(58 days)
Not Found
No
The device description focuses on the mechanical components and materials of a spinal fixation system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is described as "a posterior occipital cervical thoracic (OCT) system that consists of implants... to act as a temporary or permanent posterior fixation system to correct spinal disorders and provide stabilization of the spine...". Correcting spinal disorders and stabilizing the spine are therapeutic actions.
No
Explanation: The NorthStar OCT System is described as a posterior occipital cervical thoracic (OCT) system consisting of implants and instruments designed to correct spinal disorders and provide stabilization. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of implants and associated instruments made from various metal alloys, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The NorthStar OCT System is a surgical implant system consisting of screws, rods, plates, and other components made of metal alloys. It is designed to be implanted into the spine to provide stabilization and support.
- Intended Use: The intended use clearly states that the system is for "immobilization and stabilization of spinal segments as an adjunct to fusion" and to "restore the integrity of the spinal column." This is a structural and mechanical function within the body, not a diagnostic test performed on a sample outside the body.
The information provided describes a surgical implant device used for spinal fixation, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The NorthStar 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, cervical spine (C1-C7), and upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations,
- · Instability or deformity,
- · Failed previous fusion (e.g., pseudoarthrosis),
- · Tumors involving the cervical/thoracic spine,
- · Degenerative disease. including intractable radiculopathy and neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- · Degenerative disease of the facets with instability.
The NorthStar OCT System is 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.
The NorthStar OCT System can also be linked to other FDA-cleared SeaSpine/Orthofix screw systems with the use of transitional rods and/or transitional rod connectors.
Product codes
NKG, KWP
Device Description
The NorthStar OCT System is a posterior occipital cervical thoracic (OCT) system that consists of implants and the associated instruments used to build constructs within the body to act as a temporary or permanent posterior fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The system includes a variety of non-sterile, single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136), commercially pure titanium (Grade 2 per ASTM F67), and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537) and is comprised of polyaxial screws, rods, hooks, connectors, occipital plates, occipital screws, and set screws that can be rigidly locked together in a variety of configurations.
The NorthStar OCT System includes the associated instruments that are designed to facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants. The implants and instruments are provided in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, cervical spine (C1-C7), and upper thoracic spine (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
Non-Clinical Testing: The NorthStar OCT System demonstrated substantially equivalent mechanical performance to the predicate systems through dynamic compression bending, static compression bending, static torsion, and dynamic torsion testing per ASTM F2706.
Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SeaSpine Orthopedics Corporation Mr. Jesse Albright Manager, Regulatory Affairs 5770 Armada Dr. Carlsbad, California 92008
Re: K231654
Trade/Device Name: NorthStar OCT System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: June 5, 2023 Received: June 6, 2023
Dear Mr. Jesse Albright:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
August 3, 2023
1
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 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.
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.08.03 for
17:04:39 -04'00'
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
NorthStar OCT System
Indications for Use (Describe)
The NorthStar 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, cervical spine (C1-C7), and upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations,
- · Instability or deformity,
- · Failed previous fusion (e.g., pseudoarthrosis),
- · Tumors involving the cervical/thoracic spine,
- · Degenerative disease. including intractable radiculopathy and neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- · Degenerative disease of the facets with instability.
The NorthStar OCT System is 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.
The NorthStar OCT System can also be linked to other FDA-cleared SeaSpine/Orthofix screw systems with the use of transitional rods and/or transitional rod connectors.
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.
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3
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation | ||
|---|---|---|---|
| Address: | |||
| Phone number: | |||
| Fax number: | 5770 Armada Drive, Carlsbad, CA 92008 | ||
| (760) 216-5176 | |||
| (760) 683-6874 | |||
| Contact Person: | Jesse Albright, Manager, Regulatory Affairs | ||
| Date Prepared: | June 5, 2023 | ||
| Device Name | |||
| Trade Name: | NorthStar OCT System | ||
| Common Name: | Posterior Cervical Screw System | ||
| Spinal Interlaminal Fixation System | |||
| Classification Name: | Posterior Cervical Screw System (21 CFR 888.3075) | ||
| Appliance, Fixation, Spinal Interlaminal (21 CFR 888.3050) | |||
| Product Code(s): | NKG, KWP |
Legally Marketed Predicate Devices
2
| 510(k) Number | Product Code(s) | Trade Name(s) | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K193615 | NKG; KWP | NorthStar OCT System | SeaSpine |
| Orthopedics | |||
| Corporation | |||
| Additional Predicate Device(s) | |||
| K080526 | KWP | Sierra OCT System | SeaSpine |
| Orthopedics | |||
| Corporation |
Device Description
Device Class:
The NorthStar OCT System is a posterior occipital cervical thoracic (OCT) system that consists of implants and the associated instruments used to build constructs within the body to act as a temporary or permanent posterior fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The system
4
includes a variety of non-sterile, single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136), commercially pure titanium (Grade 2 per ASTM F67), and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537) and is comprised of polyaxial screws, rods, hooks, connectors, occipital plates, occipital screws, and set screws that can be rigidly locked together in a variety of configurations.
The NorthStar OCT System includes the associated instruments that are designed to facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants. The implants and instruments are provided in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for Use
The NorthStar OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1-C7) and upper thoracic spine (T1-T3):
- Traumatic spinal fractures and/or traumatic dislocations,
- Instability or deformity,
- . Failed previous fusion (e.g., pseudoarthrosis),
- Tumors involving the cervical/thoracic spine,
- . Degenerative disease, including intractable radiculopathy and/or myelopathy and neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- . Degenerative disease of the facets with instability.
The NorthStar OCT System is 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.
The NorthStar OCT System can also be linked to other FDA-cleared SeaSpine/Orthofix screw systems with the use of transitional rods and/or transitional rod connectors.
Summary of Technological Characteristics
The NorthStar OCT System is identical or similar to the cited predicate systems in regard to intended use/indications for use, device description, technological characteristics (e.g., operating principle, design, components, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing).
5
Non-Clinical Testing
The NorthStar OCT System demonstrated substantially equivalent mechanical performance to the predicate systems through dynamic compression bending, static compression bending, static torsion, and dynamic torsion testing per ASTM F2706.
Clinical Testing
Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the NorthStar OCT System is substantially equivalent to the cited legally marketed predicates.