(121 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
This device is a surgical implant intended for temporary stabilization during spinal fusion, not a therapeutic device designed to treat or cure a disease or condition through non-invasive means.
No
Explanation: The device is an Anterior Cervical Plate (ACP) System which is a surgical implant intended for temporary stabilization during spinal fusion. Its function is mechanical stabilization and not to provide diagnostic information.
No
The device description explicitly states it is composed of plates and screws made of titanium, which are physical hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 Cure™ Anterior Cervical Plate (ACP) System is a surgical implant made of titanium, designed for fixation in the cervical spine.
- Intended Use: The intended use is for temporary stabilization of the anterior spine during spinal fusion. This is a surgical procedure performed directly on the patient's body, not on specimens outside the body.
The information provided clearly describes a surgical implant used in vivo (within the living body), not a device used in vitro (in glass or outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Cure™ Anterior Cervical Plate (ACP) System 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), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
Product codes
KWQ
Device Description
Cure™ Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
Cure™ Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Non-clinical Testing:
Testing according to ASTM F1717 and ASTM F543 was performed on the Cure™ Anterior Cervical Plate (ACP) System to establish equivalency to the predicate device. The tests included static compression bending, static tension, static torsion, dynamic compression bending, screw insertion torque, screw pullout and screw torque to failure.
Cure™ Anterior Cervical Plate (ACP) System is equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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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 stylized image of a human face in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The faces are positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2016
Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree Street, North East Suite 440 Atlanta, Georgia 30309
Re: K160604
Trade/Device Name: Cure™ Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 16, 2016 Received: May 31, 2016
Dear Mr. Dunaway:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K160604
Device Name
Cure™ Anterior Cervical Plate (ACP) System
Indications for Use (Describe)
Cure™ Anterior Cervical Plate (ACP) System 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), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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meditech si
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
510(k) Summarv
As required by section 807.92(c)
Meditech Spine, LLC is requesting marketing clearance for the Cure™ Anterior Cervical Plate (ACP) System
| A. Sponsor/Manufacturer: | Meditech Spine, LLC
Registration Number: 3009405289
Bruce Dunaway, Chief Design Engineer
1447 Peachtree St NE Suite 440
Atlanta, GA 30309
678-974-5287 Phone
404-759-2104 Fax |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Trade Name:
Common Name:
Classification Name: | Cure™ Anterior Cervical Plate (ACP) System
Spinal Implant
Spinal intervertebral body fixation orthosis (21 CFR 888.3060
Class II,Product Code KWQ) |
| C. Predicate Device: | K072650 (IST Anterior Cervical Plate) (Primary)
K926453 (Synthes CSLP) (Additional) |
D. Device Description:
Cure™ Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
Cure™ Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
E. Intended Use:
Cure™ Anterior Cervical Plate (ACP) System 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), Deformity (defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
4
meditech spine, IIc
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
-
F. Technological Characteristics:
The technological characteristics of the Cure™ Anterior Cervical Plate (ACP) System is equivalent to the predicate device, except for the central locking mechanism. The central locking mechanism is provided to ensure that the bone screws remain in place. -
G. Non-clinical Testing:
Testing according to ASTM F1717 and ASTM F543 was performed on the Cure™ Anterior Cervical Plate (ACP) System to establish equivalency to the predicate device. The tests included static compression bending, static tension, static torsion, dynamic compression bending, screw insertion torque, screw pullout and screw torque to failure.
Cure™ Anterior Cervical Plate (ACP) System is equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
- H. Conclusion:
The testing completed as well as a comparison of the technological characteristics has demonstrated that the Cure™ Anterior Cervical Plate (ACP) System is substantially equivalent to the predicate device.