(77 days)
Not Found
No
The description focuses on the mechanical components and intended use of a surgical fixation system, with no mention of AI or ML capabilities.
No
The device is described as a "Laminoplasty Fixation System" that "holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord." This describes a mechanical support function for a surgical procedure, not a device that treats or cures a disease or condition.
No
The device is described as a fixation system used after a laminoplasty has been performed to hold or buttress an allograft. Its purpose is mechanical support and stabilization, not to diagnose a condition.
No
The device description explicitly states it is comprised of "non-sterile, single use, titanium and titanium alloy components," which are physical 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 device is a "Laminoplasty Fixation System" used in the spine to hold or buttress an allograft. This is a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The description details titanium and titanium alloy components designed to be implanted in the spine.
- 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 samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
Product codes
NQW
Device Description
The Blackstone Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium and titanium allov components. The specially shaped plates, made of commercially pure (CP) titanium, are designed to fit the anatomy of the dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.
The screws, made of titanium alloy (6AL-4V ELI, per ASTM F-136), are available in variety of lengths and diameters in order to meet individual anatomical requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
Indicated Patient Age Range
Not Found
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)
Synthes Arch™ Fixation System (K032534)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone TM Laminoplasty Fixation System.
FEB 1 8 2005
K043338 age ( of )
510(K) SUMMARY
| Name of Firm: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
|------------------------------------------|-------------------------------------------------------------------------|
| 510(k) Contact: | Dean E. Ciporkin
Director, Regulatory Affairs and Quality Assurance |
| Trade Name: | Blackstone™ Laminoplasty Fixation System |
| Common Name: | Interlaminal Fixation Appliance |
| Device Product Code
& Classification: | NQW- 888.3050 -Orthosis, Spine, Plate, Laminoplasty, Metal |
| Substantially
Equivalent Devices: | Synthes Arch™ Fixation System (K032534) |
Device Description:
The Blackstone Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium and titanium allov components. The specially shaped plates, made of commercially pure (CP) titanium, are designed to fit the anatomy of the dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.
The screws, made of titanium alloy (6AL-4V ELI, per ASTM F-136), are available in variety of lengths and diameters in order to meet individual anatomical requirements.
Intended Use / Indications for Use:
The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
Basis of Substantial Equivalence:
The Blackstone Laminoplasty Fixation System is substantially equivalent to the Synthes Arch™ Fixation System (K032534), which has been cleared by FDA for use as a laminoplasty fixation device.
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2005
Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104
Re: K043338
Trade/Device Name: Blackstone ™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NQW Dated: January 28, 2005 Received: February 1, 2005
Dear Mr. Ciporkin:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave a row a ma have determined the device is substantially equivalent (for the indications ferenced above and har sure) to legally marketed predicate devices marketed in interstate for use starsa in the encrease. 976, the enactment date of the Medical Device Amendments. or to conniner of the 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 r ou may, morely mains of the Act include requirements for annual registration, listing of general oblines pro rise first 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 n your device 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 I hat FDA has made a determination that your device complies with other requirements of the Act or any Fedcral 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.
2
Page 2 - Mr. Ciporkin
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Sincerery yours,
Mark R. Milbers
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
3
Indications for Use
510(k) Number (if known):
Device Name: Blackstone™ Laminoplasty Fixation System
Indications for Use:
The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
338
Mark A Milhous
Peter Live. and Neure
Page 1 of
510(k) Number