(86 days)
No
The 510(k) summary describes a mechanical interbody fusion device and its materials, dimensions, and mechanical testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is used for intervertebral body fusion of the spine in patients with Degenerative Disc Disease (DDD), which is a medical condition causing back pain, indicating a therapeutic purpose.
No
Explanation: The device is an interbody fusion system designed for spinal fusion, not for diagnosing medical conditions. It is a therapeutic device used for treatment.
No
The device description explicitly states the device is made of Ti-6Al-4V ELI and is an implant offered in various physical dimensions. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intervertebral body fusion of the spine" and is a physical implant used in surgery. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details a physical implant made of Ti-6Al-4V ELI, designed to be surgically placed in the spine. This is consistent with a medical device used for treatment, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body to provide information about a disease or condition.
- Focus on Mechanical Performance: The performance studies described focus on mechanical properties like compression, shear, subsidence, and expulsion, which are relevant to the structural integrity and function of a surgical implant.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. The Tranquil-L Interbody System does not fit this description.
N/A
Intended Use / Indications for Use
The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.
The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Disease (DDD). 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 I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used supplemental fixation systems.
Product codes
MAX
Device Description
The Tranquil-L Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The purpose of this traditional 510(k) is to gain clearance for additional implant footprints for the ALIF surgical approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, 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)
Using principles of mechanical engineering it was determined that the ALIF embodiment does not introduce a new worst case in compression, compression shear, or subsidence; for these test modes, results of mechanical testing on the system's worst case TLIF and PLIF constructs was presented and cleared under K170297, and those instances constitute worse case scenarios relative to all ALIF constructs. However, a new worstcase was identified for expulsion. Therefore, expulsion testing was performed on the worst case ALIF construct and compared to a legally marketed predicate. Results of this testing demonstrate substantial equivalence regarding resistance to expulsion loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K170297, K170676, K122639, K092017
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.
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2018
Nexus Spine, LLC Mr. Jared Crocker Director of Quality and Regulatory Affairs 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, Utah 84121
Re: K181702
Trade/Device Name: Tranquil-L Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 27, 2018 Received: July 31, 2018
Dear Mr. Crocker:
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) K181702
Device Name Tranquil-L Interbody System
Indications for Use (Describe)
The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.
The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in sketally mature patients with Degenerative Disc Disease (DDD). 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 I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used supplemental fixation systems.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K181702
| Submitter: | Nexus Spine LLC |
|---|---|
| Contact Person: | Mr. Jared Crocker, Director of Quality and Regulatory Affairs |
| 2825 East Cottonwood Parkway Suite 330 | |
| Salt Lake City, UT 84121 | |
| Telephone: (801) 702-8592 | |
| Fax: (801) 702-8585 | |
| Date Prepared: | September 20, 2018 |
| Trade Name: | Tranquil-L Interbody System |
| Classification, Name | |
| and Number: | Class II |
| Intervertebral body fusion device | |
| 21 CFR 888.3080 | |
| Product Code: | MAX |
Predicate Device(s):
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Primary Predicate | ||
| Nexus Spine LLC | Tranquil-L Interbody System | K170297 |
| Additional Predicates | ||
| HD LifeSciences LLC | HD Lumbar Interbody System | K170676 |
| DePuy Synthes Spine | Synthes SynCage Evolution Spacer | K122639 |
| Captiva Spine LLC | Pivotec Lumbar Interbody System | K092017 |
Device Description:
The Tranquil-L Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The purpose of this traditional 510(k) is to gain clearance for additional implant footprints for the ALIF surgical approach.
510k Summary K181702 1 of 2
4