(92 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "intervertebral body fusion device" and a "vertebral body replacement" intended for spinal fusion procedures and to replace resected vertebral bodies, which are therapeutic interventions.
No
Explanation: The provided text describes the Custom Spine PATHWAY ACIF as an intervertebral body fusion device and vertebral body replacement, and it explicitly states its intended use for spinal fusion procedures. It is a physical implant designed to provide mechanical support, not to diagnose medical conditions or analyze data to inform a diagnosis. While radiographic studies are mentioned for confirming degenerative disc disease, the device itself does not perform diagnostics; it treats the condition.
No
The device description clearly describes a physical implant made of Polyetheretherketone (PEEK) intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Custom Spine PATHWAY ACIF is an implantable medical device designed to be surgically placed inside the body to provide structural support and facilitate spinal fusion. It is a physical implant, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion or vertebral body replacement, not a diagnostic test.
- Device Description: The description details the physical characteristics of the implant (material, shape, size, features), not components for analyzing biological samples.
Therefore, based on the provided information, the Custom Spine PATHWAY ACIF is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PATHWAY ACIF, when used as an intervertebral body fusion device, is intended is for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the PATHWAY ACIF intervertebral body fusion device.
When used as a vertebral body replacement, the PATHWAY ACIF is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected and/or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft.
For all indications, the device is intended to be used with supplemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).
Product codes (comma separated list FDA assigned to the subject device)
MQP, ODP
Device Description
The PATHWAY ACIF is a cervical interbody fusion device made from Polyetheretherketone (PEEK). The device contains tantalum markers that serve as identification markers for the implant both intra-operatively and postoperatively.
The device is trapezoidal in nature and is provided in various heights ranging from 5 mm to 12 mm and a width of 15 mm, and 13 mm in length. This device has a central cavity which is to be packed with autograft. This device is provided in various degrees of lordosis (0 Degree and 7 Degree). The superior and inferior surfaces have serrated teeth to help resist implant migration/displacement.
The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
The product is provided clean and "non-sterile".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), Thoracic and/or thoracolumbar spine (T1-L5)
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)
The PATHWAY ACIF device was tested in accordance with ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Compression" and ASTM F2077-03 "Test Method For Intervertebral Body Fusion Devices". The data are located in Section 19 of this submission, "Bench Testing". The data demonstrate that the device is capable of performing in accordance with its intended use.
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.
LDR Spine MC+ (K043479), Zimmer Spine BAK/C Cervical Interbody Fusion Device (P980048), X-Spine Calix ™Spinal Implant (K083637)
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
510(K) SUMMARY
Name of Firm
Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707
DEC 2 2 2009
Official Correspondent
Saad Attiyah Suad Attiven
Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 265-5036 Fax: (973) 808-0707 E-mail: saad@customspine.com
Establishment Number
3005129649
Device Name
Legally Marketed Trade Name: PATHWAY ACIF Legally Marketed Trade Name: PATHWAT ACT
Common Name: Intervertebral fusion device with bone graft, cervical/Vertebral Body Replacement Device Classification: Class II Device Clussmeatier: 21 CFR 888.3060, 21 CFR 888.3080 Device Product Codes: MQP, ODP
Predicate Devices
r r eurcate De vices
LDR Spine MC+ (K043479), Zimmer Spine BAK/C Cervical Interbody Fusion Device (P980048), and X-Spine Calix ™Spinal Implant (K083637)
Device Description
DCVICC DODGE = p = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = The PATHWAY ACIF is a cervical interbody fusion active as identification markers for the (Polyetheretherketone). The device continues of the implant both intra-operatively and postoperatively.
The device is trapezoidal in nature and is provided in various heights ranging from 5 mm to 12 mm and a The device is trapezondan in hatale and is pro naiss a central cavity which is to be packed with width of 15 mm, and 13 mm in length This abouts of Indusis (0 Degree and 7 Degree and 7 Degree). The superior
autograft. This device is provided in various degrees of lordos autograft. This device is provided in the resist implant migration/displacement.
and inferior surfaces have serrated teeth to help resist implant migration/displacement.
1
The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
The product is provided clean and "non-sterile".
Indications for Use
The PATHWAY ACIF, when used as an intervertebral body fusion device, is intended is for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as procedures as and religion with degeneration of the disc confirmed by history and radiographic neel pain of also be and and and and and and open, anterior approach and packed states, or the use bone. Patients should receive 6 weeks of non-operative treatment with the PATHWAY ACIF intervertebral body fusion device.
When used as a vertebral body replacement, the PATHWAY ACIF is intended for use in the thoracic vincen atos aoumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected ana/of will be partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft.
For all indications, the device is intended to be used with supplemental fixation systems that have been , or an franciese in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).
Materials
The PATHWAY ACIF is made from PEEK OPTIMA LT-1 (Polyetheretherketone) and contains tantalum markers (ASTM F560).
Performance Data
The PATHWAY ACIF device was tested in accordance with ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Websited by Jan ASTM F2077-03 "Test Method For Intervertebral Body Fusion Devices". The data are located in Section 19 of this submission, "Bench Testing". The data demonstrate that the device is capable of performing in accordance with its intended use.
Substantial Equivalence Statement
The PATHWAY ACIF is equivalent to the previously cleared systems, as they utilize the same principle of operation, and has similar indications for use as the predicates, and materials.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
OEC 22 2009
Custom Spine, Inc. % Mr. Saad Attiyah Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Boulevard, Suite 201 Parsippany, New Jersey 07054
Re: K092904
Trade Name: Pathway ACIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: November 24, 2009 Received: November 27, 2009
Dear Mr. Attiyah:
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.
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
3
Page 2 - Mr. Saad Attiyah
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/ReportalProblem/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
lttp://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
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
KO92904 510(k) Number:
When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Custom Spine ACIF.
When used as a vertebral body replacement, the Custom Spine PATHWAY ACIF is intended for use in the thoracic and/or throcolumbar spine (TI-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft.
For all indications, the device is intended to be used with supplemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).
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)
Division Sign Off
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092204