(165 days)
When intended for pedicle screw fixation from T1-S1, the InCompass Spinal Fixation System 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or mvelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
The use of posterior spinal instrumentation in children has been reported in the literature. The InCompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group.
The Spinal Concepts, Inc. InCompass Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes open styled hooks and screws, which allow the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components. Closed styled implants are also provided. Offset connectors are included to provide both offset between the screw and rod and also and reduce the effort needed to contour the spinal rod. Crosslinks are provided to increase rotational stiffness to longer constructs. Two sizes of spinal rods are included with this system.
Here's an analysis of the provided text regarding the InCompass Spinal Fixation System, focusing on acceptance criteria and supporting studies, based on the requirements you outlined:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study to Prove Performance |
|---|---|---|---|
| Mechanical Performance | Static Strength | Met all functional requirements | Mechanical testing data in accordance with ASTM 1717 |
| Mechanical Performance | Fatigue Strength | Met all functional requirements | Mechanical testing data in accordance with ASTM 1717 |
| Mechanical Performance | Compatibility | Stainless steel and titanium components should not be used in the same construct (Warning) | Implicit in design and material selection, mechanical testing would verify device integrity. |
| Substantial Equivalence | Fit, Form, Function | Substantially equivalent to predicate device (BacFix Spinal Fixation System) | Comparison to predicate device and mechanical test data. |
| Biocompatibility | Material Safety | Made from biocompatible metals (Stainless Steel ASTM F-138, titanium alloy Ti6Al4V ELI ASTM F-136) | Material specifications (ASTM standards). |
Note on this section: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting and reporting against explicit, numerical "acceptance criteria" in the way one might for a diagnostic AI device. The "acceptance criteria" here are implied through conformity to standards and comparability to a predicate. The "reported device performance" is a high-level statement of meeting functional requirements.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission is for a spinal fixation system, a physical medical device, not a diagnostic AI system that uses a "test set" of patient data in the typical sense. The "testing" referred to is mechanical testing of the device itself.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as there's no patient data involved in the mechanical testing described. The mechanical tests were performed by the manufacturer, Spinal Concepts, Inc., located in Austin, TX, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth, in the context of diagnostic AI, refers to the confirmed diagnosis of cases. For a physical device like a spinal fixation system, the "ground truth" relates to material properties and mechanical integrity, which are established through standardized engineering tests, not expert clinical review of patient data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" of patient cases requiring clinical adjudication for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- MRMC Study: No. This is a spinal implant, not an AI-powered diagnostic tool. MRMC studies are used to assess the effectiveness of diagnostic tools, particularly AI, in clinical decision-making.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance Study: No. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical aspects, the "ground truth" would be the engineering specifications and performance standards defined by ASTM 1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model). For biocompatibility, the "ground truth" is adherence to ASTM F-138 and ASTM F-136 material standards. For substantial equivalence, the "ground truth" is the established performance and design of the predicate device (BacFix Spinal Fixation System).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. As there is no AI component, there is no training set or associated ground truth.
Summary Notes based on the provided text:
The provided document is a 510(k) Pre-market Notification for a spinal fixation system. Its primary purpose is to demonstrate substantial equivalence to an already legally marketed predicate device, not to prove novel clinical effectiveness through extensive patient studies or to validate an AI algorithm.
For physical orthopedic implants like the InCompass Spinal Fixation System, the regulatory pathway relies heavily on:
- Mechanical Testing: To ensure the device can withstand the forces it will encounter in the body (as demonstrated by compliance with ASTM 1717).
- Material Biocompatibility: To ensure the materials used are safe for human implantation (as demonstrated by compliance with ASTM F-138 and F-136).
- Comparison to a Predicate Device: Demonstrating that the new device has the same intended use, technological characteristics, and performance profile (either identical or as safe and effective) as a legally marketed predicate.
Therefore, many of the questions regarding AI-specific validation (test sets, training sets, expert adjudication, MRMC studies) are not relevant to this type of device submission.
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K021564 r'/2
OCT 2 5 2007
| SUBMITTED BY | Spinal Concepts, Inc.12012 Technology Blvd., Suite 100Austin, TX 78727 |
|---|---|
| ESTABLISHMENTREGISTRATION NUMBER | 1649384 |
| CONTACT PERSON | David M. Hooper, Ph.D.Director, Regulatory and Clinical Affairs |
| DATE PREPARED | May 10, 2002 |
| CLASSIFICATION NAME | Spinal Intervertebral Body Fixation OrthosisSpinal Interlaminal Fixation OrthosisPedicle Screw Spinal System |
| COMMON NAME | Spinal Fixation System |
| PROPRIETARY NAME | InCompass Spinal Fixation System |
| PREDICATE DEVICE | BacFix Spinal Fixation System (Spinal Concepts, Inc) |
InCompass Spinal Fixation System 510(k) Summary
DEVICE DESCRIPTION
The Spinal Concepts, Inc. InCompass Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes open styled hooks and screws, which allow the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components. Closed styled implants are also provided. Offset connectors are included to provide both offset between the screw and rod and also and reduce the effort needed to contour the spinal rod. Crosslinks are provided to increase rotational stiffness to longer constructs. Two sizes of spinal rods are included with this system.
MATERIALS
Components of the InCompass Spinal Fixation System are offered in Stainless Steel (ASTM F-138) and titanium alloy Ti6Al4V ELI (ASTM F-136).
WARNING: Stainless steel and titanium components should not be used in the same construct.
INDICATIONS
When intended for pedicle screw fixation from T1-S1, the InCompass Spinal Fixation System 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
{1}------------------------------------------------
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or mvelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
The use of posterior spinal instrumentation in children has been reported in the literature. The InCompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group.
MECHANICAL TEST DATA
Mechanical testing data, collected in accordance with ASTM 1717, were collected to verify the designs. Static and fatigue data were provided to demonstrate that the design met all functional requirements.
BASIS OF SUBSTANTIAL EQUIVALENCE
The InCompass Spinal Fixation System is substantially equivalent to its predicates in terms of fit, form and function. All systems are made from biocompatible metals, and include screws, hooks and rods to provide stabilization of the spine.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
0 Corporate Boulevard Rockville MD 20850
David M. Hooper, Ph.D. Manager, Regulatory and Clinical Affairs Spinal Concepts, Inc. 12012 Technology Boulevard, Suite #100 Austin, Texas 78727
K021564 Re:
Trade/Device Name: InCompass Spinal Fixation System Regulatory Number: 21 CFR 888.3070(b)(1), 888.3050, 888.3060 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis Regulatory Class: III Product Code: MNI, MNH, KWP, KWQ Dated: August 28, 2002 Received: August 29, 2002
Dear Dr. Hooper:
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. Iisting 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 331-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Dr. David M. Hooper
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 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. Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INIDICATIONS FOR USE STATEMENT
Page 1 of 2
510(k) Number (if known): K021564
Device Name: Spinal Concepts, Inc. InCompass Spinal Fixation System
Indications for Use:
When intended for pedicle serew fixation from T1-S1, the InCompass Spinal Fixation System is intended to provide immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion
The use of posterior spinal instrumentation in children has been reported in the literature. The InCompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group.
(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) OR
Over-The-Counter: (Optional Format 1-2-96)
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INIDICATIONS FOR USE STATEMENT
Page 2 of 2
510(k) Number (if known): KU2454
Device Name: Spinal Concepts, Inc. InCompass Spinal Fixation System
Indications for Use:
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
(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) OR
Over-The-Counter: (Optional Format 1-2-96)
§ 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.