(133 days)
No
The description focuses on traditional image processing, 3D modeling, and additive manufacturing based on clinician input and approval, with no mention of AI/ML algorithms for tasks like image analysis, planning, or design.
No.
The device is a surgical instrument intended to assist physicians in preoperative planning and guiding surgical procedures, not to directly treat a disease or condition.
No
The device description clearly states "3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments". It is used for surgical guidance and planning, not for diagnosing medical conditions. While it utilizes medical images for planning, its function is assistive in surgery, not diagnostic.
No
The device description explicitly states that 3D-Cut is a "patient-matched additively manufactured single use surgical instrument (PS)". This indicates a physical, hardware component, not a software-only device. While software is used in the design process, the final product is a tangible surgical instrument.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 3D-Cut is a surgical instrument used for preoperative planning, guiding bone marking, and guiding surgical instruments during bone tumor resection. This is a surgical aid, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces that it's a patient-matched surgical instrument designed to assist physicians in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis. The device's function is purely related to surgical planning and execution based on medical imaging.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies, including the resection of bone tumors, for femur, tibia and pelvis including sacrum.
Product codes
PBF
Device Description
3D-Cut is a patient-matched additively manufactured single use surgical instrument (PS). Based on a preoperative planning, the instruments are intended to assist physicians in guiding the marking of bone and guiding surgical instruments in bone tumor resection surgery, excluding joint replacement surgeries.
The 3D-Cut instruments are designed starting from patient medical images, computed tomography (CT) and magnetic resonance imaging (MRI) device. The clinician delineates the tumor on the MRI. MRI and the delineated tumor are merged onto the CT which is used to extract the 3D CAD model of the bone. A draft treatment plan is submitted for evaluation to the treating clinician. Upon surgeon's approval, a PSI is designed and again submitted to the clinician. After validation, the PSI is produced using additive manufacturing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) and magnetic resonance imaging (MRI)
Anatomical Site
femur, tibia and pelvis including sacrum.
Indicated Patient Age Range
adults and adolescents.
Intended User / Care Setting
Not Found
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)
Several tests have been conducted to demonstrate the output of the manufacturing process conforms to the device specifications. A combination of bench, cadaveric and clinical (OUS published case series) testing was executed to demonstrate the subject device is substantially equivalent to the predicate device and performs in accordance with its intended use.
Testing included biocompatibility testing in accordance with ISO 10993, testing for cleaning, sterility, dimensional stability and packaging, mechanical testing and simulated use testing on cadaveric specimen. In addition, results from clinical investigations using 3D-Cut have been reported.
Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 29, 2021
Image /page/0/Picture/1 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.
3D-Side SA % Niels Festiens Regulatory Affairs Consultant OrthoGrow NV Davincilaan 1 Zaventem. Vlaams-Brabant 1930 Belgium
Re: K212237
Trade/Device Name: 3D-Cut 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: August 30, 2021 Received: August 31, 2021
Dear Niels Festjens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
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
2
Indications for Use
510(k) Number (if known) K122237
Device Name 3D-Cut
Indications for Use (Describe)
3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing ostector of bone tumors, for femur, tibia and pelvis including sacrum.
| 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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3
K212237
510(K) SUMMARY (21CFR807.92)
SUBMITTER
Company Name: Establishment registration number: Address:
Phone number: Principal contact person: Principal contact e-mail address Additional contact person: Additional contact e-mail address Additional contact person: Additional contact e-mail address Summary date: November 24, 2021
DEVICE
Name & trade name: Classification name:
3D-Side 3013561205 Rue André Dumont 5 1435 Mont-Saint-Guibert, BE +32 (0) 10 81 35 48 Mieke Janssen mieke@ortho-grow.com Laurent Paul lp@3dside.eu Niels Festjens niels@ortho-grow.com
3D-Cut 888.3030 - Orthopaedic surgical planning and instrument guides PBF
Classification product code:
PREDICATE AND REFERENCE DEVICES
The predicate device to which substantial equivalence is claimed:
| Trade or proprietary or model name | VSP® Orthopedics |
|---|---|
| 510(k) number | K190044 |
| Decision date | August 21, 2019 |
| Classification product code | PBF |
| Manufacturer | 3D Systems, Inc. |
Reference device:
| Trade or proprietary or model name | KLS
Patient
Planning System | Martin Individual
Solutions (IPS) |
|------------------------------------|-----------------------------------|--------------------------------------|
| 510(k) number | K192979 | |
| Decision date | March 11, 2020 | |
| Classification product code | PBF | |
| Manufacturer | KLS-Martin L.P. | |
4
| Trade or proprietary or model name | FINE Osteotomy Around |
|---|---|
| The Knee | |
| 510(k) number | K193614 |
| Decision date | March 25, 2020 |
| Classification product code | HRS, HWC, PBF |
| Manufacturer | Bodycad Laboratories, Inc. |
DESCRIPTION AND FUNCTIONING OF THE DEVICE
3D-Cut is a patient-matched additively manufactured single use surgical instrument (PS). Based on a preoperative planning, the instruments are intended to assist physicians in guiding the marking of bone and guiding surgical instruments in bone tumor resection surgery, excluding joint replacement surgeries.
The 3D-Cut instruments are designed starting from patient medical images, computed tomography (CT) and magnetic resonance imaging (MRI) device. The clinician delineates the tumor on the MRI. MRI and the delineated tumor are merged onto the CT which is used to extract the 3D CAD model of the bone. A draft treatment plan is submitted for evaluation to the treating clinician. Upon surgeon's approval, a PSI is designed and again submitted to the clinician. After validation, the PSI is produced using additive manufacturing.
INDICATIONS FOR USE
3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, nonjoint replacing osteotomies, including the resection of bone tumors, for femur, tibia and pelvis including sacrum.
Comparison of Technological Characteristics with the predicate device
The subject device 3D-Cut has either identical or substantially equivalent intended use and technological features as the predicate device K190044. Both devices differ in covered anatomical regions and patient population with the subject device covering more anatomical regions and indicated to be used for adults and adolescents. A comparison with the reference devices, risk analysis, and verification and validation testing were used to evaluate the potential impact on substantial equivalence.
SUMMARY OF PERFORMANCE DATA
Several tests have been conducted to demonstrate the output of the manufacturing process conforms to the device specifications. A combination of bench, cadaveric and clinical (OUS published case series) testing was executed to demonstrate the subject device is substantially equivalent to the predicate device and performs in accordance with its intended use.
5
Testing included biocompatibility testing in accordance with ISO 10993, testing for cleaning, sterility, dimensional stability and packaging, mechanical testing and simulated use testing on cadaveric specimen. In addition, results from clinical investigations using 3D-Cut have been reported.
Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
CONCLUSION
The characteristics that determine the functionality and performance of 3D-Cut, the subject device, are substantially equivalent to the predicate device cleared under K190044. The testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.