(196 days)
No
The document describes a mechanical spinal fixation system and does not mention any AI or ML components.
Yes
The device is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction for various medical conditions like degenerative disc disease, trauma, and tumors, which are treatments for diseases or injuries.
No
The device is a fixation system (screws, rods, hooks) intended to promote fusion of the cervical spine. Its purpose is treatment, not diagnosis. The "Indications for Use" section lists conditions that the device treats, not conditions it diagnoses.
No
The device description explicitly lists hardware components such as screws, locking caps, rods, cross links, hooks, and instruments.
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 a "Posterior Cervical Fixation System" intended to "promote fusion of the cervical spine and occipito-cervico-thoracic junction." This describes a surgical implant used to stabilize the spine.
- Device Description: The device is described as consisting of "screws, locking caps, rods, cross links, hooks, and instruments." These are all components of a surgical fixation system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device is directly implanted into the body.
- Performance Studies: The performance studies described are "Mechanical Testing," which is relevant for evaluating the structural integrity and performance of a surgical implant, not an IVD.
In summary, the Kestrel Posterior Cervical Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:
- Degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Trauma (i.e fracture or dislocation)
- Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop.
Product codes
KWP
Device Description
The proposed SPINE360 Kestrel system consists of screws, locking caps, rods, cross links, hooks, and instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipito-cervico-thoracic junction (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)
Mechanical Testing was performed in accordance with ASTM F2706-08 "Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model" including Static Compression Bending, Static Torsion, Dynamic Compression Bending, Dynamic Torsion. The results of the testing indicate that the Kestrel performed comparably or superior to the Anatomica predicate system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Anatomica Posterior Cervical Fixation System K061943
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
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SPINE
360
5000 Plaza on the Lake, Suite 305 Austin, TX 78746 512-327-6400 800-640-6045 Fax · Dave Lamb dlamb@spine360.com
.
: .
January 17, 2014
CLASS OF DEVICE
.
RE: 510(k)
Premarket Notification - Kestrel Posterior Cervical Fixation System K132122
Traditional 510(k) Summary
ESTABLISHMENT REGISTRATION NUMBER | 3005841736 |
---|---|
CONTACT PERSON | Primary |
Dave Lamb | |
Quality and Regulatory Affairs | |
Phone: 512-327-6400 ext. 24 | |
Fax: 800-640-6045 | |
DATE PREPARED | June 30, 2013 |
CLASSIFICATION NAME | KWP 888.3050 - Spinal Interlaminal Fixation Orthosis |
COMMON NAME | Posterior Occipital Cervico-thoracic Spinal System |
TRADE NAME | Kestrel Posterior Cervical Fixation System |
PREDICATE DEVICE | Anatomica Posterior Cervical Fixation System K061943 |
Class II
.
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Image /page/1/Picture/1 description: The image shows the word "SPINE" in bold, stylized letters. To the left of the word, there is a number 70. To the right of the word, there are three circles. The image has a grainy, textured appearance, giving it a vintage or distressed look.
DEVICE DESCRIPTION
The proposed SPINE360 Kestrel system consists of screws, locking caps, rods, cross links, hooks, and instruments.
INTENDED USE
The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:
- Degenerative disc disease (DDD) defined as back pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Trauma (i.e fracture or dislocation)
- Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop
TECHNOLOGICAL CHARACTERISTICS
The Kestrel Posterior Cervical System implants are manufactured from titanium alloy, Ti - A16 -4V (ISO 5832/3), which conforms to ASTM F136-02a (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications) material standards. The associated Class I instruments are made primarily of surgical grade stainless steel (ISO 7153/I).
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Image /page/2/Picture/1 description: The image shows the word "SPINE" in a stylized font. The word is part of a larger design that includes what appears to be the number 360. The overall design has a somewhat distressed or textured appearance, as if it were printed on a rough surface or has been weathered.
SUBSTANTIAL EQUIVALENCE
Anatomica | Kestrel | |
---|---|---|
Indications for use | • Degenerative disc | |
disease (DDD) | ||
• Spondylolisthesis | ||
• Trauma | ||
• Spinal stenosis, | ||
curvatures | ||
• Tumor | ||
• Pseudoarthrosis | ||
• Failed previous fusion | • Degenerative disc | |
disease (DDD) | ||
• Spondylolisthesis | ||
• Trauma | ||
• Spinal stenosis, | ||
curvatures | ||
• Tumor | ||
• Pseudoarthrosis | ||
• Failed previous fusion | ||
Material | Titanium 6Al 4V ELI | Titanium 6Al 4V ELI |
Design features | Screws, connectors, hooks, | |
wires, rods connected to | ||
stabilize the vertebrae during | ||
fusion | Screws, connectors, hooks, | |
wires, rods connected to | ||
stabilize the vertebrae during | ||
fusion |
PERFORMANCE TESTING TO ESTABLISH SUBSTANTIAL EQUIVALENCE
Mechanical Testing was performed in accordance with ASTM F2706-08 "Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model" including Static Compression Bending, Static Torsion, Dynamic Compression Bending, Dynamic TorsionThe results of the testing indicate that the Kestrel performed comparably or superior to the Anatomica predicate system.
CONCLUSIONS
The Kestrel Posterior Cervical System demonstrated substantial equivalence to the predicate Anatomica System (K061943).
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is likely part of a document or letterhead. The words are all capitalized and evenly spaced. The text is horizontally oriented.
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Omni Surgical, LLC (dba. Spine 360) Mr. David Lamb 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746
Re: K132122
Trade/Device Name: Kestrel Posterior Cervical Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminar fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 11, 2013 Received: December 12, 2013
Dear Mr. Lamb:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. David Lamb
forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132122 - Page 1 of 1
Image /page/5/Picture/2 description: The image shows the word "SPINE" in a stylized font. The word is slanted upwards from left to right. The word is surrounded by a design that includes curved lines and a circle. The image is in black and white.
5000 Plaza on the Lake, Suite 305 Austin, TX 78746 512-327-6400
RE: 510(k) K132122 Premarket Notification - Kestrel Posterior Cervical Fixation System Indications for Use
The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:
- Degenerative disc disease (DDD) defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis .
- Trauma (i.e fracture or dislocation) ●
- Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis) ●
- Tumor .
- Pseudoarthrosis .
- Failed previous fusion ●
Occipital bone screws are limited to occipital fixation only. Pedicle screws are limited to placement in the upper thoracic spine (T1-T3), when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Zane W. Wyatt-S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132122