(121 days)
No
The summary describes a passive implant (cervical cage) and its mechanical properties, with no mention of AI/ML in the intended use, device description, or performance studies.
No.
The device is a cervical cage intended for spinal fusion, which is an implantable device to maintain disc space until fusion, rather than actively treating a disease or condition.
No
The document describes a cervical cage intended for spinal fusion procedures, which is a treatment device, not a diagnostic one. Its function is to "Maintain adequate disc space until fusion occurs," indicating a therapeutic purpose.
No
The device description clearly states it is an implant made of PEEK and tantalum, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior interbody spinal fusion procedures" and is an "implant" for "stabilization of the cervical column." This describes a surgical implant used in vivo (within the body) for structural support and fusion.
- Device Description: The description details a physical implant made of specific materials (PEEK and tantalum) with features like graft windows and ridges. This is consistent with a surgical device, not a diagnostic test.
- Function: The stated function is to "Maintain adequate disc space until fusion occurs," which is a mechanical function within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing.
Therefore, the INTESS™ Cervical Cage is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.
Product codes
ODP
Device Description
The INTESS™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.
Materials:
Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to 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
Cervical column, one disc level (C2-T1)
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
The following tests were conducted:
- . Static and dynamic compression per ASTM F2077
- . Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267 .
The results of this testing indicate that the INTESS™ Cervical Cage is equivalent to predicate devices.
No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
Spinal Elements, Crystal Cervical Cage (K073351)
Reference Device(s)
Zimmer, BAK/C Vista Interbody Fusion (P980048 S3), LDR Spine Cervical Interbody Fusion System (K091088), Daytona Anterior Cervical Cage System (K110733)
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.
0
APR 1 6 2014
510(k) Summary for the INTESS™ Cervical Cage
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the INTESS™ Cervical Cage
1. GENERAL INFORMATION
| Date Prepared: | April 10, 2014 |
|---|---|
| Trade Name: | INTESS™ Cervical Cage |
| Common Name: | intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device - cervical |
| Class: | II |
| Product Code: | ODP |
| CFR section: | 21 CFR section 888.3080 |
| Device panel: | Orthopedic |
| Legally Marketed | Spinal Elements, Crystal Cervical Cage (K073351) |
| Predicate Device: | Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) |
| LDR Spine Cervical Interbody Fusion System (K091088) | |
| Daytona Anterior Cervical Cage System (K110733) | |
| Submitter: | Kalitec Direct, LLC |
| 618 E. South Street, Suite 500 | |
| Orlando, FL 32801 | |
| W (407) 545-2063 | |
| 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™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.
Materials:
Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.
Function:
Maintain adequate disc space until fusion occurs.
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.
The INTESS™ Cervical 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™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.
5. NON-CLINICAL TEST SUMMARY
The following tests were conducted:
- . Static and dynamic compression per ASTM F2077
- . Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267 .
The results of this testing indicate that the INTESS™ Cervical 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™ Cervical Cage to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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
April 16, 2014
Kalitec Direct, LLC % The OrthoMedix Group, Incorporated Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K133815
Trade/Device Name: INTESS™ Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 21, 2014 Received: January 23, 2014
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
3
Page 2 - Mr. J.D. Webb
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" (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/Safetv/ReportalProblem/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.
Sincercly yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K133815
Device Name
INTESS™ Cervical Cage
Indications for Use (Describe)
The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-TI). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ----------
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
E Blogh de
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Division of
FORM FDA 3881 (9/13)
.. : :
PSC Publishing Services (301) +43-6740
Form Approved: OMB No, 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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