(294 days)
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
The Highgate Curved Rod System is available in titanium alloy (Ti6Al4V, ASTM F136) and includes rods and screws. Screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.
The provided text is a 510(k) summary for the Highgate Curved Rod System. It describes the device, its intended use, and states that substantial equivalence was demonstrated to a predicate device. It does not contain any information about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or performance outcomes beyond a general statement of substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from the given text.
The document states:
"Documentation was provided which demonstrated the Highgate Medial Curved Rods to be substantially equivalent to the previously cleared Highgate Lateral Curved Rods. The substantial equivalence is based upon equivalence in indications/intended use, manufacturing methods, interconnection mechanism, basic design, materials and testing."
This indicates that the device was cleared based on a comparison to a predicate device, rather than a de novo study with specific performance acceptance criteria and a detailed clinical or performance study report. The "testing" mentioned is likely referring to non-clinical bench testing to demonstrate similar mechanical properties or biocompatibility to the predicate, not a study assessing diagnostic or clinical performance against defined acceptance criteria in the way you have outlined.
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K023983 PAGE 1/1
SEP 2 2 2003
510(k) SUMMARY
| Sponsor: | Highgate OrthopaedicsOne Walnut StreetBoston, MA 02108 |
|---|---|
| Official ContactPerson: | Kevin Connors, President |
| Proprietary TradeName: | Highgate Curved Rod System |
| Device Description: | The Highgate Curved Rod System is available in titaniumalloy (Ti6Al4V, ASTM F136) and includes rods and screws.Screws are used to attach the rod to the thoracolumbar spine.Rods are offered in two curvatures and have circular openingsaccommodate the screws. |
| Intended Use: | The Highgate Curved Rod System is intended for unilateralscrew fixation of the anterolateral thoracolumbar spine fromT6 to L5 in skeletally mature patients. The Highgate CurvedRod System is intended to provide stabilization of a spinalsegment as an adjunct to spinal fusion. Indications for the useof this device include spondylolisthesis (Grades 1 and 2),spinal stenosis, pseudarthrosis, failed fusion or degenerativedisc disease (DDD) defined as back pain of discogenic originwith the degeneration of the disc confirmed by history andradiographic studies. The Highgate Curved Rod System is notintended for patients having severe spondylolisthesis (Grades3 and 4), deformities or curvatures, tumor or trauma i.e.vertebral fracture. |
| Materials: | The Highgate Curved Rod System components aremanufactured from titanium alloy (Ti6Al4V, ASTM F136). |
| SubstantialEquivalence: | Documentation was provided which demonstrated theHighgate Medial Curved Rods to be substantially equivalentto the previously cleared Highgate Lateral Curved Rods. Thesubstantial equivalence is based upon equivalence inindications/intended use, manufacturing methods,interconnection mechanism, basic design, materials andtesting. |
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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized eagle emblem with three parallel lines forming the wings and body. The eagle faces to the right.
Public Health Service
SEP 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Connors President Highgate Orthopaedics One Walnut Street Boston, Massachusetts 02108
K023983 Re:
Trade Name: Highgate Curved Rod System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 5, 2003 Received: September 8, 2003
Dear Mr. Connors:
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 vour 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 - Mr. Kevin Connors
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" (21CFR 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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Indications for Use Statement
510(k) Number (if known): K023983
Device Name: Highgate Curved Rod System
Indications for Use:
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from To Lo Lo in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
(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
Mark N Mathews
ivision of General Restorative I Neurological Devices
) Number ___ K023983
Confidential: Highgate Curved Rod System Modification
N/A