(30 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The Firebird Spinal Fixation System is used as an adjunct to fusion for various spinal conditions, indicating its role in treating these conditions.
No
Explanation: The document describes the Firebird Spinal Fixation System as a multi-component implant used for spinal fusion, not for diagnosing conditions. Its primary purpose is to provide fixation and stability to the spine as an "adjunct to fusion."
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 indicates a physical hardware device, not software only.
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.
- Firebird Spinal Fixation System Function: The description clearly states that the Firebird Spinal Fixation System is a spinal implant construct attached to the vertebral body by means of screws and rods. It is a physical device implanted in the body to provide stability and support during spinal fusion.
- Intended Use: The intended use is for posterior, non-cervical pedicle fixation as an adjunct to fusion. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples.
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:
-
- 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, MNI, MNH
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 cobalt chrome rods was conducted in accord with ASTM standards, and demonstrates that the system is substantially equivalent to the predicate system when using titanium alloy rods.
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, K080792, K061162
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
K09262y
SEP 2 5 2009
Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification Confidential
510(k) SUMMARY
Spinal Fixation System Modification - Cobalt Chrome Rod
Blackstone Medical, Inc. Sponsor: 1211 Hamburg Turnpike Suite 300 Wayne, NJ 07470 Registration Number: 3004606875 Whitney G. Torning, Senior Director of Regulatory Affairs Contact Person: & Quality Assurance Telephone Number: 973.406.2838 Fax Number: 973.406.2938 Email: wtorning@blackstonemedical.com Martin G. Sprunck Submitter: Regulatory Affairs Manager Manufacturer: Blackstone Medical, Inc. 1211 Hamburg Turnpike, Ste. 300 Wayne, NJ 07470 Registration Number: 3004606875 Precision Forms, Inc. Contract Manufacturer:
97 Decker Rd. Butler, NJ 07405
System Name:
Trade Name (Component): Firebird Cobalt Chrome Rod
Common Name (System): Posterior Thoracolumbar System
NKB - Orthosis, Spinal Pedicle Fixation, for Degenerative Product Code: Disc Disease
Firebird Spinal Fixation System
MNI~ Orthosis, Spinal Pedicle Fixation Subsequent Product Codes: MNH - Orthosis, Spondylolisthesis Spinal Fixation
1
Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification Confidential . . . .
| 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)
K2M, Inc. CoCr Rod (K080792 SE 4-8-08)
Applied Spine Technologies, Inc. Bar Pedicle Screw Spinal
Fixation System (K061162 SE 7-26-06) |
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:
-
- 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
Performance Data
Mechanical testing of the Firebird Spinal Fixation system with the cobalt chrome rods was conducted in accord with ASTM standards, and demonstrates that the system is substantially equivalent to the predicate system when using titanium alloy rods. The modified system has the same intended use, similar indications, technological characteristics and principles of operation as the predicate system.
Basis of Substantial Equivalence
Mechanical testing was conducted to demonstrate that the Firebird Spinal Fixation System with the addition of cobalt chrome alloy rods is substantially equivalent to the current Firebird Spinal Fixation System, (K081684 SE 9/15/08 and K082797 SE 10/17/08), which has been cleared by FDA for the purpose of building a spinal implant construct in the noncervical spine.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight, with three curved lines representing the wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 5 2009
Blackstone Medical, Inc. % Ms. Whitney G. Törning Senior Director of Regulatory Affairs & Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470
Re: K092624
Trade/Device Name: Firebird Spinal Fixation System, Firebird Cobalt Chrome Rods Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: August 24, 2009 Received: August 26, 2009
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 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 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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Whitney G. Törning
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/ucm115809.htm 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" (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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Haibau Buelup
Mark N. Melkers 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 Confidential
Indications for Use Statement
510(k) Number (if known):
System Name: Firebird Spinal Fixation System Device Name: Firebird Cobalt Chrome Rods
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. The device is indicated for all of the following indications:
- 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.
| Prescription Use X | AND/OR | Over-The-Counter Use_ |
|---|---|---|
| (Part 21 C.F.R. 801 Subpart D) | (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
Kareem S. Burney for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092624