(14 days)
Not Found
Not Found
No
The summary describes a mechanical spinal fixation device and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a "spinal fixation device" and a "Spinal System" intended to "provide immobilization and stabilization of spinal segments" and "promote fusion" for the treatment of various spinal conditions, which are therapeutic actions.
No
The device is a pedicle screw system that provides immobilization and stabilization for spinal segments as an adjunct to fusion; it does not diagnose medical conditions.
No
The device description explicitly states it is a "multiple component, anterior / posterior Spinal System which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism," and that these components are "fabricated from titanium alloy." This indicates a physical hardware device, not software only.
Based on the provided information, the OPTIMA™ posterior spinal fixation device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- OPTIMA™ Function: The description clearly states that the OPTIMA™ is a "posterior spinal fixation device" and a "pedicle screw system." It is an implantable device used to stabilize and promote fusion of the spine.
- Intended Use: The intended use describes the conditions it treats (Spondylolisthesis, fracture, scoliosis, etc.) and how it is used (as an adjunct to fusion, anterior screw fixation). This is a description of a surgical implant, not a diagnostic test.
- Device Description: The device description details the components (screws, connectors, linking mechanism) and materials (titanium alloy) of a physical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information about a patient's condition based on laboratory analysis.
Therefore, the OPTIMA™ is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OPTIMA™ is 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, the OPTIMA™ 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 such as scoliosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMAT® may be used, with posterior hook.
Product codes (comma separated list FDA assigned to the subject device)
KWO, MNH, MNI
Device Description
The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior The Of Think - Spinal System which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.
The OPT/MA™ Spinal System will allow surgeons to build a spinal implant construct to The OPTIMA - Spinal System will anow Surgeone to band a band and on the are Stablice and promote opingle use and are fabricated from titanium alloy (Ti-6AI-4V ELI) supplied from storile, are single as and are sizes of these implants are available. that conforms to AOTM 1-100.
Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to sacrum), thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
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)
Mechanical testing was carried out according to ASTM F1717-01 & ASTM F1798-97 to Mechanical testing was cat asseming The testing demonstrated substantially validate "the "OPTMA™, Spinal System in terms of intended use, operating principle, materials, shelf life, packaging materials and process.
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
AUG 4 - 2005
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
... !
| Submission Information: | ||
|---|---|---|
| Contact: | Betty Lim | Regulatory Affairs |
| Sponsor: | U&i Corporation | |
| YongHyun-Dong 529-1, Euijungbu | ||
| Kyonggi-Do, Korea 480-050 | ||
| Phone: 82-31-852-0102(ext. 254) | ||
| Fax: 82-31-852-0107 | ||
| E-mail: willerry@lycos.co.kr | ||
| Date Prepared: | July 18, 2005 | |
| Device Identification | ||
| Trade Name: | OPTIMATM Spinal System | |
| Common Name: | Rod, hook, and screw spinal instrumentation | |
| Classification Name: | Spinal Pedical Fixation Orthosis (MNI) per 21 CFR § 888.3070 | |
| Spondylolisthesis Spinal Fixation Orthosis (MNH) per 21 CFR § 888.3070 | ||
| Spinal Intervertebral Body Fixation Orthosis (KWQ) per 21 CFR § 888.3060 | ||
Substantially Equivalent Predicate Legally Marketed Devices
The subject OPTIMA™ Spinal System is substantially equivalent in intended use, operating principle, materials, shelf life, packaging materials and process to:
Exhibit 5, Page 1 of 2
1
Device Description
The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior The Of Think - Spinal System which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.
The OPT/MA™ Spinal System will allow surgeons to build a spinal implant construct to The OPTIMA - Spinal System will anow Surgeone to band a band and on the are Stablice and promote opingle use and are fabricated from titanium alloy (Ti-6AI-4V ELI) supplied from storile, are single as and are sizes of these implants are available. that conforms to AOTM 1-100.
Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system
Indications for Use:
The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for The Of Think - postener Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in the treatment or sovery opendylanciscon by autogenous bone graft having implants Skeletally Thature patients rooming ne (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OPTIMA™ is intended to provide immobilization and stabilization of In 'addition', the 'O' Think in the intents as an adjunct to fusion in the treatment of Spirial segments in shelocally matast bilities of the thoracic, lumbar and the following doda and only of only objective evidence of neurological sacran spins. - dogGhoration, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, the OPT/MA™ is indicated for patients Wilen used as an antenor solow 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, Spondylolisticslo, "Tractars," opinathrosis, or revision of failed fusion attempts.
Statement of Technological Comparison:
Mechanical testing was carried out according to ASTM F1717-01 & ASTM F1798-97 to Mechanical testing was cat asseming The testing demonstrated substantially validate "the "OPTMA™, Spinal System in terms of intended use, operating principle, materials, shelf life, packaging materials and process.
Exhibit 5, Page 2 of 2
Page 2 + 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, stylized with thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 - 2005
Ms. Betty Lim Regulatory Affairs U and I Corporation Youghyun Dong 529 1 Uijungbu, Kyunggi Do 480-050 Korea
Re: K051971
Trade/Device Name: OPTIMATM Spinal System Regulation Number: 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWO, MNH, MNI, Dated: July 20, 2005 Received: July 21, 2005
Dear Ms. Lim:
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.
3
Page 2 - Ms. Betty Lim
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,
Sincerely yours,
Stipt Rurla
ark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS for USE STATEMENT
605197
510(k) Number (if known):
Device Name: OPTIMA™ Spinal System.
Indications for Use: The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OPTIMA™ is 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, the OPTIMA™ 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 such as scoliosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMAT® may be used, with posterior hook.
× Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stept Rlwdl
Division of General, Restorative, and Neurological Devices
510(k) Number_
Exhibit 2, Page 1 of 1
Page 1 of 1