(220 days)
Not Found
No
The summary describes a physical intervertebral body fusion cage and associated instrumentation, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended for intervertebral body fusion of the spine, specifically for the treatment of symptomatic disc degeneration (DDD) and degenerative disc disease, which are medical conditions, thereby falling under the definition of a therapeutic device.
No
Explanation: The device is an intervertebral body fusion implant and associated instrumentation, used for surgical treatment of spinal conditions, not for diagnosing them. Its intended use is to facilitate fusion and provide structural support, which are therapeutic functions.
No
The device description clearly states it is a physical implant (cage) made of Ti6Al4V ELI alloy and includes physical instrumentation made of stainless steel. There is no mention of software as the primary or sole component.
Based on the provided information, the ROCCIA® MultiLIF device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- ROCCIA® MultiLIF Function: The ROCCIA® MultiLIF is an implantable device (a cage) used for intervertebral body fusion of the spine. It is surgically placed within the body to facilitate bone fusion.
- Intended Use: The intended use clearly describes a surgical procedure and the device's role in supporting spinal fusion, not in analyzing biological specimens.
- Device Description: The description focuses on the physical characteristics of the implant and the surgical instruments used for its placement.
The ROCCIA® MultiLIF is a surgical implant and associated instrumentation, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ROCCIA® MultiLIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The ROCCIA® MultiLIF implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
The ROCCIA® MultiLIF implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 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 ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Product codes (comma separated list FDA assigned to the subject device)
MAX, PHM
Device Description
The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy. The cage has a large cylindrical hollow in the middle which can be filled with bone material. The cage has numerous threaded holes that allow for correct placement of the cage.
The ROCCIA MultiLIF cage is available in a range of sizes to accommodate individual patient pathology and anatomical conditions.
The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA MultiLlF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.
The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine, thoracic spine from T1 to T12, thoracolumbar junction (T12-L1), lumbar spine, from L1 to S1
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)
Non-Clinical Performance Data:
- Mechanical Load Testing – Comparison performed with subject device and predicate device showing comparable results when tested in accordance with ASTM F2077.
- Subsidence Behavior Testing – Comparison performed with subject device and predicate device showing comparable results when tested in accordance with ASTM F2267.
- Static Expulsion Testing – Comparison performed with subject device and predicate device showing comparable results when tested.
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.
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
December 21, 2017
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Silony Medical GmbH % Indraj Bamrah Senior Regulatory Consultant Emergo Global Consulting. LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K171434
Trade/Device Name: ROCCIA® MultiLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: November 30, 2017 Received: December 4, 2017
Dear Indraj Bamrah:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Indraj Bamrah
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171434
Device Name ROCCIA® MultiLIF
Indications for Use (Describe)
The ROCCIA® MultiLIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The ROCCIA® MultiLIF implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
The ROCCIA® MultiLIF implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 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 ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
ROCCIA® MultiLIF
K171434
1. Submission Sponsor
Silony Medical GmbH
Leinfelder Straße 60
70771 Leinfelden-Echterdingen
GERMANY
Phone number: +49 711 78 25 25 40
Contact: Bircan TASDELEN
Title: Head of Quality Management and Regulatory Affairs
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327.9997
Contact: Indraj Bamrah, Senior Regulatory Consultant
Email: project.management@emergogroup.com
3. Date Prepared
December 19, 2017
4. Device Identification
| Trade/Proprietary Name: | ROCCIA® MultiLIF |
|---|---|
| Common/Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
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Page 2 of 4 Regulation Number: 888.3080 Product Code: MAX, Intervertebral Fusion Device with Bone Graft, Lumbar PHM, Intervertebral Fusion Device with Bone Graft, Thoracic Device Class: Class II Classification Panel: Orthopedic
5. Legally Marketed Predicate Device
Primary Predicate: K153419, NuVasive® CoRoent® Thoracolumbar System, NuVasive, Incorporated.
6. Device Description
The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy. The cage has a large cylindrical hollow in the middle which can be filled with bone material. The cage has numerous threaded holes that allow for correct placement of the cage.
The ROCCIA MultiLIF cage is available in a range of sizes to accommodate individual patient pathology and anatomical conditions.
The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA MultiLlF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.
The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.
7. Indications for Use Statement
The ROCCIA® MultiLIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The ROCCIA® MultiLIF implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for
5
the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
The ROCCIA® MultiLIF implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 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 ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
8. Substantial Equivalence Discussion
The ROCCIA MultiLIF has shown to be substantially equivalent to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials and performance testing.
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of ROCCIA MultiLlF and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Silony Medical GmbH completed a number of non-clinical performance tests. The ROCCIA MultiLIF is substantially equivalent to predicate devices.
The ROCCIA MultiLIF passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Mechanical Load Testing – Comparison performed with subject device and predicate device showing comparable results when tested in accordance with ASTM F2077.
- Subsidence Behavior Testing – Comparison performed with subject device and predicate device showing comparable results when tested in accordance with ASTM F2267.
- . Static Expulsion Testing – Comparison performed with subject device and predicate device showing comparable results when tested.
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
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11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device; or has different technological characteristics but design control activities show that the differences do not raise new questions of safety and effectiveness when compared to the predicate. Based on the comparison and analysis above, the ROCCIA MultiLIF is determined to be substantially equivalent to the referenced predicate device.