(533 days)
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.
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.
The provided text describes a 510(k) summary for a medical device, the icotec ETurn Spinal Implant. It focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing, primarily mechanical performance tests. This document does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Therefore, most of the requested information regarding AI device evaluation cannot be extracted.
However, I can provide what is present about the device's testing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance | Similar to legally marketed predicate devices (demonstrated via FEA, static compression, dynamic compression, dynamic torsion testing per ASTM F2077). |
| Particulate Characterization | Performed per ASTM F1877. |
| Subsidence | Performed per ASTM F2267. |
Note: Specific numerical acceptance criteria or performance metrics are not detailed in this summary; rather, the performance is stated as "similar to" or "substantially equivalent" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document describes preclinical testing (Finite Element Analysis and various mechanical tests per ASTM standards). These are typically laboratory-based tests of physical device properties, not clinical studies with patient data.
- Therefore, the concepts of "test set sample size" for patient data, "data provenance," "retrospective or prospective," or "country of origin" are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not applicable as the study described is a preclinical mechanical performance study, not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as this is a preclinical mechanical performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a preclinical mechanical performance study for a spinal implant, not an AI/Machine Learning device, and therefore no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical spinal implant, not an algorithm, so "standalone performance" in this context is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. For preclinical mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices or established mechanical principles, against which the new device's performance is compared.
8. The sample size for the training set
- Not applicable; this is a physical medical device, not an AI/Machine Learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable; no training set exists for this device.
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Section 5 – 510(k) Summary
| Submitter: | icotec agIndustriestrasse 12CH-9450 AltstaettenSwitzerland |
|---|---|
| Contact Person: | Barbara Atzenhoefer StegmeierAlquest, LLC763 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 |
| PredicateDevice(s): | Lumbar I/F Cage System (P960025)KIMBATM Spinal Implant (K052533)KIMBA™ mini (K080349) |
| DeviceDescription: | The icotec ETurn Spinal Implant is a hollow, curved frame spinal implant comprisedof carbon fiber reinforced polyetheretherketone or CF/PEEK containing 62% ± 3%carbon fibers (by volume) with 50 um tantalum threads, ≤ 0.5% (by volume). Itconsists of a windowed body with a central slot, a distraction/insertion wedge andsurface treads on its cranial and caudal surfaces that serve to guide and anchor theimplant. The smooth tread surface helps to create a significantly larger pressure-bearing contact surface between the implant and the bone than the conventionalpointed anchoring elements. |
| Intended Use: | The ETurn spinal implant is indicated for spinal fusion procedures in skeletallymature patients with degenerative disc disease (DDD) in the lumbar spine at one ortwo contiguous levels from L2 to S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by patient history and radiographic studies. TheDDD 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 havehad 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 asposterior fixation by pedicle screws and rods. |
| Functional andSafety Testing: | Finite Element Analysis (FEA) was performed to demonstrate mechanicalperformance similar to that of a legally marketed predicate device. The FEA wassupported by static compression, dynamic compression and dynamic torsion testingperformed per ASTM F2077. Particulate characterization was performed per ASTMF1877. Subsidence testing was also performed per ASTM F 2267. Thesepreclinical tests demonstrated substantially equivalent performance of the ETurndevice 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
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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
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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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§ 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.