(154 days)
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 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.
The provided document is a 510(k) premarket notification for a medical device called the "IMSE Cervical Cage." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies like those for novel technologies or AI/ML-based devices.
Therefore, the information requested for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not applicable to this submission.
This submission focuses on nonclinical testing (mechanical tests) to demonstrate that the device performs comparably to a predicate device and is safe and effective for its intended use.
Here's a summary of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The results of these [nonclinical] studies showed that the IMSE Cervical Cage met the acceptance criteria." However, specific numerical acceptance criteria and precise performance values are not detailed in this summary. The tests performed are listed as per ASTM standards, implying that the acceptance criteria are defined by those standards.
| Acceptance Criteria Category | Reported Device Performance (as stated) |
|---|---|
| Mechanical Performance | |
| Static Compression (ASTM F2077) | Met acceptance criteria |
| Dynamic Compression (ASTM F2077) | Met acceptance criteria |
| Static Compression Shear (ASTM F2077) | Met acceptance criteria |
| Dynamic Compression Shear (ASTM F2077) | Met acceptance criteria |
| Static Torsion (ASTM F2077) | Met acceptance criteria |
| Dynamic Torsion (ASTM F2077) | Met acceptance criteria |
| Subsidence (ASTM F2267) | Met acceptance criteria |
| Wear Debris (ASTM F1877) | Met acceptance criteria |
| Static Expulsion Test | Met acceptance criteria |
| Sterilization | |
| Autoclave Validation (ISO 17665) | Achieved Sterility Assurance Level (SAL) of 10^-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a mechanical device. The "test set" refers to physical units of the IMSE Cervical Cage that underwent nonclinical (mechanical) testing. The document does not specify the number of devices or "samples" used for each mechanical test, nor is data provenance in terms of country of origin or retrospective/prospective relevant for this type of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of expert review is relevant for diagnostic or AI/ML devices. For a mechanical device, the "ground truth" is established by adherence to performance standards (like ASTM) measured through engineering tests, not expert consensus on interpretations.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods are typically used for expert review of data, which is not part of this device's nonclinical performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. MRMC studies are for evaluating diagnostic performance, particularly with AI/ML systems where human readers interpret results. This is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering standards and specifications (e.g., ASTM standards) for mechanical strength, durability, and material properties, as opposed to medical diagnostic "ground truth."
8. The sample size for the training set
- Not Applicable. This is a mechanical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
{0}------------------------------------------------
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 |
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."
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 Nameand Number | Intervertebral fusion device with bone graft, cervical21 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 devicesare used to maintain disc space distraction in skeletally mature adultsrequiring intervertebral body fusion. They are designed to be used inconjunction with supplemental spinal fixation instrumentation. Theseries is comprised of cages of various fixed heights and shapes forplacement 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 Cageis indicated for use at one level in the cervical spine, from C3-C7, inskeletally mature patients who have had six weeks of non-operativetreatment for the treatment of degenerative disc disease (DDD) with up toGrade 1 spondylolisthesis. DDD is defined as neck pain of discogenic originwith degeneration of the disc confirmed by history and radiographicstudies. The device is intended for use with autogenous bone graft and withsupplemental fixation systems (such as anterior cervical plating systems, orposterior 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 ofTechnologicalComparison | IMSE Cervical Cage and its predicate devices have the same indications foruse, design, and test results. Both devices are manufactured usingmaterials with a long history of use in orthopaedic implants. |
|---|---|
| --------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
{5}------------------------------------------------
| Nonclinical TestSummary | The following tests were performed to demonstrate that the IMSE Cervical Cage issubstantially 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 acceptancecriteria. |
|---|---|
| Clinical TestSummary | No clinical tests were performed. |
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing ofthe process was conducted (using the half-cycle method) to a Sterility Assurance Level(SAL) of 10-6 per ISO 17665. |
|---|---|
| Instruments andCase | 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 aSterility 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. |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.