(196 days)
Not Found
No
The summary describes patient-specific guides created from CT scans using surgical planning software, but there is no mention of AI or ML being used in the planning or guide generation process. The focus is on 3D modeling and anatomical referencing.
No
The device is a surgical guide used to assist in the positioning of screws during spinal fusion surgery, not to treat a disease or condition itself.
No
The device is intended to assist in the precise positioning of screws during surgery, not to diagnose a condition or disease. It uses pre-operative imaging for surgical planning, but its function is interventional, not diagnostic.
No
The device description explicitly states that the MySpine Cervical guides are patient-specific physical devices fabricated based on the surgical plan. While the software is used for planning, the final device is a physical guide.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- MySpine Cervical Function: The MySpine Cervical device is a patient-specific surgical guide used intra-operatively to assist surgeons in the physical placement of screws during posterior cervical fixation surgery. It uses pre-operative imaging (CT scans) to create a physical guide that fits the patient's anatomy.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is purely mechanical and anatomical guidance during surgery.
Therefore, the MySpine Cervical device falls under the category of a surgical instrument or guide, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating quides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.
For pedicle diameters equal or less than ø4mm. Medacta provides for the pilot hole preparation into the lateral mass without penetrating the pedicle.
The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patientspecific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
QSD
Device Description
MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.
The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Cervical Guide fitting the patient's vertebral anatomy.
The MySpine Cervical Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Cervical spine, between the levels of C2 to C7.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intra-operatively, during posterior cervical fixation surgery.
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)
Non-Clinical Studies:
- Design Validation workshops to validate the design and the overall functionality of the subject device as well as to evaluate their accuracy. Two validation workshops, one for the unilateral and the other for the mass lateral guides, have been performed.
- MySpine Cervical stability assessment to evaluate the stability of the subject lateral mass guides.
- Biocompatibility data, shelf-life and sterilization studies submitted in support of the predicate devices were leveraged.
Clinical Studies:
- No clinical studies were conducted.
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.
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.
Not Found
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
December 7, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized design. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
Medacta International SA % Mr. Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive, Suite 101 Memphis. Tennessee 38141
Re: K231515
Trade/Device Name: MySpine Cervical Guides Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: QSD Dated: May 25, 2023 Received: November 27, 2023
Dear Mr. Lussier:
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" (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).
1
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.
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-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,
Colin
O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
MySpine Cervical Guides
Indications for Use (Describe)
MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating quides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.
For pedicle diameters equal or less than ø4mm. Medacta provides for the pilot hole preparation into the lateral mass without penetrating the pedicle.
The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patientspecific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.
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
510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality, Regulatory, and Clinical Research, Medacta USA
Date Prepared: May 25, 2023
II. Device
| Device Proprietary Name: | MySpine Cervical Guides |
|---|---|
| Common or Usual Name: | Posterior cervical screw placement guide |
| Classification Name: | Posterior Cervical Screw System |
| Primary Product Code: | QSD |
| Regulation Number: | 21 CFR 888.3075 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
-
FIREFLY Cervical Navigation Guide, K220132, Mighty Oak Medical Inc. A
Additionally, the following predicate devices are used within the submission: -
MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA A
-
A MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments, K173472, Medacta Interational SA
IV. Device Description
MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.
The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent
Medacta International SA
4
the template used to generate the corresponding MySpine Cervical Guide fitting the patient's vertebral anatomy.
The MySpine Cervical Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.
V. Indications for Use
MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7. For pedicle diameters equal or less than ø4mm. Medacta provides the guides for the pilot hole preparation into the lateral mass without penetrating the pedicle.
The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patient-specific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.
VI. Comparison of Technological Characteristics
The subject MySpine Cervical Guides are substantially equivalent to the predicate device, FIREFLY Cervical Navigation Guide (K220132), with regards to the following characteristics:
- Lateral mass guides' design; ●
- Instruments compatibility; ●
- Manufacturing process; ●
- Material;
- Biocompatibility;
- Device usage; and
- Packaging. ●
The subject MySpine Cervical Guides differ respect to the predicate, FIREFLY Cervical Navigation Guide (K220132), with regards to the following characteristics:
- Body region; ●
- Unilateral guides' design;
- Spinous process contact; ●
- Design workflow & related software;
- Sterility; and
- Shelf-life. ●
Discussion
The technological differences between the subject and primary predicate device do not raise new questions of safety and effectiveness since the main differences (i.e. spinous process contact, design workflow & related software, sterility and shelf-life) of the subject devices are shared with Medacta MySpine devices cleared within K203673 and K173472.
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K231515 - Page 3 of 3
Medacta International SA
Medacta International SA has not made any change to the manufacturing process, material, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices with respect to the predicate devices.
The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices respect to the predicate devices.
VII. Performance Data
Based on the risk analysis, testing activities were conducted to written protocols. The following validations and rationale are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- . Design Validation workshops to validate the design and the overall functionality of the subject device as well as to evaluate their accuracy. Two validation workshops, one for the unilateral and the other for the mass lateral guides, have been performed.
- MySpine Cervical stability assessment to evaluate the stability of the subject lateral mass guides. ●
- . Biocompatibility data, shelf-life and sterilization studies submitted in support of the predicate devices were leveraged.
Clinical Studies:
- No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the subject devices are substantially equivalent to the predicate devices.