(231 days)
Not Found
No
The document describes a mechanical spinal implant made of PEEK and titanium, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes
The device is described as an "intervertebral body fusion device" used for "spinal fusion procedures," which are therapeutic interventions.
No
The provided text describes a medical implant system intended for spinal fusion procedures, not for diagnosing conditions. Its purpose is treatment, not diagnosis.
No
The device description clearly states it is comprised of physical implants made from PEEK and titanium alloy, including spacers, plates, and screws. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is an implantable device used for spinal fusion procedures. It is a physical object inserted into the body.
- Intended Use: The intended use is for treating degenerative disc disease through surgical implantation, not for analyzing biological samples.
Therefore, this device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft.
The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX
Device Description
The DYNA-LINK Elite Stand-Alone Anterior Lumbar System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Polyetheretherketone (PEEK-OPTIMA LT1 or Zeniva ZA-500) with tantalum markers. The spacers are hollow to permit packing with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral end plates to help prevent rotation and/or migration. Additionally, the implants incorporate a titanium alloy (6AL-4V-ELI per ASTM F-136) anterior fixation plate which has integrated screw holes to allow for placement of four titanium alloy screws that anchor the implant to the adjacent vertebrae. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.
All implant components are intended for single use only and should not be reused under any circumstances. Do not use any of the DYNA-LINK Elite Stand-Alone Anterior Lumbar System components with components from any other system or manufacturer. The DYNA-LINK Elite Stand-Alone Anterior Lumbar System components should never be reused under any circumstances
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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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 according to ASTM F1717-04 including Static and Dynamic Compression, Shear, Torsion and also Screw Pushout to ASTM F543. Testing was presented to demonstrate the substantial equivalency of the DYNA-LINK Elite Stand-Alone Anterior Lumbar System.
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
Build Correspondence
Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below that.
September 13, 2018
Life Spine, Inc. Randy Lewis General Manger 13951 S Quality Drive Huntley, Illinois 60142
Re: K180215
Trade/Device Name: DYNA-LINK ELITE Stand-Alone Anterior Lumbar System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: August 14, 2018 Received: August 15, 2018
Dear Mr. Lewis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall-S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180215
Device Name
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
Indications for Use (Describe)
The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft.
The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | January 24th, 2018 |
| Trade Name: | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System |
| Regulation Name: | Intervertebral body fusion device |
| Classification: | OVD, CFR 888.3030, Class II
MAX, CFR 888.3030, Class II |
| Primary Predicate: | Life Spine Stand-Alone Space System (K091301) |
| Secondary Predicate: | Centinel Spine Midline (K150643) |
Device Description:
The DYNA-LINK Elite Stand-Alone Anterior Lumbar System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Polyetheretherketone (PEEK-OPTIMA LT1 or Zeniva ZA-500) with tantalum markers. The spacers are hollow to permit packing with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral end plates to help prevent rotation and/or migration. Additionally, the implants incorporate a titanium alloy (6AL-4V-ELI per ASTM F-136) anterior fixation plate which has integrated screw holes to allow for placement of four titanium alloy screws that anchor the implant to the adjacent vertebrae. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.
All implant components are intended for single use only and should not be reused under any circumstances. Do not use any of the DYNA-LINK Elite Stand-Alone Anterior Lumbar System components with components from any other system or manufacturer. The DYNA-LINK Elite Stand-Alone Anterior Lumbar System components should never be reused under any circumstances
4
Indications for Use of the Device:
The DYNA-LINK Elite Stand-Alone Anterior Lumbar System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft. The DYNA-LINK Elite Stand-Alone Anterior Lumbar System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
Technological Characteristics:
The DYNA-LINK Elite Stand-Alone Anterior Lumbar System is substantially equivalent to the predicate system in terms of design, indications for use and sizing.
Material:
The DYNA-LINK Elite Stand-Alone Anterior Lumbar System is comprised of Peek and Titanium. The implant is Polyetheretherketone (PEEK-OPTIMA LT1 or Zeniva ZA-500) & Titanium alloy (6AL-4V-ELI) manufactured according to ASTM F2026-02 &ASTM F136-02a. The implant device is nonsterile and is a single use component.
Performance Data:
Mechanical testing according to ASTM F1717-04 including Static and Dynamic Compression, Shear, Torsion and also Screw Pushout to ASTM F543. Testing was presented to demonstrate the substantial equivalency of the DYNA-LINK Elite Stand-Alone Anterior Lumbar System.
Conclusion:
The information presented demonstrates the substantial equivalency of the DYNA-LINK Elite Stand-Alone Anterior Lumbar System.