(27 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML components.
No.
The device is an orthopedic implant system and not a therapeutic device. It is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion.
No
Explanation: The INFINITY™ OCT System is a surgical implant system used for the stabilization and fusion of spinal segments. It consists of various mechanical components like plates, rods, screws, and connectors, and its intended use is to provide stabilization and integrity to the spinal column, not to diagnose medical conditions.
No
The device description explicitly lists hardware components such as plates, rods, hooks, screws, and connectors, and the submission is for new non-sterile versions of these hardware components.
Based on the provided text, 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.
- Device Description: The INFINITY™ OCT System is described as a system of plates, rods, hooks, screws, and connectors intended for the surgical stabilization and fusion of spinal segments. These are implantable medical devices used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states the device is for "immobilization and stabilization of spinal segments as an adjunct to fusion" and for "restor[ing] the integrity of the spinal column." This is a therapeutic and structural function, not a diagnostic one.
Therefore, the INFINITY™ OCT System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INFINITY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
- · Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- · Failed previous fusions (e.g. pseudarthrosis).
- · Tumors involving the cervical spine.
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The INFINITY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the INFINITY OCT System may be connected to the CD HORIZON® Spinal System and VERTEX® Reconstruction System rods with the INFINITY OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX® Reconstruction System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The INFINITY™ OCT System is a posterior occipitocervical-upper thoracic system. The system consists of a variety of shapes and sizes of plates, rods, hooks, set screws, multiaxial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Per this 510(k) submission, Medtronic is seeking the clearance of new non-sterile multiaxial screws (MAS), axial dominos, and MAS extension connector that will be part of the INFINITY TM OCT System. These devices are identical in design and material to those cleared in K163375 (S.E. 08/21/2017) and there is only a change in sterility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject devices do not represent a new worst-case and the testing for the predicate devices is deemed applicable for the subject devices. The sterilization justification for the predicate devices adopts the subject devices into existing steam validation documents. The subject devices and the predicate devices have identical designs, materials, and manufacturing processes. Therefore, no additional bench performance testing is needed.
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
January 11, 2023
Image /page/0/Picture/1 description: The image shows 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 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.
Medtronic Sofamor Danek USA, Inc. Ms. Laura Parr Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K223764
Trade/Device Name: INFINITY™ OCT System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: December 14, 2022 Received: December 15, 2022
Dear Ms. Parr:
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-reporting-
combination-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,
Anne D. Talley -S
for
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) K223764
Device Name INFINITY OCT System
Indications for Use (Describe)
The INFINITY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
- · Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- · Failed previous fusions (e.g. pseudarthrosis).
- · Tumors involving the cervical spine.
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The INFINITY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the INFINITY OCT System may be connected to the CD HORIZON® Spinal System and VERTEX® Reconstruction System rods with the INFINITY OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX® Reconstruction System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
- I. Medtronic Sofamor Danek USA, Inc. Company: 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Laura Beth Parr Contact: Regulatory Affairs Specialist Telephone Number: (901) 344-0614 Email: laurabeth.parr(@medtronic.com
Date Prepared: December 14, 2022
II. Proprietary Trade Name: INFINITY™ OCT System
Common Name: Posterior cervical screw system
Classification Name: Posterior Cervical Screw System (21 CFR §888.3075) Spinal Interlaminal Fixation Orthosis (21 CFR §888.3050)
Classification: Class II
Product Code: NKG, KWP
III. Predicate Devices:
| Primary Predicate | INFINITY™ OCT System (K163375,
S.E. 08/21/2017) |
|----------------------|-------------------------------------------------------------|
| Additional Predicate | Vertex® Reconstruction System
(K090714, S.E. 04/17/2009) |
IV. Device Description:
The INFINITY™ OCT System is a posterior occipitocervical-upper thoracic system. The system consists of a variety of shapes and sizes of plates, rods, hooks, set screws, multiaxial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Per this 510(k) submission, Medtronic is seeking the clearance of new non-sterile multiaxial screws (MAS), axial dominos, and MAS extension connector that will be part of the INFINITY TM OCT System. These devices are identical in design and material to those cleared in K163375 (S.E. 08/21/2017) and there is only a change in sterility.
5
V. Indications for Use:
The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
- . Traumatic spinal fractures and/or traumatic dislocations.
- . Instability or deformity.
- Failed previous fusions (e.g. pseudarthrosis). ●
- Tumors involving the cervical spine. ●
- Degenerative disease, including intractable radiculopathy and/or myelopathy, ● neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The INFINITY™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the INFINITY™ OCT System may be connected to the CD HORIZON® Spinal System and VERTEX® Reconstruction System rods with the INFINITY™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY™ OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX® Reconstruction System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
VI. Comparison of Technological Characteristics with the Predicate devices:
As established in this submission, the subject INFINITY™ OCT System devices are substantially equivalent to the identified predicate devices cleared by the FDA for
6
commercial distribution in the United States. The subject devices are identical in design to the primary predicate devices and the only change is to the sterility of the devices. Because of sterility being the only change, the subject devices were shown to be substantially equivalent and have equivalent technological characteristics to their predicate devices through comparison in areas including design, labeling/intended use, material composition, function, and sterilization.
VII. Discussion of the Non-clinical Testing/Performance Data:
The subject devices do not represent a new worst-case and the testing for the predicate devices is deemed applicable for the subject devices. The sterilization justification for the predicate devices adopts the subject devices into existing steam validation documents. The subject devices and the predicate devices have identical designs, materials, and manufacturing processes. Therefore, no additional bench performance testing is needed.
VIII. Conclusion
Based on the design features, the use of established well-known materials, feature comparisons, and indications for use, the subject INFINITY™ OCT System devices have been shown to be substantially equivalent to the legally marketed predicate devices cited in this summary.