(177 days)
P950019
No
The summary describes a physical implant (lumbar cage) and its mechanical properties and intended use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
No.
Explanation: The device is an implantable lumbar cage used for intervertebral body fusion procedures to stabilize the spinal column. While it treats a medical condition, its primary function is structural support and fusion, not a therapeutic mechanism (like delivering drugs, electrical stimulation, or heat/cold therapy) that directly alleviates pain or restores function. It facilitates a biological process (bone fusion) that, once completed, provides stability and reduces pain.
No
This device is an implantable lumbar cage used for intervertebral body fusion procedures, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is an "implant" and describes physical characteristics like ridges, graft windows, and X-ray markers, indicating it is a physical hardware device.
Based on the provided information, the INTESS Lumbar Cage is not an IVD (In Vitro Diagnostic) device.
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.
- INTESS Lumbar Cage Function: The INTESS Lumbar Cage is an implantable medical device designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a physical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae, not a diagnostic test.
- Device Description: The description details the physical characteristics of the implant (ridges, graft windows, X-ray markers), not components for analyzing biological samples.
- Performance Studies: The performance studies focus on the mechanical properties and stability of the implant (compression, subsidence, expulsion), which are relevant to a surgical implant, not a diagnostic test.
Therefore, the INTESS Lumbar Cage falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The INTESS Lumbar Cage was developed as implants for the stabilization of the lumbar spinal column. The INTESS implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.
Materials:
Zeniva® ZA-500 PEEK conforming to ASTM F2026. Unalloyed tantalum (ASTM F560)
Function:
Maintain adequate disc space until fusion occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from 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)
No clinical studies were performed. The following non-clinical tests were conducted:
- Static and dynamic compression per ASTM F2077 .
- Subsidence per ASTM F2267 ●
- . Expulsion
The results of this testing indicate that the INTESS Lumbar Cage is equivalent to 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.
RAY THREADED LUMBAR FUSION CAGE (P950019)
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.
Lucent Straight Intervertebral Body Fusion Device - K071724/K081968, BRANTIGAN I/F CAGE - P960025
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
510(k) Summary for the INTESS Lumbar Cage
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the INTESS Lumbar Cage
1. GENERAL INFORMATION
MAR 2 8 2013.
| Date Prepared: | September 26, 2012 |
|---|---|
| Trade Name: | INTESS Lumbar Cage |
| Common Name: | intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device - lumbar |
| Class: | II |
| Product Code: | MAX |
| CFR section: | 21 CFR section 888. |
| Device panel: | Orthopedic |
| Legally Marketed: | Lucent Straight Intervertebral Body Fusion Device - K071724/K081968 |
| BRANTIGAN I/F CAGE - P960025 | |
| Predicate Device: | RAY THREADED LUMBAR FUSION CAGE (P950019) |
| Submitter: | Dayne Popa |
| Kalitec Direct, LLC | |
| 555 Winderley Place - Suite 300 | |
| Maitland FL 32751 | |
| 407-545-2063 Tele | |
| Contact: | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net |
2. DEVICE DESCRIPTION
The INTESS Lumbar Cage was developed as implants for the stabilization of the lumbar spinal column. The INTESS implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.
Materials:
Zeniva® ZA-500 PEEK conforming to ASTM F2026. Unalloyed tantalum (ASTM F560)
Function:
Maintain adequate disc space until fusion occurs.
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The INTESS Lumbar Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
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4. INTENDED USE
The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
5. NON-CLINICAL TEST SUMMARY
The following tests were conducted:
- Static and dynamic compression per ASTM F2077 .
- Subsidence per ASTM F2267 ●
- . Expulsion
The results of this testing indicate that the INTESS Lumbar Cage is equivalent to predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
Kalitec Direct, LLC considers the INTESS Lumbar Cage to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2013
Kalitec Direct, LLC % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K123100
Trade/Device Name: INTESS Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 05, 2013 Received: March 11, 2013
Dear Mr. Webb:
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 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.
3
Page 2 - Mr. J.D. Webb
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Frin DKeith
Mark N. Melkerson Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): __ K 123100 ._______________________________________________________________________________________________________________________________________
Device Name: INTESS Lumbar Cage
Indications for Use:
The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices