(90 days)
Not Found
No
The summary describes a mechanical pedicle screw system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is used to treat specific medical conditions, such as degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis.
No
Explanation: The Blackstone Pedicle Screw System is a surgical implant designed for fixation in the spine ("pedicle screw fixation"). Its intended use is as an "adjunct to fusion," meaning it helps in the process of fusing vertebrae together, rather than diagnosing a medical condition.
No
The device description explicitly states that the system consists of physical components like pedicle screws, set screws, and screw bodies, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Blackstone Pedicle Screw System is for "posterior, non-cervical pedicle fixation" and is used as an "adjunct to fusion." This describes a surgical implant used directly on a patient's body.
- Device Description: The device consists of "pedicle screws, set screws, and screw bodies." These are physical components designed for surgical implantation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description contains none of these elements.
The information describes a surgical implant used for spinal fixation, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Blackstone Pedicle Screw 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 regardless of the intended use:
-
- 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 Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
Product codes
NKB, MNI, MNH
Device Description
The Blackstone Pedicle Screw System consists of an assortment of multiaxial and monoaxial pedicle screws, set screws, and screw bodies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle
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 Blackstone Pedicle Screw System was conducted which demonstrates that the system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K994217, K020674, K013558, K003735, K023498, K030581, K030862, K080407, K052123, K052151
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K081684'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable.
SEP 1 5 2008
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Confidential
510(k) SUMMARY
Blackstone Medical, Inc. Pedicle Screw System
| 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: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
| Registration Number: | 1225457 |
| Contract Manufacturer: | Marox Corporation
373 Whitney Avenue
Holyoke, MA 01040-2766
Pulse Technologies
2000 AM Drive
Quakertown, PA 18951
Structure Medical, Inc.
2975 S. Horseshoe Dr., Suite 400
Naples, FL 34104
Omni Components, Inc.
46 River Rd.
Hudson, NH 03051 |
1
K081684
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Confidential
| Trade Name: | Blackstone Pedicle Screw 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 | |
| Common Name: | Posterior Thoracolumbar 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 | |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | Blackstone Medical, Inc. Spinal Fixation System (SFS): |
| · 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 Lateral Offset Components | |
| (K030581 SE 6-26-03) | |
| · Blackstone SFS Rigid Cross Connector | |
| (K030862 SE 4-17-03) | |
| · Blackstone SFS Parallel Rod Connectors | |
| (K080407 SE 3-13-08) | |
| · Synthes Pangea Spine System (K052123 SE 9/23/05 | |
| & K052151 SE 12-7-05) |
Intended Use / Indications for Use
The Blackstone Pedicle Screw 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 regardless of the intended use:
2
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Confidential
-
- 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 Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
Technological Characteristics
The Blackstone Pedicle Screw System consists of an assortment of multiaxial and monoaxial pedicle screws, set screws, and screw bodies.
Performance Data
Mechanical testing of the Blackstone Pedicle Screw System was conducted which demonstrates that the system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.
Substantial Equivalence
The Blackstone Pedicle Screw System, the Blackstone Medical SFS System (K080407 SE 3/13/08), and the Synthes Pangea Spine System (K052123 SE 9/23/05) have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the Blackstone Pedicle Screw System and its predicates are technical characteristics that have been addressed mechanical verification testing. These differences do not present any new issues of safety or effectiveness, therefore, the Blackstone Pedicle Screw System is substantially equivalent to its predicate devices.
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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2008
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: K081684
Trade/Device Name: Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: June 13, 2008 Received: June 17, 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 G. 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 the reporting 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 toll-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 M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Pedicle Screw System Confidential
Indications for Use Statement
510(k) Number (if known): KO816889
Device Name: Pedicle Screw System
Indications for Use:
The Blackstone Pedicle Screw 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 regardless of the intended use:
-
- 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 Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, 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 1
FOR M. MELKERSON
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K08/684