(274 days)
Not Found
No
The 510(k) summary describes a physical interbody cage system made of carbon fiber reinforced PEEK and titanium coating. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is described as an "interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine," indicating its use in treating a medical condition (degenerative disc disease) and restoring physiological function (spinal fusion).
No
The device description clearly states that these are interbody cages designed to restore intervertebral height and facilitate spinal fusion, which are therapeutic rather than diagnostic functions.
No
The device description explicitly states it is an "interbody cage system" manufactured from "high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®)" and incorporates a "porous titanium coating." This describes a physical implant, 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 icotec Interbody Cage System is an implantable device designed to restore intervertebral height and facilitate spinal fusion. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use describes surgical procedures for spinal fusion, not diagnostic testing of biological samples.
Therefore, the icotec Interbody Cage System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Indications for Use
510(k) Number (if known)
K172480
Device Name icotec Interbody Cage System
Indications for Use (Describe) icotec Cervical Cage
The icotec Cervical Cage is intended for spinal fusion procedures at one level (C2-T1) in skeltally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
icotec PLIF Cage
The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.
icotec ETurn™ TLIF Cage
The icotec ETurn™ TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The icotec Interbody Cage System (i.e., icotec Cervical Cage, icotec PLIF Cage, and icotec ETurn TLIF Cage) is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a porous titanium coating. The devices are intended to be used with supplemental spinal fixation.
There is one type of cervical cage and two lumbar cages (1.e., PLIF and ETurn TLIF) included in this portfolio. Each cage is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), lumbar spine (L2-S1)
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)
Preclinical Testing:
The non-clinical tests performed by the company include static and dynamic compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267), and expulsion testing of the worst case construct. The results of the performed tests demonstrate that the icotec Interbody Cage System is substantially equivalent to legally marketed predicate devices.
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.
K122588, K080588, K100305, K111792, K092193, K093669, K112095, K111119
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 17, 2018
icotec ag % Samuel Pollard Senior Associate Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Affairs 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K172480
Trade/Device Name: icotec Interbody Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: April 20, 2018 Received: April 20, 2018
Dear Samuel Pollard:
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 of medical device-related 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.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K172480
Device Name icotec Interbody Cage System
Indications for Use (Describe) icotec Cervical Cage
The icotec Cervical Cage is intended for spinal fusion procedures at one level (C2-T1) in skeltally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
icotec PLIF Cage
The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.
icotec ETurn™ TLIF Cage
The icotec ETurn™ TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
1 510(k) Summary
| Device Trade Name: | icotec Interbody Cage System |
|---|---|
| Manufacturer: | icotec ag |
| Industriestrasse 12 | |
| 9450 Altstätten | |
| Switzerland | |
| Contact: | Ms. Valeria Consiero |
| Assistant QM/RA | |
| icotec ag | |
| Industriestrasse 12 | |
| 9450 Altstaetten, Switzerland | |
| Phone: +41 71 757.0055 | |
| Fax: +41 71 757.0001 | |
| valeria.consiero@icotec.ch | |
| Prepared by: | Mr. Samuel Pollard |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NE, Suite 1000 | |
| Washington, DC 20005 | |
| Phone: 202.552.5800 | |
| spollard@mcra.com | |
| Date Prepared: | August 4, 2017 |
| Classification: | 21 CFR §888.3080 |
| Common Name: | Intervertebral body fusion device |
| Class: | II |
| Product Code: | ODP, MAX |
| Primary Predicates: | Cervical: Ortho Development Vusion CS+ (K122588) |
| Lumbar: Scient'X Tribeca Cage (K080588) | |
| Additional Predicates: | icotec ETurn Spinal Implant (K100305), Kimba Cage (K111792), |
| Precision Spine Shurfit PLIF Interbody Cage (K092193) and | |
| CoAlign AccuLIF (K093669, K112095), Zimmer TM-S Fusion | |
| Device (K111119) |
5
Indications for Use:
Cervical
The icotec Cervical Cage is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone.
This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
PLIF
The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.
TLIF
The icotec ETurn™ TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.
Device Description:
The icotec Interbody Cage System (i.e., icotec Cervical Cage, icotec PLIF Cage, and icotec ETurn TLIF Cage) is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a porous titanium coating. The devices are intended to be used with supplemental spinal fixation.
6
There is one type of cervical cage and two lumbar cages (1.e., PLIF and ETurn TLIF) included in this portfolio. Each cage is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.
Predicate Devices:
The icotec Interbody Cage System is substantially equivalent to the predicate devices cited on the previous page with respect to indications, design, function, and performance.
Preclinical Testing:
The non-clinical tests performed by the company include static and dynamic compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267), and expulsion testing of the worst case construct. The results of the performed tests demonstrate that the icotec Interbody Cage System is substantially equivalent to legally marketed predicate devices.
Conclusion:
The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the icotec Interbody Cage System to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.