(50 days)
No
The document describes a spinal implant system made of titanium and cobalt alloys, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction to treat various medical conditions such as degenerative disc disease, trauma, and spinal tumors. This therapeutic purpose aligns with the definition of a therapeutic device.
No
The device is a spinal system intended to promote fusion of the cervical spine. It physically treats conditions like degenerative disc disease, trauma, and spinal tumors, rather than diagnosing them.
No
The device description explicitly states that the products are fabricated from titanium alloy and cobalt alloy, indicating a hardware-based implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states this is a "spinal system" consisting of plates and screws made from titanium and cobalt alloys. These are implants designed to be surgically placed within the body.
- Intended Use: The intended use is to "promote fusion of the cervical spine and occipito-cervico-thoracic junction." This is a surgical procedure, not a diagnostic test performed on samples outside the body.
This device is a surgical implant used for spinal fusion, not an IVD.
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:
- devenerative 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
A new occipital plate design is being added to the Sierra spinal system. All products are fabricated from titanium alloy and cobalt 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), 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.
0
CONFIDENTIAL
| Sierra™M |
|---|
| ---------- |
| Special 510(k) Summary | APR 16 2008 | |||
|---|---|---|---|---|
| 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: | February 25, 2008 | |||
| Trade name: | Sierra™ | |||
| Common name: | Occipital plate | |||
| 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 design of the occipital plates in this submission is substantially equivalent to the predicate devices.
Description:
A new occipital plate design is being added to the Sierra spinal system. All products are fabricated from titanium alloy and cobalt 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:
- devenerative 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, .
1
Sierra™M
- 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 occipital plates in this notification are components of SeaSpine's stand alone occipitocervico-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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2008
SeaSpine, Inc. % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, CA 92081-7862
Re: K080526
Trade/Device Name: Sierra™ OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 27, 2008 Received: March 28, 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 (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.
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 N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
6080526 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 AND/OR Over-The-Counter-Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K080526
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