(236 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal fixation system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as providing "immobilization and stabilization of spinal segments as an adjunct to fusion" and is intended for treating various medical conditions of the spine, including "traumatic spinal fractures", "instability or deformity", "tumors", and "degenerative disease". These are all direct treatments for medical conditions.
No
Explanation: This device is a posterior spinal fixation system designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is an implantable device used for treatment, not for diagnosing medical conditions.
No
The device description explicitly lists various hardware components made of titanium and cobalt chromium alloys, such as rods, screws, and plates, which are implanted into the spine. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing and immobilizing spinal segments. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details physical implants (rods, screws, plates, etc.) made of metal alloys and the instruments for their insertion. This is consistent with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process that would be performed in a laboratory setting to diagnose a condition.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Precision Spine Reform® POCT System is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Precision Spine Reform® POCT 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; 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 Precision Spine Reform® POCT 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.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The Reform® POCT System is a posterior spinal fixation system intended for fusion of the Occipital, Cervical, and Thoracic regions of the spine (Occiput-T3). The system consists of a variety of rods, occipital plates, occipital screws, polyaxial screws, cross-connectors, lateral offset, domino connectors, and hooks to achieve an implant construct that closely matches patient anatomy. The Reform POCT System implants are fabricated from titanium, titanium alloy, or cobalt chromium alloys as described by standards such as ASTM F136, ASTM F1537, or ISO 5832-3. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instruments necessary for inserting and securing the implants. The components are supplied clean and "NON-STERILE". All implants are single use only and should not be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, cervical spine (C1 to C7), thoracic spine from T1-T3, Occiput-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 Reform® POCT System has been tested in the following test modes:
- Dynamic axial compression per ASTM F2706
- Dynamic torsion per ASTM F2706
The results of this non-clinical testing show that the strength of the Reform® POCT System is substantially equivalent to legally marketed 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.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration."
April 11, 2018
Precision Spine, Inc. % Meredith L. May, MS, RAC Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K172495
Trade/Device Name: Reform® POCT System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 8, 2018 Received: March 15, 2018
Dear Ms. May:
We have reviewed vour 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 of medical device-related 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
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -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 | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number ( if known ) | K172495 |
|---|---|
| Device Name | Reform® POCT System |
| Indications for Use (Describe) | |
| The Precision Spine Reform® POCT 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; 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 Precision Spine Reform® POCT 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. | |
| 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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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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| Submitter's Name: | Precision Spine, Inc. |
|---|---|
| Submitter's Address: | 2050 Executive Drive |
| Pearl, MS 39208 | |
| Submitter's Telephone: | 601.420.4244 |
| Contact Person: | Meredith L. May, MS, RAC |
| Empirical Consulting | |
| 719.291.6874 | |
| Date Summary was Prepared: | 16 August 2017 |
| Trade or Proprietary Name: | Reform® POCT System |
| Common or Usual Name: | Orthosis, Cervical Spinal Pedicle Fixation |
| Appliance, Fixation, Spinal Interlaminal | |
| Classification: | Unclassified |
| Product Code: | NKG, KWP |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Reform® POCT System is a posterior spinal fixation system intended for fusion of the Occipital, Cervical, and Thoracic regions of the spine (Occiput-T3). The system consists of a variety of rods, occipital plates, occipital screws, polyaxial screws, cross-connectors, lateral offset, domino connectors, and hooks to achieve an implant construct that closely matches patient anatomy. The Reform POCT System implants are fabricated from titanium, titanium alloy, or cobalt chromium alloys as described by standards such as ASTM F136, ASTM F1537, or ISO 5832-3. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instruments necessary for inserting and securing the implants. The components are supplied clean and "NON-STERILE". All implants are single use only and should not be reused under any circumstances.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices are considered substantially equivalent as they are similar or identical in material, indications for use, sterility, and size offerings.
INDICATIONS FOR USE
The Precision Spine Reform® POCT 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; 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 Precision Spine Reform® POCT System is also intended to restore the
5
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 indications for use for the Reform® POCT System is similar to that of the predicate devices listed in Table 5-1.
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|-----------------------|-------------------|
| K162300 | Reform® POCT System | Precision Spine, Inc. | Primary |
| K151755 | OASYS® System | Stryker | Additional |
| K153631 | Virage® | Zimmer Spine | Additional |
Table 5-1: Predicate Devices
TECHNOLOGICAL CHARACTERISTICS
The following technological characteristics are similar between the subject and predicate devices:
- Indications for Use ●
- Principles of operation ●
- Materials
- Sterility
PERFORMANCE DATA
The Reform® POCT System has been tested in the following test modes:
- Dynamic axial compression per ASTM F2706 ●
- Dynamic torsion per ASTM F2706
The results of this non-clinical testing show that the strength of the Reform® POCT System is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Reform® POCT System is substantially equivalent to the predicate device.