(104 days)
The CONTOUR II™ Spinal System is intended for noncervical, pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, the CONTOUR II™ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
The CONTOUR II™ Spinal System (KWP) is also intended for use as a posterior noncervical, nonpedicle system indicated for degenerative disc disease which is defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies. spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.
When used as an anterior fixation system, the CONTOUR II™ Spinal System (KWO) is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor. pseudoarthosis, or revision of failed fusion attempts.
The CONTOUR II™ Spinal System is an anterior / posterior spinal fixation system consisting of pedicle screws, L and straight connecting rods as well as a variety of clamps and cross connectors. The CONTOUR II™ implant components are fabricated from Ti-6AI-4V ELI per ASTM F 136. Various sizes of these implants are available.
The provided document is a 510(k) summary for the CONTOUR II™ Spinal System, a medical device for spinal fixation. It details the device's indications for use, its classification, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML device.
The 510(k) process for a Class II medical device like the CONTOUR II™ Spinal System focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics and acceptance criteria from a study in the way an AI/ML device would. The "safety information" section on page 4 describes user qualifications rather than device performance.
Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies, training set details) is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three curved lines representing the eagle's body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2006
Mr. John Kapitan Director of Regulatory Affairs and Quality Altiva Corporation 9800-I Southern Pines Boulevard Charlotte, North Carolina 28273
Re: K053070 Trade Name: Contour II Spinal System Regulation Number: 21 CFR 888.3070 (b) (1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNH, MNI, KWQ, KWP Dated: December 1, 2005 Received: December 2, 2005
Dear Mr. Kapitan:
This letter corrects our substantially equivalent letter of February 13, 2006.
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 (OS) 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. John Kapitan
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Helmut Lachenmann
Mark N. Melkerson Acting 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
510(k) Number (if known): K053070
Device Name: CONTOUR II™ Spinal System
Indications for Use:
The CONTOUR II™ Spinal System is intended for noncervical, pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, the CONTOUR II™ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
The CONTOUR II™ Spinal System (KWP) is also intended for use as a posterior noncervical, nonpedicle system indicated for degenerative disc disease which is defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies. spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.
When used as an anterior fixation system, the CONTOUR II™ Spinal System (KWO) is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor. pseudoarthosis, or revision of failed fusion attempts.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Sign-Off
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(to) Number________________________________________________________________________________________________________________________________________________________________
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DATE PREPARED: 12/07/05 I.
II. SUBMITTER:
Altiva Corporation 9800 Southern Pines Blvd. Suite I Charlotte, NC 28273
CONTACT PERSON: III.
John Kapitan Director of Regulatory Affairs & Quality Assurance
TRADE/PROPRIETARY NAME: CONTOUR II™ Spinal System IV.
DEVICE CLASSIFICATION: V.
Orthosis, Spinal Pedicle Fixation, (MNI) per 21 CFR 888.3070 Pedicle Screw Spinal System, (MNH) per 21 CFR 888.3070 Spinal Intervertebral Body Fixation Orthosis, (KWQ) per 21 CFR 888.3060 Spinal Interlaminal Fixation Orthosis, (KWP) per 21 CFR 888.3050
VI. PREDICATE DEVICES:
Arcan Orthopedics, Contour Spinal Fixation System (K971457) Class II Decision Date: July 16, 1997 (and) U & I Corporation, Optima Spinal System (K031585) Class II Decision Date: June 27, 2003 (and) Ultium Spinal Plating System, Altiva Corporation (K962784) Class II Decision Date: October 2, 1996
SUBSTANTIAL EQUIVALENCE CONCLUSIONS: VII.
Altiva concludes that the intended use for the Altiva CONTOUR II™ Spinal System is the same as that of the predicate device, and that the technological characteristics demonstrate that they are equivalent to the predicate device.
Thus, this premarket notification has demonstrated substantial equivalence.
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DEVICE DESCRIPTION: VIII.
DE FICE DEBORT FOO!!
The CONTOUR II™ Spinal System is an anterior / posterior spinal fixation system consisting of THE CONTOON IF - Spinal Bytten II an Sat screws, L and straight connecting rods as well as a Fedicie serews, blem Clamps, C Clanips, SC 0NT0UR II™ implant components are fabricated from transvelse (COSS) miking moonamalir The OCT. ISTM F 136. Various sizes of these implants are available.
IX. MATERIALS:
MATERIALS:
All components are manufactured from Ti-6AI-4V ELI per ASTM F136-02 implant grade titanium allov.
INDICATION FOR USE: X.
The CONTOUR II™ Spinal System is intended for noncervical, pedicle fixation to provide The CONTOON IT - Spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, luston in the treatively of including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, the CONTOUR II™ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous sponeylonshows (Oralo's attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
The CONTOUR II™ Spinal System (KWP) is also intended for use as a posterior noncervical, The OOTT OOTC . " Uppated for degenerative disc disease which is defined as back pain of dicogenic noinpearer of stem marcator of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.
When used as an anterior fixation system, the CONTOUR II™ Spinal System (KWQ) is indicated for which about as an antrative disease which is defined as back pain of the discogenic origin with patients with at general re affirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.
SAFETY INFORMATION: XI.
Only surgeons trained and experienced in spinal decompression and bone grafting techniques should use the Altiva CONTOUR II™ Spinal System. In addition, thorough familiarization with the implants, instrumentation, and surgical technique is essential. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
CONCLUSION [21 CFR: 807.92(b)(3)] XII.
Altiva Corp. believes sufficient information is included to reach a determination of substantial equivalence. We conclude that the subject device is as safe and effective.
N/A