(253 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
A therapeutic device is typically involved in the treatment or cure of a disease or condition, or restoring function. This device is described as an immobilization and stabilization system for the spine, which is a supportive rather than directly therapeutic role in the sense of initiating biological healing or curing a disease.
No
The device description clearly states "neon3™ is a modular, posterior system used for the surgical stabilization and fixation of the occipital, cervical and thoracic regions of the spine." This describes a surgical implant used for treatment, not diagnosis. The "Intended Use" also details various conditions for which the device provides immobilization or restores integrity, all of which are therapeutic actions rather than diagnostic.
No
The device description clearly states that neon3™ is a "modular, posterior system used for the surgical stabilization and fixation" and lists physical components like "longitudinal rods, screw and hook anchors, and interconnecting devices". This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for stabilizing the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details mechanical components like rods, screws, and hooks, which are used in surgery.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). There is no mention of this in the provided text.
- Performance Studies: The performance studies described are mechanical tests, not clinical studies evaluating diagnostic accuracy.
Therefore, neon3™ is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and 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. neon3™ 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 of fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
neon3™ is a modular, posterior system used for the surgical stabilization and fixation of the occipital, cervical and thoracic regions of the spine. The system components include longitudinal rods, screw and hook anchors, and interconnecting devices such as anchor- to-rod connectors, and rod-to-rod and screw-to-screw crosslinks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical spine (C1 to C7) and the thoracic spine (T1 to T3), craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to 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)
Mechanical testing of worst case neon3TM craniocervical constructs included static and dynamic compression bending and static torsion according to ASTM F1717 as well as static and dynamic compression bending and static and dynamic torsion per ASTM F2706. The mechanical test results demonstrate that neon3TM performance is substantially equivalent to the predicate devices.
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.
K142838, K962314, K150650, K033480, K073420
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
ulrich GmbH & Co. KG % Mr. Hans Stover President and CEO ulrich medical USA, Inc. 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K161032
Trade/Device Name: neon3TM universal OCT spinal stabilization Regulatory Class: Unclassified Product Code: NKG, KWP Dated: December 2, 2016 Received: December 5, 2016
Dear Mr. Stover:
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.
VincentJ. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
K161032
Device Name
neon3TM universal OCT spinal stabilization
Indications for Use (Describe)
neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and 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. neon3™ 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 of fusion.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 8 – 510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is written in a bold, slanted font, with the "U" extending into a black square on the left side. Below the word "Ulrich" is the text "medical USA" in a smaller, non-bold font.
| Date: | 2 December 2016 |
|---|---|
| Sponsor: | ulrich GmbH & Co. KG |
| Buchbrunnenweg 12 | |
| 89081 Ulm | |
| Germany | |
| Phone: +49 (0) 731-9654-1304 | |
| Fax: +49 (0) 731-9654-2802 | |
| Contact Person: | Hans Stover |
| ulrich medical USA, Inc. | |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Trade Name: | neon3™ universal OCT spinal stabilization |
| Common Name: | Posterior occipital-cervical-thoracic system, |
| Cervical Pedicle Screw Spine Fixation | |
| Device Classification: | Unclassified |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code: NKG, KWP | |
| Submission Purpose: | To add occipital-cervical and cervicothoracic construct components to the |
| cleared neon3™ system including rods, plates, screws, hooks, crosslinks | |
| and fasteners. | |
| Device Description: | neon3™ is a modular, posterior system used for the surgical stabilization and |
| fixation of the occipital, cervical and thoracic regions of the spine. The | |
| system components include longitudinal rods, screw and hook anchors, and | |
| interconnecting devices such as anchor- to-rod connectors, and rod-to-rod | |
| and screw-to-screw crosslinks. | |
| Indications for Use: | neon3™ 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 to C7) and the | |
| thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic | |
| dislocations; instability or deformity; failed previous fusions (e.g. | |
| pseudarthrosis); tumors involving the cervical/thoracic 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. | |
| neon3™ 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 | |
| Materials: | neon3TM components are manufactured from Grade 2 titanium (ASTM F67), |
| Ti-6Al-4V titanium alloy (ASTM F136) or Cobalt Chrome (ASTM F1537) | |
| Primary Predicate: | Synapse Occipital-Cervical-Thoracic (OCT) System (DePuy Synthes Spine, |
| K142838) | |
| Additional Predicates: | Halifax Interlaminar Clamp (Osteonics- K962314), neon3TM (K150650 – |
| ulrich medical GmbH & Co. KG) and Ascent™ POCT System (Blackstone | |
| Medical, K033480 and K073420) | |
| Performance Data: | Mechanical testing of worst case neon3TM craniocervical constructs included |
| static and dynamic compression bending and static torsion according to | |
| ASTM F1717 as well as static and dynamic compression bending and static | |
| and dynamic torsion per ASTM F2706. | |
| The mechanical test results demonstrate that neon3TM performance is | |
| substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | neon3TM possesses technological characteristics similar to one or more of |
| the predicate devices. These include: | |
| x intended use (as described above) | |
| x basic design (rod-based having screw and/or hook anchors), | |
| x material (titanium / titanium alloy), | |
| x sizes (dimensions are comparable to those offered by the predicate | |
| systems) and | |
| Minor differences in technological characteristics were identified and shown | |
| to not raise new questions of safety and effectiveness. Therefore the | |
| fundamental scientific technology of neon3TM is the same as previously | |
| cleared devices. | |
| Conclusion: | neon3TM possesses the same intended use and technological |
| characteristics as the predicate devices. Therefore neon3TM is substantially | |
| equivalent for its intended use. |
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