(154 days)
Not Found
No
The summary describes a physical implantable device made of PEEK with tantalum markers, intended for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests of the physical device.
Yes
The device is an intervertebral fusion device used to treat degenerative disc disease, which involves maintaining disc space distraction and promoting bone fusion to alleviate symptoms. This direct intervention for a medical condition qualifies it as a therapeutic device.
No
This device is an intervertebral fusion device, designed to maintain disc space and facilitate fusion, not to diagnose a condition. Its indication for use is for treatment of degenerative disc disease, not diagnosis.
No
The device description clearly states it is a physical implant made from PEEK with tantalum markers, designed for surgical implantation in the cervical spine. It is a hardware device, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The IMSE Cervical Cage is an implantable device used in surgery to fuse vertebrae in the cervical spine. It is a structural device, not a diagnostic test.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a diagnostic test.
- Device Description: The description details the physical characteristics and materials of the implant, not components of a diagnostic test kit or instrument.
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the device (compression, shear, torsion, subsidence, expulsion), which are relevant for an implantable device, not a diagnostic test.
The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral fusion device, the IMSE Cervical Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior screw systems) cleared for use in the cervical spine.
Product codes
ODP
Device Description
The IMSE Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The IMSE Cervical Cage of intervertebral body fusion devices are made from the PEEK (Solvay Zeniva ZA-500) radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C3-C7
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
Nonclinical Test Summary: The following tests were performed to demonstrate that the IMSE Cervical Cage is substantially equivalent to other predicate devices. Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Static and Dynamic Torsion ASTM F2077 Subsidence Test per ASTM F2267 Wear Debris ASTM F1877 Static Expulsion Test The results of these studies showed that the IMSE Cervical Cage met the acceptance criteria.
Clinical Test Summary: No clinical tests were performed.
Key Metrics
Not Found
Predicate Device(s)
K 133529
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/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 symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
The Institute of Musculoskeletal Science & Education Mr. Ed McShane Director of Development 418 E. Lancaster Ave Wayne, Pennsylvania 19087
Re: K162003
Trade/Device Name: IMSE Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: December 1, 2016 Received: December 1, 2016
Dear Mr. McShane:
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 devicerelated 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.
1
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,
Vincent J. Devlin -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) K162003
Device Name IMSE Cervical Cage
Indications for Use (Describe)
When used as a cervical intervertebral fusion device, the IMSE Cervical Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior screw systems) cleared for use in the cervical spine.
| 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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C)
3
Traditional 510(k) Summary
as required by section 807.92(c).
IMSE Cervical Cage K162003
| Revised | 12/20/16 |
|---|---|
| Submitter: | The Institute of Musculoskeletal Science & Education |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Contact Person | Ed McShane |
| Director of Development | |
| Phone: (484) 420-4286 | |
| Fax: (484) 318-8031 | |
| Email: emcshane@imseinstitute.org | |
| Trade Name | IMSE Cervical Cage |
| Common Name | Intervertebral Body Fusion Device |
| Device Class | Class II |
| Classification Name | |
| and Number | Intervertebral fusion device with bone graft, cervical |
| 21 CFR 888.3080 | |
| Classification Panel: | Orthopedic |
| Product Code | ODP |
| Reason for 510k | New Device |
| Predicate Devices | Camber Spine Coveris Cervical Cage (K 133529) |
| Device Description | The IMSE Cervical Cage series of intervertebral body fusion devices |
| are used to maintain disc space distraction in skeletally mature adults | |
| requiring intervertebral body fusion. They are designed to be used in | |
| conjunction with supplemental spinal fixation instrumentation. The | |
| series is comprised of cages of various fixed heights and shapes for | |
| placement in the cervical spine. Each cage has a hollow center to | |
| allow placement of autograft inside of the cage. Ridges on the | |
| superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. | |
| The IMSE Cervical Cage of intervertebral body fusion devices are | |
| made from the PEEK (Solvay Zeniva ZA-500) radiolucent material with | |
| embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively. |
4
| Indications for Use | When used as a cervical intervertebral fusion device, the IMSE Cervical Cage
is indicated for use at one level in the cervical spine, from C3-C7, in
skeletally mature patients who have had six weeks of non-operative
treatment for the treatment of degenerative disc disease (DDD) with up to
Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic
studies. The device is intended for use with autogenous bone graft and with
supplemental fixation systems (such as anterior cervical plating systems, or
posterior screw systems) cleared for use in the cervical spine. |
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| The implant is manufactured from ASTM2026 Solvay Zeniva | |
|---|---|
| Materials: | ZA-500 implant grade Polyetheretherketone (PEEK) |
| Statement of
Technological
Comparison | IMSE Cervical Cage and its predicate devices have the same indications for
use, design, and test results. Both devices are manufactured using
materials with a long history of use in orthopaedic implants. |
| --------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
5
| Nonclinical Test
Summary | The following tests were performed to demonstrate that the IMSE Cervical Cage is
substantially equivalent to other predicate devices. Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Static and Dynamic Torsion ASTM F2077 Subsidence Test per ASTM F2267 Wear Debris ASTM F1877 Static Expulsion Test The results of these studies showed that the IMSE Cervical Cage met the acceptance
criteria. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test
Summary | No clinical tests were performed. |
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing of
the process was conducted (using the half-cycle method) to a Sterility Assurance Level
(SAL) of 10-6 per ISO 17665. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instruments and
Case | The instrument and case will be shipped non-sterile and will be autoclaveable,
validation testing of the process was conducted (using the half-cycle method) to a
Sterility Assurance Level (SAL) of 10-6 per ISO 17665. |
| Conclusion | The IMSE Cervical Cage is substantially equivalent to its predicate devices. This conclusion is based upon the fact the IMSE Cervical Cage and its predicate devices have the same indications for use, design and technical characteristics, test results, and there are no different questions of safety and effectiveness. |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |