(49 days)
Not Found
No
The summary describes a mechanical spinal implant system and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as promoting fusion of the cervical spine and occipito-cervico-thoracic junction to treat various medical conditions such as degenerative disc disease, spondylolisthesis, trauma, and spinal tumors, which are therapeutic interventions.
No
This device is a spinal system (implants and instruments) intended for promoting fusion, not for diagnosing medical conditions.
No
The device description explicitly lists physical components made of titanium alloy, cobalt alloy, stainless steel, Radel, and aluminum alloy, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Sierra spinal system is a collection of implants (screws, rods, plates, etc.) designed to be surgically implanted into the cervical and thoracic spine to promote fusion and provide stability. It is used to treat conditions like degenerative disc disease, trauma, and spinal stenosis.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from the patient. Its function is purely mechanical and structural within the body.
Therefore, the Sierra spinal system falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
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 back 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
MNI, KWP
Device Description
The Sierra spinal system will include polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component, and are being offered in a wide variety of sizes. All product is supplied "NON-STERILE" and must be sterilized prior to use.
Sierra will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with Radel and aluminum alloy being used in a few handles. All items 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)
All products passed testing per applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K002733, K010681, K013222, K022190, K030103, K041203, K042508, K022048, K033961, K043229, K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, K053483
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
NOV 16 2006
K06293Y
Sierra™
CONFIDENTIAL
510(K) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.
| Submitter Information: | SeaSpine, Inc.
Contact: Diana Smith
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.
Contact: Diana Smith, Manager of
Regulatory Affairs and Quality Assurance
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
| Date Summary Prepared: | September 25, 2006 |
| Classification Name: | Pedicle Screw Spinal System
MNI (Class II) - 888.3070(b)(1)
Spinal Interlaminal Fixation Orthosis
KWP (Class II) – 888.3050 |
| Common/Usual Name: | Polyaxial screws, rods, locking caps,
occipital plates, occipital screws, lateral
connectors, crossbars, hooks, components,
and instruments |
| Device Trade Name: | Sierra™ |
The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).
1
(The statements of intended use are identical.) 1. Intended 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 back 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.
2. Description:
The Sierra spinal system will include polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component, and are being offered in a wide variety of sizes. All product is supplied "NON-STERILE" and must be sterilized prior to use.
Sierra will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with Radel and aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use.
3. Technological Characteristics:
The various implants and instruments in this notification are components of SeaSpine's new stand alone OCT spinal fixation system called, Sierra. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.
2
4. Comparison Analysis:
The overall designs of the polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components in this submission are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the Sierra polyaxial screws, rods, locking caps, occipital components, lateral connectors, contoured crossbars, hooks, and components to the predicate devices.
3
Sierra™
| Feature | Sierra | DePuy Acromed's
Summit and
Mountaineer OCT
Spinal Systems | Interpore Cross
International's
Altius OCT System | Medtronic Sofamor
Danek's Vertex
Reconstructive
System | Substantially
Equivalent |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------|-----------------------------|
| Intended Use | The intended use of the Sierra
spinal system is to promote
fusion of the cervical spine and
occipito-cervico-thoracic
junction (occiput-T3). | Similar | Similar | Similar | Yes |
| Indications for
Use | ⚫degenerative disc disease
(DDD) as defined by back 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. | Similar | Similar | Similar | Yes |
| Design | Polyaxial screws, rods, locking
caps, occipital plates, occipital
screws, lateral connectors,
crossbars, hooks, and
components. | Similar | Similar | Similar | Yes |
| Polyaxial
Screws | Various sizes. | Similar | Similar | Similar | Yes |
| Locking Cap | Various sizes. | Similar | Similar | Similar | Yes |
| Lateral
Connectors | Various sizes. | Similar | Similar | Similar | Yes |
| Crossbars | Various sizes. | Similar | Similar | Similar | Yes |
| Occipital Plates | Various sizes. | Similar | Similar | Similar | Yes |
| Occipital
Screws | Various sizes. | Similar | Similar | Similar | Yes |
| Hooks | Various sizes. | Similar | Similar | Similar | Yes |
| Rods | Various sizes. | Similar | Similar | Similar | Yes |
| Material | Titanium alloy and cobalt alloy. | Similar | Similar | Similar | Yes |
| Sterile | Non-sterile | Similar | Similar | Similar | Yes |
| Method of
Sterilization | High-temperature steam | Similar | Similar | Similar | Yes |
| Mechanical
Strength | All products passed testing per
applicable standards. | Similar | Similar | Similar | Yes |
Table 1: Summary of Design Comparison
4
-
A financial certification or disclosure statement or both, as required by part 54 (i) of this chapter:
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration. -
For submission claiming substantial equivalence to a device which has been (j) classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III Summary). The 510(K) submitter shall also ccrtify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807.94.
A Premarket Notification Class III Certification and Summary is not needed for this submission as the products under consideration are class II.
- A statement that the submitter believes, to the best of his or her knowledge, (k) that all data and information submitted in the Premarket notification are truthful and accurate and that no material fact has been omitted.
A Premarket Notification Truthful and Accurate Statement is included on the following page.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SeaSpine, Inc. % Ms. Ethel Bernal Document Control Specialist 2302 La Mirada Drive Vista, California 92081-7862
NOV 16 2006
Re: K062934
Trade/Device Name: SIERRA Regulation Number: 21 CFR 888.3070, 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: MNI, KWP Dated: September 25, 2006 Received: September 28, 2006
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.
6
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
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
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter-Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 11062934 |
|---|---|
| --------------- | ---------- |
31