(298 days)
Not Found
Not Found
No
The document describes a physical implant (vertebral body replacement and intervertebral fusion device) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The NUBIC and RABEA devices are explicitly indicated for use in treating medical conditions such as replacing vertebral bodies due to tumor or trauma/fracture, and for treating cervical disc disease, which are therapeutic indications.
No
The device description and intended use clearly state that this is an implant (vertebral body replacement or intervertebral fusion device) designed for treatment, not for diagnosing conditions.
No
The device description clearly describes physical implants (rectangular frames with surface spikes) intended for surgical implantation, which are hardware components.
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 NUBIC and RABEA devices are implants used to replace or fuse vertebral bodies in the spine. They are physical devices implanted into the body, not used to analyze samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing.
Therefore, the NUBIC and RABEA devices, as described, fall under the category of implantable medical devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
NUBIC device:
When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the NUBIC devices are intended for use in skeletally mature patients 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). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One NUBIC device is used per intervertebral space. A connecting screw is available which allows the NUBIC device (without strut) to be physically attached to the SIGNUS TOSCA II anterior cervical plate systems if desired.
RABEA device:
When used as a vertebral body replacement, the RABEA devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The RABEA device is intended to be implanted in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the RABEA devices are intended for use in skeletally mature patients 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). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One RABEA device is used per intervertebral space.
Product codes (comma separated list FDA assigned to the subject device)
MQP; ODP
Device Description
NUBIC™ device: The basic shape of the NUBIC device is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the Signus TOSCA II anterior cervical plate if the surgeon so chooses.
RABEA™ device: The basic shape of the RABEA device is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
NUBIC device: thoracolumbar spine (T1 to L5); cervical spine (C3 to T1)
RABEA device: thoracolumbar spine (T1 to L5); cervical spine (C3 to T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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
K0 82848 page 1 of Z
| 510(k) Summary | |
|---|---|
| Sponsor: | JUL 2 4 2009 |
| SIGNUS Medizintechnik GmbH | |
| 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: | NUBIC™ device |
| Device Classification | Class II |
| Classification Name: | Spinal vertebral body replacement device; Intervertebral fusion device with |
| bone graft, cervical | |
| Regulation: | 888.3060; 888.3080 |
| Device Product Code: | MQP; ODP |
| Device Description: | The basic shape of the NUBIC device is a rectangular frame. The upper and |
| lower aspects of the implant are open with surface spikes which assist in the | |
| positive anchorage and seating of the implant between the superior and | |
| inferior vertebral bodies. The device is available in a variety of sizes | |
| enabling the surgeon to choose the size best suited to the individual | |
| pathology and anatomical condition. A connecting screw is available which | |
| permits attachment of the NUBIC (without strut) to the Signus TOSCA II | |
| anterior cervical plate if the surgeon so chooses. | |
| Intended Use: | When used as a vertebral body replacement, the NUBIC devices are |
| indicated for use in skeletally mature patients to replace a vertebral body | |
| that has been resected or excised due to tumor or trauma/fracture. The | |
| device is intended for use in the thoracolumbar spine (from T1 to L5) and is | |
| intended for use with supplemental internal fixation. The NUBIC device | |
| may be implanted singularly or in pairs and may be used with allograft or | |
| autograft. | |
| When used as an intervertebral fusion device, the NUBIC devices are | |
| intended for use in skeletally mature patients 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). The cervical device is to be used in | |
| patients who have had six weeks of non-operative treatment. The devices | |
| are designed for use with autograft to facilitate fusion and intended for use | |
| with supplemental internal fixation. One NUBIC device is used per | |
| intervertebral space. A connecting screw is available which allows the | |
| NUBIC device (without strut) to be physically attached to the SIGNUS | |
| TOSCA or TOSCA II anterior cervical plate systems if desired. | |
| Materials: | The NUBIC device is manufactured from polyetheretherketone (PEEK- |
| OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker | |
| pins in the implants and the connecting screw are manufactured from | |
| titanium alloy (Ti-6Al-4V) as described by ASTM F136. | |
| Substantial | |
| Equivalence: | Documentation was provided which demonstrated the NUBIC to be |
| substantially equivalent to previously cleared devices. The substantial | |
| equivalence is based upon equivalence in basic design, intended use, | |
| indications, anatomic sites and performance. |
:
()
and the state of the state of the states and
1
K082848 Page 2 of Z
| 510(k) Summary | |
|---|---|
| Sponsor: | SIGNUS Medizintechnik GmbH |
| 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: | RABEA™ device |
| Device Classification | Class II |
| Classification Name: | Spinal vertebral body replacement device; Intervertebral fusion device with |
| bone graft, cervical | |
| Regulation: | 888.3060; 888.3080 |
| Device Product Code: | MQP; ODP |
| Device Description: | The basic shape of the RABEA device is a rectangular frame. The upper |
| and lower aspects of the implant are open with surface spikes which assist | |
| in the positive anchorage and seating of the implant between the superior | |
| and inferior vertebral bodies. The device is available in a variety of sizes | |
| enabling the surgeon to choose the size best suited to the individual | |
| pathology and anatomical condition. | |
| Intended Use: | When used as a vertebral body replacement, the RABEA devices are |
| indicated for use in skeletally mature patients to replace a vertebral body | |
| that has been resected or excised due to tumor or trauma/fracture. The | |
| device is intended for use in the thoracolumbar spine (from T1 to L5) and is | |
| intended for use with supplemental internal fixation. The RABEA device is | |
| intended to be implanted in pairs and may be used with allograft or | |
| autograft. |
When used as an intervertebral fusion device, the RABEA devices are
intended for use in skeletally mature patients 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). The cervical device is to be used in
patients who have had six weeks of non-operative treatment. The devices
are designed for use with autograft to facilitate fusion and intended for use
with supplemental internal fixation. One RABEA device is used per
intervertebral space. |
| Materials: | The RABEA device is manufactured from either titanium alloy (Ti-6Al-4V)
as described by ASTM F136 or polyetheretherketone (PEEK-OPTIMA®
LT1, Invibio™) as described by ASTM F2026. Integral marker pins in the
PEEK implants are manufactured from titanium alloy (Ti-6Al-4V) as
described by ASTM F136. |
| Substantial
Equivalence: | Documentation was provided which demonstrated the RABEA to be
substantially equivalent to previously cleared devices. The substantial
equivalence is based upon equivalence in basic design, intended use,
indications, anatomic sites and performance. |
. . . .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SIGNUS Medizintechnik GmbH % Dr. Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, OH 44026-2141
Re: K082848
Trade/Device Name: NUBIC™ and RABEA™ Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: July 22, 2009 Received: July 23, 2009
JUL 2 4 2009
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 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 of it rate of your may (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Dr. Karen E. Warden
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Harbare frels
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K08 2848 Page 1 of 2
Indications for Use Statement
510(k) Number:
Device Name: NUBIC device
Indications for Use:
When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the NUBIC devices are intended for use in skeletally mature patients 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). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One NUBIC device is used per intervertebral space. A connecting screw is available which allows the NUBIC device (without strut) to be physically attached to the SIGNUS TOSCA II anterior cervical plate systems if desired.
Prescription Use (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)
Ea
(EXT for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K082848
5
K082848 page 2 of
Over-the-Counter Use
Indications for Use Statement
510(k) Number:
Device Name: RABEA device
Indications for Use:
When used as a vertebral body replacement, the RABEA devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The RABEA device is intended to be implanted in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the RABEA devices are intended for use in skeletally mature patients 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). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One RABEA device is used per intervertebral space.
Prescription Use X (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
En (Ext for Mux)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_に08ことよ48