgical Guide and Surgical Planning Software | | Classification Name: | Bone Cutting Instrument And Accessories | | Regulation Number: | 21 CFR §872.4120 | | Product Code: | DZJ | | Subsequent Product Code: | LLZ | ## III. LEGALLY MARKETED PREDICATE DEVICES | Predicate Number: | K192282 | |-----------------------|------------------------| | Predicate Trade Name: | MedCAD AccuPlan System | | Product Code: | DZJ | {5}------------------------------------------------ ## IV. LEGALLY MARKETED REFERENCE DEVICES | Predicate Number: | K103136 | |-----------------------|-----------------------------------------| | Predicate Trade Name: | SurgiCase mandible/maxillofacial guides | | Product Code: | JEY | | Predicate Number: | K170419 | | Predicate Trade Name: | SurgiCase Viewer | | Product Code: | LLZ | | Predicate Number: | K210347 | | Predicate Trade Name: | VSP System | | Product Code: | DZJ, LLZ | | Predicate Number: | K120956 | | Predicate Trade Name: | VSP System | | Product Code: | DZJ, LLZ | ## V. DEVICE DESCRIPTION SUMMARY The TechMah CMF (tmCMF) Solution is a family of personalized product solutions for trauma and reconstruction procedures in the mandible and midface. The solution is comprised of Surgeon Review Tool (SRT) software, and maxillofacial and mandibular surqical instruments (surgical quides, anatomical models, and dental splints). The surqical instruments are patient-specific devices and are designed utilizing CT and dental scan patient image data. Surgical guides are patient-specific devices or templates that are based on preoperative software planning and are designed to fit a specific patient. These guides are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the marking of bone for plate fixation screws and the position of the osteotomy marking slots. Surgical guides are available for treatment (maxilla and mandible) and harvesting (fibula, iliac crest, and scapula). Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit. Anatomical models are patient-specific models that are based on pre-operative anatomy and surgical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing preoperative, intra-operative, and post-operative anatomical models as guidance. Anatomical models are available for treatment (maxilla and mandible), and harvesting (fibula, iliac crest, and scapula) anatomy. Anatomical models can be used to check {6}------------------------------------------------ quide fit. Dental splints are patient-specific devices or templates that are based on preoperative software surgical planning and are designed to fit a specific patient. Dental splints are available as single splint desired occlusions or combined splint-in-splint option. These templates are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the dental alignment of bone and teeth. The Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs. The SRT software is accessed through a web interface from a surgeon's device. ## VI. INTENDED USE/INDICATIONS FOR USE The tmCMF Solution is intended for use as a software system and image seqmentation 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 tmCMF Solution, 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 anatomical models, surgical guides, and dental splints for use in maxillofacial and mandibular surgery. The surgical guides and dental splints are intended to be used for the maxillofacial and mandibular bone in maxillofacial and mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options. {7}------------------------------------------------ # VII. SUBSTANTIAL EQUIVALENCE COMPARISON | | tmCMF Solution<br>(Subject device) | MedCAD® AccuPlan® System<br>(Predicate device) K192282 | SurgiCase Viewer<br>(K170419) Reference Device | SurgiCase<br>mandible/maxillofacial guides<br>(K103136) Reference Device | VSP System<br>(Reference device)<br>K210347 | |--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The tmCMF Solution is<br>intended for use as a software<br>system and image<br>segmentation system for the<br>transfer of imaging information<br>from a medical scanner such<br>as a CT-based system. The<br>input data file is processed by<br>the tmCMF Solution, and the<br>result is an output data file that<br>may then be provided as<br>digital models or used as input<br>to a rapid prototyping portion<br>of the system that produces<br>physical outputs including<br>anatomical models, surgical<br>guides, and dental splints for<br>use in maxillofacial and<br>mandibular surgery. The<br>surgical guides and dental<br>splints are intended to be used<br>for the maxillofacial and<br>mandibular bone in<br>maxillofacial and mandibular<br>surgery. The tmCMF Solution<br>is also intended as a<br>preoperative software tool for<br>simulating/evaluating surgical<br>treatment options. | The MedCAD® AccuPlan®<br>System is intended for use as a<br>software system and image<br>segmentation system for the<br>transfer of imaging information<br>from a medical scanner such as<br>a CT based system. The input<br>data file is processed by the<br>MedCAD® AccuPlan® System<br>and the result is an output data<br>file that may then be provided as<br>digital models or used as input to<br>a rapid prototyping portion of the<br>system that produces physical<br>outputs including anatomical<br>models, surgical guides, and<br>dental splints for use in<br>maxillofacial surgery. The<br>surgical guides and dental<br>splints are intended to be used<br>for the maxillofacial bone in<br>maxillofacial surgery. The<br>MedCAD® AccuPlan® System is<br>also intended as a preoperative<br>software tool for simulating /<br>evaluating surgical treatment<br>options. | SurgiCase Viewer is intended<br>to be used as a software<br>interface to assist in<br>visualization and<br>communication of treatment<br>options. | SurgiCase Guides are intended to<br>be used as surgical tools to<br>transfer a pre-operative plan to the<br>surgery. The devices are intended<br>to guide the marking of bone<br>and/or guide surgical instruments<br>in mandibular and maxillofacial<br>surgical procedures | The VSP® System is<br>intended for use as a<br>software system and<br>image segmentation<br>system for the transfer of<br>imaging information from a<br>medical scanner such as a<br>CT based system.<br>The input data file is<br>processed by the VSP®<br>System and the result is an<br>output data file that may<br>then be provided as digital<br>models or used as input to<br>a rapid prototyping portion<br>of the system that<br>produces physical outputs<br>including anatomical<br>models, templates, and<br>surgical guides for use in<br>maxillofacial surgery. | | Preoperative<br>software | Yes | Yes | Yes | Yes | Image transformation into<br>3D models, Computer<br>Aided Design, Surgical<br>planning / simulation | | Additive<br>manufacturing of<br>splint, guides, and<br>models | Yes | Yes | Unknown | Yes | 3D Printing to produce<br>physical output devices | | Data Inputs | Images from medical scanners | Images from medical scanners | Images from medical<br>scanners | Images from medical scanners | DICOM file from Medical<br>Scanner (CT, CBCT),<br>patient contoured and<br>standard implant .STL files;<br>input from<br>Physician | | | | | | | | | | tmCMF Solution<br>(Subject device) | MedCAD® AccuPlan® System<br>(Predicate device) K192282 | SurgiCase Viewer<br>(K170419) Reference Device | SurgiCase<br>mandible/maxillofacial guides<br>(K103136) Reference Device | VSP System<br>(Reference device)<br>K210347 | | Data Outputs | Output for dental splints,<br>surgical guides, and<br>anatomical models | Output for dental splints, surgical<br>guides, and anatomical models | Approved plans and designs | Output for dental splints, surgical<br>guides, and anatomical models | Output for dental splints,<br>surgical guides, and<br>anatomical models | | Physical Outputs | Dental splints, surgical guide,<br>anatomical models, and<br>patient-specific case reports | Dental splints, surgical guide,<br>anatomical models, and patient-<br>specific case reports | Unknown | Dental splints, surgical guide, | Dental splints, surgical<br>guide,<br>anatomical models | | Sterilization | Device is provided non-sterile<br>and is steam sterilized by the<br>end-user | Device is provided non-sterile<br>and is steam sterilized by the<br>end-user | Unknown | Device is provided non-sterile and<br>is steam sterilized by the end-user | Steam sterilization | | Manufacturing<br>Method | Additive Manufacturing | Additive Manufacturing | Unknown | Additive Manufacturing | Additive Manufacturing | | Web Interface | Yes | Unknown | Yes | No | Unknown | | 2D Image Display<br>Axial<br>Sagittal<br>Coronal | Yes | Yes | Yes | Yes | Yes | | 3D Visualization | Yes | Yes | Yes | Yes | Yes | | Installation<br>Required | No | Unknown | No | Yes | Unknown | | Physician<br>Interaction with<br>Planning and<br>Physician Model /<br>Guide Approval | Yes | Yes | Yes | Yes | Yes | | Single Use | Yes | Yes | NA | Yes | Yes | {8}------------------------------------------------ {9}------------------------------------------------ ## VIII. INDICATIONS FOR USE COMPARISON The tmCMF Solution has equivalent indication for use as its predicate device. The primary indication is to utilize pre-operative imaging data to perform surgical case planning and create patient-specific instrumentation to transfer the pre-operative plan on the patient in the operating room. ## Differences - . The predicate specifically refers to maxillofacial surgery, whereas the subject device covers both maxillofacial and mandibular surgeries, which is equivalent to the reference device (K103136). - . The predicate device does not include graft harvesting surgical guides, whereas the subject does. However, the predicate device (K120956) used by the current predicate (K192282) also included harvesting surgical guides, which is equivalent to the reference device (K210347) - . The predicate device has a limited contact for the splint whereas the subject device has a prolonged contact for splints to allow for post-op usage of up to 30 days. However, the predicate device (K120956) used by the current predicate (K192282) also has a prolonged contact for splints to allow for postop usage of up to 30 days, which is equivalent to the reference device (K210347). ## IX. TECHNOLOGICAL COMPARISON (WITH PREDICATE DEVICE) ### Similarities to Predicate The tmCMF Solution has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicates including input case data, manipulation, and surgical planning. The principles of operation and technological characteristics are either identical or substantially equivalent to the predicate. The system has similar technological characteristics including: - System inputs: images from medical scanners (ex: CT), dental models, and/or . implant files (.STL) - . System outputs: physical and/ or digital outputs such as patient-specific anatomical models, guides, and splints - Materials: biocompatible polymers - Sterility assurance level of 1x10-6 ● The intended use of the subject device and the predicate both provide tools and accessories (software for image manipulation, anatomical models, splints, and guides) for use in reconstructive surgery. Additionally, both the subject and the predicate device are intended to be used by trained personnel with active support {10}------------------------------------------------ from the surgeon. Differences to Predicate - The predicate specifically refers to maxillofacial surgery, whereas the subject ● device covers both maxillofacial and mandibular surgeries. - . The predicate device does not include graft harvesting surgical quides, whereas the subject does. However, the predicate device (K120956) used by the current predicate (K192282) also included harvesting surgical guides. - The predicate device has a limited contact for the splint whereas the subject device has a prolonged contact for splints to allow for post-op usage of up to 30 days. However, the predicate device (K120956) used by the current predicate (K192282) also has a prolonged contact for splints to allow for postop usage of up to 30 days. ## X. TECHNOLOGICAL COMPARISON (WITH REFERENCE DEVICES) Reference device K170419: - The reference device served as a technologically equivalent device for the ● Surgeon Review Tool (SRT). Reference device K103136: - . This reference device was used to establish performance equivalence data. Reference devices K210347 and K120956: - The reference devices served as the basis for establishing equivalence on physical product features and offerings, product material compositions and their manufacturing processes. The reference devices encompass anatomical models, surgical guides, and dental splints, with the subject device utilizing similar product features and identical materials to ensure a state of equivalence. The addition of the reference device comparison presents another substantially equivalent device with identical physical outputs, materials, and manufacturing processes. ## XI. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY The following performance data were provided in support of the substantial equivalence determination. ## Cleaning Testing was performed to validate the end-user cleaning protocol of the subject {11}------------------------------------------------ device per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and AAMI TIR 30. ## Sterilization Testing was performed to validate the end-user sterilization protocol of the subject device per ISO 17665-1, ISO 17665-2, and ANSI/AAMI ST79. ## Biocompatibility Biocompatibility assessment per the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and biocompatibility testing per ISO 10993-1:2018 for its contact classification was conducted to ensure the biocompatibility of the materials and manufacturing process used in the tmCMF surgical instruments. ## Software Verification and Validation Software Verification and Validation Testing was conducted in accordance with the requirements of IEC 62304:2006/A1:2015. The following FDA quidance documents were also followed: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Device Software Functions. ## Usability Usability was validated in accordance with IEC 62366-1:2020. ## Benchtop Performance Benchtop performance testing was performed to demonstrate the performance of the tmCMF Solution and substantial equivalence with the predicate device. The testing aligns with the test strategy and performance metrics used by the predicate. | Hardware Performance<br>Verification | Testing demonstrated that the surgical guide and<br>dental splint meets the predetermined acceptance<br>criteria. | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cadaveric Benchtop<br>Performance Testing | Comparison of pre-operative surgical plan to post-<br>operative CT measurements. Results passed the<br>predetermined acceptance criteria, indicating<br>substantial equivalence. | | Hardware Integrity test<br>Verification | Testing demonstrated that the instruments meet the<br>predetermined acceptance criteria. | | Hardware Verification<br>Inspection and Analysis | Testing demonstrated that instruments' implementation<br>is compliant with the acceptance criteria. | {12}------------------------------------------------ | Surgical Case Verification | Testing demonstrated that the surgical case reports<br>are compliant with acceptance criteria. | |----------------------------|-------------------------------------------------------------------------------------------------------| | System Validation | Testing demonstrated that the system has met user<br>needs and is compliant with acceptance criteria. | # XII. CONCLUSION The tmCMF Solution has the same intended use as the predicate device and similar technological characteristics as the predicate and reference devices. Therefore, the subject device is substantially equivalent.