(211 days)
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No
The document describes a spinal implant system and its intended use, focusing on materials, geometries, and mechanical performance testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as an intervertebral body fusion device and vertebral body replacement device, which are used to treat medical conditions (degenerative disc disease, tumors, fractures) and restore function (spinal stability, height of collapsed vertebral body), indicating a therapeutic purpose.
No
This device is an intervertebral body fusion device and a vertebral body replacement device, used for structural support and to facilitate fusion, not for diagnosing medical conditions.
No
The device description clearly states it is a "Spinal System" containing "cages" made of "carbon fiber reinforced polymer material," which are physical implants. The performance studies also describe testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implantable surgical device used for spinal fusion and vertebral body replacement. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and materials of the implants (cages, carbon fiber reinforced polymer).
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies described are mechanical tests (compression, torsion) relevant to the structural integrity of an implant, not diagnostic accuracy metrics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., 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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.
Product codes
MAX, MOP
Device Description
The CONCORDE Bullet Spinal System contains cages featuring a bulleted nose to aid in insertion into the vertebral body. The CONCORDE Bullet Spinal System proposed additional cages are offered in carbon fiber reinforced polymer material. They are available in various geometries and sizes to accommodate patient anatomy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
radiographic studies
Anatomical Site
lumbar spine (L2-S1), thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance data per ASTM F 2077 were submitted to characterize the subject CONCORDE Bullet Spinal System components addressed in this notification. Specifically, static and dynamic compression testing as well as static and dynamic torsion testing were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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K110694 1 of 3
510(K) SUMMARY
OCT 1 1 2011
- A. Submitter Information
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767
Daphney Germain-Kolawole Contact Person: Regulatory Affairs Associate Voice: (508) 880-8395 (508) 828-3797 E-Mail: dgermain@its.jnj.com
- B. Date Prepared 3/11/2011
- C. Device Name
Fax:
Trade/Proprietary Name: CONCORDE Bullet Spinal System Common/Usual Name: Intervertebral Body Device Classification Name: Spinal intervertebral body fixation orthosis per 21 CFR §888.3060 Intervertebral body fusion device per 21 CFR §888.3080
D. Predicate Device Name
Trade name: LUMBAR I/F CAGE® (P960025) CONCORDE® VBR Spinal System (K052746) DePuy Spine Cages (K081917)
DePuy Spine, Inc., a Johnson & Johnson Company
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K110694 2 of 3
Device Description E.
The CONCORDE Bullet Spinal System contains cages featuring a bulleted nose to aid in insertion into the vertebral body. The CONCORDE Bullet Spinal System proposed additional cages are offered in carbon fiber reinforced polymer material. They are available in various geometries and sizes to accommodate patient anatomy.
F. Intended Use
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., 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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.
DePuy Spine, Inc., a Johnson & Johnson Company
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K110694- 3 of 3
Summary of Similarities and Differences in Technological Characteristics, F. Performance and Intended Use
The proposed modifications to the DePuy Spine CONCORDE Bullet Spinal System are identical to the predicate devices with one minor difference. The only change is the inclusion of cages of differing heights and lengths that were not originally cleared in the predicate 510k. The design, materials, and technology remain identical to the predicate systems.
હ. Materials
Manufactured from carbon-fiber reinforced polymer with tantalum wires.
H. Performance Data
Performance data per ASTM F 2077 were submitted to characterize the subject CONCORDE Bullet Spinal System components addressed in this notification. Specifically, static and dynamic compression testing as well as static and dynamic torsion testing were performed.
l. Conclusion
Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device
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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 or bird-like figure with three wing-like shapes. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 1 2011
DePuy Spine, Inc. % Ms. Daphney Germain-Kolawole Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K110694
Trade/Device Name: CONCORDE Bullet Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: September 22, 2011 Received: September 23, 2011
Dear Ms. Germain-Kolawole:
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, Trug, 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 contractly and 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 af the Act
4
Page 2 - Ms. Daphney Germain-Kolawole
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); medical device reporting (reporting of marinal device-related adverse events) (21 CFR 803); good manufacturing practice requirements as st 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 100-1000.
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/ucm 1 1 800 7, please 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" (211758) Prot 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/ReportaProblem/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,
Peter
CC
Da
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KII 0694
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: CONCORDE® Bullet Spinal System
Indications For Use:
The CONCORDE. CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Bullet). TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The CONCORDE. CONCORDE: Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., TI-LS) 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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior. middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K110694 510(k) Number_
DePuy Spine, Inc., a Johnson & Johnson Company
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