(21 days)
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vesses in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
The Cure™ Lumbar Plate 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™ Lumbar Plate 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.
The provided text describes a medical device, the Cure™ Lumbar Plate System, and its 510(k) premarket notification to the FDA. The information focuses on regulatory approval and equivalence to a predicate device, rather than the performance of a software or AI-driven diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/software device performance, is not present in the provided text.
The document states that the Cure™ Lumbar Plate System is substantially equivalent to a predicate device (K022791 Synthes Anterior Tension Band System) based on technological characteristics and non-clinical testing.
Here's a breakdown of the available information based on your request, highlighting what is not applicable or not found:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Mechanical function and properties | Equivalent to predicate device (Synthes Anterior Tension Band System) |
| Bacterial Endotoxin Limits | Passed testing according to ANSI/AAMI ST-72:2011 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as the document describes non-clinical mechanical and biological compatibility testing, not a clinical study on human subjects or an AI diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as there is no mention of a "test set" in the context of expert ground truth for a diagnostic device. The evaluation was based on engineering and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This describes a physical implantable device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable in the context of diagnostic accuracy. For the non-clinical testing, the "ground truth" would be established engineering standards (ASTM F1717) and biological standards (ANSI/AAMI ST-72:2011).
8. The sample size for the training set:
This information is not applicable as there is no AI component or training set described.
9. How the ground truth for the training set was established:
This information is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2017
Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, Georgia 30309
Re: K171538
Trade/Device Name: Cure™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 15, 2017 Received: Mav 26, 2017
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 Part 801); medical device reporting (reporting of medical device
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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 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" (21 CFR 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,
Vincent J. Devlin -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171538
Device Name Cure™ Lumbar Plate System
Indications for Use (Describe)
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vesses in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
| Type of Use (Select one or both, as applicable) |
|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) |
| [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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meditech spine, IIo
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
510(k) Summarv
June 14, 2017
As required by section 807.92(c)
Meditech Spine, LLC is requesting marketing clearance for the Cure™ Lumbar Plate 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: Cure™ Lumbar Plate System Common Name: Spinal Implant Classification Name: Spinal intervertebral body fixation orthosis (21 CFR 888.3060 Class II,Product Code KWQ)
- C. Predicate Device: K022791 (Synthes Anterior Tension Band System)
- D. Device Description:
The Cure™ Lumbar Plate 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™ Lumbar Plate 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:
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
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meditech spi
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
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F. Technological Characteristics:
The technological characteristics of the Cure™ Lumbar Plate System are equivalent to the predicate device with the exception of 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 was performed on the Cure™ Lumbar Plate System to establish equivalency to the predicate device. The tests included static compression bending, static torsion, and dynamic compression bending.
Cure™ Lumbar Plate System is equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
Bacterial Endotoxin Testing (BET) has been conducted in accordance with ANSI/AAMI ST-72:2011.
- H. Conclusion:
The testing completed as well as a comparison of the technological characteristics has demonstrated that the Cure™ Lumbar Plate System is substantially equivalent to the predicate device.
§ 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.