(265 days)
No
The description focuses on manual manipulation of images by trained employees using COTS software, with physician input and review. There is no mention of automated learning or decision-making processes characteristic of AI/ML.
No
This device is a surgical instrument and planning system, not a therapeutic device. It assists in surgical procedures by providing guides and planning, but it does not directly treat or alleviate a medical condition.
No.
The device is described as a "surgical instrument" and a "collection of two individual pieces of software and associated additive manufacturing equipment" intended for "preoperative planning" and "guiding the marking of bone and/or guide surgical instruments." Its purpose is to create patient-specific anatomical models, surgical guides, and reports to aid in osteotomies, not to diagnose a medical condition.
No
The device description explicitly states that the system includes "associated additive manufacturing equipment" and produces "patient-specific physical and digital outputs," including "anatomical models" and "surgical guides," which are physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Intended Use: The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and guiding surgical procedures (osteotomies) in the foot. It works with medical images of the patient's anatomy, not with specimens taken from the body.
- Device Description: The system involves software and additive manufacturing equipment to create physical and digital outputs (anatomical models, surgical guides, case reports) based on patient imaging data. This is a surgical planning and guidance tool, not a diagnostic test performed on biological samples.
Therefore, the function and intended use of the MedCAD® AccuStride™ System clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in nonacute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).
Product codes (comma separated list FDA assigned to the subject device)
PBF
Device Description
The MedCAD® AccuStride™ System is a collection of two individual pieces of software and associated additive manufacturing equipment intended to provide a variety of outputs to support non-acute, nonjoint replacing osteotomies in the foot. The system uses electronic medical images of the patient's anatomy or with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, surgical guides, and patient-specific case reports.
Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during and prior to delivery of the final outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Foot
Indicated Patient Age Range
Adult and pediatric patients 12 years of age and older.
Intended User / Care Setting
Trained MedCAD employees, with clinical input and review from the physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Wear Debris Testing (leveraged from K223421): Cutting / drilling instruments were used on a worst-case titanium surgical guide. The quantity and morphology of wear debris was characterized per ASTM F1877. Results: PASS. The wear debris generated by the subject device is less than that reported in the literature to be safe.
Simulated Use Cadaver Validation Testing: Subject devices were manufactured to support simulated surgeries in cadavers. Guides were created to support bunion and metadductus, metatarsal 2+3, akin, and calcaneal osteotomies. Usability and fit was evaluated for all cases. Post-op angle and position data was also collected and compared to pre-surgical plans (bunion and metadductus only). Results: PASS. All samples met the predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RedPoint Medical Better Bunion System (K220717)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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March 13, 2025
MedCAD % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Suite 120 Woodstock, Georgia 30188
Re: K241811
Trade/Device Name: MedCAD® AccuStride™ System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: February 7, 2025 Received: February 7, 2025
Dear Mr. Gracyalny:
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.
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 medical devices and radiation-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-regulatory
2
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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
MedCAD® AccuStride™ System
Indications for Use (Describe)
The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).
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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K241811 Page 1 of 4
K241811 510(k) Summary MedCAD® AccuStride™ System
March 11, 2025
Sponsor
MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 (214) 453-8864 x305
Contacts
Secure BioMed Evaluations Justin Gracyalny, MSE 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory(@SecureBME.com
Name of Device and Classification Name
Device Name: MedCAD® AccuStride™ System Regulation Name: Orthopaedic Surgical Planning And Instrument Guides Regulation Number: 888.3030 Product Code: PBF Classification Panel: Orthopedic
Predicate Device(s)
RedPoint Medical Better Bunion System (K220717)
Reference Device(s)
MedCAD® AccuPlan® Orthopedics System (K223421) MedCAD® AccuPlan® System (K223024)
Indications for Use:
The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in nonacute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).
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Device Description
The MedCAD® AccuStride™ System is a collection of two individual pieces of software and associated additive manufacturing equipment intended to provide a variety of outputs to support non-acute, nonjoint replacing osteotomies in the foot. The system uses electronic medical images of the patient's anatomy or with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, surgical guides, and patient-specific case reports.
Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during and prior to delivery of the final outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.
Sterilization Validation
Sterilization validation information was leveraged from the reference device (K223421). No new testing was required for the subject device.
Biocompatibility Validation
Biocompatibility information was leveraged from the reference device (K223421). No new testing was required for the subject device.
Performance Testing
Performance testing for the MedCAD® AccuStride™ System is summarized in the table below:
| Test | Test Method Summary | Results |
|---|---|---|
| Wear Debris Testing | ||
| (leveraged from | ||
| K223421) | Cutting / drilling instruments were used on a worst-case | |
| titanium surgical guide. The quantity and morphology of | ||
| wear debris was characterized per ASTM F1877. | PASS | |
| The wear debris generated by | ||
| the subject device is less than | ||
| that reported in the literature | ||
| to be safe. | ||
| Simulated Use | ||
| Cadaver Validation | ||
| Testing | Subject devices were manufactured to support simulated | |
| surgeries in cadavers. Guides were created to support | ||
| bunion and metadductus, metatarsal 2+3, akin, and | ||
| calcaneal osteotomies. Usability and fit was evaluated for | ||
| all cases. Post-op angle and position data was also | ||
| collected and compared to pre-surgical plans (bunion and | ||
| metadductus only). | PASS | |
| All samples met the | ||
| predetermined acceptance | ||
| criteria. |
Substantial Equivalence
The MedCAD® AccuStride™ System is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, Minor
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differences in the surgical planning and manufacturing processes are verified and validated in the performance data in accordance with the intended use.
The input is images from medical scanners. Physical outputs include surgical guides and anatomical models. Biocompatible materials are used in the creation of the subject devices.
All devices are intended to aid in foot orthopedic surgeries. These systems are intended to be utilized by trained employees with the approval by the physician.
| Property | MedCAD®
AccuPlan® AccuStride™ System | RedPoint Medical
Better Bunion System
K220717 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT). | The Better Bunion System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only. |
| Anatomical Location | Foot | Foot and ankle |
| Preoperative software | Yes | Yes |
| Data inputs | Images from medical scanners | Images from medical scanners |
| System Outputs | Surgical guides, anatomical models, and patient-specific case reports | Surgical guides and patient-specific case reports |
| Materials | Biocompatible polymers and Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy |
| Sterilization | Provided non-sterile and is steam sterilized by the end-user | Provided non-sterile and is steam sterilized by the end-user |
| Manufacturing Method | Additive Manufacturing | Additive Manufacturing |
| Patient Contact | Externally Communicating – Tissue / Bone / Dentin; Limited (