(187 days)
No
The summary describes a physical implant made of PEEK with a porous architecture and tantalum markers. There is no mention of software, algorithms, or any technology that would process data or learn. The performance studies focus on mechanical properties of the implant.
Yes.
The device is indicated for use in patients with degenerative disc disease to facilitate fusion in the lumbar spine, which directly addresses a medical condition and aims to improve patient health outcomes.
No
The device is an implantable intervertebral body fusion device used to facilitate fusion in the lumbar spine, not to diagnose a condition.
No
The device description clearly states the device is a sterile, single-use implant made of PEEK with tantalum markers, indicating it is a physical hardware device intended for surgical implantation.
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 Coalesce™ Lumbar Interbody Fusion System is a sterile, single-use implant made of PEEK, designed for surgical implantation in the lumbar spine.
- Intended Use: The intended use is to facilitate fusion in the lumbar spine in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
- Input Imaging Modality: The mention of x-ray is for visualizing the implanted device in vivo, not for diagnostic testing of a sample.
Therefore, the Coalesce™ Lumbar Interbody Fusion System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is indicated for use as an 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 with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The proposed devices within the Coalesce™ Lumbar Interbody Fusion System are sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the lumbar spinal column in lumbar intervertebral body fusion procedures.
Each device within the Coalesce™ System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under x-ray in vivo.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
lumbar spine (L2 to 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)
Functional performance testing, including static and dynamic compression and compression shear, subsidence, and expulsion, has been conducted per applicable standards as recommended through the FDA guidance document for Intervertebral Body Fusion Device. The standards are (ASTM) F2077-14. Test Methods for Intervertebral Body Fusion Devices, (ASTM) F2267-04, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression, and (ASTM) F1877-16, Standard Practice for Characterization of Particles. Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2017
Vertera, Inc. Mr. Wei Chang Project Leader 739 Trabert Avenue NW Suite F Atlanta, Georgia 30318
Re: K163506
Trade/Device Name: Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 23, 2017 Received: Mav 24, 2017
Dear Mr. Chang:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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) K163506
Device Name
Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System
Indications for Use (Describe)
The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is indicated for use as an 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 with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine.
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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Image /page/3/Picture/1 description: The image shows the logo for Vertera Spine. The logo consists of a green circle with a white "V" inside, followed by the word "Vertera" in a thin, sans-serif font, also in green. To the right of "Vertera" and rotated 90 degrees is the word "spine", also in a thin, sans-serif font and in green.
Traditional 510(k) Summary
Date Submitted: June 16, 2017
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(e).
- A. 510(k) Submitter: Vertera, Inc. Establishment Registration No. 3012232921 739 Trabert Ave. NW. Suite F Atlanta, Georgia 30318 Phone: (571) 758-3783 Fax: (678) 669-1975
- B. Company Contact: Wei (Allen) Chang Project Leader (571) 758-3783 allen.chang@verteraspine.com
C. Device Information: Trade Name(s):
Coalesce™ Lumbar Interbody Fusion System
- Coalesce™-Straight Interbody Fusion Device .
- Coalesce™-Convex Interbody Fusion Device .
- Coalesce™-Crescent Interbody Fusion Device
- Coalesce™-Lateral Interbody Fusion Device 0
- Coalesce™-Anterior Interbody Fusion Device ●
- Coalesce™-Oblique Interbody Fusion Device 0
Common Name: Lumbar Interbody Fusion Device
- Intervertebral Body Fusion Device, Lumbar D. Classification Name: MAX, 888.3080
- ட். Predicate Device(s): Eisertech, LLC, Interbody Cage, K140348, Primary
Vertera, Inc., Hedgehog, K143685, Reference Amendia, Zeus®, K151322, Reference Medtronic, Clydesdale®, K151128, Reference
ட் Physical Description:
The proposed devices within the Coalesce™ Lumbar Interbody Fusion System are sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the lumbar spinal column in lumbar intervertebral body fusion procedures.
4
Each device within the Coalesce™ System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under x-ray in vivo.
-
G. Indications for Use:
The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is indicated for use as an 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 with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine. -
H. Comparison of Technological Characteristics:
The Coalesce™ Lumbar Interbody Fusion System is substantially equivalent in function and intended use to the primary predicate device manufactured by Eisertech, LLC, Interbody Cage (K140348). -
l. Non-Clinical Testing:
Functional performance testing, including static and dynamic compression and compression shear, subsidence, and expulsion, has been conducted per applicable standards as recommended through the FDA guidance document for Intervertebral Body Fusion Device. The standards are (ASTM) F2077-14. Test Methods for Intervertebral Body Fusion Devices, (ASTM) F2267-04, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression, and (ASTM) F1877-16, Standard Practice for Characterization of Particles. Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices. -
J. Conclusion:
Based on comparison to predicate devices and non-clinical performance testing, Vertera, Inc.'s Coalesce™ Lumbar Interbody Fusion System has demonstrated to be substantially equivalent to FDA-cleared legally marketed predicate devices.
Wei (Allen) Chang Project Leader
Image /page/4/Picture/11 description: The image shows the logo for Vertera Spine. The logo consists of a green circle with a white "V" inside, followed by the word "Vertera" in a thin, green font. To the right of "Vertera" is the word "Spine" in a smaller, light gray font, oriented vertically.
739 Trabert Ave. NW. Suite F Atlanta. GA 30318 Phone: 571-758-3783