(133 days)
Not Found
No
The device description and intended use focus on the mechanical properties and function of an expandable interbody fusion device made of traditional materials. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is used to treat degenerative disc disease and provide structural stability in the spine, which falls under the definition of a therapeutic device.
No
The device is an interbody fusion device, specifically an implant used for spinal fusion to treat degenerative disc disease. It provides structural stability and is filled with bone graft material. It does not diagnose medical conditions.
No
The device description explicitly states the device is made from titanium alloy, PEEK polymer, and cobalt chromium molybdenum alloy, indicating it is a physical implant, not software.
Based on the provided information, the ALTERA™ Spacer 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, tissue) to provide information for diagnosis, monitoring, or screening.
- The ALTERA™ Spacer is an implantable medical device used in surgery to provide structural support for spinal fusion. It is physically inserted into the patient's body.
The description clearly states its intended use is for surgical implantation in the lumbosacral spine to treat degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The ALTERA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The ALTERA™ Spacer is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The ALTERA™ Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA™ Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The device is available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
The ALTERA™ Spacer is made from titanium allov, as specified in ASTM F136. F1295, and F1472. Internal components are made from radiolucent PEEK polymer and cobalt chromium molybdenum alloy, as specified in ASTM F2026 and F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-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)
Mechanical testing (static and dynamic compression, static and dynamic compression shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device." June 12, 2007. ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Results demonstrate that the ALTERA® Spacer performs equivalently to or better than the predicate CALIBER® Spacer.
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.
K102293, K072970 & K122097, K113465
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.
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K140411 page 1 of 2
510(k) SUMMARY: ALTERA™ Spacer
JUL 0 1 204
| Company: | Globus Medical Inc. |
|---|---|
| 2560 General Armistead Avenue | |
| Audubon, PA 19403 | |
| (610) 930-1800 |
Contact: Christina Kichula Group Manager, Regulatory Affairs
Date Prepared: February 17, 2014
Device Name: ALTERA™ Spacer
Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code: MAX Regulatory Class: II, Panel Code: 87
- CALIBER® Spacer (K102293) Predicate(s): PATRIOT® Spacer (K072970 & K122097) CoAlign Innovation AccuLIF® TL Cage (K113465)
Purpose:
The purpose of this submission is to request clearance for the ALTERA™ Spacer.
Device Description:
The ALTERA™ Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA™ Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The device is available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
The ALTERA™ Spacer is made from titanium allov, as specified in ASTM F136. F1295, and F1472. Internal components are made from radiolucent PEEK polymer and cobalt chromium molybdenum alloy, as specified in ASTM F2026 and F1537.
Indications for Use:
The ALTERA™ Spacer is an interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of
1
the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The ALTERA™ Spacer is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.
Performance Data:
Mechanical testing (static and dynamic compression, static and dynamic compression shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device." June 12, 2007. ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Results demonstrate that the ALTERA™ Spacer performs equivalently to or better than the predicate CALIBER® Spacer.
Basis for Substantial Equivalence:
The ALTERA™ Spacer is similar to the predicate systems with respect to technical characteristics, performance, design, materials, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. The ALTERA™ Spacer's safety and effectiveness profile is similar to the cited predicates.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side. The bird is composed of thick, curved lines, giving it a modern and abstract appearance.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2014
Globus Medical, Incorporated Ms. Christina Kichula Group Manager. Regulatory Affairs 2560 General Armistead Avenue Audubon. Pennsylvania 19403
Re: K140411
Trade/Device Name: ALTERATM Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 30, 2014 Received: June 2. 2014
Dear Ms. Kichula:
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 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
3
Page 2 - Ms. Christina Kichula
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.
Sincerely yours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140411
Device Name
ALTERA™ Spacer
Indications for Use (Describe)
The ALTERA™ Spacer is an interbody fusion device in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s).
The ALTERATM Spacer is to be tilled with autogenous bone graft material. The device is intended to be used with supplemental fixation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Dinitriev. Pr
A
Division of
FORM FDA 3881 (1/14)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.