(27 days)
Not Found
No
The summary describes a physical implant (a spinal cage) and its intended use and materials. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The performance studies are based on mechanical testing of the device itself.
No
The device is an implant for spinal surgery, indicated for indications such as vertebral body replacement and intervertebral body fusion. While it aims to restore biomechanical integrity and aid healing, its primary function is structural support and stabilization rather than therapeutic intervention in the sense of treating a disease through a direct therapeutic action or energy delivery.
No
The provided text describes the Cougar® LS Lateral Cage System as an implantable device used to replace or restore vertebral bodies and for intervertebral body fusion. Its purpose is to physically support the spine and facilitate healing, not to diagnose medical conditions.
No
The device description clearly states the implants are manufactured from Carbon Fiber Reinforced Polymer (CFRP) material and are physical cages intended for surgical implantation. This indicates a hardware medical device, not a software-only one.
Based on the provided text, the Cougar® LS Lateral Cage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a person's health. The Cougar® LS Lateral Cage System is a surgical implant designed to be placed within the human body to treat spinal conditions.
- The intended use and device description clearly describe a physical implant for surgical procedures. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies mentioned are related to the mechanical properties of the implant (compression, shear, expulsion, subsidence), not the accuracy of a diagnostic test.
Therefore, the Cougar® LS Lateral Cage System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cougar® LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. The 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 Cougar® LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The Cougar® LS Lateral System implants are manufactured from Carbon Fiber Reinforced Polymer (CFRP) material. Cages are available with 15° lordotic configurations, widths of 18mm and 21mm, and heights ranging from 10mm to 20mm in 2mm increments. The cages' lengths are 45mm, 50mm, 55mm, and 60mm.
The cage structure is radiolucent with tantalum X-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft.
The implants may be utilized in either an open or minimally invasive surgical approach. The implants are placed using a lateral surgical approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T1 to L5), L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Performance data per ASTM F2077-11 and ASTM F2267-04 was submitted to characterize the subject Cougar LS Lateral Cage implants addressed in this notification. This testing was comprised of static and dynamic compression, static and dynamic compressive shear, expulsion, and subsidence testing on the proposed 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.
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
长122896 page 1 of 3
:
510(K) SUMMARY
OCT 18 2012
| A. | Submitter Information | |
|---|---|---|
| Manufacturer: | Medos International Sárl | |
| Chemin-Blanc 38 | ||
| 2400 Le Locle, Switzerland | ||
| Submitter: | DePuy Spine, Inc. | |
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person: | Kirsten Lehmuller | |
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Telephone number: | 508-828-3291 | |
| Fax number: | 508-828-3797 | |
| Email: | klehmull@its.jnj.com | |
| B. | Date Prepared | September 20, 2012 |
| C. | Device Name | |
| Trade/Proprietary Name: | Cougar® LS Lateral Cage System | |
| Common/Usual Name: | Spinal Intervertebral Body Fixation Orthosis, | |
| Intervertebral body fusion 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: DePuy Spine Cougar® LS Lateral Cage System (K082128, K110454)
1
E. Device Description
The Cougar® LS Lateral System implants are manufactured from Carbon Fiber Reinforced Polymer (CFRP) material. Cages are available with 15° lordotic configurations, widths of 18mm and 21mm, and heights ranging from 10mm to 20mm in 2mm increments. The cages' lengths are 45mm, 50mm, 55mm, and 60mm.
The cage structure is radiolucent with tantalum X-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft.
The implants may be utilized in either an open or minimally invasive surgical approach. The implants are placed using a lateral surgical approach.
F. Intended Use
The Cougar® LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. The 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 Cougar® LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six
2
months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The proposed modification to the DePuy Cougar LS Lateral System (i.e. increase in lordotic angle) results in a device that is substantially equivalent to the predicates. The footprint of the subject devices remains unchanged from the predicate Cougar LS devices. The increase in lordotic angle provides the same strength and performance as the predicate devices. The materials and technology remain identical to the predicate system.
Materials G.
The proposed cages are manufactured from Carbon Fiber Filled PEEK-OPTIMA LT1 Compound (CFRP).
H. Performance Data
Performance data per ASTM F2077-11 and ASTM F2267-04 was submitted to characterize the subject Cougar LS Lateral Cage implants addressed in this notification. This testing was comprised of static and dynamic compression, static and dynamic compressive shear, expulsion, and subsidence testing on the proposed device.
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medos International Sárl % Depuy Spine, a Johnson and Johnson Company Ms. Kristen Lehmuller Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
OCT 1 8 2012
Re: K122896
Trade/Device Name: Cougar® LS Lateral Cage Implants Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: September 20, 2012 Received: September 21, 2012
Dear Ms. Lehmuller:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
4
Page 2 - Ms. Kristen Lehmuller
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/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,
Sincerely yours,
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): ≤ (22796
Device Name: Cougar® LS Lateral Cage Implants
Indications For Use:
The Cougar® LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. The 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 Cougar® LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122896