(30 days)
Not Found
No
The summary describes a physical implantable device made of PEEK and tantalum for spinal fusion. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven functionality. The performance studies focus on the physical properties and equivalence to a predicate device.
Yes
The device is indicated for intervertebral body fusion of the spine to treat degenerative disc disease, which involves mitigating a medical condition.
No
The device, InFill™, is an intervertebral body fusion device used for spinal fusion, not for diagnosing conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that InFill™ is a radiolucent implantable device made of PEEK and tantalum, indicating it is a physical hardware implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that InFill™ is a device for intervertebral body fusion of the spine. This is a surgical implant used within the body.
- Device Description: The description details a "radiolucent implantable device" made of PEEK and tantalum, designed to be placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
InFillTM is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ 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™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The InFill™ intervertebral body fusion device is a radiolucent implantable device The in in in - fine PEEK and tantalum (marker material). The implant is available in manatatored 110 11011 * 11011 * 11 11 11 11 11 11 11 11 11 11 11 11 11.
The InFill™ intervertebral body 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
Spine, 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)
I crior name been performed for the InFill™ intervertebral body fusion device to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.
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.)
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.
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
JUL 13 2012
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: | June 12, 2012 |
| CONTACT PERSON: | Rebecca K Pine |
| 1601 Elm Street, Suite 300 | |
| Dallas, TX 75201 | |
| Phone: 760.809.5178 | |
| Fax: 760.290.3216 | |
| TRADE NAME: | InFill™ Intervertebral Body Fusion Device |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION | |
| NAME: | Intervertebral Body Fusion Device |
| DEVICE | |
| CLASSIFICATION: | Class 2, per 21 CFR 888.3080 |
| PRODUCT CODE | MAX |
PREDICATE DEVICES: InFill™ Intervertebral Body Fusion Device (K103729)
Substantially Equivalent To:
The modified InFill™ Intervertebral Body Fusion Device is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill™ Intervertebral Body Fusion Device cleared under premarket notification K103729.
Description of the Device Subject to Premarket Notification:
The InFill™ intervertebral body fusion device is a radiolucent implantable device The in in in - fine PEEK and tantalum (marker material). The implant is available in manatatored 110 11011 * 11011 * 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
The InFill™ intervertebral body fusion device is provided sterile, for single use only.
Indication for Use:
InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. pations. Int in - is doigh 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 sprade I spondylolisthesis. DDD is defined as back pain of discogenic origin with Grade I sponsylonation 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
Pinnacle Spine Group Modified InFill™ Intervertebral Body Fusion Device
Page 10 of 56 Premarket Notification
Page 1 of 2
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treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Technical Characteristics:
The modified InEill™ intervertebral body fusion device has identical physical and technical characteristics to the predicate device.
Performance Data:
I crior name been performed for the InFill™ intervertebral body fusion device to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.
The modified InFill™ intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions.
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™ intervertebral body fusion device is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the InFill™ intervertebral body fusion device (K103729).
Pinnacle Spine Group Modified InFill™ Intervertebral Body Fusion Device
Page 11 of 56 Premarket Notification
page 2 of 2.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pinnacle Spine Group % Ms. Rebecca K. Pine 1601 Elm Street, Suite 300 Dallas. Texas 75201
JUL 13 2012
Re: K121733
Trade/Device Name: InFill™ Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 -Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: June 12, 2012 Received: June 13, 2012
Dear Ms. Pine:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your becaused on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreat 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 I ou may, therefore, mains 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 I loase of advisou that I Driver internetion that your device complies with other requirements of the Act that I Dri has mass a and regulations administered by other Federal agencies. You must of any I edelul stutures and regulaments, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Rebecca K. Pine
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _Kl21733
Device Name: InFill™ Intervertebral Body Fusion Device
Indications for Use:
InFillTM is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate patients. InFill™ is intended for use at either one level or two contiguous levels in tusion. InFill+++ is mended for use at of deserverative diseded on beek pain of the lumbar spine, from L2 to ST, for une readers as a grouped as back pain of (DDD) with up to Grade I spondylonomission of the disc confirmed by history and discogenic offgin with degeneration of the ense be used in patients who have had radiographic studies. The lunbal de vices in to to be used with the EDA for used at least six months of noti-operative treatment. This in the more of the FDA for use in the lumbar spine.
AND/OR
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 ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
signature
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Division Sign-Off) Diysion of Surgical, Orthopedici, and Restorative Devices
510(k) Number K121733