(33 days)
No
The summary describes a mechanical spinal fixation system comprised of screws and rods. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as a "Spinal Fixation System" intended to provide "immobilization and stabilization of spinal segments, as an adjunct to fusion," for various spinal conditions like spondylolisthesis, fracture, scoliosis, and tumor, which clearly indicates a therapeutic purpose.
No
The Blackstone Spinal Fixation System is described as a system of implants (screws and rods) used to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is to fix anatomical issues, not to diagnose them.
No
The device description explicitly states it is a "titanium alloy, multiple component system comprised of a variety of non-sterile, single use components" including "screws and rods," indicating it is a physical hardware device, not software only.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Blackstone Spinal Fixation System is described as a system of screws and rods made of titanium alloy, intended to be surgically implanted into the spine.
- Intended Use: The intended use is for spinal fixation, providing immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical procedure performed directly on the patient's body.
The description clearly indicates a surgically implanted device used for structural support within the body, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
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 (1.3 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 spondylolisthesis with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis;
- Spinal turnor: and f)
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-podicle fixation, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis;
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- e) Pseudarthrosis:
- Tumor; 1)
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.
Product codes
MNH, KWQ, MNI
KWO, MNH, MNI
Device Description
The Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw is a 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 Blackstone™ Spinal Fixation System consists of an assortment of screws and rods which have received 510k clearance (K994217, K013558 & K003735). The 4.5mm Multi-Axial Screws are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217, K013558 & K003735).
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, thoracic, lumbar and sacral 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
APR 0 3 2002
Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4. 5mm Multi-Axial Screw (System Addition)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Name of Firm: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Alan Lombardo
Director of Engineering |
| Trade Name: | Blackstone™ Spinal Fixation System
4.5mm Multi-Axial Screw (System Addition) |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code
& Classification: | MNH 888.3070 - Spondylolisthesis Spinal
Fixation Device System
KWQ 888.3060 - Spinal Intervertebral Body Fixation
Orthosis
MNI 888.3070 - Pedicle Screw Spinal System |
| Substantially
Equivalent Devices: | DePuy Motech Moss Miami Spinal System (K980477,
K982320). |
page 1 of 2
K020674#### Device Description:
The Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw is a 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 Blackstone™ Spinal Fixation System consists of an assortment of screws and rods which have received 510k clearance (K994217, K013558 & K003735). The 4.5mm Multi-Axial Screws are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217, K013558 & K003735).
Summary
Revision 1
1
page 2 of 2
K 020674
Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw (System Addition)
Intended Use / Indications for Use:
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 (1.3 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 spondylolisthesis with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis;
- Spinal turnor: and f)
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-podicle fixation, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis;
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- e) Pseudarthrosis:
- Tumor; 1)
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Blackstone™ 4.5mm Multi-Axial Screw by its very nature is substantially equivalent to the DePuy Motech Moss Miami Spinal System (K980477, K982320) which has been cleared by FDA for certain anterior and pedicle fixation use indications.
Summary
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alan Lombardo Director, Engineering Blackstone Medical, Inc. 90 Brookdale Drive Springfield, MA 01104
APR 0 3 2002
Re: K020674
Trade/Device Name: Blackstone Spinal Fixation System 4.5mm Multi-Axial Screw Regulation Number: 21 CFR 888.3060, 21 CFR, 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, spondylolisthesis spinal fixation device system, pedicle screw spinal system Regulatory Class: Class II Product Codes: KWO, MNH, MNI Dated: February 26, 2002 Received: March 1, 2002
Dear Mr. Lombardo:
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.
3
Page 2 -- Mr. Alan Lombardo
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millkenen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw (System Addition)
510(k) Number: K020674
page 1 of 2
Device Name: Blackstone™ Spinal Fixation System
Indications for Use:
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:
- Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; a)
- 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 spondylolisthesis 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 fixation, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis;
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
Mark n Mullever
(Division Sign-Off)
Summary
Division of General, Restorative and Neurological Devices
Revision 1
510(k) Number
5
Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw (System Addition)
- e) Pseudarthrosis;
- f) Tumor;
- Trauma (i.e., fracture or dislocation); g)
- h) Previous failed fusion.
page 2 of 2
Kodo674
Concurrence of CDRH, Office of device Evaluation
Prescription Use
(Per 21 CFR801.109
OR
Over-The-Counter Use
Mark n Millerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020674
Revision 1