(22 days)
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No
The document describes a spinal implant system (connectors) and its intended use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The device description is purely mechanical.
Yes.
The device is indicated for various spinal conditions, including degenerative disk disease, spondylolisthesis, fracture, and spinal stenosis, with the stated purpose of providing immobilization and stabilization of spinal segments as an adjunct to fusion. These indications and functions point to a therapeutic purpose.
No
The SCS system is indicated for treatment of various spinal conditions and for stabilization and immobilization of spinal segments. It is a surgical implant, not a device used to diagnose a medical condition.
No
The device description explicitly states it is a physical component ("connectors") used to connect rods and screws of a spinal system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly indicate that the SCS system is a surgical implant used to provide immobilization and stabilization of spinal segments. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the SCS system described is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).
When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below.
Posterior pedicle systems are 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNH, MNI
Device Description
The SCS Claris Extended OmniAxial Connectors are available in two sizes (medium and long) and are used to connect the rods and screws of the SCS Claris Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Spine (back, discogenic origin), L5-S1 joint, lumbar and sacral spine, thoracic, lumbar, and sacral spine
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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K021919 - -
510(k) SUMMARY of Safety and Effectiveness
page I of 1
| Sponsor: | OrthoTec, LLC
9595 Wilshire Blvd. Suite 502
Beverly Hills, CA 90212
Phone: (310) 557-2000 & (310) 273-1500
Fax: (310) 843-9500 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Patrick Bertranou, MD |
| Proprietary
Trade Name: | SCS Claris Spinal System Extended OmniAxial Connectors (CO05 & CO07) |
| Device
Description: | The SCS Claris Extended OmniAxial Connectors are available in two sizes
(medium and long) and are used to connect the rods and screws of the SCS
Claris Spinal System. |
| Intended Use: | When used as a nonpedicle posterior system, the SCS system is indicated for
patients with: degenerative disk disease defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic
studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis,
kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).
When used as an anterolateral/anterior system the SCS system is indicated
for patients with: degenerative disk disease defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic
studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis,
kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the SCS system is indicated for use
in skeletally mature patients L3 and below who are: having severe
spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using
autogenous bone graft only, having the device fixed or attached to the lumbar
and sacral spine, having the device removed after the development of a solid
fusion mass. Screw fixation is limited to L3 and below.
Posterior pedicle systems are 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: degenerative
spondylolisthesis with objective evidence of neurologic impairment, fracture,
dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion
(pseudarthrosis). |
| Materials: | The SCS Claris Spinal System Extended OmniAxial Connectors (CO05 &
CO07) are manufactured from titanium alloy (ASTM F136 / ISO 5832-3). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the SCS Claris Extended
OmniAxial Connectors (CO05 & CO07) to be substantially equivalent to the
previously cleared SCS OmniAxial Connector (CO04). The substantial
equivalence is based upon equivalence in indications/intended use,
manufacturing methods, interconnection (attachment) mechanism, basic design
and materials. |
1
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 the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 2002
OrthoTec. LLC c/o Ms. Karen E. Warden, MEBE 8202 Sherman Road Chesterland, OH 44026-2141
Re: K021919
Trade/Device Name: SCS Claris Spinal System - Extended OmniAxial Connectors Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, KWQ, MNH, MNI Dated: May 29, 2002 Received: June 11, 2002
Dear Ms. Warden:
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.
2
Page 2 - Ms. Karen E. Warden
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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
3
Indications for Use Statement
510(k) Number (if known): KO2 19 | 9
Device Name: SCS Claris Spinal System
Indications for Use:
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)
When used as an anterolateral/anterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients who are:
having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 ioint
receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral soine having the device removed after the development of a
solid fusion mass. screw fixation is limited to L3 and below.
Posterior pedicle systems are 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:
degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)
(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)
Over-the-Counter Use
Sty Ruda
Division Sign-Off Division of General, Restorative and Neurological Devices
OR
KOL 919 510(k) Number -