(29 days)
Not Found
Not Found
No
The summary describes a mechanical implant for vertebral body replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vertebral body replacement system, which serves a therapeutic purpose by replacing resected or excised vertebral bodies due to tumor or trauma/fracture.
No
The device is described as a vertebral body replacement system, an implantable medical device, rather than a device used for diagnosis. Its intended use is to replace a resected or excised vertebral body.
No
The device description clearly describes a physical, modular vertebral body replacement system made of components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant designed to replace a vertebral body in the spine. It is a physical device implanted within the body, not used to test samples outside the body.
The ATHLET™ System is a surgical implant used for vertebral body replacement.
N/A
Intended Use / Indications for Use
The ATHLET™ VBR is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The ATHLET™ System is intended for use with supplemental fixation and should be implanted in pairs.
Product codes
MQP
Device Description
The ATHLET™ VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Documentation was provided which demonstrated the ATHLET™ VBR to be substantially equivalent to previously cleared vertebral body replacement devices. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites and performance.
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.
Not Found
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.
Not Found
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).
Not Found
§ 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
K0812330
・
7. 510(k) Summary
:
:
JUN 1 0 2008
| Sponsor: | SIGNUS Medizintechnik GmbII
Carl-Zeiss-Strasse 2
D-63755 Alzenau, GERMANY
Tel. + 49 (0) 6023 9166-136
Fax + 49 (0) 6023 9166-161
Url: http://www.signus-med.de |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jörg Degen, Regulatory Affairs, QM |
| Proposed Trade Name: | ATHLET™ VBR |
| Device Classification | Class II |
| Classification Name: | Spinal vertebral body replacement device |
| Regulation: | 888.3060 |
| Device Product Code: | MQP |
| Device Description: | The ATHLET™ VBR System is a lordotic, modular vertebral body
replacement system. Caudal and cranial components are offered in a variety
of heights and are assembled to create a device construct. An intermediate
component is also available and is used between one caudal and one cranial
component. The device construct comprises a central cannula for bone graft
and lateral fenestrations for bony in-growth. |
| Intended Use: | The ATHLET™ VBR is indicated for use to replace a vertebral body that
has been resected or excised due to tumor or trauma/fracture. The device is
intended for use as a vertebral body replacement in the thoracolumbar spine
(from T1 to L5). The ATHLET™ System is intended for use with
supplemental fixation and should be implanted in pairs. |
| Materials: | The ATHLET™ VBR components are manufactured from
polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by
ASTM F2026. Integral marker pins are manufactured from titanium alloy
(Ti-6Al-4V) as described by ASTM F136. |
| Substantial
Equivalence: | Documentation was provided which demonstrated the ATHLET™ VBR to
be substantially equivalent to previously cleared vertebral body replacement
devices. The substantial equivalence is based upon equivalence in basic
design, intended use, indications, anatomic sites and performance. |
1
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SIGNUS Medizintechnik GmbH % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026
JUN 1 0 2008
Re: K081332
Trade/Device Name: ATHLET™ VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 12, 2008 Received: May 12, 2008
Dear Dr. Warden:
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.
2
Page 2 - Karen E. Warden, Ph.D.
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-frec number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: K081332
Device Name: ATHLETIM VBR
Indications for Use:
The ATHLET™ System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The ATHLET™ system is intended for use with supplemental internal fixation and intended to be implanted in pairs.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden for mkm
Division of General. Re and Neurological Devices
510(k) Number K081332