(260 days)
Not Found
No
The device description and intended use are for a physical implant (PEEK cage) used in spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing of the implant.
Yes
This device is an intervertebral body fusion device implanted to improve spinal stability and support fusion in patients with degenerative disc disease, which qualifies it as a therapeutic device.
No
The device is an intervertebral body fusion device used for spinal fusion procedures, not for diagnosing medical conditions.
No
The device description clearly states it is an "intervertebral body fusion device that is implanted into the vertebral body space," indicating it is a physical implant, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a "PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE" which is an "intervertebral body fusion device that is implanted into the vertebral body space". This is a surgically implanted device used to stabilize the spine and promote fusion.
- Intended Use: The intended use is for spinal fusion procedures in patients with degenerative disc disease. This involves a surgical procedure, not laboratory testing of samples.
The description clearly indicates a physical implant used in a surgical setting, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade 1 Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.
The Cervical devices are indicated for spinal fusion procedures at one level in the cervical --spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral
space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.
All lumbar and cervical devices are intended for use with autogenous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP
Device Description
The PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK -Optima (per ASTM F2026).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral Spine (L2-S1, C3-T1)
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)
The following tests were performed on the worst case subject devices: static compression, static compression-sheer, static torsion, dynamic compression, dynamic compression-sheer and dynamic torsion testing per ASTM F2077 and subsidence testing per ASTM F2267. The testing demonstrated substantially equivalent performance of the subject device as compared the legally marketed predicate devices.
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.
K071983 Aesculap PEEK Spinal Implant System, K082848 Nubic by Signus
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
Image /page/0/Picture/1 description: The image shows the logo for "NEOORTHO". The logo consists of a black square with a white swirl inside on the left, followed by the word "NEOORTHO" in black, bold, sans-serif font. The letters are closely spaced, giving the word a solid, unified appearance.
MAY 2 9 2014
| SECTION 6 | ||
|---|---|---|
| 510(k) Summary | ||
| Proprietary Name | PEEK CAGE FOR THE VERTEBRAL | |
| SPINE NEOSPACE | ||
| Date Prepared | May 28, 2014 | |
| 510(K) Number | K132852 | |
| Submitter | NEOORTHO Produtos Ortopedicos S/A | |
| Rua Angelo Domingos Durigan, 607 | ||
| Cascatinha | ||
| Curitiba-PR, Brazil 82020-340 | ||
| Telephone: +55 41 3535-1033 | ||
| Fax: +55 41 3535-1018 | ||
| Official Contact | Tara Conrad | |
| TechLink International Consulting | ||
| 18851 NE 29th Avenue Suite 720 | ||
| Aventura, FL 33180 | ||
| TEL- (305) 377-0077 | ||
| Common Name | Intervertebral body fusion device | |
| Regulation Number & Product Codes | MAX -21 CFR §888.3060 | |
| ODP- 21 CFR §888.3080 | ||
| Classification Panel | Orthopedic | |
| Predicate Device Identification | K071983 Aesculap PEEK Spinal Implant System | |
| K082848 Nubic by Signus |
Device Description
The PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK -Optima (per ASTM F2026).
Indications for Use Statement
The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade 1 Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.
1
The Cervical devices are indicated for spinal fusion procedures at one level in the cervical --spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral
space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.
All lumbar and cervical devices are intended for use with autogenous bone graft.
Substantial Equivalence
The fundamental scientific technology, design, and materials of the subject device are substantially equivalent to the legally marketed predicates.
Performance Testing
The following tests were performed on the worst case subject devices: static compression, static compression-sheer, static torsion, dynamic compression, dynamic compression-sheer and dynamic torsion testing per ASTM F2077 and subsidence testing per ASTM F2267. The testing demonstrated substantially equivalent performance of the subject device as compared the legally marketed predicate devices.
Conclusion .
The subject device and predicate devices share indications for use, primary implant design and equivalent material of manufacture.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person or a symbol of care and support. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2014
NEOORTHO Produtos Ortopedicos S/A % Ms. Tara Conrad TechLink International Consulting 18851 Northeast 29th Avenue, Suite 720 Aventura, Florida 33180
Re: K132852
Trade/Device Name: PEEK Cage for the Vertebral Spine NeoSpace Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: April 25, 2014 Received: April 29, 2014
Dear Ms. Conrad:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Tara Conrad
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K132852
Device Name PEEK Cage for the Vertebral Spine NeoSpace
Indications for Use (Describe)
The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade ! Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.
The Cervical devices are indicated for spinal fusion procedures at one level in the cervical spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.
All lumbar and cervical devices are intended for use with autogenous bone graft.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, Ph
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