(175 days)
No
The device description focuses on the material, shape, and mechanical properties of the vertebral body replacements, with no mention of AI or ML capabilities.
Yes
The device is a vertebral body replacement used to treat damaged, collapsed, or unstable vertebrae due to tumor or trauma, which directly addresses a health condition.
No
The device description indicates that Ellys and Aurys Vertebral Body Replacements are implants designed to replace damaged or unstable vertebral bodies. These are treatment devices, not diagnostic ones. Although they are radio-translucent to allow for diagnostic imaging after implantation, the devices themselves do not perform diagnostic functions.
No
The device description clearly details physical implants made of PEEK material, designed to replace vertebral bodies. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace damaged, collapsed, or unstable vertebral bodies in the spine due to tumor or trauma. This is a surgical implant used directly in the body.
- Device Description: The description details the physical characteristics and materials of the vertebral body replacements, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Ellys and Aurys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.c. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.
Product codes
MQP
Device Description
The Ellys components are kidney shaped and are used in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the space for home graft. The implant is always implanted in the vertical position. These components are available in various heights (8mm-150mm) to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.
The Aurys components are trapezoidal in cross sccion and are used singly. The interior of these components have three hollow compartments that run the vertically and are provided for the placement of bone grafi. I like the Aurys components are also available in various hcights (9mm-1.50mm) and have angled ends to match the angle of the vertebral endplates. The ends have ridges similar to the Ellys to interface with the vertebral endplates. There are also holes evenly spaced on the medial/lateral surfaces to complete bone graft impaction after insertion.
Both the l'llys and Aurys components are fabricated from pure poly(ether cther ketone) (PEIFA). This material closcly matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shickling clicci. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and thoracic spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
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)
Testing was performed per ASTM F1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Date February 16, 2004
033109
Page 1 of 1
MAR 2 3 2004
Submitter
Scient x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name
Vertebral Body Replacement Device
Classification name
Vertebral Body Replacement Device per 21 CFR section 888.3060
Equivalent Device
The Ellys and Aurys VBR are similar in design, material fixation and indication and indications as the PENK Tertris® (Signus Medical, K031757), and Verte-Stack™ (Medtronic, K021791).
Device Description
The Ellys components are kidney shaped and are used in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the space for home graft. The implant is always implanted in the vertical position. These components are available in various heights (8mm-150mm) to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.
The Aurys components are trapezoidal in cross sccion and are used singly. The interior of these components have three hollow compartments that run the vertically and are provided for the placement of bone grafi. I ike the Aurys components are also available in various hcights (9mm-1.50mm) and have angled ends to match the angle of the vertebral endplates. The ends have ridges similar to the Ellys to interface with the vertebral endplates. There are also holes evenly spaced on the medial/lateral surfaces to complete bone graft impaction after insertion.
Both the l'llys and Aurys components are fabricated from pure poly(ether cther ketone) (PEIFA). This material closcly matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shickling clicci. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.
Intended Use
Ellys and Aurys Vertebral Hody Replacements are vertebral body replacements for use in the lumbar and thorace spine (T1-I 5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR (16.2 Hemispherical Screws with Offset Clamps and 05.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.
Summary Nonclinical Tests
Testing was performed per ASTM F1717.
1
Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight. The seal is black and white.
Public Health Service
MAR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scient'x, Inc. C/o Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K033109
Trade Name: Ellys and Aurys Vertebral Body Replacements Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: February 16, 2004 Received: February 23, 2004
Dear Mr. Webb:
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 elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Mr. J.D. Webb
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours,
Sincerely yours,
Mark N Milliman
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
3
510(k) number (if known): K033109
Page 1 of 1
Device Name: Ellys and Aurys Vertebral Body Replacements
Indications for Use:
Ellys and Aurys_Vertebral Body Replacements Indications for Use Amended
Ellys and Aurys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.c. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.
(PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use
(Optional format 1-2-96) ________
ﻟﺴ
(Division Sign-off)
Division of General, Neurological
and Restorative Devices
OR
Division of General, Restorative, and Neurological Devices
510(k) Number K033109