(27 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML components.
Yes
The device is intended to treat various spinal conditions such as degenerative disc disease, spondylolisthesis, and trauma, by providing spinal fixation as an adjunct to fusion.
No.
The document describes the Firebird Spinal Fixation System as an implantable device used for spinal fusion, not for diagnosing medical conditions.
No
The device description explicitly states it is a "multiple component system comprised of a variety of non-sterile, single use components" made of "titanium alloy". This clearly indicates a physical hardware device, not software only.
Based on the provided information, the Firebird Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Firebird Spinal Fixation System clearly states it is a system of components implanted into the spine for fixation. It does not involve the analysis of biological samples.
- The intended use and device description focus on surgical implantation and mechanical support. The system is used to stabilize the spine in patients with various conditions.
- There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
Therefore, the Firebird Spinal Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
- l ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- spondylolisthesis,
-
- trauma (i.e., fracture or dislocation),
-
- spinal stenosis,
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- tumor.
-
- pseudoarthrosis, and
-
- failed previous fusion
The Firebird Spinal Fixation Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
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)
Mechanical testing of the Firebird Spinal Fixation system with the Side-loading Body was conducted in accord with ASTM standards, and demonstrates that the system is substantially equivalent to predicate systems. The additional component does not change the intended use, indications, technological characteristics or principles of operation of the Firebird Spinal Fixation System.
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.
K081684, K082797, K092624, K080407, K082572
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
§ 888.3070 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
FEB - 4 2010
Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification
510(k) SUMMARY
.
Spinal Fixation System Modification - Side-loading Body
| Sponsor: | Blackstone Medical, Inc.
1211 Hamburg Turnpike
Suite 300
Wayne, NJ 07470 |
|---------------------------|-----------------------------------------------------------------------------------|
| Registration Number: | 3004606875 |
| Contact Person: | Whitney G. Törning, Senior Director of Regulatory Affairs
& Quality Assurance |
| Telephone Number: | 973.406.2838 |
| Fax Number: | 973.406.2938 |
| Email: | wtorning@blackstonemedical.com |
| Submitter: | Martin G. Sprunck.
Regulatory Affairs Manager |
| Manufacturer: | Orthofix, Inc.
1720 Bray Central Dr.
McKinney, TX 75069 |
| Registration Number: | 2183449 |
| Contract Manufacturer: | Structure Medical, Inc.
2975 S. Horseshoe Drive
Naples, Florida 34104 |
| System Name: | Firebird Spinal Fixation System |
| Trade Name (Component): | Firebird Side-loading Body |
| Common Name (System): | Posterior Thoracolumbar System |
| Product Code: | NKB - Orthosis, Spinal Pedicle Fixation, for Degenerative
Disc Disease |
| Subsequent Product Codes: | MNI - Orthosis, Spinal Pedicle Fixation |
Firebird Spinal Fixation System Modification - 510(k) Summary
1
Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification
| Regulatory Classifications: | Class III Preamendment Device, 888.3070 - Pedicle Screw
Spinal System - *Class III Summary and Certification
Required
Class II – 888.3070 - Pedicle Screw Spinal System |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | Blackstone Pedicle Screw System (K081684 SE 9/15/08)
Blackstone Pedicle Screw System, 4.0 mm Screws
(K082797 SE 10/17/08)
Firebird Spinal Fixation System, Cobalt-Chrome Rods
(K092624 SE 9/25/09)
Blackstone Spinal Fixation System (K080407 SE 3-13-08)
Synthes Universal Spine System (USS) (K082572 SE 11-
24-08) |
Intended Use / Indications for Use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
- I ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- spondylolisthesis,
-
- trauma (i.e., fracture or dislocation),
-
- spinal stenosis,
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- tumor.
-
- pseudoarthrosis, and
-
- failed previous fusion
The Firebird Spinal Fixation Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
Technological Characteristics
The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.
2
Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification
Performance Data
Mechanical testing of the Firebird Spinal Fixation system with the Side-loading Body was conducted in accord with ASTM standards, and demonstrates that the system is substantially equivalent to predicate systems. The additional component does not change the intended use, indications, technological characteristics or principles of operation of the Firebird Spinal Fixation System.
Basis of Substantial Equivalence
Mechanical testing was conducted to demonstrate that the Firebird Spinal Fixation System with the addition of the Side-loading Body is substantially equivalent to the current Firebird Spinal Fixation System, (K081684 SE 9/15/08, K082797 SE 10/17/08 and K092624 SE 9/25/09), which has been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, which is the department's symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB - 4 2010
Blackstone Medical, Inc. % Ms. Whitney G. Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470
Re: K100044
Trade/Device Name: Firebird Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: January 07, 2010 Received: January 08, 2010
Dear Ms. Törning:
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 agamst 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
4
Page 2 - Ms. Whitney G. Törning
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucr 1 1 800 .jpht for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21168 Production 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 tollofire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification
Indications for Use Statement
510(k) Number (if known):
System Name: Firebird Spinal Fixation System Device Name: Firebird Side-loading Body
Indications for Use:
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
- l ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- spondylolisthesis,
-
- trauma (i.e., fracture or dislocation),
-
- spinal stenosis,
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- tumor.
-
- pseudoarthrosis, and
-
- failed previous fusion
The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
AND/OR
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1__ of_1_______________________________________________________________________________________________________________________________________________________________
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K100044 510(k) Number