(116 days)
Not Found
No
The summary describes a physical interbody fusion device made of PEEK and tantalum, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for intervertebral body fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The device is an interbody fusion device, designed for implantation to facilitate spinal fusion, not for diagnosing medical conditions.
No
The device description explicitly states the device is manufactured from PEEK and tantalum, which are physical materials, indicating it is a hardware device.
Based on the provided information, 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 and Intended Use: The InFill® interbody fusion device is an implantable device made of PEEK and tantalum, intended for surgical implantation in the spine to facilitate fusion. It is a physical device used within the body, not a test performed on a sample outside the body.
The description clearly indicates a surgical implant used for structural support and fusion within the lumbar spine. This falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are radiolucent implantable devices manufactured from PEEK and tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are 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
lumbar spine, from 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)
All necessary performance testing, has been completed for the InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF devices including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion to assure substantial equivalence to the predicate devices.
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.
K103729, K121733, K124012, K080699, K131350
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
MAR 3 1 2014
6. 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: | March 22, 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® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the |
| InFill® 60-ALIF | |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION NAME: | Intervertebral Body Fusion Device |
| DEVICE CLASSIFICATION: | Class II |
| REGULATION NUMBER | 888.3080 (product code: MAX) |
| PREDICATE DEVICES: | InFill Interbody Fusion Device (K103729, K121733, K124012) |
| Novel TL Spinal Spacer System, (K080699) | |
| Calix-A Lumbar Spinal Implant System (K131350) |
Substantially Equivalent To:
The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF devices are substantially equivalent in intended use, principal of operation and technological characteristics to the InFill Interbody Fusion Device, Novel Spinal Spacer System and the Calix-A Lumbar Spinal Implant System.
Description of the Device Subject to Premarket Notification:
The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are radiolucent implantable devices manufactured from PEEK and tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient.
. The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are provided sterile, for single use
1
only.
Indication for Use:
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
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 | In Fill®
intervertebral
body fusion
devices, (41-
TLIF Convex
Oblique, 43-
/44-TLIF
Contour
Oblique, 60-
ALIF) | In Fill®
intervertebral
body fusion
device
(K103729,
K121733,
K124012) | Novel TL
Spinal Spacer
System,
(K080699) | Calix-A
Lumbar
Spinal
Implant
System
(K131350) | Biomet
Enclave
(K081636) |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------|--------------------------------|
| Shape | Box-shaped,
bullet nose
Oval shape,
bullet nose
Banana-shaped,
bullet nosed | Box-shaped,
bullet nose | Banana-shaped,
bullet nosed | Oval shape,
bullet nose | Oval
shape,
bullet nose |
| Bone to implant
surface | Surface teeth | SAME | SAME | SAME | SAME |
| Bone graft
support feature | Central
fenestration | SAME | SAME | SAME | SAME |
| Primary
implant
material | PEEK OPTIMA
® | SAME | SAME | SAME | SAME |
| Surgical
Approach | Transforaminal
Anterior | Lateral
Transforaminal | Transforaminal | Anterior | Anterior |
Pinnacle Spine Group, LLC InFill® Product Family
2
Performance Data:
All necessary performance testing, has been completed for the InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF devices including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion to assure substantial equivalence to the predicate devices.
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® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF devices are determined by Pinnacle Spine Group, LLC, to be substantially equivalent to existing legally marketed devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2014
Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine Consultant 1601 Elm Street, Suite 1930 Dallas, Texas 75201
Re: K133721
Trade/Device Name: Infill® Interbody Fusion Devices (Infill® 41-TLIF Convex Oblique, Infill® 43-TLIF Contour Oblique, Infill® 44-TLIF Contour Oblique, and the Infill® 60-ALIF)
Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 9, 2014 Received: January 10, 2014
Dear Ms. Pine:
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
4
Page 2 - Ms. Rebecca K. Pine
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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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
5
Indications for Use
510(k) Number (if known) K133721
Device Name InFill® Interbody Fusion Devices
Indications for Use (Describe)
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbardevices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
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.
球的方法: 大利亚 FOR FDA USE ONLY ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
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."