(90 days)
Not Found
No
The device description focuses on the material and mechanical design of an intervertebral body fusion device, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is surgically implanted to fuse vertebrae in patients with degenerative disc disease, which is a medical condition, thus treating a specific disease.
No
The device is an intervertebral body fusion device intended for spinal fusion procedures, meaning it is a therapeutic implant and not a device used to diagnose a medical condition. Its function is to provide structural support for fusion after diagnosis has already occurred.
No
The device description clearly states the device is made from PEEK and titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body to diagnose, monitor, or screen for diseases or conditions.
- Device Description and Intended Use: The provided information clearly describes a physical implantable device (an intervertebral body fusion device) intended to be surgically placed within the body to facilitate spinal fusion. It is a structural device used in a surgical procedure.
The description focuses on the device's material, construction, dimensions, and how it is used in a surgical context with other implants and bone graft. This is entirely different from the function of an IVD.
N/A
Intended Use / Indications for Use
The PATHWAY 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 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.
Product codes
MAX
Device Description
The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK Optima. The device is made from multiple PEEK segments. The segments are serrated on the superior and inferior surfaces. The PEEK segments are attached with titanium pins and have a titanium linkage that attaches the segments. This pins and the linkage provide the means to form into its final articulated shape.
The titanium alloy pins serve as markers providing visual aid in determining the location of the implant both intra and postoperatively.
The articulated device foot print ranges from 8 mm through 14 mm in height, 20mm in width and 35 mm in length.
The implants are non-sterile and instruments are provided clean and non-sterile. These devices are to be sterilized by the user facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, 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
Not Found
Summary of Performance Studies
Performance data per ASTM 2077 and ASTM 2267 and compared to the predicate devices. In addition, cadaver testing demonstrated the PATHWAY AVID is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program.
Key Metrics
Not Found
Predicate Device(s)
K071724, K990148, K001340, K030833, K070082
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section 22. 510(k) Summary
:
JUN - 1 2009
As Required By Section 807.92(c)
| Submitter: | Custom Spine
1140 Parsippany Blvd, Suite 201
Parsippany, NJ 07054 | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Saad Attiyah
Manager of Regulatory Affairs and Quality Assurance
Voice: (973) 265-5036
Fax: (973) 808-0707 | |
| Date Prepared: | May 15, 2009 | |
| Device Class: | II | |
| | Classification Names: Per 21 CFR § 888.3080, Intervertebral Body Fusion Device | |
| Classification Panel: | Orthopedics | |
| Product Code:
Proprietary Name: | MAX
PATHWAY AVID | |
| Predicate Devices: | Spinal Elements Lucent® (K071724)
Depuy Acromed™ Stackable Cage™ System
(K990148, K001340, K030833)
Vertebration XYcor™ (K070082) | |
| Device Description: | The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK
Optima. The device is made from multiple PEEK segments. The segments are
serrated on the superior and inferior surfaces. The PEEK segments are attached
with titanium pins and have a titanium linkage that attaches the segments. This
pins and the linkage provide the means to form into its final articulated shape. | |
| | The titanium alloy pins serve as markers providing visual aid in determining the
location of the implant both intra and postoperatively. | |
| | The articulated device foot print ranges from 8 mm through 14 mm in height,
20mm in width and 35 mm in length. | |
| | The implants are non-sterile and instruments are provided clean and non-sterile.
These devices are to be sterilized by the user facility. | |
| Intended Use: | The PATHWAY 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 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. | |
| Materials: | This product is manufactured from Polyetheretherketone (PEEK) as per ASTM F2026 and contains titanium (Ti-6Al-4V) as per ASTM F136, implant grade titanium. | |
| Performance Data: | Performance data per ASTM 2077 and ASTM 2267 and compared to the predicate devices. In addition, cadaver testing demonstrated the PATHWAY AVID is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program. | |
| Summary of
Technological
Characteristics | PATHWAY AVID has been evaluated in accordance with the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices", June 12, 2007 and demonstrates substantial equivalent performance to the identified predicate device systems. | |
.
1
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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 or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2009
Custom Spine, Inc. % Saad Attivah 1140 Parsippany Blvd., Suite 201 Parsippany, NJ 07054
Re: K090566
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: February 19, 2009 Received: March 3, 2009
Dear Mr. Attivah:
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, Or us 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 misburandi, nomd adulteration.
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 devise ( ran 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 liating (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.
3
Page 2 - Mr. Saad Attiyah
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrb/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clarence Buchholz
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 6. Indication For Use
The PATHWAY 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 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 an 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 × AND/OR
Over-The-Counter Use
(Part 21 C.F.R. 801 Subpart D)
(21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aun Her
ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Numb