(26 days)
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No
The document describes a mechanical vertebral body replacement system and its line extension, focusing on material properties and dimensions. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is described as a "vertebral body replacement system" used for the "thoraco-lumbar spine" to replace collapsed, damaged, or unstable vertebral bodies. These actions are inherently therapeutic, aiming to treat or alleviate a medical condition.
No
Explanation: The device is a vertebral body replacement system, which is a surgically implanted device used to replace a damaged vertebral body, not to diagnose a condition.
No
The device description explicitly states it is a vertebral body replacement system, which is a physical implant (hardware). The modifications are limited to the dimensions of the implant (cage).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vertebral body replacement system intended to replace a vertebral body." This is a surgical implant used directly in the body.
- Device Description: The description details a "vertebral body replacement system" and "implant (cage) dimensions." This further confirms it's a physical device for surgical implantation.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on samples.
The information provided describes a surgical implant used to replace a damaged vertebral body, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.
The use of allograft and/or autograft with the SupStance VBR System is optional.
Product codes (comma separated list FDA assigned to the subject device)
87 MQP
Device Description
The proposed Creaspine SupStance VBR System, Line Extension, is a modification of the original Creaspine SupStance VBR System that was the subject of K072537. This device modification has been submitted as a Special 510(k) Premarket Notification because the proposed SupStance VBR System, Line Extension, is identical in intended use and fundamental scientific technology to the parent SupStance VBR System originally described in K072537.
The modifications made to the parent device to produce the proposed SupStance VBR System, Line Extension, are limited to the expansion of the implant (cage) dimensions available.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoraco-lumbar spine (T1- L5)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing) in the "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s" (issued May 3, 2004). The data collected confirms that the mechanical properties of the proposed line extension to the SupStance VBR System product line are comparable to those of the predicate devices. The information and data collected support a claim of substantial equivalence for the proposed SupStance VBR System, Line Extension to the specified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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
K081564 (pg. 1 of 2)
JUN 3 0 2008
SPECIAL 510(K) SUMMARY
Creaspine SupStance Vertebral Body Replacement System, Line Extension
| Proprietary Name: | Creaspine SupStance Vertebral Body Replacement System |
|---|---|
| Common Name: | Spinal Vertebral Body Replacement System |
| Proposed Regulatory Class: | Class II |
| Spinal intervertebral body fixation orthosis | |
| 21 CFR 888.3060 | |
| Device Product Code: | 87 MQP, Spinal Vertebral Body Replacement Device |
| For Information Contact: | Marc Bernard |
| Regulatory Affairs Director | |
| PTIB Xavier Arnozan | |
| Avenue du Haut-Lévèque | |
| 33600 Pessac - France | |
| Telephone +33 557 102 854 | |
| Fax: +33 557 102 886 | |
| Email: marc.bernard@creaspine.com | |
| Date Summary Prepared: | June 3, 2008 |
Predicate Devices
The proposed Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System), Line Extension is substantially equivalent to the Creaspine SupStance VBR System subject of K072537 and the following legally marketed spinal vertebral body replacement devices:
- Surgical Titanium MeshIM System (DePuy-Acromed™, Inc., K003043) .
- Surgical Dynamics Mesh Cage System (United States Surgical, K003709) �
Device Description
The proposed Creaspine SupStance VBR System, Line Extension, is a modification of the original Creaspine SupStance VBR System that was the subject of K072537. This device modification has been submitted as a Special 510(k) Premarket Notification because the proposed SupStance VBR System, Line Extension, is identical in intended use and fundamental scientific technology to the parent SupStance VBR System originally described in K072537.
1
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The modifications made to the parent device to produce the proposed SupStance VBR System, Line Extension, are limited to the expansion of the implant (cage) dimensions available. The line extension includes the implants with the length and diameter combinations bolded in the following table:
| Diameter | Ø19 | Ø22 | Ø25 | Ø28 |
|---|---|---|---|---|
| Angulation | 0° | 5° | 5° | 5° |
| Length | 30 | 30 | 30 | 30 |
| 32.5 | 32.5 | 32.5 | 32.5 | |
| 35 | 35 | 35 | 35 | |
| 37.5 | 37.5 | 37.5 | 37.5 | |
| 40 | 40 | 40 | 40 | |
| 42.5 | 42.5 | 42.5 | 42.5 | |
| 45 | 45 | 45 | 45 | |
| 47.5 | 47.5 | 47.5 | 47.5 | |
| 50 | 50 | 50 | 50 | |
| 52.5 | 52.5 | |||
| 55 | 55 |
Intended Use
The SupStance VBR System, Line Extension is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.
The use of allograft and/or autograft with the SupStance VBR System is optional.
Statement of Technological Comparison
The subject device shares the same intended use, basic design concepts, and materials as that of the predicate devices. Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing) in the "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s" (issued May 3, 2004). The data collected confirms that the mechanical properties of the proposed line extension to the SupStance VBR System product line are comparable to those of the predicate devices. The information and data collected support a claim of substantial equivalence for the proposed SupStance VBR System, Line Extension to the specified predicate devices.
2
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 stylized caduceus symbol on the right, which is a staff entwined with snakes, representing medicine and health. To the left of the caduceus is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PTIB Xavier Arnozan % Mr. Marc Bernard Regulatory Affairs Director Avenue du Haut-Lévèque 33600 Pessac-France
JUN 3 0 2008
Re: K081564
Trade/Device Name: Creaspine SupStance Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 3, 2008 Received: June 4, 2008
Dear Mr. Bernard:
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 - Mr. Marc Bernard
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 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. Mullean
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K081564
Device Name: Creaspine SupStance Vertebral Body Replacement System, Line Extension
Indications for Use:
The Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.
The use of allograft and/or autograft with the SupStance VBR System is optional.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological, Restorative, and Neurological Deveral,
June 3, 2008
age 1 of 1