(147 days)
Not Found
No
The summary describes a physical interbody fusion device made of titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing standards.
Yes.
The device is designed for intervertebral body fusion of the spine, specifically for treating degenerative disc disease, which is a medical condition. Its intended use is to facilitate fusion and alleviate pain, meeting the definition of a therapeutic device.
No
The device is an interbody fusion system designed to facilitate spinal fusion in patients with degenerative disc disease. Its purpose is therapeutic (fusion), not diagnostic (identifying a medical condition).
No
The device description explicitly states the device is made of Ti-6Al-4V ELI and is an implant offered in various physical dimensions, indicating it is a physical medical 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.
- Tranquil™ Interbody System Function: The Tranquil™ Interbody System is a surgical implant designed to be placed within the body to facilitate spinal fusion. It is a structural device, not a device that analyzes biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test performed on a specimen.
- Device Description: The description focuses on the material (Ti-6Al-4V ELI), dimensions, and sterilization method, all of which are characteristic of a surgical implant.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with IVD devices.
Therefore, based on the provided information, the Tranquil™ Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tranquil™ 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™ Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The cervical device is to be implanted via an open, anterior approach and packed with autogenous bone. The cervical device is to be used in patients who have had six weeks of non-operative treatment. This device system is intended for use with supplemental internal fixation systems.
The Tranquil™ Lumbar Interbody System is intended for use at either one level or two contiguous levels (12-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 1 spondylolisthesis or retrolisthesis at the involved levels. The patients may have had a previous nonfusion spinal surgery at the involved level(s). The device is intended to be used with supplemental internal fixation systems.
Product codes
MAX, ODP
Device Description
The Tranquil 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 both cervical and lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (C3 to C7, 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)
Verification activities based on ASTM F2077, ASTM F2267 and expulsion testing were performed. The mechanical testing demonstrated the device can be expected to perform in a manner substantially equivalent to the predicates listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160547, K083425, K130699, K071724, K081968, K073351, K091088, K090707, 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nexus Spine, LLC Mr. Jared Crocker Director of Quality and Regulatory Affairs 2825 East Cottonwood Parkway. Suite 330 Salt Lake City, Utah 84121
June 27, 2017
Re: K170297
Trade/Device Name: Tranquil Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: May 24, 2017 Received: May 25, 2017
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. 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
1
related 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
2
Indications for Use
510(k) Number (if known) K170297
Device Name
Tranquil Interbody System
Indications for Use (Describe)
The Tranquil™ 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™ Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The cervical device is to be implanted via an open, anterior approach and packed with autogenous bone. The cervical device is to be used in patients who have had six weeks of non-operative treatment. This device system is intended for use with supplemental internal fixation systems.
The Tranquil™ Lumbar Interbody System is intended for use at either one level or two contiguous levels (12-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 1 spondylolisthesis or retrolisthesis at the involved levels. The patients may have had a previous nonfusion spinal surgery at the involved level(s). The device is intended to be used with supplemental internal fixation systems.
| 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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3
510(k) Summary
| 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: | June 26, 2017 |
| Trade Name: | Tranquil Interbody System |
| Classification, Name | |
| and Number: | Class II |
| Intervertebral body fusion device | |
| 21 CFR 888.3080 | |
| Product Code: | MAX, ODP |
Product Code:
Predicate Device(s):
| Manufacturer | Device | 510(k)/PMA Number |
|---|---|---|
| Primary Predicate | ||
| K2M | Cascadia Interbody System | K160547 |
| Other Predicates | ||
| Adaptive Specialty | Fusion Advantage Cervical Cage | |
| Fusion Advantage Lumbar Cage | K083425 | |
| K2M | Aleutian | K130699 |
| Spinal Elements | Lucent | K071724/ K081968 |
| Spinal Elements | Crystal Cervical Cage | K073351 |
| LDR Spine | Cervical Interbody Fusion System | K091088 |
| Meditech | Talos PLIF | K090707 |
| Captiva Spine | PivoTEC Lumbar Interbody Fusion | |
| Device (LFID) | K092017 |
Device Description:
The Tranquil 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 both cervical and lumbar spine. The devices and instruments
4
| | are provided clean and non-sterile for steam sterilization at the user's
facility. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The TranquilTM 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 TranquilTM Cervical Interbody System is intended for spinal fusion
procedures at one level in the cervical spine (C3 to C7) in skeletally mature
patients with degenerative disc disease (defined as neck pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic
studies) of the cervical spine. The cervical device is to be implanted via an
open, anterior approach and packed with autogenous bone. The cervical
device is to be used in patients who have had six weeks of non-operative
treatment. This device system is intended for use with supplemental interna
fixation systems. |
| | The TranquilTM Lumbar 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 1
spondylolisthesis or retrolisthesis at the involved levels. The patients may
have had a previous non-fusion spinal surgery at the involved level(s). The
device is intended to be used with supplemental internal fixation systems. |
| Statement of
Technological
Comparison: | The Tranquil Interbody System is manufactured using additive
manufacturing, but the predicate devices are machined of the same material.
This difference does not impact the substantial equivalence of the devices.
The Tranquil Interbody System is substantially equivalent to the above
listed predicate devices in terms of materials, design, indications for use and
operational principles. |
| Performance Data: | Verification activities based on ASTM F2077, ASTM F2267 and expulsion
testing were performed. The mechanical testing demonstrated the device
can be expected to perform in a manner substantially equivalent to the
predicates listed above. |
| Conclusion: | Documentation provided demonstrates the Tranquil Interbody System is
substantially equivalent to predicate devices. |