(513 days)
No
The description focuses on the mechanical design and material of a lumbar interbody fusion device, with no mention of AI or ML capabilities.
Yes.
The device is used for intervertebral body fusion procedures to treat degenerative disc disease, which is a medical condition.
No
The device is an implantable interbody fusion device, used for treatment of degenerative disc disease, not for diagnosis.
No
The device description clearly describes a physical implantable device made of PEEK OPTIMA LT1, designed for intervertebral body fusion. It mentions mechanical tests and a cadaver trial, which are typical for hardware devices, 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a physical implantable device (a lumbar interbody cage) used in surgical procedures to fuse vertebrae. It is used in vivo (within the body), not in vitro (in a lab setting with specimens).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVDs.
The IMPIX Lumbar Interbody Device is a surgical implant used for spinal fusion.
N/A
Intended Use / Indications for Use
IMPIX Lumbar Interbody Device is 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 Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The IMPIX Lumbar Cage is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the IMPIX-L are open, to allow the surgeon to pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to the varying morphology of patients, the IMPIX Lumbar Cages are available in various sizes. The IMPIX Lumbar Cage is machined from PEEK OPTIMA LT1.
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)
Tests performed, according to ASTM F2077 & ASTM F2267, indicate that the IMPIX Lumbar Interbody Fusion devices meet required mechanical strengths. Tests conducted included axial compression, compressive shear, resistance to subsidence and resistance to expulsion.
In addition, a cadaver trial was performed to demonstrate implantation technique.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IMPIX Lumbar Interbody Device, MAX (K072226)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/2 description: The image shows the word "MEDICREA" in bold, black letters inside of a rectangular border. The first letter, "M", has a design on the left side of it. There is a small circle to the right of the "A".
510(K) SUMMARY
MAY 1 9 2010
1. GENERAL INFORMATION
| Date Submitted | December 18, 2008 |
|---|---|
| Trade Name | IMPIX-ALIF LUMBAR Interbody Device (Model IMPIX-LA) |
| IMPIX-ALIF D LUMBAR Interbody Device (Model IMPIX-LAD) | |
| IMPIX-TLIF LUMBAR Interbody Device (Model IMPIX-TLIF) | |
| Common Name | intervertebral body fusion device |
| Classification Name | intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketed | |
| predicate devices | IMPIX Lumbar Interbody Device, MAX (K072226) |
| Submitter | MEDICREA Technologies |
| Z.I. Chef de Baie | |
| 17000 La Rochelle, France | |
| Contact | Donald W. GUTHNER |
| 111 Hill Road | |
| Douglasville, PA 19518 |
2. PREDICATE DEVICE DESCRIPTION
The IMPIX Lumbar Cage is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the IMPIX-L are open, to allow the surgeon to pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to the varying morphology of patients, the IMPIX Lumbar Cages are available in various sizes. The IMPIX Lumbar Cage is machined from PEEK OPTIMA LT1.
1
Image /page/1/Picture/2 description: The image shows the word "MEDICREA" in bold, black letters on a white background. The letters are enclosed in a black rectangular border. There is a registered trademark symbol to the right of the letter A. To the left of the word is a partial graphic of an unknown object.
3. DESCRIPTION OF DEVICE MODIFICATION
The purpose of this submission is to submit three new Lumbar Interbody devices:
- IMPIX-LA
- IMPIX-LAD -
- IMPIX-TLIF -
Those three new devices and previously cleared in K072226 IMPIX-L Interbody devices are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ only in design.
4. INTENDED USE
IMPIX Lumbar Interbody Device is 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 Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
5. PERFORMANCE DATA
Tests performed, according to ASTM F2077 & ASTM F2267, indicate that the IMPIX Lumbar Interbody Fusion devices meet required mechanical strengths. Tests conducted included axial compression, compressive shear, resistance to subsidence and resistance to expulsion.
In addition, a cadaver trial was performed to demonstrate implantation technique.
6. CLINICAL TESTING
Not applicable to this device
7. CONCLUSIONS
Based on the 510(k) Summary and the information provided herein, we conclude that the IMPIX LUMBAR Interbody Fusion Devices are substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.
8. Additional Information
No additional information.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAY 1 9 2010
Medicrea Technologies % Donald W. Guthner Orgenix, LLC 111 Hill Road Douglassville, PA 19518
Re: K083798
rcoos770
Trade/Device Name: Impix ALIF Lumbar IBF, ALIF-D Lumbar IBF, TLIF Lumbar IBF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 12, 2010 Received: May 13, 2010
Dear Mr. Guthner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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 connivelo phor the 2011-170, the accordance with the provisions of the Federal Food, Drug, teches hat fa vo occh rocation require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 on may, morely inams of the Act include requirements for annual registration, listing of general controls provisions of vactice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability acanceration. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see aboye) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be may be subject to attentions. 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 r loase of the rised that I Dr o losean that your device complies with other requirements of the Act that + 2 . deval statutes and regulations administered by other Federal agencies. You must or any I 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 - Mr. Donald W. Guthner
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/ucm11.5809.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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Barbara Buchner
Mark N. Melkerso Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: IMPIX Lumbar Interbody Devices
Indications for Use
IMPIX Lumbar Interbody Device is 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 Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X : (Part 21 CFR 801 Subpart D)
AND/OR
ANNER FRID CUTATION WALL BARN AND ART ART ART ARE ARM AND ARM AND AND AND AND AND AND AND AND A
Over-The-Counter Use (21 CFR 801 Subpart C)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K083798 510(k) Number_
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