(104 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for a variety of spinal conditions, which are therapeutic interventions.
No
Explanation: The CONTOUR II™ Spinal System is described as a "spinal fixation system" intended for immobilization and stabilization of spinal segments as an "adjunct to fusion." This indicates its role as a therapeutic device that provides physical support and fixation, rather than a device designed to identify or diagnose medical conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, clamps, and cross connectors fabricated from Ti-6AI-4V ELI. This indicates it is a hardware-based medical device, not software-only.
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. They are used outside of the body.
- CONTOUR II™ Spinal System Function: The CONTOUR II™ Spinal System is a surgical implant used to stabilize and immobilize the spine within the body. It is a physical device implanted during surgery.
- Intended Use: The intended use clearly describes its purpose as a spinal fixation system for treating various spinal conditions by providing structural support. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Device Description: The device description details the components of a surgical implant (screws, rods, clamps).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, based on the provided information, the CONTOUR II™ Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 (KWQ) 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.
Product codes
MNH, MNI, KWQ, KWP
Device Description
The CONTOUR II™ Spinal System is an anterior / posterior spinal fixation system consisting of screws, L and straight connecting rods as well as a Fedicie screws, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical, pedicle fixation, thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3 and below
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Only surgeons trained and experienced in spinal decompression and bone grafting techniques should use the Altiva CONTOUR II™ Spinal System.
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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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.
1
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.
4
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.