(436 days)
The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style.
Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.
This document is a 510(k) premarket notification for an Interbody Cage and does not contain the specific type of detailed acceptance criteria and study results typically found in performance studies for AI/ML-driven medical devices. The device is a physical implant, not a software algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.
However, I can extract the relevant "performance data" that addresses the device's equivalence to predicates, which serves as the "acceptance criteria" and "study" in the context of this 510(k) submission.
Here's a summary of the information that can be extracted, adapting the request to the nature of the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit for 510(k) of physical device) | Reported Device Performance (Summary from Document) |
|---|---|
| Material Equivalence: New materials (Vestakeep 4iR PEEK, Titanium Alloy) must have equivalent or superior mechanical properties to previously cleared materials (Zeniva ZA-500 PEEK). | • Vestakeep 4iR PEEK is "equivalent in mechanical properties" to Zeniva ZA-500.• Titanium alloy devices are "substantially stronger than those made from PEEK." |
| Size/Geometric Equivalence: New implant sizes must not represent a new "worst-case" scenario compared to the previously tested worst-case size. | • All additional sizes are "larger in bearing footprint than the worst-case size tested for K113478."• The "worst-case size testing submitted as part of K113478 applies to all devices that are part of this current submission." |
| Biocompatibility: Materials must meet established medical grade standards. | • PEEK (ASTM F2026) with Tantalum (ASTM F560)• Titanium alloy (ASTM F136) |
| Mechanical Strength: Device must withstand intended loads. | • "Additional testing (compression) per ASTM F2077 verified that the addition of new materials did not introduce a new worst-case." |
| Radiographic Visualization: For PEEK devices, radiographic markers must be present. | • Tantalum pins are embedded in PEEK versions for radiographic visualization. |
2. Sample sized used for the test set and the data provenance:
- The document mentions "worst-case size testing submitted as part of K113478" and "Additional testing (compression) per ASTMF F2077." However, it does not specify the sample size for these tests for the current submission or the original K113478.
- Data Provenance: The tests are likely prospective mechanical tests conducted on the manufactured devices/materials, rather than clinical data from human subjects. The country of origin of the data is not specified but is implicitly tied to the manufacturer/testing labs involved in the 510(k) process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device submission. "Ground truth" in the sense of expert clinical annotation is not relevant here. Engineering standards and physical measurements are used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Mechanical testing against industry standards (e.g., ASTM F2077) does not involve adjudication in this manner.
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:
- Not Applicable. This is for a physical interbody fusion cage, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is for a physical interbody fusion cage.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Based on engineering standards and physical properties: The "ground truth" for this device's performance evaluation lies in meeting established mechanical testing standards (e.g., ASTM F2077 for compression strength of intervertebral body fusion devices), material specifications (ASTM F2026, ASTM F560, ASTM F136), and demonstrating equivalence in design (geometry, footprint) to predicate devices. The goal is to show that the new variations (materials, sizes) do not introduce new safety or effectiveness concerns compared to already cleared devices.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Eisertech. LLC Mr. Lukas Eisermann Chief Executive Officer 1133 Columbia Street, Suite 107 San Diego, California, 92101
Re: K140348
Trade/Device Name: Interbody Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 25, 2015 Received: March 27, 2015
Dear Mr. Eisermann:
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
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Page 2 - Mr. Lukas Eisermann
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 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/Resourcesfor You/Industry/default.htm. 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 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.
Sincerely vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140348
Device Name Interbody Cage
Indications for Use (Describe)
The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
| 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) |
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510(k) Summary:
| Date: | April 21, 2015 |
|---|---|
| Company: | Eisertech, LLC1133 Columbia StreetSuite 107San Diego, California 92101 |
| Contact: | Lukas Eisermannlukas@eisertech.com888-262-2817x101 |
Type of 510(k) submission: Traditional
| Trade Name: | Interbody Cage |
|---|---|
| Common Name: | Intervertebral FusionDevice with Bone Graft,Lumbar |
| Classification Name: | Orthosis, spinal intervertebral fusion |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification: | Class II |
| Product Code: | MAX |
Purpose of the Submission
The purpose of this special 510(k) is to gain clearance for additional implant sizes and material options.
Description of device
The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style.
Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.
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The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to
{4}------------------------------------------------
S1. These DDD patients may also have up to Grade I spondvlolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which as been cleared by the FDA for use in the lumbar spine.
Materials
The devices are manufactured either from medical grade PEEK (ASTM F2026) with tantalum radiographic markers (ASTM F560), or from titanium alloy (ASTM F136). The specific grades of PEEK used may be either Zeniva ZA-500 (Solvay) or Vestakeep 4iR (Evonik).
Predicate Devices
Primary Predicate:
Eisertech, LLC PLIF Cage (K113478)
Additional Predicates:
Titan Spine Endoskeleton (K083714) Alphatec GLIF Cage (K090425)
Reference Predicates:
K7, LLC - K133126 - Lumbar Cages Cogent Spine - K132738 - Lumbar Cage DiFusion - K123969 - ALIF Cage SpineWorks - K133340 - ALIF Cage
Technological Characteristics
The Interbody Cage geometry is similar to that cleared in K113478. The worstcase size testing submitted as part of K113478 applies to all devices that are part of this current submission.
The main material of construction is either PEEK (ASTM F2026) or titanium allov (ASTM F136). When used, the PEEK may be either Zeniva ZA-500 supplied by Solvay Advanced Polymers, which is one of the materials approved in K113478, or Vestakeep i4R, supplied by Evonik, Inc, which is the new material option being requested.
Performance Data
The additional materials and sizes do not alter the performance of the device. The additional PEEK option is equivalent in mechanical properties. The devices
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made from titanium alloy are substantially stronger than those made from PEEK. All additional sizes are larger in bearing footprint than the worst-case size tested for K113478. Additional testing (compression) per ASTFM F2077 verified that the addition of new materials did not introduce a new worst-case. Therefore, the subject Interbody Cage is substatially equivalent to its predicates.
§ 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.