(60 days)
No
The summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes
The device is described as "intended to provide immobilization of spinal segments as an adjunct into fusion" and to "restore the integrity of the spinal column," which are therapeutic actions.
No
This device is a spinal fixation system, intended for immobilization and stabilization of spinal segments, not for diagnosis.
No
The device description explicitly states that the Invictus OCT System consists of physical components such as plates, screws, rods, connectors, and surgical instruments made of titanium alloy, cobalt chromium, and stainless steel. These are hardware components, not software.
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 description clearly states that the Invictus™ OCT Spinal Fixation System is a system of implants (plates, screws, rods, etc.) designed for internal fixation and stabilization of the spine during bone graft healing and/or fusion. These are surgically implanted devices.
- Intended Use: The intended use describes the conditions for which the device is used to provide immobilization and stabilization of spinal segments. This is a mechanical function within the body, not a diagnostic test performed on a sample outside the body.
The text describes a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Invictus™ OCT Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into 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 of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and 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 Invictus OCT Spinal Fixation 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 advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.
Product codes
NKG
Device Description
The Invictus™ OCT Spinal Fixation System is a posterior approach system designed to stabilize the cervico-thoracic spine and/or occiput with or without fusion. The Invictus OCT system is intended to be compatible with Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.
The Invictus OCT implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus OCT System consists of a variety of shapes and sizes of plates, screws, rods, cross connectors, rod-to-rod connectors and general surgical instruments that provide internal fixation and stabilization during bone graft healing and/or fusion mass development.
The Invictus OCT implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.
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)
Nonclinical testing performed on the Invictus OCT system supports substantial equivalence to the predicate devices. The following testing was performed:
- Static and dynamic compression bending per ASTM F2706
- Static and dynamic torsion per ASTM F2706 ●
- . Static flexion-extension moment per ASTM F1798
The results demonstrate that the proposed Invictus OCT system is substantially equivalent to the predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K191185, K200936, K153631, K161032, K111076, K093319, K200130, K161363, K192938
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.
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December 18, 2020
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.
Alphatec Spine, Inc. Ruby Zheng Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K203125
Trade/Device Name: Invictus™ OCT Spinal Fixation System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG Dated: December 11, 2020 Received: December 14, 2020
Dear Ruby Zheng:
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
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 (OS) 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,
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)
Device Name Invictus™ OCT Spinal Fixation System
Indications for Use (Describe)
The Invictus™ OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniccervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and 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 Invictus OCT Spinal 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 advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ System offered by Alphates Spine using various rod-to-rod connectors and/or transitional rods.
| 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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Image /page/3/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is black. There is a black line underneath the word. The "TM" symbol is in the upper right corner of the word.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
Phone: (760) 431-6884
Fax: (760) 431-0289 |
|----|------------------------|-------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Ruby Zheng
Regulatory Affairs Specialist
Contact Phone: (760) 494-6884 |
| | Date Summary Prepared: | December 18, 2020 |
II. DEVICE
| Name of Device: | InvictusTM OCT Spinal Fixation System |
|---|---|
| Common or Usual Name: | Posterior Cervical Screw System |
| Classification Name: | Posterior Cervical Screw System |
| (21 CFR 888.3075) | |
| Regulatory Class: | Class II |
| Product Code: | NKG |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K191185 | NKG, KWP | Solanas® Posterior OCT Fixation System | Alphatec Spine |
| Additional Predicate Devices | |||
| K200936 | NKG | Invictus™ CT Spinal Fixation System | Alphatec Spine |
| K153631 | NKG, KWP | Zimmer Virage® OCT Spinal Fixation System | Zimmer Spine |
| K161032 | NKG, KWP | Neon3™ Universal OCT Spinal Stabilization | Alphatec Spine |
| K111076 | NKG, KWP, MNI | Solanas Avalon Posterior Fixation System | Alphatec Spine |
| K093319 | KWP | NuVasive® VuePoint® OCT System | Nuvasive |
| K200130 | NKG, KWP | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International SA |
4
Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are black. There is a trademark symbol in the upper right corner of the logo.
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K161363 | NKB, KWP, MNH, | ||
| MNI, OSH | Arsenal® Spinal Fixation System | Alphatec Spine | |
| K192938 | NKB.KWP | Invictus™ Spinal Fixation | |
| System | Alphatec Spine |
IV. DEVICE DESCRIPTION
The purpose of this submission is to add occipital components to the previously cleared Invictus™ CT Spinal Fixation System (K200936). The Invictus™ OCT Spinal Fixation System is a posterior approach system designed to stabilize the cervico-thoracic spine and/or occiput with or without fusion. The Invictus OCT system is intended to be compatible with Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.
The Invictus OCT implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus OCT System consists of a variety of shapes and sizes of plates, screws, rods, cross connectors, rod-to-rod connectors and general surgical instruments that provide internal fixation and stabilization during bone graft healing and/or fusion mass development.
The Invictus OCT implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.
V. INDICATIONS FOR USE
The indications for use of the Invictus™ OCT Spinal Fixation System are identical to those of the predicate Solanas® Posterior OCT Fixation System:
The Invictus™ OCT Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into 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 of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and 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 Invictus OCT Spinal Fixation 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 advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.
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Image /page/5/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are black. There is a trademark symbol in the upper right corner of the logo. There is a black line underneath the logo.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Nonclinical testing performed on the Invictus OCT system supports substantial equivalence to the predicate devices. The following testing was performed:
- Static and dynamic compression bending per ASTM F2706
- Static and dynamic torsion per ASTM F2706 ●
- . Static flexion-extension moment per ASTM F1798
The results demonstrate that the proposed Invictus OCT system is substantially equivalent to the predicate devices for nonclinical testing.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.