(269 days)
No
The description focuses on patient-matched, 3D-printed surgical guides based on CT images, without mentioning AI or ML for image analysis, planning, or guide generation. The process appears to be based on traditional image processing and CAD/CAM techniques.
No
The device is described as a "surgical instrument" and "surgical drilling/cutting guides" used to assist in pre-operative planning and guiding surgical instruments, not for directly treating a disease or condition.
No
Explanation: The device is described as a surgical instrument and patient-matched guide for pre-operative planning and guiding surgical instruments, not for diagnosing conditions.
No
The device description explicitly states that the device is "additively manufactured (3D printed)" and are "surgical drilling/cutting guides," indicating a physical hardware component.
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 Function: The description clearly states that this device is a "surgical instrument" and "surgical drilling/cutting guides" used to assist in pre-operative planning and guiding surgical instruments during osteotomy procedures. It is used on the patient during surgery, not for testing specimens from the patient.
- Intended Use: The intended use is to assist in surgical procedures around the knee, not to diagnose or monitor a condition through laboratory testing.
Therefore, this device falls under the category of a surgical instrument or guide, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy, Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.
Product codes
PBF
Device Description
The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The primary purpose of this 510(k) notification is to add PSI Guides for closingwedge and derotation osteotomies.
Material: Polyamide (PA2200).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT)
Anatomical Site
around the knee
Indicated Patient Age Range
adults only
Intended User / Care Setting
health care professionals
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
Verification and validation (V&V) activities included the following:
- Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries of worst-case surgical approach and type of PSI-guide. Precision and accuracy of the subject device was demonstrated. The guides used in these studies were identical to the subject device in terms of design, material, methods of construction, patient matching process, manufacturing, and surgical technique.
- An analysis was performed to compare the subject devices and the predicate devices regarding verification of precision and accuracy in design and manufacturing as well as regarding cleaning and sterilization. The analysis showed that the subject devices are as safe and as effective as the predicate device described in K221615.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
November 7, 2024
Newclip Technics Robert Poggie Regulatory Consultant to Newclip Technics PA de la Lande Saint Martin 45 rue des Garottieres Haute Goulaine, 44115 France
Re: K240415
Trade/Device Name: Newclip Patient-matched instrumentation non sterile PSI 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: October 8, 2024 Received: October 8, 2024
Dear Robert Poggie:
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 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
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Indications for Use
Submission Number (if known)
Device Name
Newclip Patient-matched instrumentation non sterile PSI
Indications for Use (Describe)
The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy. Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.
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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K240415 - 510(k) Summary Newclip Patient-matched instrumentation non sterile PSI
In accordance with 21 CFR 807.92, the following information is a 510(k) Summary for the Newclip Patient-matched instrumentation non sterile PSI.
A. SUBMITTER INFORMATION
| Sponsor Name: | NEWCLIP TECHNICS |
|---|---|
| Sponsor Address: | P.A. de la Lande Saint Martin, 45 rue des Garottières, |
| F-44115 Haute-Goulaine, FRANCE | |
| Submitter Name: | BioVera, Inc. |
| Submitter Address: | 65 Promenade Saint-Louis, |
| Notre-Dame-De-L'Ile-Perrot, QC, J7W 3J6, CANADA | |
| Contact Person: | Robert A. Poggie, PhD |
| Phone & Fax Number: | (514) 901-0796 |
| Date of Preparation: | October 8th, 2024 |
B. DEVICE IDENTIFICATION
| Device Trade Name: | Newclip Patient-matched instrumentation non sterile PSI |
|---|---|
| Device Common Name: | Orthopaedic Surgical Planning and Instrument Guides |
| Classification Code: | PBF |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| Classification Panel: | Orthopedic |
| Regulation: | 21 CFR 888.3030 |
C. PREDICATE DEVICE
| K221615 (Primary) | Newclip Patient-matched instrumentation non sterile PSI |
|---|---|
| K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides |
| (Materialise N.V). |
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D. DEVICE DESCRIPTION
The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The primary purpose of this 510(k) notification is to add PSI Guides for closingwedge and derotation osteotomies.
Material: Polyamide (PA2200).
E. INDICATIONS FOR USE
The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy, Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Newclip Patient-matched instrumentation non sterile PSI have the same or similar technological characteristics as the predicate devices.
Target population: The Newclip Patient-matched instrumentation non sterile PSI are intended for the same subset of the target population (i.e. adults only) of the predicate devices.
Material: The Newclip Patient-matched instrumentation non sterile PSI uses the same additively manufactured (AM) Polyamide material as the predicate devices.
Manufacturing method: The Newclip Patient-matched instrumentation non sterile PSI are manufactured using the same AM method as the predicate devices.
Imaging technique: The Newclip Patient-matched instrumentation non sterile PSI uses the same image technique (CT) as the predicate device (K221615).
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Comparison of the technological characteristics and indicated use of the subject and predicate devices demonstrate that the subject device is substantially equivalent to the predicate device.
G. PERFORMANCE DATA
Verification and validation (V&V) activities included the following:
- · Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries of worst-case surgical approach and type of PSI-guide. Precision and accuracy of the subject device was demonstrated. The guides used in these studies were identical to the subject device in terms of design, material, methods of construction, patient matching process, manufacturing, and surgical technique.
- · An analysis was performed to compare the subject devices and the predicate devices regarding verification of precision and accuracy in design and manufacturing as well as regarding cleaning and sterilization. The analysis showed that the subject devices are as safe and as effective as the predicate device described in K221615.
H. CONCLUSION
The information presented in this 510(k) notification show the Newclip Patient-matched instrumentation non sterile PSI to be substantially equivalent to the legally marketed predicate devices.