(71 days)
Not Found
No
The document describes a physical implantable device and its mechanical properties, with no mention of software, algorithms, or AI/ML technologies.
No
The device is an interbody fusion device, which is an implant used to facilitate spinal fusion, not a therapeutic device in the sense of delivering therapy or treatment.
No
This device is an interbody fusion device, indicated for treating degenerative disc disease by facilitating spinal fusion. It is an implantable device used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a radiolucent implantable device manufactured from PEEK and tantalum, which are hardware components.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a physical implantable device (an interbody fusion device) used in spinal surgery. Its purpose is to facilitate the fusion of vertebrae, not to analyze biological samples for diagnostic purposes.
The information provided clearly indicates a surgical implant, not a diagnostic test.
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® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® 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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.
July 14, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pinnacle Spine Group, LLC % Rebecca Pine Consultant 1601 Elm Street, Suite 300 Dallas, Texas 75201
Re: K151184
Trade/Device Name: Infill® Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 18, 2015 Received: May 19, 2015
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Rebecca 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 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K151184 |
| 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 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. | |
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
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
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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information unless it displays a currently valid OMB number."
3
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: | July 8, 2015 |
| CONTACT PERSON: | Rebecca K Pine |
| 1601 Elm Street, Suite 300 | |
| Dallas, TX 75201 | |
| Phone: 760.809.5178 | |
| Fax: 760.290.3216 | |
| TRADE NAME: | InFill® Interbody Fusion Devices |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION NAME: | Intervertebral Body Fusion Device |
| DEVICE CLASSIFICATION: | Class II, per 21 CFR 888.3080 |
| PRODUCT CODE | MAX |
| PREDICATE DEVICES: | (primary) InFill® Interbody Fusion Device (K133721) |
| ALIF STS Interbody Fusion Device (K112316) | |
| Interform Interbody Cage System (K131082) |
Substantially Equivalent To:
The modified InFill® Interbody Fusion Device is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill® Interbody Fusion Device cleared under premarket notification K133721 and the ALIF ST Interbody Fusion Device (K112316) and Interform Interbody Cage System (K131082).
Description of the Device Subject to Premarket Notification:
The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient.
The InFill® interbody fusion device is provided sterile, for single use 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
4
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 modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device. An additional length (26mm) has been added to the product family.
| Technical
Characteristics | InFill® interbody
fusion devices,
(60-ALIF) | InFill® interbody
fusion device (60-
ALIF)
(K133721) | ALIF STS
Interbody Fusion
Device
(K112316) | Interform
Interbody Cage
System
(K131082) |
|-------------------------------|---------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------|
| Shape | Oval-shaped, bullet
nose | Oval-shaped, bullet
nose | Oval-shaped | Oval-shaped, bullet
nose |
| Bone to implant
surface | Surface teeth | Surface teeth | Surface roughness | Surface teeth |
| Bone graft
support feature | SAME | Central
fenestration | Central
fenestration | Central
fenestration |
| Primary implant
material | PEEK OPTIMA
LT1 ® | PEEK OPTIMA
LT1 ® | Titanium | PEEK |
| Surgical
Approach | SAME | Anterior | Anterior | ALIF |
| Lengths (mm) | 25, 26, 28 | 25, 28 | "small"
"medium"
"large" | 24, 28, 30 |
| Widths (mm) | 32, 36, 39 | 36, 39 | "small"
"medium"
"large" | 30, 36, 39 |
| Heights (mm) | 8-18 | 10-18 | 8-17 | 10-20 |
Performance Data:
An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions.
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Basis for Determination of Substantial Equivalence:
The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill® interbody fusion device is found to have a safety and effectiveness profile that is similar to the predicate device and is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the predicate devices.