(40 days)
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:
- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Spinal Stenosis
- Fracture/Dislocation
- Tumors
- Pseudoarthrosis
- Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.
The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.
The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.
To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.
The purpose of this submission is to add transition rods and rod connectors
This document is a 510(k) summary for a medical device called the Atoll Cervico-Thoracic System. It is a premarket notification to the FDA to demonstrate substantial equivalence to existing legally marketed devices.
It describes a spinal implant system and its intended use, rather than a diagnostic device or AI software. Therefore, the questions related to studies proving acceptance criteria for device performance, ground truth, expert involvement, and AI specific metrics (like MRMC studies) are not applicable in this context. These questions typically apply to diagnostic devices, particularly those involving image analysis or AI algorithms, where performance relies on measurable metrics against a 'ground truth'.
For this device, "acceptance criteria" are related to mechanical and material properties, and "substantially equivalent" claims. The study proving acceptance is typically mechanical testing and material characterization, not clinical studies with patients for diagnostic accuracy.
Here's an attempt to answer the relevant aspects based on the provided text, while explicitly stating where information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|
| Intended Use: Promote fusion of cervico-thoracic regions (C1-T3) for conditions like Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Fracture/Dislocation, Tumors, Pseudoarthrosis, Revision surgery. Specific limitations for screw placement (T1-T3 only, not cervical spine). Hooks and rods for stabilization post-fracture/dislocation/trauma. Linkability to Theken Coral Spinal System. | Device shares the same intended use as the predicate device (Theken - Atoll Cervico-Thoracic System, K070638) and comparable devices (Synthes CerviFix System, Interpore Cross Altius OCT System). |
| Design: Similar design principles for spinal instrumentation (screws, hooks, rods, connectors). | Device shares similar design as the predicate and comparable devices. (Specific design details are not provided in this summary, but implied by the equivalence claim). |
| Physical Characteristics/Material Composition: Manufactured from Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3. | Device shares similar physical characteristics and material composition (Ti-6Al-4V per ASTM F136 and ISO 5832-3) as the predicate and comparable devices. |
Note: The acceptance criteria for this type of medical device are typically defined by engineering standards for mechanical strength, biocompatibility, and manufacturing quality, and by demonstrating that the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use, design, and materials.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a 510(k) submission for a spinal implant, not a diagnostic device or AI algorithm that would typically involve a "test set" of data for performance evaluation in the way described. The "test" for this device would involve mechanical testing and material characterization, the specifics of which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic accuracy studies of image-based or clinical data, which is not the nature of this device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not relevant to this device's 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
This information is not applicable. MRMC studies are specifically for evaluating diagnostic performance of imaging systems, often with AI assistance. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of data-driven performance evaluation. For this device, the "ground truth" would be related to established engineering standards for material properties and mechanical performance, and the clinical outcomes for the predicate devices that established their safety and effectiveness.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this device submission.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" in the context of this device submission.
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Theken Spine, LLC
Atoll Cervico-Thoracic System
K08079 o
3/17/2008
510(K) Summary (21 CFR Part 807.92)
Submitter Information A
APR 2 9 2008
| Submitter's Name: | Theken Spine, LLC | APR 29 2008 |
|---|---|---|
| Address: | 1800 Triplett Blvd.Akron, Ohio 44306 | |
| Telephone Number: | 330-475-8600 | |
| Fax Number: | 330-773-7697 | |
| Contact Person: | Dale Davison | |
| Date Prepared: | 17 March 2008 | |
| B. Device Information | ||
| Trade Name: | Atoll™ Cervico-Thoracic System | |
| Common Name: | Posterior Cervical Instrumentation | |
| Classification: | Class II System with the corresponding product codes:KWP 888.3050 - Spinal Interlaminal Fixation OrthosisMNI 888.3070(b)(1) - Pedicle Screw Spinal System | |
| Predicate Device: | Theken - Atoll Cervico-Thoracic System (K070638) | |
| Comparable Device: | Synthes (USA) - CerviFix System (K990965)/Starlock SystemInterpore Cross International - Altius OCT System (K033961) | |
| Material Composition: | Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 | |
| Subject Device Description: | The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.The purpose of this submission is to add transition rods and rod connectors |
{1}------------------------------------------------
Intended Use:
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:
- Degenerative Disc Disease (as identified by neck or . back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
- Spinal Stenosis .
- Fracture/Dislocation .
- Tumors .
- Pseudoarthrosis .
- Revision of previous cervical and upper thoracic spine ● surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.
C. Substantial Equivalence
The characteristics of the Atoll Cervico-Thoracic System are similar to the following predicate devices:
-
- Atoll Cervico-Thoracic System (K070638) manufactured by Theken Spine and cleared by the FDA on May 30", 2007.
Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices. Therefore, Theken Spine believes that there is sufficient evidence to conclude that the Atoll Cervico-Thoracic System is substantially equivalent to existing legally marketed devices.
- Atoll Cervico-Thoracic System (K070638) manufactured by Theken Spine and cleared by the FDA on May 30", 2007.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with flowing lines, representing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2008
Theken Spine % Mr. Dale Davison Vice President of Engineering 1800 Triplett Blvd Akron, OH 44306
K080790 Re:
Trade/Device Name: Theken Atoll Cervico-Thoracic System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI Dated: April 10, 2008 Received: April 11, 2007
Dear Mr. Davison:
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 -- Mr. Dale Davison
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson 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
510(k) Number (if known):
Device Name: AtollTM Cervico-Thoracic System
Indications For Use:
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervicothoracic regions of the spine (C1 - T3). The intended indications are as follows:
- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin . with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- Fracture/Dislocation .
- Tumors .
- Pseudoarthrosis .
- Revision of previous cervical and upper thoracic spine surgery .
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/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)
Neil A.Olsen for
Division of General, Restorative, and Neurological Devices
510(k) Number K080790
Page 1 of 1
§ 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.