(49 days)
Not Found
Not Found
No
The summary describes a physical implantable device (intervertebral body fusion device/vertebral body replacement) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as an "intervertebral body fusion device" and a "vertebral body replacement device" intended to treat degenerative disc disease, tumors, or traumatic injury, which are medical conditions, thus indicating a therapeutic purpose.
No
The device is described as an intervertebral body fusion device and a vertebral body replacement device, intended for surgical implantation to facilitate fusion or replace a vertebral body. Its function is treatment, not diagnosis.
No
The device description clearly indicates a physical implantable device ("basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet-shaped anterior surface") used for spinal fusion and vertebral body replacement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the ORIA Natura Spacer is an implantable device used for intervertebral body fusion and vertebral body replacement in the spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information provided focuses on the surgical use and physical characteristics of the device, which is consistent with a surgical implant rather than an IVD.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
When used as a vertebral body replacement device, the ORIA Natura Spacer is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
MQP, MAX
Device Description
The ORIA Natura has a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet-shaped anterior surface. It is available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1, thoracic and lumbar spine, from T1 to 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K073669 Page 10f / 1
6. 510(k) Summary
:
| Sponsor: | Choice Spine, LP
314 Erin Drive, Suite 102
Knoxville, TN 37919
Phone: 865.246.3333
Fax: 865.246.3334 | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact
Person: | G. Todd Hawkins.
Director of Regulatory Affairs / Quality Assurance | FEB 13 200 |
| Proposed
Proprietary
Trade Name: | ORIA Natura Spacer | |
| Classification
Name | 888.3060 - Spinal Intervertebral Body Fixation Orthosis,
888.3080 - Spinal Intervertebral Body Fusion Device | |
| Device Product
Code: | MQP, MAX | |
| Device
Description: | The ORIA Natura has a basic rectangular shape, a hollow center for placement
of bone graft and a smooth bullet-shaped anterior surface. It is available in an
assortment of height, length and anteroposterior angulation combinations to
accommodate many different anatomic requirements. | |
| Intended Use: | When used as an intervertebral body fusion device, the ORIA Natura Spacer is
indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in
skeletally mature patients who have had six months of non-operative treatment.
The device is intended for use at either one level or two contiguous levels for
the treatment of degenerative disc disease (DDD) with up to Grade I
spondylolisthesis. DDD is defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies. The
device system is designed for use with supplemental fixation (e.g., ORIA
Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion. | |
| | When used as a vertebral body replacement device, the ORIA Natura Spacer is
intended for use in the thoracic and lumbar spine, from T1 to L5, for the
replacement of a collapsed or unstable vertebral body resulting from a tumor or
traumatic injury. The device system is designed for use with supplemental
fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft
to facilitate fusion. | |
| Materials: | The ORIA Natura Spacer components are manufactured from
polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by
ASTM F2026. Integral radiopaque markers are manufactured from tantalum as
described by ASTM F560. | |
| Substantial
Equivalence: | Documentation was provided which demonstrated the ORIA Natura Spacer to
be substantially equivalent to previously cleared devices. The substantial
equivalence is based upon equivalence in intended use, indications, anatomic
sites, performance and material of manufacture. | |
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:
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1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
FEB 13 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Choice Spine, LP % Ms. Karen Warden Regulatory Affairs Specialist 8202 Sherman Road Chesterland, OH 44026-2141
Re: K073669
Trade/Device Name: ORIA Natura Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: December 21, 2007 Received: December 26, 2007
Dear Ms. 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 - Ms. Karen Warden
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 M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K073669
Page 1 of 1
5. Indications for Use Statement
07 3669 510(k) Number:
Device Name: ORIA Natura Spacer
Indications for Use:
When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
When used as a vertebral body replacement device, the ORIA Natura Spacer is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
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)
Dalvare Bneehn
on Sign-t Division of General, Restorative, and Neurological Devices
510(k) Number K073669
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