(140 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Spinal System" intended for "posterior fixation of the cervical and upper thoracic spine" as an "adjunct to fusion for stabilization." This clearly indicates its use in treating medical conditions related to the spine, making it a therapeutic device.
No
The BLACKBIRD™ Spinal System is described as a comprehensive system for posterior fixation of the cervical and upper thoracic spine, intended to be implanted. Its purpose is to stabilize the spine as an "adjunct to fusion," treating conditions like degenerative disc disease, spondylolisthesis, and trauma. This device description clearly defines it as an implantable medical device for stabilization and fusion, not a device used to identify, measure, or monitor a medical condition.
No
The device description clearly states it is a "comprehensive system for posterior fixation of the cervical and upper thoracic spine" and lists various physical implant components made from specific alloys (polyaxial screws, rods, hooks, etc.). This indicates it is a hardware-based medical device, not software-only.
No, 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 about a person's health.
- Device Description: The BLACKBIRD™ Spinal System is a system of implants (screws, rods, hooks, etc.) made from metal alloys. These are surgically implanted into the body.
- Intended Use: The intended use is for the stabilization of the cervical and upper thoracic spine as an adjunct to fusion. This is a surgical procedure performed directly on the patient's anatomy.
The description clearly indicates a surgically implanted device used for structural support within the body, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine (C1-T3) for the following conditions:
- degenerative disc disease (DDD; defined as neck pain of discogenic origin with . degeneration of the disk as confirmed by history & radiographic studies)
- spondylolisthesis
- trauma
- fracture / dislocation
- spinal stenosis
- atlanto/axial fracture with instability
- . tumor
- revision of previous cervical spine surgery
The use of polyaxial screws is limited to placement in the thoracic spine (T1-T3) "for anchoring the construct only" and is not intended to be placed in the cervical spine. The use of the rods and hook components are intended for use in (C1-T3). This system can be linked to a Ø6.0mm rod system such as the Choice Spine Starfire™ Pedicle Screw System.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Choice Spine BLACKBIRD™ Spinal System is a comprehensive system for posterior fixation of the cervical and upper thoracic spine. It is to be implanted posteriorly. The system is composed of polyaxial screws and smooth shaft polyaxial screws in various sizes, set screws, straight rods, pre bent rods, transition rods, rod to rod cross connectors, lateral offset connectors, rod transition connectors. and hooks. All implant components will be made from Ti 6Al 4V-ELI alloy or Cobalt 28- Chromium 6- Molybdenum per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C1-T3)
Indicated Patient Age Range
Skeletally mature patients
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)
Performance testing was completed by an independent laboratory following ASTM F1717. The tests included static compression bending, static torsion and dynamic compression bending, Additionally Torsional gripping capacity, axial gripping capacity, flexion extension / cantilever bending results were tested per ASTM 1798-97(20008). The performance testing required is the equivalent same for the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K050979, K070638, K052201, K071380
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K133214 Page 1 of 2
MAR 0 7 2014
510(k) Summary
| Date Prepared: | January 24, 2014 |
|---|---|
| Company: | Choice Spine, LP |
| 400 Erin Drive, Knoxville, TN 37919 | |
| Tel: 865.246.3333 Fax: 865.246.3334 | |
| Regulatory Contact: | Kim Finch, Manager of Regulatory Affairs |
| kfinch@choicespine.net | |
| Trade Name: | BLACKBIRD™ Spinal System |
| Product Class: | Class II |
| Classification: | 888.3050 Spinal Interlaminal Fixation Orthosis |
| Product Codes: | KWP |
| Panel Code: | 87 |
Device Description:
The Choice Spine BLACKBIRD™ Spinal System is a comprehensive system for posterior fixation of the cervical and upper thoracic spine. It is to be implanted posteriorly. The system is composed of polyaxial screws and smooth shaft polyaxial screws in various sizes, set screws, straight rods, pre bent rods, transition rods, rod to rod cross connectors, lateral offset connectors, rod transition connectors. and hooks. All implant components will be made from Ti 6Al 4V-ELI alloy or Cobalt 28- Chromium 6- Molybdenum per ASTM F1537.
Indications for Use:
The BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine (C1-T3) for the following conditions:
- degenerative disc disease (DDD; defined as neck pain of discogenic origin with . degeneration of the disk as confirmed by history & radiographic studies)
- spondylolisthesis ●
- trauma ●
- fracture / dislocation .
- spinal stenosis
- atlanto/axial fracture with instability .
- . tumor
- revision of previous cervical spine surgery .
The use of polyaxial screws is limited to placement in the thoracic spine (T1-T3) "for anchoring the construct only" and is not intended to be placed in the cervical spine. The use of the rods and hook components are intended for use in (C1-T3). This system can be linked to a Ø6.0mm rod system such as the Choice Spine Starfire™ Pedicle Screw System.
1
Predicate Device(s):
The BLACKBIRD™ Spinal System is substantially equivalent to the previously cleared Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Systems.
Performance Standards:
Performance testing was completed by an independent laboratory following ASTM F1717. The tests included static compression bending, static torsion and dynamic compression bending, Additionally Torsional gripping capacity, axial gripping capacity, flexion extension / cantilever bending results were tested per ASTM 1798-97(20008). The performance testing required is the equivalent same for the predicate devices.
Substantial Equivalence:
The characteristics of the BLACKBIRD™ Spinal System are similar to the predicate devices Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Systems. Equivalence is based on the similarities of the intended use, design, physical characteristics when compared to the predicates, and system component materials.
Choice Spine concludes that the BLACKBIRD™ Spinal System is substantially equivalent when compared to the predicate legally marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Choice Spine, LP Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K133214
Trade/Device Name: Blackbird Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 23, 2014 Received: January 28, 2014
Dear Ms. Finch:
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 forth in the quality systems (QS) regulation (2) 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. Kim Finch
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" (21CFR 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,
Vincent Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
7.0 Indications for Use
510(k) Number K133214
Device Name: BLACKBIRD™ Spinal System
The BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine (C1-T3) for the following conditions:
- degenerative disc disease (DDD; defined as neck pain of discogenic origin with . degeneration of the disk as confirmed by history & radiographic studies)
- . spondylolisthesis
- trauma �
- . fracture / dislocation
- � spinal stenosis
- atlanto/axial fracture with instability .
- . tumor
- . revision of previous cervical spine surgery
The use of polyaxial screws is limited to placement In the thoracic spine (T1-T3) "for anchoring the construct only" and is not intended to be placed in the cervices spine. The rods and hook components are intended for use in (C1-T3). This system can be linked to a Ø6.0mm rod system such as the Choice Spine Starfire™ Pedicle Screw System.
Prescription Use_ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin O'Neill
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133214
.
Attachment D