(64 days)
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.
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.
This is a 510(k) premarket notification for a medical device, the InFill® Interbody Fusion Devices. The primary goal of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This type of submission does not typically involve clinical trials or studies to establish novel performance criteria or the effectiveness of a new technology. Instead, it relies on demonstrating that the new device is as safe and effective as a previously cleared device.
Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth for a new clinical study proving the device meets acceptance criteria is largely not applicable in the context of this 510(k) submission.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device (InFill® Interbody Fusion Device, K133721). The device performance is primarily assessed through a Finite Element Analysis (FEA), not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
| Acceptance Criteria (Demonstration of Substantial Equivalence to K133721) | Reported Device Performance (Summary from FEA) |
|---|---|
| Similar Indication/Intended Use | The Indication/Intended Use of the modified device is the same as the predicate device. For intervertebral body fusion of the spine in skeletally mature patients, used with autogenous bone graft to facilitate fusion. Intended for one or two contiguous levels in the lumbar spine (L2-S1) for treatment of DDD with up to Grade I spondylolisthesis, after at least six months of non-operative treatment, and used with supplemental internal spinal fixation systems. Compatible with anterior, lateral, and transforaminal approaches. |
| Similar Fundamental Scientific Technology | The fundamental scientific technology of the modified device has not changed and is the same as the predicate device. |
| Similar Physical and Technical Characteristics | The modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device, with the addition of a 26mm length to the product family for 42-TLIF and 43-TLIF models. (Detailed comparison in Section 6. Technical Characteristics table). |
| No New Safety or Performance Questions Raised | The FEA identified the worst-case construct and characterized it. The results demonstrated that no new mechanical testing is required. The analysis concluded that the new device sizes are substantially equivalent to the predicate device and did not raise new safety or performance questions. |
2. Sample size uses for the test set and data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical performance test. The "test set" here would refer to the designs analyzed in the FEA.
- Data Provenance: The analysis was a Finite Element Analysis (FEA), a computational simulation. It is not based on patient data from a specific country or retrospective/prospective collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in a clinical sense, is not established for an FEA. Instead, the FEA relies on engineering principles, material properties, and design specifications.
4. Adjudication method for the test set:
- Not applicable. This concept applies to human reader studies or clinical trials, not FEA.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device. MRMC studies are not performed for interbody fusion devices in a 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device. The "standalone performance" was the FEA, demonstrating mechanical equivalence.
7. The type of ground truth used:
- For the FEA, the "ground truth" would be the fundamental laws of physics and material science, along with validated computational models and established engineering criteria for spinal implants. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in this context. The FEA aims to prove mechanical equivalence.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device using FEA.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine Consultant 1601 Elm Street, Suite 300 Dallas, Texas 75201
Re: K150206
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: March 10, 2015 Received: March 12, 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
April 3, 2015
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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 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 | |
| 510(k) Number (if known) | Form Approved: OMB No. 0910-0120 |
| K150206 | Expiration Date: January 31, 2017See PRA Statement below. |
| 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® interbodyfusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for thetreatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are tobe used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device isintended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbarspine. These implants may be implanted via a variety of open or minimally invasive approaches. These approachesinclude 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) |
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| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301)-443-6740 | EP | |
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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 9, 2015 |
| CONTACT PERSON: | Rebecca K Pine1601 Elm Street, Suite 300Dallas, TX 75201Phone: 760.809.5178Fax: 760.290.3216 |
| TRADE NAME: | InFill® Interbody Fusion Devices |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATIONNAME: | Intervertebral Body Fusion Device |
| DEVICECLASSIFICATION: | Class 2, per 21 CFR 888.3080 |
| PRODUCT CODE | MAX |
PREDICATE DEVICES: (primary) InFill® Interbody Fusion Device (K133721)
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.
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® 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
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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. 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.
| TechnicalCharacteristics | InFill® interbodyfusion devices,(41-TLIF convex,42-TLIF lordoticoblique; 43-TLIFContour) | InFill® interbodyfusion device (41-TLIF convex, 42-TLIF lordoticoblique; 43-TLIFContour)(K133721) |
|---|---|---|
| Shape | Box-shaped, bulletnoseBanana-shaped,bullet nosed | SAME |
| Bone to implantsurface | Surface teeth | SAME |
| Bone graftsupport feature | Centralfenestration | SAME |
| Primary implantmaterial | PEEK OPTIMALT1 ® | SAME |
| SurgicalApproach | Transforaminal | SAME |
| Lengths | 42-TLIF26mm28mm30mm43-TLIF26mm28mm30mm32mm34mm | 42-TLIF30mm43-TLIF28mm30mm32mm34mm |
| Heights | 41-TLIF8-16mm42-TLIF8-16mm | 41-TLIF8-12mm14mm16mm42-TLIF8-10mm12mm14mm16mm |
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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.
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 InFill® interbody fusion device (K133721).
§ 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.