(84 days)
Not Found
No
The provided text describes a physical medical device (intervertebral body fusion devices and vertebral body replacement devices) made of polymer/carbon fiber composite. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The device description focuses on the material, shape, and mechanical properties.
No
The device is described as an intervertebral body fusion device and/or a vertebral body replacement device, designed to restore biomechanical integrity and facilitate fusion in the spine, not to administer a therapy.
No
The device description indicates it is an intervertebral body fusion device and vertebral body replacement device, which are used for treatment and structural support, not for diagnosis.
No
The device description explicitly states it consists of "polymer/carbon fiber composite cages and implantation instruments," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a system of implants (cages) and implantation instruments used for spinal fusion and vertebral body replacement. These are surgically implanted devices.
- Intended Use: The intended use clearly states the devices are used as intervertebral body fusion devices and vertebral body replacement devices in the lumbar and thoracolumbar spine. This involves surgical procedures and the placement of physical implants within the body.
- No Specimen Analysis: There is no mention of analyzing any specimens taken from the patient's body. The device's function is structural support and facilitating fusion, not diagnostic testing of biological samples.
Therefore, based on the provided information, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic.
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 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., 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 (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The Concorde Curve System consists of polymer/carbon fiber composite cages and implantation instruments. Cages are available in varying shape and size configurations to match patient anatomy. The polymer/carbon fiber cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.
The CONCORDE® Curve System is made from carbon-fiber reinforced polymer with tantalum wires.
The purpose of this submission is to obtain market clearance for the proposed sterile components to the CONCORDE® Curve System. The proposed device is identical to the predicate device except that the proposed device will be terminally sterilized by DePuy Spine. The design characteristics, performance, intended use, materials, and technology remain identical to the predicate system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2-S1), Thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Skeletally mature patients
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)
Testing was performed to determine the effects of gamma radiation on the cages. The testing was performed in compliance with ASTM F2077, static axial and dynamic axial testing was performed to demonstrate substantial equivalence post-sterilization and again with 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.
CONCORDE® Curve System ( K101923)
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
§ 888.3080 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.
0
103743
510(K) SUMMARY
| MAR 17 2011 | |
|---|---|
| Submitter: | DePuy Spine, Inc. |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Contact Person: | Eugene Bang |
| Regulatory Affairs Associate | |
| Voice: (508) 977-3966 | |
| Fax: (508) 828-3797 | |
| Email: ebang@its.jnj.com | |
| Date Prepared: | December 21, 2010 |
| Trade Name: | CONCORDE® Curve System |
| Device Class: | Class II |
| Product Code(s): | MAX, MQP |
| Classification Name: | Intervertebral Body Fusion Device |
| per 21 CFR §888.3080 | |
| Spinal Intervertebral Body Fixation Orthosis | |
| per 21 CFR §888.3060 | |
| Predicate Device: | CONCORDE® Curve System ( K101923) |
| Device Description: | The Concorde Curve System consists of polymer/carbon fiber composite |
| cages and implantation instruments. Cages are available in varying | |
| shape and size configurations to match patient anatomy. The | |
| polymer/carbon fiber cage structure is radiolucent with tantalum x-ray | |
| markers so that healing can be assessed by normal radiographic methods. | |
| The cages have ridges or teeth that resist rotation and migration and | |
| have cavities to accept packing of bone graft. |
:
ﺮ
Page 1 of 3
1
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 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., 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.
Materials:
Technological Characteristics:
The CONCORDE® Curve System is made from carbon-fiber reinforced polymer with tantalum wires.
The purpose of this submission is to obtain market clearance for the proposed sterile components to the CONCORDE® Curve System. The proposed device is identical to the predicate device except that the proposed device will be terminally sterilized by DePuy Spine. The design characteristics, performance, intended use, materials, and technology remain identical to the predicate system.
DePuy Spine, Inc., a Johnson & Johnson Company
se 2 of 3
2
Performance Data:
Testing was performed to determine the effects of gamma radiation on the cages. The testing was performed in compliance with ASTM F2077, static axial and dynamic axial testing was performed to demonstrate substantial equivalence post-sterilization and again with the predicate device.
Conclusion:
Based on the predicate comparison and testing, the subject device CONCORDE® Curve System is substantially equivalent to the predicate device.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DePuy Spine, Inc. % Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
MAR 1 7 201
Re: K103743
Trade/Device Name: CONCORDE® Curve System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: February 15, 2011 Received: February 16, 2011
Dear Mr. Bang:
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
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
4
Page 2 - Mr. Eugene Bang
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 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), pleáse go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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.
$\tau*{2}$ B. $D*{2}h$
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): C103743
Device Name: CONCORDE® Curve 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., 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.
Prescription Use X
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 Survice! Orthopedic. and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________