(204 days)
No
The device description and intended use are for a spinal implant system made of titanium alloy. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The sections specifically looking for mentions of AI, DNN, ML, image processing, training sets, test sets, performance studies, and key metrics are all marked as "Not Found".
Yes
The device is intended to treat and promote fusion for various medical conditions like degenerative disc disease, trauma, and spinal stenosis, which are therapeutic actions.
No.
The device is a spinal system designed to promote fusion, treat various spinal conditions, and stabilize the spine. It is an implantable medical device used for treatment, not diagnosis.
No
The device description explicitly states that the device is fabricated from titanium alloy and includes physical components like rod connectors, crossbars, and set screws. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to promote fusion of the cervical spine and occipito-cervico-thoracic junction. This is a surgical implant used directly on the patient's body.
- Device Description: The device consists of physical components like rod connectors, crossbars, and set screws made from titanium alloy. These are hardware components for spinal surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:
- degenerative disc disease (DDD) as defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies,
- . spondylolisthesis,
- trauma (i.e., fracture or dislocation), .
- spinal stenosis, .
- atlantoaxial fracture with instability, .
- occipitocervical dislocation, .
- revision of previous cervical spine surgery, and/or .
- spinal tumor. .
The occipital bone screws are limited to occipital fixation only.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Product codes
KWP
Device Description
Rod connectors, crossbars and set screws are being added to the Sierra spinal system. All products are fabricated from titanium alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.
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), occipital, upper thoracic spine (T1-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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062934, K022048, K033961, K043229
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.
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APR 1 7 2008
CONFIDENTIAL
Sierra™M
Special 510(k) Summary
| Submitter: | SeaSpine Inc.
2302 La Mirada Dr.
Vista, CA 92081
Phone: (760) 727-8399
Fax: (760) 727-8891 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact person: | Ethel Bernal, Regulatory Affairs Manager |
| Date prepared: | September 25, 2007 |
| Trade name: | SierraTM |
| Common name: | Rod connectors, crossbars, set screws |
| Classification name: | Spinal Interlaminal Fixation Orthosis
KWP (Class II) - 888.3050 |
Substantial equivalence claimed to:
The devices used for comparison in this summary are SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229).
The overall designs of the rod connectors, crossbars and set screws in this submission are substantially equivalent to the predicate devices.
Description :
Rod connectors, crossbars and set screws are being added to the Sierra spinal system. All products are fabricated from titanium alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.
Intended use: (The statements of intended use are identical.)
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:
- degenerative disc disease (DDD) as defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis. .
- trauma (i.e., fracture or dislocation), .
- . spinal stenosis.
- atlantoaxial fracture with instability, .
- occipitocervical dislocation, .
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Sierra™
Page 2 of 2
CONFIDENTIAL
- revision of previous cervical spine surgery, and/or
- . spinal tumor.
The occipital bone screws are limited to occipital fixation only.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Summary of technological characteristics:
The rod connectors, crossbars and set screws in this notification are components of ScaSpine's stand alone occipito-cervico-thoracic spinal fixation system called Sierra. The addition of the new devices has not altered the fundamental scientific technology of the previously cleared system. The devices in this submission have substantially equivalent technological characteristics to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2008
SeaSpine % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, CA 92081
Re: K072729
Trade/Device Name: SierraTM Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: April 14, 2008 Received: April 19, 2008
Dear Ms. Bernal:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Ethel Bernal
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K072729 510(k) Number (if known):
Device Name: Sierra
Indications for Use:
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:
- degenerative disc disease (DDD) as defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies,
- . spondylolisthesis,
- trauma (i.e., fracture or dislocation), .
- spinal stenosis, .
- atlantoaxial fracture with instability, .
- occipitocervical dislocation, .
- revision of previous cervical spine surgery, and/or .
- spinal tumor. .
The occipital bone screws are limited to occipital fixation only.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
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 CDRH, Office of Device Evaluation (ODE)
Neil R. Orl fwrnxn
Division of General, Restorative, and Neurological Devices
510(k) Number K072729
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