(146 days)
Not Found
No
The document describes a physical implantable device (intervertebral body cage) and its intended use and mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is described as an "Intervertebral Body Cage" used to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, or for spinal fusion procedures in patients with degenerative disc disease. These applications clearly indicate its use in treating medical conditions or supporting body structures for therapeutic purposes.
No
This device is an implantable medical device used to provide structural stability in the spine after a vertebral body has been removed or to aid in spinal fusion. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition but rather treats an existing one.
No
The device description clearly states it is a physical implantable device made of titanium alloy, intended for surgical implantation in the spine. It is a hardware device, not software.
Based on the provided text, 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 ATLAS Intervertebral Body Cage is an implantable device used to provide structural stability in the spine. It is a physical object inserted into the body during surgery.
- Intended Use: The intended uses are for vertebral body replacement and lumbar intervertebral body fusion, both of which are surgical procedures involving the implantation of a device.
- No Mention of Samples or Testing: The text does not mention any analysis of biological samples or diagnostic testing.
Therefore, the ATLAS Intervertebral Body Cage is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as vertebral body replacement, the ATLAS Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) the interior spacer may be packed with bone grafting material. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time.
When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to S1. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation.
For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.
Product codes (comma separated list FDA assigned to the subject device)
MQP, MAX
Device Description
This submission is intended to seek clearance for a product line extension to the ATLAS Spinal Cage VBR. The extension includes the addition of 8mm, 10mm, 12mm, 14mm, and 16mm cages to the current offering. Additionally adding the product code MAX for Intervertebral body fusion devices CFR 21 888.3080.
The Spinal Edge ATLAS Intervertebral Body Cage is an Intervertebral Body Cage device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each cage has an axial hole to allow grafting material to be packed inside. Protrusions on the superior and inferior surfaces of the device will grip the cortical endplates of the adjacent vertebrae and resist expulsion. The Spinal Edge ATLAS Intervertebral Body Cage components are available in titanium alloy conforming to ASTM F-136 specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5), L2 to S1
Indicated Patient Age Range
skeletally mature individuals
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 testing was completed using the largest size ATLAS Intervertebral Body Cage (17mm). The devices were tested in accordance with ASTM F2267-04, "Standard Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression" and ASTM F2077-03 "Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model".
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
10.0 510(k) Summary
-
- Sponsor
FEB - 2 2010
- Sponsor
Spinal Edge LLC 2275 Research Blvd. Suite 527 Rockville, MD 20805
| Primary Contact: | Ravi Sharma PhD |
|---|---|
| Telephone: | 1- 866-915-9468 |
August 3, 2009 Date Prepared:
2. ATLAS Intervertebral Body Cage:
ATLAS Intervertebral Body Cage Proprietary Name: Common/Usual Name: ATLAS Intervertebral Body Cage Classification Name: ATLAS Intervertebral Body Cage (21 CFR 888.3060), Class II Product Code MQP and (21 CFR 888.3080), Class II Product Code MAX
3. Predicate Devices
K060916 - Atlas Spinal Cage K083815 - Lanx Fusion System K990148 - Stackable Cage System
4. Device Description
This submission is intended to seek clearance for a product line extension to the ATLAS Spinal Cage VBR. The extension includes the addition of 8mm, 10mm, 12mm, 14mm, and 16mm cages to the current offering. Additionally adding the product code MAX for Intervertebral body fusion devices CFR 21 888.3080.
The Spinal Edge ATLAS Intervertebral Body Cage is an Intervertebral Body Cage device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each cage has an axial hole to allow grafting material to be packed inside. Protrusions on the superior and inferior surfaces of the device will grip the cortical endplates of the adjacent vertebrae and resist expulsion. The Spinal Edge ATLAS Intervertebral Body Cage components are available in titanium alloy conforming to ASTM F-136 specifications.
1
5. Intended Use
When used as vertebral body replacement, the ATLAS Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) the interior spacer may be packed with bone grafting material. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time.
When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to S1. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation.
For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.
6. Technological Characteristics and Substantial Equivalent
The Spinal Edge ATLAS Intervertebral Body Cage devices being added to the product line have the same indications for use, operating principles and are made of the same materials as the predicate devices.
Representative samples of the ATLAS Intervertebral Body Cage device underwent testing to demonstrate comparable function and performance characteristics its predicate The additional device sizes in this submission do not introduce any new devices. questions of safety and effectiveness. Mechanical testing and engineering analysis of the results demonstrated comparable mechanical properties to the predicate device.
7. Performance Testing
Performance testing was completed using the largest size ATLAS Intervertebral Body Cage (17mm). The devices were tested in accordance with ASTM F2267-04, "Standard Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression" and ASTM F2077-03 "Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model".
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Spinal Edge, LLC % CHS Business Associates, LLC Ms. Christina Vacca President 33650 Reserve Way Avon, Ohio 44011
FEB ~ 2 2010
Re: K092774
Trade/Device Name: ATLAS Intervertebral Body Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: January 12, 2010 Received: January 19, 2010
Dear Ms. Vacca:
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
3
Page 2 - Ms. Christina Vacca
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-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Oohau Ruchur
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
9.0 Indications for Use Statement
510(k) Number (if Known): K092774
Indications for Use:
When used as vertebral body replacement, the ATLAS Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) the interior spacer may be packed with bone grafting material. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time.
When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to S1. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation.
For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wh
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K092774 510(k) Number_
Page 1 of 1 - 1
Spinal Edge LLC ATLAS Intervertebral Body Cage - 510(k)