(59 days)
Not Found
No
The description focuses on patient-specific guides fabricated based on pre-operative surgical planning using radiological images and surgical planning software. There is no mention of AI or ML being used in the planning or guide fabrication process.
No.
The device is a surgical guide intended to assist in the positioning of pedicle screws, not directly treat a disease or condition.
No
The device is described as a surgical guide used for the placement of pedicle screws during spinal fusion procedures. It aids the surgeon in positioning implants based on pre-operative planning using radiological images, which is a procedural aid, not a diagnostic function.
No
The device description explicitly states that the guides are "manufactured from medical grade nylon for sintering" and are "single use, patient matched, pedicle targeted technology involving the production of patient specific guides". This indicates a physical, patient-specific hardware component is a core part of the device, in addition to the surgical planning software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- MySpine Device Function: The MySpine devices are described as patient-specific surgical guides used intraoperatively (during surgery) to assist surgeons in the placement of pedicle and sacro-iliac screws for spinal fusion procedures. They are physical tools used to guide surgical instruments based on pre-operative planning using radiological images.
- Lack of Biological Sample Testing: The description does not mention any testing of biological samples. The device's function is to guide surgical procedures, not to analyze biological material for diagnostic purposes.
Therefore, the MySpine devices fall under the category of surgical instruments or guides, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MySpine MC and Drill Pilot
MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC is intended as a lumbar and sacral posterior guide for patients requiring spinal fusion between the levels of L1 to S1.
The device is provided with two options:
• Drill based
• K-wire based
MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC K-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.
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 on the basis of the surgical plan to precisely reference the placement of the imponents intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for noncervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine Anchor guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use.
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. 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. The MySpine guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared posterior fixation screw system intended to be used.
Product codes (comma separated list FDA assigned to the subject device)
PQC, QSR
Device Description
MySpine Unilateral Guides are a line extension to Medacta's MySpine pedicle and sacro-iliac screw placement guides. Identically to the other Medacta MySpine products, the subject guides are single use, patient matched, pedicle targeted technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine Unilateral Guides have been designed starting from the correspondent bilateral guides which have been modified to allow the drilling of only the left or the right side of vertebra/sacrum through the left or right tube.
Identically to the predicate devices, MySpine Unilateral Guides are manufactured from medical grade nylon for sintering and they can be provided in both non-sterile and sterile version.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiological images
Anatomical Site
non-cervical, posterior spinal, T1 to L5, L1 to S1, S1, S2, Ilium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 workshop to validate the design and the overall functionality of the subject device as well as to evaluate their accuracy;
- MySpine Unilateral Guides optional design features rationale to demonstrate that these features do not alter docking stability nor instruments guidance parameters, thus they are not considered a worst case;
- 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.
K203673, K220888, K200792, K173472
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
July 21, 2023
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.
Medacta International SA % Mr. Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive, Suite 101 Memphis. Tennessee 38141
Re: K231483
Trade/Device Name: MySpine Unilateral Guides Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: PQC, QSR Dated: May 23, 2023 Received: May 23, 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 (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.
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
1
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 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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K231483
Device Name MySpine Unilateral Guides
Indications for Use (Describe) MySpine MC and Drill Pilot
MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC is intended as a lumbar and sacral posterior guide for patients requiring spinal fusion between the levels of L1 to S1.
The device is provided with two options:
• Drill based
· K-wire based
MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC K-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.
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 on the basis of the surgical plan to precisely reference the placement of the imponents intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for noncervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine Anchor guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use.
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. 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. The MySpine guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared posterior fixation screw system intended to be used.
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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510(k) Summary
Submitter I.
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, Sr. Director, Quality, Regulatory, and Clinical, Medacta USA Date Prepared: May 23, 2023 Date Revised: July 19, 2023
II. Device
| Device Proprietary Name: | MySpine Unilateral Guides |
|---|---|
| Common or Usual Name: | Pedicle screw placement guide |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Primary Product Code | PQC |
| Secondary Product code | QSR |
| Regulation Number: | 21 CFR 888.3070 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
-
A MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA
Additionally, the following predicate devices are used within the submission: -
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides, K220888, Medacta A International SA
-
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, K200792, Medacta International A SA
-
MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments, K173472, Medacta Interational SA
5
IV. Device Description
MySpine Unilateral Guides are a line extension to Medacta's MySpine pedicle and sacro-iliac screw placement guides. Identically to the other Medacta MySpine products, the subject guides are single use, patient matched, pedicle targeted technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine Unilateral Guides have been designed starting from the correspondent bilateral guides which have been modified to allow the drilling of only the left or the right side of vertebra/sacrum through the left or right tube.
Identically to the predicate devices, MySpine Unilateral Guides are manufactured from medical grade nylon for sintering and they can be provided in both non-sterile and sterile version.
V. Indications for Use
. MvSpine MC and Drill Pilot
MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.
The device is provided with two options:
- Drill based
- . K-wire based
MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC K-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.
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 on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.
. MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine Anchor guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use.
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical
6
placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only.
Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared posterior fixation screw system intended to be used.
VI. Comparison of Technological Characteristics
The subject MySpine Unilateral Guides are substantially equivalent to the predicate MySpine (K203673, K220888, K200792 and K173472) with regards to the following characteristics:
- Body region ●
- Spinous process contact;
- Anchoring points; ●
- Instruments compatibility; ●
- Design workflow and related software;
- Manufacturing process;
- Material;
- Biocompatibility;
- Device usage;
- Sterility;
- Shelf-life; and ●
- Packaging. ●
The subject MySpine Unilateral Guides differs respect to the predicate MySpine (K203673, K220888, K200792 and K173472) with respect to the unilateral guide design, not raising any new issue of safety and effectiveness thanks to the ensured contact on both sides.
Discussion
The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness.
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, performance testing was conducted to written protocols. The following validation and rationale are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- Design validation workshop to validate the design and the overall functionality of the subject ● device as well as to evaluate their accuracy;
7
- MySpine Unilateral Guides optional design features rationale to demonstrate that these features . do not alter docking stability nor instruments guidance parameters, thus they are not considered a worst case;
- . Biocompatibility data, shelf-life and sterilization studies submitted in support of the predicate devices were leveraged.
Clinical Studies:
- . No clinical studies were conducted.
Conclusion VIII.
The information provided above supports that the subject devices are substantially equivalent to the predicate devices.