(218 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities. The performance studies focus on mechanical testing.
No.
The Firebird Spinal Fixation System is a surgical implant intended to provide stability to the spine as an adjunct to fusion, not to provide therapy itself.
No
Explanation: The Firebird Spinal Fixation System is a medical device designed for stabilizing the spine as an adjunct to fusion. Its purpose is to physically support and fix the spine, not to identify or diagnose medical conditions.
No
The device description explicitly states it consists of "Hooks and Iliac Connectors," which are physical hardware components used for spinal fixation. The summary also describes performance studies involving static and dynamic testing of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a surgical implant for spinal fixation. This is a therapeutic device used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The device components are described as hooks and iliac connectors, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an implantable surgical device.
N/A
Intended Use / Indications for Use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in 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
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, KWP
Device Description
The additional, non-pedicle components presented in this premarket notification consist of Hooks and Iliac Connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Evaluations of the proposed components for addition to the Firebird Spinal Fixation System were conducted and demonstrate that the expanded system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.
Static compression bending, static torsion, and dynamic compression bending were conducted and results were compared to the predicate Firebird systems when used for the same intended use of iliac fixation.
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.
K092624, K082797, K081684, K080407, K082572, K030383, K993030, K024348
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
K093926, Page 1 of 3
Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Expansion
510(k) SUMMARY
Blackstone Medical, Inc. Expanded Firebird Spinal Fixation System
| Date: | 7-23-2010 | JUL 2 8 2010 |
|---|---|---|
| Sponsor: | Blackstone Medical, Inc. | |
| 1211 Hamburg Turnpike | ||
| Suite 300 | ||
| Wayne, NJ 07470 | ||
| Registration Number: | 3004606875 | |
| Contact Person: | Russell Johnson | |
| Regulatory Affairs | ||
| Telephone Number: | ||
| Fax Number: | ||
| Email: | 214-937-2000 | |
| 800-445-1923 | ||
| russelljohnson@orthofix.com | ||
| Submitter: | Martin G. Sprunck | |
| Regulatory Affairs Manager | ||
| Manufacturer: | Orthofix, Inc. | |
| 1720 Bray Central Dr. | ||
| McKinney, TX 75069 | ||
| Registration Number: | 2183449 | |
| Contract Manufacturers: | Pulse Technologies | |
| 2000 AM Drive | ||
| Quakertown, PA 18951 |
Structure Medical, Inc.
2975 S. Horseshoe Dr., Suite 400
Naples, FL 34104
Accellent, Inc.
6500 Zane Avenue North, Suite 105 | |
Brooklyn Park, MN 55429
Firebird Spinal Fixation System Additions – 510(k) Summary Page 1 of 3
1
K093926 Page 2 of 3
| Trade Name: | Firebird Spinal Fixation System |
|---|---|
| Product Code: | NKB - Orthosis, Spinal Pedicle Fixation, for Degenerative |
| Disc Disease | |
| Subsequent Product Codes: | MNI – Orthosis, Spinal Pedicle Fixation |
| MNH - Orthosis, Spondylolisthesis Spinal Fixation | |
| KWP - Appliance, Fixation, Spinal Interlaminal | |
| Common Name: | Posterior Thoracolumbar/Iliosacral System |
| Regulatory Classification: | Class III preamendment Device, 888.3070 - Pedicle Screw |
| Spinal System - *Class III Summary and | |
| Certification Required | |
| Class II – 888.3070 – Pedicle Screw Spinal System | |
| Class II - 888.3050 - Spinal Interlaminal Fixation Orthosis | |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | • Firebird Spinal Fixation System, Cobalt-Chrome Rods |
| (K092624 SE 9-25-09) | |
| • Blackstone Pedicle Screw System, 4.0 mm Screws | |
| (K082797 SE 10-17-08) | |
| • Blackstone Pedicle Screw System (K081684 SE 9-15-08) | |
| • Blackstone Medical, Inc. Spinal Fixation System (SFS), | |
| represented by that system's most recent premarket | |
| notification, K080407 SE 3-13-08 | |
| • Synthes Universal Spine System Iliosacral/Polyaxial | |
| System (K082572 SE 11-24-08) | |
| • DePuy Acromed Moss Miami Spinal System (K030383 | |
| SE 2-26-2010) | |
| • DePuy Acromed Isola System (K993030 SE 12/29/1999) | |
| • DePuy Acromed Monarch Spine System (K024348 SE | |
| 1/28/2003) |
Intended Use / Indications for Use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in 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)
Firebird Spinal Fixation System Additions – 510(k) Summary Page 2 of 3
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2
Page 3 of 3 K093926
-
- spondylolisthesis,
-
- trauma (i.e., fracture or dislocation),
- spinal stenosis, 4)
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- tumor,
-
- pseudoarthrosis, and
-
- failed previous fusion
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or $2 spinal level.
The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.
Technological Characteristics
The additional, non-pedicle components presented in this premarket notification consist of Hooks and Iliac Connectors.
Performance Data
Evaluations of the proposed components for addition to the Firebird Spinal Fixation System were conducted and demonstrate that the expanded system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.
Static compression bending, static torsion, and dynamic compression bending were conducted and results were compared to the predicate Firebird systems when used for the same intended use of iliac fixation.
Substantial Equivalence
The expanded Firebird Spinal Fixation System and its predicate systems have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the proposed component and their predicates are technical characteristics that have been addressed by mechanical evaluations. These differences do not present any new issues of safety or effectiveness, therefore, the expanded system is substantially equivalent to its predicate systems.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized eagle-like symbol. The text is arranged in a circular fashion around the symbol. The symbol itself is composed of three curved lines that resemble a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 8 2000
Blackstone Medical, Inc. % Mr. Russell Johnson 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470
Re: K093926
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, MNI, MNH, KWP Dated: July 07, 2010 Received: July 08, 2010
Dear Mr. Johnson:
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 misJeading.
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 - Mr. Russell Johnson
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/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/ReportalProblem/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 vours.
Raibarg Buclus
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 Expansion Confidential
Indications for Use Statement
510(k) Number (if known): ___ K093926
JUL 2 8 2010
System Name: Firebird Spinal Fixation System Device Name: Non-Pedicle Components
Indications for Use:
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in 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
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
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 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K093926 510(k) Number_