(115 days)
Not Found
No
The summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an "intervertebral body fusion" device used for the "treatment of degenerative disc disease (DDD)", which are therapeutic applications.
No
The device is an interbody fusion device designed for treatment of degenerative disc disease, not for diagnosis. Its purpose is to facilitate spinal fusion, not to identify or characterize medical conditions.
No
The device description clearly states it is a radiolucent implantable device manufactured from PEEK and tantalum, indicating it is 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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The InFill® cervical interbody fusion device is an implantable surgical device used to facilitate fusion of vertebrae in the spine. It is physically placed within the patient's body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae, not analyzing biological samples.
The provided information describes a medical device used in surgery, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The InFill® cervical interbody fusion device is intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone grafi to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. The InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The InFill® Cervical Interbody Fusion device are radiolucent implantable devices manufactured from PEEK Optima LT1 and tantalum ASTM F560 (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient.
The InFill® Cervical Interbody Fusion device is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C2 to T1
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)
To establish substantial equivalence with predicate devices, testing was performed including static/dynamic axial compression, static/dynamic torsion, subsidence and expulsion. All performance test values met the established acceptance criteria.
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.
Calix- Cervical Spinal Implant System (K083637, K112036), Bengal Cervical System (K081917)
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
MAY 0 5 2014
510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Pinnacle Spine Group, LLC |
|---|---|
| DATE PREPARED: | May 1, 2014 |
| CONTACT PERSON: | Rebecca K Pine |
| 1601 Elm Street, Suite 1930 | |
| Dallas, TX 75201 | |
| Phone: 760.809.5178 | |
| Fax: 760.290.3216 | |
| TRADE NAME: | InFill® Cervical |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION | |
| NAME: | Intervertebral Body Fusion Device |
| DEVICE | |
| CLASSIFICATION: | Class II |
| REGULATION | |
| NUMBER | 888.3080 (product code: ODP) |
| PREDICATE DEVICES: | Calix- Cervical Spinal Implant System (K083637, K112036) |
| Bengal Cervical System (K081917) |
Substantially Equivalent To:
The InFill® Cervical Interbody Fusion device are substantially equivalent in intended use, principal of operation and technological characteristics to the Calix Cervical Spinal Implant System and the Bengal Cervical System.
Description of the Device Subject to Premarket Notification:
The InFill® Cervical Interbody Fusion device are radiolucent implantable devices manufactured from PEEK Optima LT1 and tantalum ASTM F560 (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient.
The InFill® Cervical Interbody Fusion device is provided sterile, for single use only.
Indication for Use:
InFill® cervical interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® cervical interbody fusion device is designed
ﺮ ﺍ
1
for use with autogenous bone graft to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2-T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.
Technical Characteristics:
The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF have similar physical and technical characteristics to the predicate devices, as illustrated in the table below.
| Technical
Characteristics | InFill® cervical
intervertebral
body fusion
devices | Calix Cervical
Spinal Implant
System (K083637,
K112036) | Bengal Cervical
System (K081917) |
|-------------------------------|--------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------|
| Shape | Box-shaped, bullet
nose | SAME | SAME |
| Bone to implant
surface | Surface teeth | SAME | SAME |
| Bone graft
support feature | Central
fenestration | SAME | SAME |
| Primary implant
material | PEEK OPTIMA
LT1 ® | SAME | Carbon
fiber
reinforced polymer
(PEEK) |
| Surgical
Approach | Anterior | Anterior | Anterior |
Performance Data:
To establish substantial equivalence with predicate devices, testing was performed including static/dynamic axial compression, static/dynamic torsion, subsidence and expulsion. All performance test values met the established acceptance criteria..
Basis for Determination of Substantial Equivalence:
Upon reviewing the performance data provided in this submission and comparing intended use, design, materials, principle of operation and overall technological characteristics, the InFill® Cervical Interbody Fusion devices are determined by Pinnacle Spine Group. LLC, to be substantially equivalent to existing legally marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administr 10903 New Hampshire Aven Document Control Center - WO6 Silver Spring, MD 20993-0002
May 5, 2014
Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine Consultant 1601 Elm Street. Suite 1930 Dallas, Texas 75201
Re: K140066
Trade/Device Name: InFill® Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class H Product Code: ODP Dated: April 3, 2014 Received: April 4, 2014
Dear Ms. Pinc:
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. Rebecca K. Pine
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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/McdicalDevices/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 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
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140066
Device Name
InFill® Cervical Interbody Fusion Device
Indications for Use (Describe)
The InFill® cervical interbody fusion device is intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone grafi to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. The InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.
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.
FOR FDA USE ONLY CALL . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
James P. Bertram -S 2014.05.05 15:28:35 -04'00
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