(56 days)
No
The description focuses on patient-matched, 3D-printed surgical guides based on CT scans, with no mention of AI or ML in the planning or guide generation process.
No
The device is described as a surgical instrument and patient-matched guides used to assist in pre-operative planning and guiding surgical instruments during osteotomies, rather than directly treating a disease or condition.
No
Explanation: The device is described as a "surgical instrument" and "surgical drilling/cutting guides" used to assist in pre-operative planning and guiding surgical instruments for osteotomies. Its purpose is to facilitate implantation and is not focused on identifying, assessing, or monitoring medical conditions.
No
The device is described as "patient-matched devices (PSI Guides)" that are "additively manufactured (3D printed)" and are "surgical drilling/cutting guides". This clearly indicates a physical, hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Newclip Patient-matched instrumentation non sterile PSI is a surgical instrument designed to assist in pre-operative planning and guide surgical instruments during surgery on the patient's body. It is used in vivo (within the body) as a surgical aid.
- Intended Use: The intended use clearly states it's a "surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments" for specific osteotomy procedures. This is a surgical function, not a diagnostic test on a sample.
- Device Description: The description reinforces that these are "surgical drilling/cutting guides" used to "assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments."
The device utilizes patient imaging (CT) for planning and creating the patient-matched guide, but the device itself is a surgical tool used during the procedure, not a diagnostic test performed on a biological sample.
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, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing 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 guides 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 purpose of this 510(k) notification is to add PSI Guides for High Tibial Lateral and Anterior Closing 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
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
The two steps in verification & validation (V&V) activities for the subject device were: (1) a worst-case analysis for design and manufacturing of the PSI guides, and (2) a worst-case analysis of the usability of the subject PSI guides in simulated surgery.
(1) The validation and verification activity for manufacturing PSI quides was performed by three NewClip operators with low, medium, and high levels of experience (novice, intermediate, expert) applied to worst-case guide design and manufacture followed by comparison of dimensions, design, correction, and placement of the PSI guide. The results of this work demonstrated similar precision and accuracy of design, correction, and manufacture as the predicate PSI guide cleared in K240415.
(2) The simulated use of the worst-case and subject PSI guides was performed by the same three novice surgeons using the same performance measures and acceptance criteria as reported in K240415. The results showed the subject PSI guides to be positioned without issue via lateral and anterior approaches, the planned correction to be achieved, and preservation of the hinge throughout the simulated surgery.
The results of V&V activities demonstrate that the subject device is as safe and effective as the predicate device described in K240415.
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: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder blue font, and the word "ADMINISTRATION" in a smaller blue font below.
February 13, 2024
NewClip Technics % Robert Poggie, PhD President BioVera. Inc. 65 Promenade Saint Louis Notre-Dame-de-L'Ile-Perrot, QC J7W3J6 Canada
Re: K243912
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: December 19, 2024 Received: December 19, 2024
Dear Dr. 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.
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"
1
(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 OS 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 Rue"). 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-devices/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-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
2
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)
K243912
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, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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
K243912 Page 1 of 3
510(k) Summary for K243912 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 & Email: | (514) 349-7226 & orthobob@biovera.ca |
| Date of Preparation: | February 12th, 2025 |
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
5
D. DEVICE DESCRIPTION
The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting guides 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 purpose of this 510(k) notification is to add PSI Guides for High Tibial Lateral and Anterior Closing 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, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing 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 has the same or similar technological characteristics and indicated uses as the predicate device.
Target population: The Newclip Patient-matched instrumentation non sterile PSI are intended for the same subset of the target population (adults) of the predicate device.
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.
Imagery technique: The Newclip Patient-matched instrumentation non sterile PSI uses the same image technique (CT) as the predicate device (K240415).
6
Surgeon training and documentation: The training of US surgeons on the new subject guides is performed with the presentation materials and training-form cleared in K240415, with the tibial closing wedge quides for anterior and lateral approaches.
The subject and predicate devices are indicated to be used as surgical instruments to assist in pre-operative planning and/or in guiding surgical instruments when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e. computed tomography (CT)). The primary predicate device are PSI guides for opening femoral and tibial, closing-femoral, and derotation wedge osteotomies about the knee whereas the subject device includes PSI guides for closing-tibial lateral and anterior approach osteotomies. The subject device is designed to be compatible with implants from the Newclip Activmotion Range. The intended purpose of the subject and predicate devices is the same, namely patient matched instruments for osteotomies about the knee.
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
The two steps in verification & validation (V&V) activities for the subject device were: (1) a worst-case analysis for design and manufacturing of the PSI guides, and (2) a worst-case analysis of the usability of the subject PSI guides in simulated surgery.
(1) The validation and verification activity for manufacturing PSI quides was performed by three NewClip operators with low, medium, and high levels of experience (novice, intermediate, expert) applied to worst-case guide design and manufacture followed by comparison of dimensions, design, correction, and placement of the PSI guide. The results of this work demonstrated similar precision and accuracy of design, correction, and manufacture as the predicate PSI guide cleared in K240415.
(2) The simulated use of the worst-case and subject PSI guides was performed by the same three novice surgeons using the same performance measures and acceptance criteria as reported in K240415. The results showed the subject PSI guides to be positioned without issue via lateral and anterior approaches, the planned correction to be achieved, and preservation of the hinge throughout the simulated surgery.
The results of V&V activities demonstrate that the subject device is as safe and effective as the predicate device described in K240415.
H. CONCLUSION
The information in this 510(k) shows the Newclip Patient-matched instrumentation non sterile PSI to be substantially equivalent to the legally marketed predicate device.