(28 days)
No
The document describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is intended to treat various medical conditions of the spine, such as spondylolisthesis, fracture, scoliosis, tumor, and degenerative disc disease, by providing immobilization and stabilization, which aligns with the definition of a therapeutic device.
No
This device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not one that gathers or processes data to diagnose a condition.
No
The device description explicitly states it is comprised of "titanium alloy devices in a variety of non-sterile, single-use components" and is "attached to the vertebral body by means of screws and hooks," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Blackstone Spinal Fixation System is a physical implant made of titanium alloy intended to be surgically implanted into the spine to provide stabilization and immobilization. Its intended use is to treat various spinal conditions by mechanically fixing spinal segments.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens from the patient. The device is a physical implant used directly on the patient's anatomy.
Therefore, the Blackstone Spinal Fixation System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture:
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis:
- f) Spinal tumor; and
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses:
- c) spinal stenosis:
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- f) pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor:
- f) pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation)
Product codes
KWP, KWQ, MNH, MNI
Device Description
The Blackstone Spinal Fixation System (SFS) is comprised of titanium allov (Ti-6AL-4V ELI per ASTM F136) devices in a variety of non-sterile, single-use components. This system allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws and hooks to the non-cervical spine.
The SFS Parallel Rod Connectors will function as rod connectors. They are fabricated of titanium alloy (Ti-6AL-4V) and are provided in both top-loading and front-loading configurations. Both configurations allow for rod components to be connected side-to-side, rather than end-to-end, as with the currently marketed Blackstone SFS Axial Domino (Connector) (K030241 SE 2-21-03).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine, L5-S1 joint, lumbar and sacral spine (L3 and below), thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon
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
Mechanical testing was conducted to demonstrate that the Blackstone Spinal Fixation System Parallel Rod Connectors are substantially equivalent to the Blackstone™ Spinal Fixation System (K994217 SE 2-28-00), and Blackstone™ SFS Axial Domino (K030241 SE 2-21-03) which have been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine.
Key Metrics
Not Found
Predicate Device(s)
K994217 SE 2-28-00, K020674 SE 4-3-02, K013558 SE 1-23-02, K003735 SE 5-8-01, K023498 SE 11-13-02, K013885 SE 2-1-02, K022399 SE 8-6-02, K022605 SE 8-21-02, K030241 SE 2-21-03, K030862 SE 4-17-03, K030581 SE 6-26-03
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
510(K) SUMMARY
| Name of Firm: | Blackstone Medical, Inc.
1211 Hamburg Turnpike
Wayne, NJ 07470 | MAR 13 2008 |
|------------------------------------------|---------------------------------------------------------------------------------|-------------|
| 510(k) Contact: | Whitney Törning, Senior Director of Regulatory Affairs and
Quality Assurance | |
| Trade Name: | Blackstone SFS Parallel Rod Connectors | |
| Common Name: | Rod and screw spinal instrumentation | |
| Device Product Code
& Classification: | KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis | |
| | KWQ - 888.3060 - Spinal Intervertebral Body Fixation
Orthosis | |
| | MNH - 888.3070 – Spondylolisthesis Spinal Fixation Device
System | |
| | MNI - 888.3070 - Pedicle Screw Spinal System | |
Substantially Equivalent Devices:
Blackstone™ SFS (K994217 SE 2-28-00) Blackstone™ SFS 4.5mm Multi-Axial Screws (K020674 SE 4-3-02) Blackstone™ SFS 4.5mm Mono-Axial Screws (K013558 SE 1-23-02) Blackstone™ SFS 2nd Gen. Cross-Connector (K003735 SE 5-8-01) Blackstone™ SFS Modified Multi-Axial Screws (K023498 SE 11-13-02) Blackstone™ SFS Hooks (K013885 SE 2-1-02) Blackstone™ SFS Spacers (K022399 SE 8-6-02) Blackstone™ SFS Staple & Washer (K022605 SE 8-21-02) Blackstone™ SFS Axial Domino (K030241 SE 2-21-03) Blackstone™ SFS Rigid Cross Connector (K030862 SE 4-17-03) Blackstone™ SFS Lateral Offset (K030581 SE 6-26-03)
Device Description:
The Blackstone Spinal Fixation System (SFS) is comprised of titanium allov (Ti-6AL-4V ELI per ASTM F136) devices in a variety of non-sterile, single-use components. This system allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws and hooks to the non-cervical spine.
The SFS Parallel Rod Connectors will function as rod connectors. They are fabricated of titanium alloy (Ti-6AL-4V) and are provided in both top-loading and front-loading configurations. Both configurations allow for rod components to be connected side-to-side, rather than end-to-end, as with the currently marketed Blackstone SFS Axial Domino (Connector) (K030241 SE 2-21-03).
1
Intended Use / Indications for Use:
The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture:
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis:
- f) Spinal tumor; and
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses:
- c) spinal stenosis:
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- f) pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor:
- f) pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation)
2
Basis of Substantial Equivalence:
Mechanical testing was conducted to demonstrate that the Blackstone Spinal Fixation System Parallel Rod Connectors are substantially equivalent to the Blackstone™ Spinal Fixation System (K994217 SE 2-28-00), and Blackstone™ SFS Axial Domino (K030241 SE 2-21-03) which have 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
Blackstone Medical, Inc. % Ms. Whitney Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, NJ 07470
Re: K080407
Trade/Device Name: Blackstone™ Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWQ, KWP Dated: February 12, 2008 Received: February 14, 2008
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 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.
4
Page 2 - Ms. Whitney Törning
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at to}]-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
KO80407 510(k) Number (if known):
Device Name: Blackstone™ Spinal Fixation System
Indications for Use:
The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation;
- d) Scoliosis;
- e) Kyphosis:
- Spinal tumor: and f)
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- pseudoarthrosis: f)
- previous failed fusion; and g)
- h) trauma (i.e., fracture or dislocation
Neil R.C. Dahl forman
(Division Sign-Off)
Division of General, Restorative. and Neurological Devices
Page 1 of 2
510(k) Number K080467
6
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- spinal stenosis; c)
- spinal deformities (i.e., scoliosis, kyphosis, lordosis); d)
- tumor; e)
- pseudoarthrosis: f)
- previous failed fusion; and g)
- h) trauma (i.e., fracture or dislocation)
Prescription Use X AND/OR Over-The-Counter Use -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (21 CFR 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 2 of _ 2
Netke Order mtm
(Division Division of General, Restorative, and Neurological Devices
Ko80407 510(k) Number_