(70 days)
No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with various spinal conditions, which is a therapeutic purpose.
No
Explanation: The device is an implantable plate intended for stabilization during spinal fusion, not for diagnosing medical conditions. Its function is to provide physical support, not to identify diseases or conditions.
No
The device description explicitly states the device is a titanium alloy plate, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The IST Anterior Cervical Plate is a physical implant made of titanium alloy, designed for surgical fixation of the cervical spine. It is used within the body, not to test samples from the body.
- Intended Use: The intended use clearly describes a surgical procedure for stabilizing the spine, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the IST Anterior Cervical Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Spondvlolisthesis .
- Trauma (i.e., fractures or dislocations) .
- Tumors .
- Deformity (defined as kyphosis, lordosis, or scollosis) .
- Pseudoarthrosis .
- Failed previous fusions .
Product codes
KWQ
Device Description
The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to C7 levels of the cervical spine
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 mechanical test results based on ASTM F1717 demonstrate that the IST ACP System can be expected to perform in a manner substantially equivalent to the predicate devices for purposes of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041469, K926453, K945700, K030866
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Attachment 2: 510(k) Summary
| DATE: | November 21, 2007 |
|---|---|
| SUBMITTER: | Innovative Spinal Technologies, Inc. |
| 111 Forbes Boulevard | |
| Mansfield, MA 02048 | |
| Telephone: 508/452-3500 | |
| Fax: 508/452-3600 | |
| CONTACT PERSON: | Gina Yeh |
| Manager, Regulatory Affairs | |
| TRADE NAME: | IST Anterior Cervical Plate System NOV 28 2007 |
| FDA CLASSIFICATION / CODE: | 888.3060 / KWQ |
DEVICE DESCRIPTION: The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
INTENDED USE: The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Spondvlolisthesis .
- Trauma (i.e., fractures or dislocations) .
- Tumors .
- Deformity (defined as kyphosis, lordosis, or scollosis) .
- Pseudoarthrosis .
- Failed previous fusions .
PREDICATE DEVICES: The predicate devices include: X-Spine Anterior Compact Plate (ACP) System (K041469) and Synthes CSLP System (K926453, K945700 and K030866)
PERFORMANCE DATA: The mechanical test results based on ASTM F1717 demonstrate that the IST ACP System can be expected to perform in a manner substantially equivalent to the predicate devices for purposes of safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized depiction of a human figure, with three faces overlapping to represent the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2007
Innovative Spinal Technologies % Ms. Gina Yeh Manager, Regulatory Affairs 111 Forbes Blvd. Mansfield, Massachusetts 02048
K072650 Re:
Trade/Device Name: IST Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 18, 2007 Received: September 19, 2007
Dear Ms. Yeh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use surver in the encreated) 70 the enactment date of the Medical Device Amendments, or to commerce pror to 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). who cosmette for (110) was 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can thay be subject to basil addess a cegulations, 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 r lease be actived that the reading 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); good manufacturing practice requirements as set Of A rat 0077) woods (21 (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. product in allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
2
Page 2 - Ms. Gia Yeh
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark H. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 3: Instructions for Use
Indication for Use Statement
510(k) Number: K072650 and the control of the control of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution
Device Name: IST Anterior Cervical Plate System
Indications:
The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Trauma (i.e., fractures or dislocations) .
- Tumors .
- Deformity (defined as kyphosis, lordosis, or scoliosis) .
- Pseudoarthrosis .
- Failed previous fusions .
Prescription Use _ _ X _______________________________________________________________________________________________________________________________________________________ e for a commission (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 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 of General, Restorative, and Neurological Devices
| 510(k) Number | K072650 |
|---|---|
| --------------- | --------- |