(67 days)
The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).
Patients should have six months of non-operative treatment prior to surgery.
These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.
These implants are intended for use with Biedermann Motech supplemental internal fixation products.
The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants:
The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm.
Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis.
The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation.
The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.
This document is a 510(k) premarket notification for a medical device (TELIX K Interbody System), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against detailed acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially points 2, 3, 4, 5, 6, 7, 8, 9 which relate to data, ground truth establishment, and clinical studies) are not applicable or not present in this type of regulatory submission. This document describes a physical intervertebral body fusion device, not an AI or algorithm.
Here's an analysis based on the provided text, addressing only the applicable points:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are derived from relevant ASTM standards for intervertebral body fusion devices, and the "reported device performance" refers to the results of mechanical bench testing.
| Acceptance Criterion (Based on ASTM Standards) | Reported Device Performance (Summary) |
|---|---|
| Mechanical performance suitable for intervertebral body fusion devices (e.g., adequate static and dynamic compression, torsion, compression-shear, and subsidence characteristics) | "The results of the worst case biomechanical testing of the TELIX K Interbody System indicate that the system is substantially equivalent to the identified predicate/reference devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests, but implies a sufficient number of samples were tested to meet ASTM standard requirements for substantiation.
- Data Provenance: Not applicable in terms of patient data. The data is from mechanical bench testing of the device components.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. This relates to mechanical testing against standards, not expert-derived ground truth on patient data.
4. Adjudication method for the test set:
- Not applicable. This relates to mechanical testing governed by standardized protocols, not human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This document refers to a physical implant and mechanical testing, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- For the mechanical bench testing, the "ground truth" is defined by the acceptance limits and methodologies of the ASTM standards (ASTM F2077-14 and ASTM F2267-04).
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical device subject to mechanical testing, not an AI/algorithm.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.
Summary based on the document:
The provided document describes a 510(k) premarket notification for a physical medical device, the TELIX K Interbody System. The intent of this submission is to demonstrate substantial equivalence to an already legally marketed device, primarily through non-clinical bench testing to ensure mechanical performance aligns with established standards for intervertebral body fusion devices.
The "acceptance criteria" are implied by the referenced ASTM standards (ASTM F2077-14 and ASTM F2267-04), which dictate the performance requirements for such implants regarding static compression, dynamic compression, torsion, compression-shear, and subsidence. The study conducted was non-clinical bench testing, specifically mechanical tests. No clinical trials or studies involving human patients were performed or deemed necessary for this 510(k) submission ("No clinical tests were performed."). Therefore, concepts like data provenance from patient studies, expert consensus, MRMC studies, or training sets for AI algorithms are not relevant to this specific regulatory submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biedermann Motech GmbH & Co. KG Mr. Gerd Federle Director of Quality Management Bertha-von-Suttner-Str. 23 78054 Villingen-Schwenningen GERMANY
June 2, 2017
Re: K170890
Trade/Device Name: TELIX K Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 24, 2017 Received: March 27, 2017
Dear Mr. Federle:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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/ResourcesforYou/Industry/default.htm. 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.
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.
Mark N. Melkerson -S
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) K170890
Device Name TELIX K Interbody System
Indications for Use (Describe)
The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).
Patients should have six months of non-operative treatment prior to surgery.
These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.
These implants are intended for use with Biedermann Motech supplemental internal fixation products.
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
1. Submitter, Correspondent and Manufacturer
| Submitter Name: | Biedermann Motech GmbH & Co. KG |
|---|---|
| Submitter Address: | Bertha-von-Suttner-Str. 2378054 Villingen-SchwenningenGermany |
| Contact Person: | Gerd FederleDirector of Quality ManagementPhone: +49 7720 8510-545Fax: +49 7720 8510-66gfe@biedermann.com |
| Date of Submission: | 03/24/2017 |
| Manufacturer Name: | Biedermann Motech GmbH & Co. KG |
| Manufacturer Address: | Bertha-von-Suttner-Str. 2378054 Villingen-SchwenningenGermany |
2. Device Identification
| Device Trade Name: | TELIX K Interbody System |
|---|---|
| Device Common Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification Name: | Intervertebral Body Fusion with Bone Graft, Lumbar |
| Classification Code: | MAX, Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3080 |
| Regulation Name: | Intervertebral body fusion device |
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3. Predicate Device
| Predicate Device: | Depuy Spine Devex System - DePuy Spine, Inc (K081917) |
|---|---|
| Reference Devices: | Aleutian IBF System – K2M, Inc. (K082698) |
| – MectaLIF - Medacta International (K110927) |
- | T-PAL Spacer System - Synthes USA Products LLC (K162358)
4. Device Description
The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants:
The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm.
Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis.
The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation.
The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.
5. Material
The implants are manufactured from ASTM F 136 implant grade titanium alloy Ti-6AI-4V ELI.
6. Indications for Use
The TELIX K Interbody System is indicated for use as intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).
Patients should have six months of non-operative treatment prior to surgery.
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Image /page/5/Picture/2 description: The image shows a logo with the text "BIEDERMANN" stacked on top of "MOTEC H". The text is in a sans-serif font and is aligned to the left. There is a black square in the upper right corner of the logo, partially obscuring the top right corner of the square border around the logo.
These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.
These implants are intended for use with Biedermann Motech supplemental internal fixation products.
7. Technological Characteristics and Substantial Equivalence
Like the predicate device (DEVEX System – K081917) the TELIX K Interbody System consists of cages that are available in varying sizes to fit the patient's anatomical and physiological requirements.
The TELIX K cages are of a similar design and made from Titanium alloy Ti-6Al-4V, as the predicate is.
The System is intended to provide intervertebral body fusion in skeletally mature patients, as the predicate is.
8. Performance Data
8.1 Non-Clinical Test Summary
The TELIX K Interbody System was evaluated per the FDA Guidance Document for Industry and FDA Staff; Class II Special Controls Guidance Document Intervertebral Body Fusion Device.
The following testing was done to show substantial equivalence of our system:
Bench testing - mechanical
Mechanical testing according to ASTM F2077-14 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 standard (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) was performed in order to provide data to support a substantial equivalence determination. These tests were performed to support system related performance under consideration of well-established acceptance criteria. Performance testing included:
- Static Compression
- Dynamic Compression
- Static Torsion
- Static Compression-Shear ■
- Dynamic Compression-Shear ■
- Subsidence
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Result: The results of the worst case biomechanical testing of the TELIX K Interbody System indicate that the system is substantially equivalent to the identified predicate/reference devices.
8.2 Clinical Test Summary
No clinical tests were performed.
9. Substantial Equivalence Summary and Conclusion
There are no differences between the devices which would raise new concerns regarding safety or effectiveness.
Based on available 510(k) information provided, comparison to predicate devices and performance testing, the TELIX K Interbody System can be considered substantially equivalent to the predicate/reference devices.
§ 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.