(84 days)
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain 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 (pseudoarthrosis)
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion.
In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 (pseudoarthrosis)
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
The provided text describes a medical device submission (510(k)) for the PLUS™ Pivot Link Universal System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI algorithm or diagnostic performance.
The document is a regulatory submission for a spinal instrumentation system, focusing on its design, materials, indications for use, and a claim of substantial equivalence to previously cleared devices based on mechanical testing. It's a traditional medical device submission, not one related to an AI/ML powered device.
Therefore, I cannot provide the requested information for the following reasons:
- No AI/ML Component: The device described in the document is a physical spinal instrumentation system (rods, hooks, screws), not an AI algorithm or a diagnostic imaging device. As such, concepts like "acceptance criteria for device performance" in the context of sensitivity, specificity, AUC, human reader improvement, and ground truth establishment (other than for materials testing) are not applicable to this submission.
- No Performance Study as Described: The document mentions "Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." This mechanical testing is done to ensure the structural integrity and functionality of the physical components, not to assess diagnostic accuracy or an AI's performance.
If you have a document describing an AI/ML medical device, I would be happy to analyze it for the requested information.
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AUG 0 1 2002
Image /page/0/Picture/2 description: The image shows the logo for SpineVision. The logo consists of a stylized black icon above the word "SpineVision" in a sans-serif font. Below the company name is the tagline "Spine systems for specialists" in a smaller font. The logo is simple and modern, and the tagline suggests that the company specializes in spine-related medical devices or services.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | SpineVision, Inc.3003 Summit Blvd., Suite 1500Atlanta, GA 30319Phone: 404-460-5077 |
|---|---|
| 510(K) CONTACT: | Lynnette WhitakerVice President, Regulatory Affairs574-269-3701 |
| TRADE NAME: | PLUS™ Pivot Link Universal System |
| COMMON NAME: | Rod, Hook, and Screw Spinal Instrumentation |
| CLASSIFICATION: | 888.3050 Spinal Interlaminal Fixation Orthosis888.3070 Pedicle Screw Spinal System |
| DEVICE PRODUCT CODE: | Product code: 87 KWP, MNH, MNI |
| SUBSTANTIALLYEQUIVALENT DEVICES: | PLUS Pivot Link Spinal System, SpineVision, Inc. |
DEVICE DESCRIPTION AND INTENDED USE:
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
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INDICATIONS FOR USE
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain 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 (pseudoarthrosis) .
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
- have the device removed after the development of a solid fusion. .
In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 (pseudoarthrosis) .
BASIS OF SUBSTANTIAL EQUIVALENCE:
The components of the PLUS Pivot Link Universal System are identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA for posterior spinal use. Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of three human profiles facing to the right, with lines extending above them to create a sense of upward movement or flight. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 01 2002
Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Incorporated 3003 Summit Boulevard, Suite 1500 Atlanta, Georgia 30319
Re: K021507
Trade/Device Name: PLUSTM Pivot Link Universal System Regulation Number: 888.3050 and 888.3070 Regulation Name: Spinal Interlaminal Fixation Orthosis, Pedicle Screw Spinal System and Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Code: KWP, MNI, and MNH Dated: May 8, 2002 Received: May 9, 2002
Dear Ms. Whitaker:
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. Lynnette Whitaker
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- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
Mark N. Mellem
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
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510(k) Number (if known) ≤ ≥ ≤ ≤ ≤ ≤ ○ 7
PLUS™ Pivot Link Universal System, Additional Components Device Name:
Indications for Use:
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain 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 (pseudoarthrosis)
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
- receive fusions using autogenous bone graft only; ●
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
- have the device removed after the development of a solid fusion. .
In addition, the PLUS Pivot Link Universal System is a pedicle screw system 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 (pseudoarthrosis)
| Concurrence of CDRH. Office of Device Evaluation |
|---|
| -------------------------------------------------- |
Mark N. Milliken
Division Sign-Off Division of General. Restorative and Neurological Devices
510(k) Number K021507
Prescription Use
OR (Per 21 CFR 801.109) Over-The Counter Use
§ 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.