(533 days)
Not Found
No
The document describes a physical spinal implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant for spinal fusion procedures used to treat degenerative disc disease, which falls under the definition of a therapeutic device.
No
The device is a spinal implant intended for spinal fusion procedures. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical spinal implant made of carbon fiber reinforced polyetheretherketone (CF/PEEK) with tantalum threads. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion procedures in the lumbar spine. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is a physical implant made of carbon fiber reinforced PEEK.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body to provide structural support and facilitate fusion.
N/A
Intended Use / Indications for Use
The ETurn spinal implant is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ETurn devices are to be used with autogenous bone graft. Patients should have had at least six (6) months of non-operative care prior to treatment with this device.
The ETurn spinal implant is intended for use with supplemental fixation such as posterior fixation by pedicle screws and rods.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The icotec ETurn Spinal Implant is a hollow, curved frame spinal implant comprised of carbon fiber reinforced polyetheretherketone or CF/PEEK containing 62% ± 3% carbon fibers (by volume) with 50 um tantalum threads, ≤ 0.5% (by volume). It consists of a windowed body with a central slot, a distraction/insertion wedge and surface treads on its cranial and caudal surfaces that serve to guide and anchor the implant. The smooth tread surface helps to create a significantly larger pressure-bearing contact surface between the implant and the bone than the conventional pointed anchoring elements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L2 to S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Finite Element Analysis (FEA) was performed to demonstrate mechanical performance similar to that of a legally marketed predicate device. The FEA was supported by static compression, dynamic compression and dynamic torsion testing performed per ASTM F2077. Particulate characterization was performed per ASTM F1877. Subsidence testing was also performed per ASTM F 2267. These preclinical tests demonstrated substantially equivalent performance of the ETurn device as compared 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.
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
Section 5 – 510(k) Summary
| Submitter: | icotec ag
Industriestrasse 12
CH-9450 Altstaetten
Switzerland |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barbara Atzenhoefer Stegmeier
Alquest, LLC
763 287 3830 (phone)
763 287 3836 (fax) |
| Date Prepared: | April 4, 2011 |
| Trade Name: | ETurn Spinal Implant |
| Common Name: | Intervertebral body fusion device |
| Classification: | Class II, Intervertebral Body Fusion Device, 21 CFR 888.3080 |
| Product Code: | MAX |
| Predicate
Device(s): | Lumbar I/F Cage System (P960025)
KIMBATM Spinal Implant (K052533)
KIMBA™ mini (K080349) |
| Device
Description: | The icotec ETurn Spinal Implant is a hollow, curved frame spinal implant comprised
of carbon fiber reinforced polyetheretherketone or CF/PEEK containing 62% ± 3%
carbon fibers (by volume) with 50 um tantalum threads, ≤ 0.5% (by volume). It
consists of a windowed body with a central slot, a distraction/insertion wedge and
surface treads on its cranial and caudal surfaces that serve to guide and anchor the
implant. The smooth tread surface helps to create a significantly larger pressure-
bearing contact surface between the implant and the bone than the conventional
pointed anchoring elements. |
| Intended Use: | The ETurn spinal implant is indicated for spinal fusion procedures in skeletally
mature patients with degenerative disc disease (DDD) in the lumbar spine at one or
two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by patient history and radiographic studies. The
DDD patients may also have up to Grade I spondylolisthesis at the involved level.
The ETurn devices are to be used with autogenous bone graft. Patients should have
had at least six (6) months of non-operative care prior to treatment with this device.
The ETurn spinal implant is intended for use with supplemental fixation such as
posterior fixation by pedicle screws and rods. |
| Functional and
Safety Testing: | Finite Element Analysis (FEA) was performed to demonstrate mechanical
performance similar to that of a legally marketed predicate device. The FEA was
supported by static compression, dynamic compression and dynamic torsion testing
performed per ASTM F2077. Particulate characterization was performed per ASTM
F1877. Subsidence testing was also performed per ASTM F 2267. These
preclinical tests demonstrated substantially equivalent performance of the ETurn
device as compared to legally marketed predicate devices. |
| Conclusion: | Icotec considers the ETurn to be equivalent to the predicate devices listed above.
This conclusion is based upon the devices' similarities in principles of operation,
technology, materials and indications for use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 1 2011
Icotec AG % Alquest, LLC Ms. Barbara Atzenhoefer Stegmeier 4050 Olson Memorial Highway, Suite 350 Minneapolis, Minnesota 55422
Re: K100305
Trade/Device Name: ETurn Spinal Implant Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 18, 2011 Received: July 19, 2011
Dear Ms. Stegmeier:
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
2
Page 2 - Ms. Barbara Atzenhoefer Stegmeier
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 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,
E. Keith
For Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4 - Indications for Use Statement
PreMarket Notification Number: K100305
Device Name: ETurn Spinal Implant
Indications For Use:
The ETurn spinal implant is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ETurn devices are to be used with autogenous bone graft. Patients should have had at least six (6) months of non-operative care prior to treatment with this device.
The ETurn spinal implant is intended for use with supplemental fixation such as posterior fixation by pedicle screws and rods.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
K
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K100305 510(k) Number.
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