(183 days)
Not Found
No
The summary describes a physical interbody fusion device and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used to treat degenerative disc disease and provide structural stability in the spine, which are therapeutic functions.
No
The device is an interbody fusion device, a surgical implant used for structural stability, not for diagnosis. Its purpose is to treat degenerative disc disease by fusing vertebrae, not to identify or characterize medical conditions.
No
The device description clearly states it is a physical implant made of polymer and titanium alloy, including plates and screws. It is an interbody fusion device, not a software application.
Based on the provided text, the InterContinental™ Plate-Spacer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the InterContinental™ Plate-Spacer is an implantable medical device used for spinal fusion. It is a physical structure inserted into the body to provide stability and promote bone growth.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is mechanical support and facilitating fusion.
Therefore, the InterContinental™ Plate-Spacer falls under the category of an implantable surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InterContinental™ Plate-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 InterContinental™ Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.
Product codes
OVD
Device Description
The InterContinental™ Plate-Spacer is a lateral lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. InterContinental™ is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to aid in expulsion resistance. InterContinental™ is to be filled with autogenous bone graft material, and is to be used with titanium alloy bone screws, with or without hydroxyapatite coating. Bone screws are used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation.
The spacer in the InterContinental™ Plate-Spacer is manufactured from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. The plates in the InterContinental™ Plate-Spacer are manufactured from titanium alloy, as specified in ASTM F136, and F1295. The screws in the InterContinental™ Plate-Spacer are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
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 consisting of static and dynamic compression, static and dynamic compression-shear, subsidence, expulsion, and fatigue bending was conducted by in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, to demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 2 0 2011
510(k) SUMMARY: InterContinental™ Plate-Spacer
| Company: | Globus Medical Inc.
2560 General Armistead Avenue
Audubon, PA 19403
(610) 930-1800 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.
Vice President, Regulatory & Clinical Affairs |
| Date Prepared: | March 10, 2011 |
| Device Name: | InterContinental™ Plate-Spacer |
| Classification: | Per 21 CFR as follows:
§888.3080: Intervertebral Body Fusion Device
Product Code: OVD
Regulatory Class: II, Panel Code: 87 |
| Predicate(s): | INDEPENDENCE® Spacer (K082252)
PATRIOT® TransContinental™ LLIF Spacer (K093242
CoRoent® XL-F (K071795) |
Purpose:
The purpose of this submission is clearance of the InterContinental™ Plate- Spacer as a modification of the cleared INDEPENDENCE® device.
Device Description:
The InterContinental™ Plate-Spacer is a lateral lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. InterContinental™ is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to aid in expulsion resistance. InterContinental™ is to be filled with autogenous bone graft material, and is to be used with titanium alloy bone screws, with or without hydroxyapatite coating. Bone screws are used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation.
The spacer in the InterContinental™ Plate-Spacer is manufactured from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. The plates in the InterContinental™ Plate-Spacer are manufactured from titanium alloy, as specified in ASTM F136, and F1295. The screws in the InterContinental™ Plate-Spacer are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
1
Indications for Use:
The InterContinental™ Plate-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 InterContinental™ Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.
Performance Data:
Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, subsidence, expulsion, and fatigue bending was conducted by in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, to demonstrate substantial equivalence to the predicate devices.
Basis for Substantial Equivalence:
The InterContinental™ Plate-Spacer has been found to be substantially equivalent to the predicates with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 0 2011
Globus Medical Inc. % Kelly J. Baker, Ph.D. Vice President, Regulatory & Clinical Affairs 2560 General Armistead Avenue Audubon. Pennsylvania 19403
Re: K103382
Trade/Device Name: InterContinental™ Plate-Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: April 15, 2011 -Received :- April 18-201-1-
Dear Dr. Baker:
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
3
Page 2 - Kelly J. Baker, Ph.D.
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), 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,
K. B. M.
for.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K103382 510(k) Number:
InterContinental™ Plate-Spacer_ Device Name:
INDICATIONS:
The InterContinental™ Plate-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 InterContinental™ Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- i Prescription Use ____________________________________________________________________________________________________________________________________________________________ OR OR OR (Per 21 CFR §801.109)
Over-The-Counter Use_
. . . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIO 3382 510(k) Number_