(109 days)
Not Found
No
The device description and intended use focus on the physical characteristics and surgical application of a titanium mesh system for spinal procedures. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is used to replace diseased or fractured vertebral bodies, achieving anterior decompression and restoring spine height, directly treating pathological conditions.
No.
The device (Blackstone Medical Surgical Mesh System) is intended for use in replacing vertebral bodies, restoring height, and treating fractures, which are therapeutic interventions rather than diagnostic processes.
No
The device description clearly states it is comprised of a hollow cylindrical tube made from titanium, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Blackstone Medical Surgical Mesh System: This device is an implantable surgical device designed to be placed inside the human body to replace or support vertebral bodies in the spine. It is a structural implant, not a diagnostic tool that analyzes biological samples.
The description clearly outlines its use in surgical procedures for spinal conditions, not for laboratory testing of patient specimens.
N/A
Intended Use / Indications for Use
The Blackstone Medical Surgical Mesh System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Mesh is also indicated for treating fractures of the thoracic and lumbar spine.
The Surgical Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. It is recommended to pack bone graft material inside the mesh cage prior to implantation.
The Surgical Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Mesh System is the Blackstone Medical Spinal Fixation System.
Product codes
MQP
Device Description
The Blackstone Medical, Inc. Surgical Mesh System is comprised of a hollow cylindrical tube made from commercially pure (CP) titanium conforming to ASTM F-67. The walls of the tube are perforated with evenly spaced diamond-shaped openings. These openings and the hollow core allow grafting material to be placed inside the device to help achieve solid fusion. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individual anatomical conditions. The end rings, standard ring and screws of the device are made of titanium alloy (6AL-4V ELI, per ASTM F136). The end rings, which are placed onto each end of the tube, feature spikes on the exterior sides that help prevent lateral movement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoraco-lumbar spine (T1-L5)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
KD32744
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Surgical Mesh System Confidential
JUN 2 7 2003
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™ Surgical Mesh System |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Device Product Code
& Classification: | MQP- 888.3060 - Spinal Vertebral Body Replacement Device |
| Substantially
Equivalent Devices: | DePuy AcroMed™ Surgical Titanium Mesh System (K003043)
Synthes SynMesh™ Spacer System (K003275)
Surgical Dynamics™ (SDI) Mesh Cage System (K003709) |
Device Description:
The Blackstone Medical, Inc. Surgical Mesh System is comprised of a hollow cylindrical tube made from commercially pure (CP) titanium conforming to ASTM F-67. The walls of the tube are perforated with evenly spaced diamond-shaped openings. These openings and the hollow core allow grafting material to be placed inside the device to help achieve solid fusion. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individual anatomical conditions. The end rings, standard ring and screws of the device are made of titanium alloy (6AL-4V ELI, per ASTM F136). The end rings, which are placed onto each end of the tube, feature spikes on the exterior sides that help prevent lateral movement of the device.
1
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Surgical Mesh System Confidential
Intended Use / Indications for Use:
The Blackstone Medical Surgical Mesh System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Mesh is also indicated for treating fractures of the thoracic and lumbar spine.
The Surgical Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. It is recommended to pack bone graft material inside the mesh cage prior to implantation.
The Surgical Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Mesh System is the Blackstone Medical Spinal Fixation System.
BASIS OF SUBSTANTIAL EQUIVALENCE:
By its very nature, the Blackstone™ Surgical Mesh System is substantially equivalent to the DePuy AcroMed Surgical Titanium Mesh™ System (K003043), Synthes SynMesh™ Spacer System (K003275), and the Surgical Dynamics™ (SDI) Mesh Cage System (K003709), which have been cleared by FDA for use in patients with tumor, trauma or fractures.
2
Image /page/2/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 three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is arranged in a circular fashion, following the contour of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2003
Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104
Re: K030744
Trade Name: Blackstone™ Surgical Titanium Mesh System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP (Vertebral Body Replacement Device) Dated: May 27, 2003 Received: May 28, 2003
Dear Mr. Ciporkin:
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.
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Page 2 - Mr. Dean E. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Mark A. Mulhearn
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
510(k) # K030744:
Device Name: Blackstone™ Surgical Titanium Mesh System
Indications for Use:
The Blackstone Medical Surgical Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Mesh is also indicated for treating fractures of the thoracic and lumbar spine.
The Surgical Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. It is recommended to pack bone graft material inside the mesh cage prior to implantation.
The Surgical Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Mesh System is the Blackstone Medical Spinal Fixation System.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
for Mark N. Mulkerson
Division Sign-Off) Division of General. Rest rative and Neurological Devices
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