(79 days)
The Cyclone™ Anterior Cervical Plate System is a unilateral fixation device intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures). tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
The Cyclone™ Anterior Cervical Plate System is a unilateral fixation device consisting of cervical plates (locking mechanism is pre-assembled to plates) and unicortical screws made from titanium alloy in conformance with ASTM F136. The plates are offered in one-level, two-level, three-level, and four-level fusion configurations (14mm-88mm). There are four different lengths of the standard 4mm diameter screw (12, 14, and 18mm). The rescue screw has a diameter of 4.4mm and lengths are 12, 14 and 16mm.
The provided text is a 510(k) summary for the "Cyclone™ Anterior Cervical Plate System" and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, or AI/software analysis.
Therefore, I cannot populate the table or answer the questions you've posed as the necessary information is not present in the given document. The document describes a traditional medical device (a spinal plate and screws) and its regulatory clearance, not a software or AI-driven diagnostic device that would typically involve the kind of performance studies and ground truth establishment you're asking about.
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510(k) Summary of Safety and Effectiveness
| (1) | Submitter's name: | Encore Medical, L.P. |
|---|---|---|
| Submitter's address: | 9800 Metric Blvd, Austin, TX 78758 | |
| Submitter's telephone number: | (512) 834-6237 | |
| Contact person: | Debbie De Los Santos | |
| Date summary prepared: | February 9, 2004 | |
| (2) | Trade or proprietary device name: | Cyclone™ Anterior Cervical PlateSystem |
| Common or usual name: | Anterior Cervical Plate | |
| Classification name: | 888.3060 - Spinal Intervertebral BodyFixation Orthosis | |
| (3) | Predicate devices: | Cyclone™ Anterior Cervical Plate System |
- (4) Subject device description:
The Cyclone™ Anterior Cervical Plate System is a unilateral fixation device consisting of cervical plates (locking mechanism is pre-assembled to plates) and unicortical screws made from titanium alloy in conformance with ASTM F136. The plates are offered in one-level, two-level, three-level, and four-level fusion configurations (14mm-88mm). There are four different lengths of the standard 4mm diameter screw (12, 14, and 18mm). The rescue screw has a diameter of 4.4mm and lengths are 12, 14 and 16mm.
(5) Subject device intended use:
The Cyclone™ Anterior Cervical Plate System is a unilateral fixation device intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures). tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
(6) Basis for Substantial Equivalence:
The Cyclone [M Anterior Cervical Plate System is similar in design, indications and materials to Cyclone™ Anterior Cervical Plate System (K031214).
MAY - 6 2004
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 three bars across its body, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2004
Ms. Debbie De Los Santos Supervisor, Regulatory/Clinical Services 9800 Metric Boulevard Austin, TX 78758
Re: K040397
Trade/Device Name: Cyclone™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 12, 2004 Received: February 17, 2004
Dear Ms. De Los Santos:
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 such 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); 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.
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Page 2 - Ms. Debbie De Los Santos
This letter will 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 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 Office of Compliance at (301) 594- 4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Milkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): __Ko 40 3 9 7
Device Name: Cyclone™ Anterior Cervical Plate Line Extension
Indications For Use:
Cyclone™ Anterior Cervical Plate Indications For Use
The Cyclone™ Anterior Cervical Plate is a unilateral fixation device intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)_
Mark N. Milkersen
Division of General, Restorative, and Neurological Devices
510(k) Number.
N/A