(50 days)
Not Found
No
The summary describes a physical intervertebral fusion device and its mechanical properties, with no mention of AI or ML technology in its design, function, or intended use.
Yes.
The device is used for the treatment of degenerative disc disease and acts as an intervertebral fusion device to facilitate fusion, which aims to alleviate back pain and stabilize the spine.
No
The device description states it is a "hollow structural frame" used for fusion, and the intended use describes it as an "intervertebral fusion device." This indicates its purpose is therapeutic (fusion) rather than diagnostic (identifying or detecting disease).
No
The device description clearly describes a physical implant (hollow structural frame with surface spikes) intended for surgical implantation in the lumbar spine. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, treating degenerative disc disease. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a physical implant designed to be placed between vertebral bodies.
- 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 and provide diagnostic information. This device is a surgical implant used in vivo for treatment.
N/A
Intended Use / Indications for Use
When used as an intervertebral fusion device, the MOBIS® II devices are intended for use at one or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The basic shape of the MOBIS® II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and two angulations thereby 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
lumbar spine, from L2 to S1
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)
Mechanical testing of the worst case MOBIS® II was performed according to ASTM F2077 and included static and dynamic compression. The subsidence properties were evaluated according to ASTM F2267.
The mechanical test results demonstrate that the MOBIS® II device performance is substantially equivalent to the 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.
MOBIS® and PEEK TETRIS™ (K111792), Python (K090064)
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.
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K131372 Page 1 of 2
510(k) Summary
Date: Sponsor: 20 June 2013 SIGNUS Medizintechnik GmbH
Industriestrasse 2
.
JUL 0 2 2013
| D-63755 Alzenau, GERMANY | |
|---|---|
| Tel. + 49 (0) 6023 9166-136 | |
| Fax + 49 (0) 6023 9166-161 | |
| Url: http://www.signus-med.de | |
| Contact Person: | Joachim Schneider, Quality Management/Regulatory Affairs |
| Trade Names: | MOBIS ® II |
| Device Classification | Class II |
| Classification Name: | Intervertebral fusion device with bone graft, lumbar |
| Regulation: | 888.3080 |
| Device Product | |
| Code: | MAX |
| Device Description: | The basic shape of the MOBIS ® II devices is a hollow structural |
| frame having a rounded, tapered leading face. The upper and lower | |
| aspects of the implant are open. Surface spikes assist in the positive | |
| anchorage and seating of the implant between the vertebral bodies. | |
| The device is available in a variety of sizes and two angulations | |
| thereby enabling the surgeon to choose the size best suited to the | |
| individual pathology and anatomical condition. | |
| Intended Use: | When used as an intervertebral fusion device, the MOBIS ® II |
| devices are intended for use at one or two contiguous levels in the | |
| lumbar spine, from L2 to S1, 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 lumbar device is | |
| to be used in patients who have had six months of non-operative | |
| treatment. Patients with previous nonfusion spinal surgery at the | |
| involved level may be treated with the device. The devices are | |
| intended for use with a supplemental internal fixation system and | |
| with autograft to facilitate fusion. | |
| Materials: | The MOBIS ® II devices are manufactured from polyetheretherketone |
| (PEEK-OPTIMA ® LT1, Invibio ® ) as described by ASTM F2026. | |
| Integral marker pins used in the devices are manufactured from | |
| tantalum as described by ASTM F560. | |
| Predicate Devices: | MOBIS ® and PEEK TETRIS ™ (K111792) |
| Python (K090064) | |
| Performance Data: | Mechanical testing of the worst case MOBIS ® II was performed |
| according to ASTM F2077 and included static and dynamic | |
| compression. The subsidence properties were evaluated according | |
| to ASTM F2267. | |
| The mechanical test results demonstrate that the MOBIS ® II device | |
| performance is substantially equivalent to the predicate devices. |
1
Technological Characteristics:
MOBIS® II possesses the same technological characteristics as the predicate devices. These include:
- . performance (as described above),
- basic design (hollow structural frame), .
- . material (PEEK polymer and tantalum), and
- sizes (widths, lengths and heights are within the range(s) . offered by the predicate).
Therefore the fundamental scientific technology of the MOBIS® II device is the same as previously cleared devices.
The MOBIS® II devices possess the same intended use and technological characteristics as the predicate devices. Therefore the MOBIS® II is substantially equivalent for its intended use.
Conclusion:
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circular fashion around the top of the emblem.
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
July 2, 2013
SIGNUS Medizintechnik GmbH % BackRoads Consulting, Incorporated Dr. Karen E. Warden Representative / Consultant P.O. Box 566 Chesterland. Ohio 44026
Re: K131372
Trade/Device Name: MOBIS® II Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 8, 2013 Received: May 13, 2013
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. 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
3
Page 2 – Dr. Karen E. Warden
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (301) 796-7100 or at its Internet address :
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
For Erin L. Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 7 - Indications for Use Statement
510(k) Number: K131372
Device Name: MOBIS® II
Indications for Use:
When used as an intervertebral fusion device, the MOBIS® II devices are intended for use at one or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.
Prescription Use X
OR Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)