(138 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal implant components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to "immobilize and stabilize the spine as an adjunct to fusion" and "restore the integrity of the spinal column" for various medical conditions, indicating a therapeutic purpose.
No
The device is a system for immobilizing and stabilizing the spine as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components (screws, rods, cross-connectors) made from titanium and cobalt chrome alloys, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilize and stabilize the spine as an adjunct to fusion". This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device consists of "polyaxial screws, set screws, rods, and cross-connector components" which are implanted into the spine. This is consistent with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, 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 Proficient™ Cervical Spine 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 whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient™ Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient™ transition rods.
Product codes
NKG
Device Description
The Proficient™ Posterior Cervical Spine System consists of a selection of non-sterile, single use polyaxial screws, set screws, rods, and cross-connector components manufactured from titanium (ASTM F136 and ASTM F67) and cobalt chrome alloys (ASTM F1537 and ASTM F1058). The surgeon attaches the rod, screw, and cross connectors to the cervicothoracic region of the spine in order to stabilize the spine during fusion of vertebral bodies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (C2-C7) and thoracic (T1-T3) spinal segments
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
Spine Wave performed the following testing to demonstrate the Proficient™ Posterior Cervical Spine System is substantially equivalent to its predicate:
- Static and dynamic compression bending (per ASTM F1717)
- Static and dynamic torsion (per ASTM F1717) ●
- Axial grip (per ASTM 1798) o
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K150650, K112068, K151885, K153631
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2017
Spine Wave, Inc. Ms. Sanja Jahr Regulatory Affairs Specialist Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K162639
Trade/Device Name: Proficient™ Posterior Cervical Spine System Regulatory Class: Unclassified Product Code: NKG Dated: January 5, 2017 Received: January 6, 2017
Dear Ms. Jahr:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162639
Device Name
Proficient™ Posterior Cervical Spine System
Indications for Use (Describe)
The Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, 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 Proficient™ Cervical Spine 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 whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient™ Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient™ transition rods.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Proficient™ Posterior Cervical Spine System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1870 |
| Telefax: | 203-944-9493 |
| Contact: | Sanja Jahr |
| Date Prepared: | January 5, 2016 |
2. Device Information
| Trade Name: | Proficient™ Posterior Cervical Spine System |
|---|---|
| Common Name: | Posterior Cervico-Thoracic Fixation system |
| Classification: | Unclassified, Pre-Amendment |
| Classification Name: | Orthosis, Cervical Pedicle Screw Spinal Fixation |
| Product Code: | NKG |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new posterior cervico-thoracic fixation system.
4. Predicate Device Information
The Proficient™ Posterior Cervical Spine System described in this submission is substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Synapse™ OCT System | DePuy Synthes, Inc. | K142838 |
| Reference Predicate Devices | Manufacturer | 510(k) No. |
| neon3 TM | Ulrich Medical | K150650 |
| Zero-PTM VA | Synthes Spine, Inc. | K112068 |
| Mountaineer® OCT Spinal System | Depuy Synthes Inc. | K151885 |
| Virage® OCT Spinal Fixation System | Zimmer Spine, Inc | K153631 |
4
5. Device Description
The Proficient™ Posterior Cervical Spine System consists of a selection of non-sterile, single use polyaxial screws, set screws, rods, and cross-connector components manufactured from titanium (ASTM F136 and ASTM F67) and cobalt chrome alloys (ASTM F1537 and ASTM F1058). The surgeon attaches the rod, screw, and cross connectors to the cervicothoracic region of the spine in order to stabilize the spine during fusion of vertebral bodies.
6. Indications for Use
The Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, 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 Proficient™ Posterior Cervical Spine 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 whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient™ Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient™ transition rods.
7. Comparison of Technological Characteristics
The substantial equivalence of the Proficient™ Posterior Cervical Spine System to the predicates is demonstrated by similarity in indications for use, materials and performance.
8. Performance Data
Spine Wave performed the following testing to demonstrate the Proficient™ Posterior Cervical Spine System is substantially equivalent to its predicate:
- Static and dynamic compression bending (per ASTM F1717)
- Static and dynamic torsion (per ASTM F1717) ●
- Axial grip (per ASTM 1798) o
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Proficient™ Posterior Cervical Spine System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.