(213 days)
Not Found
No
The summary describes a mechanical implantable device for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "supplemental fixation device" intended for "achieving supplemental fusion" in various spinal conditions, indicating its use in treating medical conditions.
No
Explanation: The device is a posterior, non-pedicle supplemental fixation device intended for surgical use to achieve supplemental fusion in specific spinal conditions. It is an implantable device that clamps bilaterally to the spinous processes and is used for treatment, not diagnosis.
No
The device description clearly states it is an "implantable device" and a "multi-component device consisting of two sets of plates," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the BridgePoint™ Spinous Process Clamp System is an implantable device that clamps to the spinous processes of the spine. This is a surgical implant used in vivo (within the body) for structural support and fixation.
- Intended Use: The intended use describes its application in spinal surgery for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor. This is a therapeutic and structural application, not a diagnostic test performed on a sample.
Therefore, the BridgePoint™ Spinous Process Clamp System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BridgePoint™ Spinous Process Clamp System is a posterior, non-pedicle supplemental fixation device, intended for use in non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand alone use.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The BridgePoint™ Spinous Process Clamp- Posterior Fixation System is an implantable device that clamps bilaterally to the spinous processes. It is a multi-component device consisting of two sets of plates. Each set is composed of a male and female plate. Two sets are coupled by two rigid posts that connect and pivot at the midline. The plates have a male and female component which slide and result in a variable plate length. These sliding plates are locked by a lateral set screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1)
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)
Mechanical testing for BridgePoint™ Spinous Process Clamp- Posterior Fixation System was performed that provides reasonable assurance of safety and effectiveness for device's Performance testing was performed per the recognized consensus intended use. standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry This testing documented both static and fatigue performance and FDA Staff. characteristics. This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior non-pedicle supplemental fixation. As a result of this testing, the BridgePoint™ Spinous Process Clamp System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NuVasive® Spinous Process Plate System (K073278)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 2 2011
BridgePoint™ Spinous Process Clamp- Posterior Fixation System
Alphatec Spine
510(k) SUMMARY September 2010
Submitter: Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Direct: (760) 494-6739 Fax: (760) 431-0289
Official Contact: Olga Lewis, Regulatory Affairs Specialist
Trade/Model Name: BridgePoint™ Spinous Process Clamp-Posterior Fixation System
Spinal Intervertebral Body Fixation Orthosis Common Name:
Classification Regulation: KWP - Spinal Interlaminal Fixation Orthosis
Device Description:
The BridgePoint™ Spinous Process Clamp- Posterior Fixation System is an implantable device that clamps bilaterally to the spinous processes. It is a multi-component device consisting of two sets of plates. Each set is composed of a male and female plate. Two sets are coupled by two rigid posts that connect and pivot at the midline. The plates have a male and female component which slide and result in a variable plate length. These sliding plates are locked by a lateral set screw.
Indications for Use
The BridgePoint™ Spinous Process Clamp System is a posterior, non-pedicle supplemental fixation device, intended for use in non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand alone use.
Substantial Equivalence:
The BridgePoint™ Spinous Process Clamp System is substantially equivalent in intended use and function to NuVasive® Spinous Process Plate System (K073278)
Confidential and Proprietary
Page 23-2
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BridgePoint™ Spinous Process Clamp- Posterior Fixation System
Image /page/1/Picture/2 description: The image contains a logo or emblem with stylized text. The text "Alphatec Spine" is visible, with the word "Alphatec" appearing above "Spine". The font is somewhat stylized, giving it a unique appearance. The logo is simple and clean, with a focus on the text.
Technological Characteristics Comparison:
The BridgePoint™ Spinous Process Clamp System is substantially equivalent to the referenced device in that it is intended to be used for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in non-cervical spine (T1-S1).
Material composition is identical to numerous other Alphatec Spine products that have been cleared via the 510(k) process.
Nonclinical Performance Data:
Mechanical testing for BridgePoint™ Spinous Process Clamp- Posterior Fixation System was performed that provides reasonable assurance of safety and effectiveness for device's Performance testing was performed per the recognized consensus intended use. standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry This testing documented both static and fatigue performance and FDA Staff. characteristics. This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior non-pedicle supplemental fixation. As a result of this testing, the BridgePoint™ Spinous Process Clamp System is substantially equivalent to the predicate device.
Page 23-3
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 2 2011
Alphatec Spine, Inc. % Ms. Olga Lewis Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K103205
Trade Name: BridgePoint Spinous Process Clamp - Posterior Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: K WP Dated: May 09, 2011 Received: May 10, 2011
Dear Ms. Lewis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Olga Lewis
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For M. Thomas c.c.n
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K103205
Device Name: BridgePoint™ Spinous Process Clamp - Posterior Fixation System
Indications For Use:
The BridgePoint™ Spinous Process Clamp System is a posterior, non-pedicle supplemental fixation device, intended for use in non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand alone use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_KIO3205
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