(327 days)
No reference devices were used in this submission
No
The summary describes a 3D printed intervertebral cage and its mechanical properties, with no mention of AI or ML in its design, function, or intended use.
Yes
The device is used to treat degenerative disc disease and facilitate spinal fusion, which are therapeutic interventions.
No
This device is an implantable intervertebral body fusion cage, designed to provide structural support for spinal fusion, not to diagnose a condition.
No
The device description explicitly states the device is an implant manufactured from titanium alloy, which is a hardware component.
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: The description clearly states that the IMPIX 3D Print cages are implants designed for intervertebral body fusion procedures. They are surgically placed within the body to provide structural support and promote bone fusion.
- Intended Use: The intended use describes a surgical procedure to treat degenerative disc disease by implanting the device. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with in vitro diagnostics.
Therefore, the IMPIX 3D Print cages are medical devices intended for surgical implantation, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
IMPIX 3D Print cages are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
IMPIX 3D Print cages are to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The IMPIX 3D Print PLIF, IMPIX 3D Print TLIF, and IMPIX 3D Print TLIF-S are intervertebral lumbar devices, which consists of a variety of shapes and sizes. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function: The 3D printed Lumbar cage was developed as an implant:
- To provide immobilization and stabilization of anterior spinal segments
- to augment the development of a solid spinal fusion
- to provide stability to ease fusion
- to be mechanically resistant to allow the fusion of the operated level
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-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 Test Summary:
Testing was performed on the system following the protocols outlined in ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and in the ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".
The following tests were conducted: Static Compression, Static Compression-shear, Dynamic Compression, Dynamic Compression-shear, Subsidence test, and Expulsion test
Clinical Test Summary:
No clinical studies were performed. Published literature was used to demonstrate substantial equivalence.
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.
K2M Cascadia Interbody System (K150481), MEDICREA INTERNATIONAL IMPIX-L (K072226), CAPSTONE® Spinal System (K121760), MEDICREA IMPIX ALIF (K083798), NUVASIVE INTERFIXED SYSTEM (K151214)
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.
No reference devices were used in this submission
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 the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2017
Medicrea International S.A. Mr. David Ryan VP Product Development and Marketing 5389 route de Strasbourg 69140 Rillieux-la-Pape FRANCE
Re: K163595
Trade/Device Name: IMPIX 3D Print Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 10, 2017 Received: October 13, 2017
Dear Mr. Ryan:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/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/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 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,
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) K163595
Device Name IMPIX 3D Print cages
Indications for Use (Describe)
IMPIX 3D Print cages are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
IMPIX 3D Print cages are to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
MEDICREA INTERNATIONAL's IMPIX 3D PRINT CAGES
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Posterior Lumbar 3D Print spinal system:
Date Prepared: 09 November 2017
69140 Rillieux-La-Pape
FR
-
- Submitter:
MEDICREA INTERNATIONAL
- Submitter:
5389 route de Strasbourq - Vancia
Contact Person:
David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourq - Vancia 69140 Rillieux-La-Pape FR
-
- Trade name: IMPIX 3D Print Cages
Regulatory Identification/ Classification
Intervertebral Body Fusion Device with Bone Graft, lumbar Regulation Number: 21CFR 888.3080 Product Code: MAX Class II
-
- Predicate or leqally marketed devices which are substantially equivalent:
Primary predicate:
- K2M Cascadia Interbody System (K150481)
Additional predicate:
- MEDICREA INTERNATIONAL IMPIX-L (K072226) ●
- CAPSTONE® Spinal System (K121760) o
- MEDICREA IMPIX ALIF (K083798) ●
- NUVASIVE INTERFIXED SYSTEM (K151214) ●
No reference devices were used in this submission
4
Description of the device: 4.
The IMPIX 3D Print PLIF, IMPIX 3D Print TLIF, and IMPIX 3D Print TLIF-S are intervertebral lumbar devices, which consists of a variety of shapes and sizes. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function: The 3D printed Lumbar cage was developed as an implant:
- · To provide immobilization and stabilization of anterior spinal segments
- · to augment the development of a solid spinal fusion
- · to provide stability to ease fusion
- · to be mechanically resistant to allow the fusion of the operated level
5. Indication for Use
IMPIX 3D Print cages are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
IMPIX 3D Print cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
6. Substantial equivalence claimed to predicate devices
The IMPIX 3D Print cages are technologically similar to the already cleared Lumbar Interbody Device in terms of intended use, materials used, mechanical safety and performances
- K2M Cascadia Interbody System (K150481) ●
- MEDICREA INTERNATIONAL IMPIX-L (K072226) ●
- MEDICREA INTERNATIONAL IMPIX-L (K072226) ●
- CAPSTONE® Spinal System (K121760) ●
- MEDICREA IMPIX ALIF (K083798) ●
- NUVASIVE INTERFIXED SYSTEM (K151214) ●
5
7. Non-clinical Test Summary:
Testing was performed on the system following the protocols outlined in ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and in the ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".
The following tests were conducted: Static Compression, Static Compression-shear, Dynamic Compression, Dynamic Compression-shear, Subsidence test, and Expulsion test
8. Clinical Test Summary 0
No clinical studies were performed. Published literature was used to demonstrate substantial equivalence.
9. Conclusions Non clinical and Clinical
MEDICREA® INTERNATIONAL IMPIX 3D Print Cages are substantially equivalent to its predicate devices in terms of indications for use, design, material and function.