(323 days)
CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications: The CONCORDE, 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), TLIF (CONCORDE, 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. The CONCORDE, 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.
BENGAL System Indications: The BENGAL System is indicated for use as an intervertebral body fusion device 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation may be used. The BENGAL System is 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This 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. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation.
The BENGAL, CONCORDE, COUGAR, DEVEX, and LEOPARD Systems consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft materials. These Systems also contain Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific pass/fail metrics. | Performance data were submitted to characterize the BENGAL, CONCORDE, COUGAR, DEVEX and LEOPARD Systems. |
Explanation: The document does not explicitly define quantifiable acceptance criteria (e.g., minimum tensile strength, specific fatigue life cycles) or report numerical outcomes for the device's performance against such criteria. Instead, it states that "Performance data were submitted to characterize" the systems. This suggests a submission of various tests (likely mechanical and biocompatibility) whose results were evaluated against established standards for spinal implants, rather than specific P&F metrics stated in this summary.
Study Details
-
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified. The document states "Performance data were submitted to characterize the BENGAL, CONCORDE, COUGAR, DEVEX and LEOPARD Systems," but does not mention the number of units or test subjects involved in these performance tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document focuses on the technical aspects and regulatory approval rather than clinical study design or data origin.
-
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The document discusses performance data for medical devices (spinal implants), which typically involves engineering and material testing rather than expert-based ground truth establishment as seen in diagnostic imaging or clinical trials.
-
Adjudication method for the test set: Not applicable. As this pertains to mechanical performance data of spinal implants, adjudication methods like 2+1 or 3+1 are not relevant. Testing would follow standardized protocols (e.g., ASTM, ISO).
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for diagnostic devices that involve human interpretation of images or data. The submitted document pertains to spinal implants, which are surgical devices.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concept is for AI/software devices. The devices in question are physical spinal implants.
-
The type of ground truth used: For physical spinal implants, the "ground truth" for performance would typically be established through engineering standards, mechanical testing results, and material specifications. For instance, fatigue testing to a certain number of cycles, static compression strength, and biocompatibility testing results would constitute the "ground truth" for their physical properties and safety.
-
The sample size for the training set: Not applicable. There is no mention of an algorithm or AI model requiring a training set.
-
How the ground truth for the training set was established: Not applicable, as there is no training set.
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K081917. Page 1 of 3
VI. 510(k) Summary
MAY 2 2 2009
- SUBMITTER: DePuy Spine, Inc. 325 Paramount Drive Ravnham, MA 02767
Frank S. Jurczak CONTACT PERSON:
DATE PREPARED: July 2, 2008
CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis, Spinal Intervertebral Fusion
BENGAL® System PROPRIETARY NAME: CONCORDE™ System COUGAR™ System DEVEX® System LEOPARD® System
- PREDICATE DEVICES: Lumbar I/F Cage System (P960025) DEVEX Mesh System (K023835) BAK Interbody Fusion System (P950002) BAK/Cervical (BAK/C) Interbody Fusion System (P980048) Cimplicity Spinal Fixation System (K073320) DePuy AcroMed VBR System (K031635), (K030833), (K041722) CONCORDE VBR Spinal System (K052746) DEVEX Mesh System (K023835)
- The BENGAL, CONCORDE, COUGAR, DEVEX, and DEVIČE DESCRIPTION: LEOPARD Systems consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft materials.
These Systems also contain Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
CONCORDE, COUGAR, DEVEX, and LEOPARD Systems INTENDED USE: Indications The CONCORDE, 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
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K081917 Page Z.of 3
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), TLIF (CONCORDE, 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.
The CONCORDE, 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.
BENGAL System Indications
The BENGAL System is indicated for use as an intervertebral body fusion device 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation may be used.
The BENGAL System is 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is
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K081917 page 3 of 3
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 this system is intended for use with DePuy Spine supplemental internal fixation.
MATERIALS: The BENGAL, CONCORDE, COUGAR and LEOPARD Systems are made from carbon-fiber reinforced polymer with tantalum beads. The DEVEX System is manufactured from ASTM F136 implant grade titanium alloy.
PERFORMANCE DATA:
Performance data were submitted to characterize the BENGAL, CONCORDE, COUGAR, DEVEX and LEOPARD Systems.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2009
DePuy Spine, Inc % Mr. Frank Jurczak Regulatory Affairs Associate 325 Paramount Drive Raynham, MA 02767
Re: K081917
Trade/Device Name: DePuy Spine BENGAL, CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: May 20, 2009 Received: May 21, 2009
Dear Mr. Jurczak:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jumel D. Barry
For Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use IV.
510(k) Number (if known): _长O81917
DePuy Spine Cages (BENGAL, CONCORDE, COUGAR, DEVEX, Device Name: LEOPARD Systems)
Indications For Use:
CONCORDE. COUGAR, DEVEX, and LEOPARD Systems Indications
The CONCORDE, 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 PLF (CONCORDE), TLIF (CONCORDE, 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.
The CONCORDE, 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 turnors, 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.
BENGAL System Indications
The BENGAL System is indicated for use as an intervertebral body fusion device 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation may be used.
The BENGAL System is 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This 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. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation.
OR Over-The-Counter Use: Prescription Use: × (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kim Hui
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K081917
§ 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.