(231 days)
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No
The summary describes a physical intervertebral body fusion device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an intervertebral body fusion device intended for spinal fusion procedures to treat degenerative disc disease, which is a medical condition.
No
Explanation: This device is an intervertebral body fusion device intended for spinal fusion procedures. It is a therapeutic device used in surgery, not a diagnostic tool. The document describes its intended use for treating degenerative disc disease, its materials, and mechanical testing, all of which confirm its therapeutic, not diagnostic, function.
No
The device description explicitly states it is an intervertebral body fusion device made of PEEK and metal components, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an intervertebral body fusion device made of PEEK and metal alloys, designed to be implanted in the spine. This is a medical device for treatment, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the PATHWAY AVID intervertebral body fusion device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PATHWAY AVID intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have Grade I Spondylolisthesis at involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s).
The device is intended to be used with supplemental fixation systems that have been cleared for the lumbosacral spine (i.e. posterior pedicle screws and rod systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted from a transforaminal approach (TLIF).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The proposed modification subject device is to be provided to the users in one of two configurations: the predicate device containing PEEK Optima LT1with titanium hinges and linkages (Ti-6Al-4V, ASTM F136) or the proposed PEEK Optima LT1 with MP35N (Co-Cr-Ni-Mo Alloy, ASTM F562). This product is manufactured from PEEK (Polyetheretherketone) as per ASTM F2026 and contains either titanium (Ti-6Al-4V, ASTM F136) marker and linkages or MP35N (Co-Cr-Ni-Mo, ASTM F562) markers and linkages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbosacral spine (L2-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)
Tensile testing of the linkages was conducted comparing the predicate AVID Interbody Fusion Device (K090566) and the proposed modification. This mechanical data indicates that the linkage and hinge pins with the proposed modification show equivalence to the titanium linkages and hinge pins of the predicate. Previous mechanical testing conducted on the predicate (K090566) demonstrated that the failure modes were in the PEEK spacer, and not the linkage or hinge pins.
Corrosion testing was performed on the linkage system and the hinge pins in accordance with ASTM F 2129-08 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices". The data demonstrates that these devices display acceptable corrosion resistance in the ASTM F 2129 test.
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.
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FEB - 6 2012
Section VII. 510(K) SUMMARY
Date Prepared
February 3, 2012
Name of Firm
Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707
Official Correspondent
David Brumfield Senior VP of Research and Development, Quality, and Regulatory 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 265-5043 Fax: (973) 808-0707 E-mail: dbrumfield@customspine.com
Establishment Number
3005129649
Device Name
Legally Marketed Trade Name: PATHWAY AVID Common Name: Intervertebral Body Fusion Device Device Classification: Class II Regulation Number: 21 CFR 888.3080 Device Product Codes: MAX
Predicate Devices PATHWAY AVID K090566
Description of Modified Device
The proposed modification subject device is to be provided to the users in one of two configurations: the predicate device containing PEEK Optima LT1with titanium hinges
1
and linkages (Ti-6Al-4V, ASTM F136) or the proposed PEEK Optima LT1 with MP35N (Co-Cr-Ni-Mo Alloy, ASTM F562).
Indications for Use
The PATHWAY AVID intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have Grade I Spondylolisthesis at involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s).
The device is intended to be used with supplemental fixation systems that have been cleared for the lumbosacral spine (i.e. posterior pedicle screws and rod systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted from a transforaminal approach (TLIF).
Materials
This product is manufactured from PEEK (Polyetheretherketone) as per ASTM F2026 and contains either titanium (Ti-6Al-4V, ASTM F136) marker and linkages or MP35N (Co-Cr-Ni-Mo, ASTM F562) markers and linkages.
Performance Data
Tensile testing of the linkages was conducted comparing the predicate AVID Interbody Fusion Device (K090566) and the proposed modification. This mechanical data indicates that the linkage and hinge pins with the proposed modification show equivalence to the titanium linkages and hinge pins of the predicate. Previous mechanical testing conducted on the predicate (K090566) demonstrated that the failure modes were in the PEEK spacer, and not the linkage or hinge pins.
Corrosion testing was performed on the linkage system and the hinge pins in accordance with ASTM F 2129-08 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices". The data demonstrates that these devices display acceptable corrosion resistance in the ASTM F 2129 test. See complete test report in Section 2 of the Response to FDA Deficiency letter of 07 October 2011.
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Substantial Equivalence Statement
Custom Spine believes that the proposed addition to the PATHWAY AVID family has the same indications for use, same technological characteristics, same design, and the same interbody material (PEEK) structure.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 6 2012
Custom Spine, Inc. % Mr. David Brumfield Senior Vice President of Research and Development, Quality and Regulatory 1140 Parsippany Boulevard, Suite 201 Parsippany, New Jersey 07054
Re: K111726
Trade/Device Name: PATHWAY AVID Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 27, 2012 Received: February 01, 2012
Dear Mr. Brumfield:
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 fround 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.
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Page 2 - Mr. David Brumfield
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 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, Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section VII. Indications for Use
510(k) Number (if known): LL | | |22 Device Name: PATHWAY AVID
The PATHWAY AVID Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s).
The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign . . ) Division of Surgical, Orthopedic, and Restorative Devices
K111726 510(k) Number_________________________________________________________________________________________________________________________________________________________________