(14 days)
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.
The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior Spinal System which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.
The OPTIMA™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote fusion. The implants are sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) supplied from stock that conforms to AOTM 1-100. Various sizes of these implants are available.
Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system
Here's a breakdown of the acceptance criteria and the study details for the OPTIMA™ Spinal System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal as Performed Testing) | Reported Device Performance (Testing Standard Met) |
|---|---|
| Mechanical testing to validate intended use, operating principle, materials, shelf life, packaging materials and process. | Mechanical testing carried out according to ASTM F1717-01 & ASTM F1798-97. The testing demonstrated substantial equivalence to the predicate device. |
Note: The provided document is a 510(k) summary for a spinal system, which is a medical device. For such devices, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical performance metrics often seen with diagnostic software. The "reported device performance" is the successful completion of these standard mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The "test set" in this context refers to the physical samples of the OPTIMA™ Spinal System components used for mechanical testing, not a dataset of patient images or clinical data. The quantity of implants tested is not specified, but it would have been sufficient to meet the requirements of the ASTM standards.
- Data Provenance: Not applicable. The testing described is mechanical, conducted in a lab environment to assess the physical properties and performance of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable for this type of device and study. "Ground truth" in this context usually refers to a definitive diagnosis or condition established by medical experts for evaluating the accuracy of a diagnostic device. For the OPTIMA™ Spinal System, the "ground truth" for its performance is its physical integrity and mechanical properties as demonstrated by standardized engineering tests.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing according to ASTM standards does not involve adjudication by experts in the way clinical diagnostic studies do. The results are objective measurements against defined criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices to evaluate human reader performance with and without AI assistance. The OPTIMA™ Spinal System is a surgical implant, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The OPTIMA™ Spinal System is a physical medical implant, not an algorithm or software requiring standalone performance testing.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance (demonstrating substantial equivalence) was compliance with established engineering standards (ASTM F1717-01 & ASTM F1798-97) through mechanical testing. This verifies the physical and mechanical properties of the device are equivalent to, or better than, the predicate device.
8. The Sample Size for the Training Set
Not applicable. The device is a surgical implant, not an AI or machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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 CorporationYongHyun-Dong 529-1, EuijungbuKyonggi-Do, Korea 480-050Phone: 82-31-852-0102(ext. 254)Fax: 82-31-852-0107E-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
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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
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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.
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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
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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
§ 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.