(57 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Cervical Plate System" intended for "temporary stabilization of the anterior spine during the development of cervical spinal fusions" for various medical conditions like degenerative disc disease, trauma, and tumors, indicating its use in treating health conditions.
No
This device is a surgical implant designed for stabilization during spinal fusion, not for diagnosing medical conditions. It is used to treat conditions already diagnosed, such as degenerative disc disease or spinal stenosis.
No
The device description explicitly states it includes titanium alloy plates and screws, which are hardware components.
Based on the provided information, 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 and Intended Use: The Kepler I Cervical Plate System is a surgical implant made of titanium alloy. Its intended use is to stabilize the cervical spine during fusion procedures. This is a physical device used in vivo (within the body) during surgery, not a test performed in vitro (outside the body) on a sample.
The description clearly indicates a surgical implant for structural support, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Kepler I Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Kepler I Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
Product codes
KWQ
Device Description
The Kepler I Cervical Plate System is a system that includes titanium alloy (per ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available if various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
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 (static and dynamic compression testing and static torsion testing per ASTM F1717-10), which characterized the performance of the predicate was not required to be repeated. There are no changes in design, materials or manufacturing processes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Orbbo Surgical, LLC. % Ms. Tamala Wampler Regulatory and Quality Consultant Novus Management Group, LLC. 6686 Dimmick Road West Chester, Ohio 45069
Re: K163602
Trade/Device Name: Kepler I Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 20, 2016 Received: December 21, 2016
Dear Ms. Wampler:
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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
Lori A. Wiggins -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) K163602 Device Name Kepler I Cervical Plate System Indications for Use (Describe)
The Kepler I Cervical Plate System is intended for anterior screw fixation at the vertebral bodies
of the cervical spine (C2-C7). The Kepler I Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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)
FORM FDA 3881 (9/13) -Page-1-of-2- PSC Publishing Services (301) 443-6740 EF
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: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
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| Submitter's Name: | Orbbö, LLC. (Orbbö Surgical, LLC.) |
|---|---|
| Submitter's Address: | 555 W. 5th Street, 35th Floor |
| Los Angeles, CA 90013 | |
| Submitter's Telephone: | (800) 942-1880 |
| Company Contact Person: | Eric Garofano |
| CEO | |
| Contact Person: | Tamala J. Wampler |
| Novus Management Group, LLC. | |
| 513-593-4944 | |
| Date Summary was Prepared: | 12/19/2016 |
| Trade or Proprietary Name: | Kepler I Cervical Plate System |
| Common or Usual Name: | Spinal Fixation Device |
| Classification: | Class II per 21 CFR §888.3060 Spinal Intervertebral body |
| fixation orthosis | |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |
| Panel Code: | 87 |
5. 510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Kepler I Cervical Plate System is a system that includes titanium alloy (per ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available if various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.
INDICATIONS FOR USE
The Kepler I Cervical Plate System is intended for anterior screw fixation at the vertebral bodies
of the cervical spine (C2-C7). The Kepler I Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
PREDICATES
Kepler I Cervical Plate System is substantially equivalent to the Blue Mountain Cervical Plate System (K150036). The subject and predicate devices have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicate:
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- Indications for Use
- Materials of manufacture
- Structural support mechanism
Table 5-1 Predicate Devices
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K150036 | Blue Mountain Cervical Plate System | Spineway | Primary |
TECHNOLOGICAL CHARACTERISTICS
The Kepler I Cervical Plate System is the same as the predicate device. The materials, screw type, screw diameters and lengths, plate widths, thickness and lengths, and screw locking mechanism is the same as the predicate device.
PERFORMANCE TESTING
Kepler I Cervical Plate System was evaluated to demonstrate equivalence to the predicate devices. Mechanical testing (static and dynamic compression testing and static torsion testing per ASTM F1717-10), which characterized the performance of the predicate was not required to be repeated. There are no changes in design, materials or manufacturing processes.
CONCLUSION
Kepler I Cervical Plate System has the same intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The overall technology characteristics lead to the conclusion that the Kepler I Cervical Plate System is substantially equivalent to the predicate devices.