(173 days)
No
The description focuses on the physical characteristics, materials, and mechanical performance of a spinal fusion implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interbody fusion device intended for use in spinal fusion procedures to treat degenerative disc disease, which clearly indicates a therapeutic purpose to restore function and alleviate symptoms.
No.
The device description clearly states its purpose is for spinal fusion procedures and providing structural support and biologic fusion, not for diagnosing medical conditions.
No
The device description clearly states it is an "Interbody Fusion Device (IBD) implants" manufactured from "medical grade titanium alloy" and intended for surgical implantation. This indicates a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Endoskeleton® TL IBD is an implantable device made of titanium alloy. It is surgically placed in the spine to facilitate fusion.
- Intended Use: The intended use is for spinal fusion procedures in patients with Degenerative Disc Disease. This is a surgical treatment, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Endoskeleton® TL IBD is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. This device is intended for use supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.
Product codes
MAX
Device Description
The Endoskeleton® TL Interbody Fusion Device (IBD) implants are available in a various sizes with a variety of lordotic angles (0, 7 or 12 degrees), to accommodate patient anatomy. Lengths range from 40 to 60mm, widths from 18 to 26m and heights range from 8 to 16mm. Endoskeleton® TL IBD implants are intended for treatment in Lateral Lumbar Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a farge hollow region in the center to house bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-AV-ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Mechanical testing, including static compression-shear, static torsion, subsidence, expulsion, dynamic compression, dynamic compression-shear, and dynamic torsion have been performed per ASTM F2077 and ASTM F2267 on the subject Endoskeleton® TL IBD and the results have shown them to be substantially equivalent to the predicate interbody devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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JUL 0 2 2014
510(k) Summary Endoskeleton® TL IBD June 5, 2014
| Company: | Titan Spine, LLC |
|---|---|
| 6140 West Executive Drive, Suite A | |
| Mequon, WI 53092, USA | |
| Establishment | |
| Registration: | 3006340236 |
| Primary Contact: | Christine Scifert |
| Phone: 901-831-8053 | |
| Company Contact: | Jane Rodd |
| Phone: 866-822-7800 | |
| Fax: | |
| 262-242-7802 | |
| Trade Name: | Endoskeleton® TL Interbody Fusion Device |
| Common Name: | Intervertebral fusion device with bone graft, lumbar |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | 87- Orthopedic |
| Product Code: | MAX |
Device Description:
The Endoskeleton® TL Interbody Fusion Device (IBD) implants are available in a various sizes with a variety of lordotic angles (0, 7 or 12 degrees), to accommodate patient anatomy. Lengths range from 40 to 60mm, widths from 18 to 26m and heights range from 8 to 16mm. Endoskeleton® TL IBD implants are intended for treatment in Lateral Lumbar Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a farge hollow region in the center to house bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone.
1
An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. All implantable... components are manufactured from medical grade titanium alloy (Ti-6Al-AV-ELI).
Indications for Use:
The Endoskeleton® TL IBD is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. This device is intended for use supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.
Substantial Equivalence:
The subject Endoskeleton® TL IBD components were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the following interbody devices, previously cleared by the FDA:
- . Titan Spine: Endoskeleton® TO - K102067
- Titan Spine: Endoskeleton(r) TA VBR K032812 ●
- . Nuvasive XLIF - K071795
The Indications for Use, Materials, and Geometry for predicate devices are all inclusive of the subject device. The difference between the subject and predicate devices are different sizes and geometry. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Mechanical testing, including static compression-shear, static torsion, subsidence, expulsion, dynamic compression, dynamic compression-shear, and dynamic torsion have been performed per ASTM F2077 and ASTM F2267 on the subject Endoskeleton® TL IBD and the results have shown them to be substantially equivalent to the predicate interbody devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Titan Spine, LLC % Ms. Christine Scifert Memphis Regulatory Consulting. LLC 3416 Roxee Run Cove Bartlett. Tennessee 38133
Re: K140055
Trade/Device Name: Endoskeleton® TL Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 5. 2014 Received: June 6, 2014
Dear Ms. Scifert:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Christine Scifert
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" (2) 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/ReportalProblem/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 yours.
Ronald P. Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Endoskeleton® TL Interbody Fusion Device
Indications for Use (Describe)
The Endoskeleton® TL IBD is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. Patients should have received 6 months of non-operative treatment prior to treament with the devices. This device is intended for use with supplemental fixation systems cleared for use in these DDD paients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
: 上一篇: 上一篇: FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
MICHIGAN
DEPARTMENT OF
ENVIRONMENTAL QUALITY
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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