(24 days)
Not Found
No
The 510(k) summary describes a physical interbody device and an inserter instrument. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The modifications described are purely mechanical to the inserter instrument.
Yes
The device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms. It acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation, which is a therapeutic function addressing a medical condition.
No
The device, the Incite Anchored Cervical Interbody Device, is an implant used as a spacer for spinal fusion, not to diagnose a condition.
No
The device is a physical implant (PEEK and titanium alloy) and a surgical instrument (stainless steel inserter), not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant and its associated instrument for treating degenerative disc disease in the cervical spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as an interbody device (implant) and an inserter (surgical instrument). These are physical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant and instrument.
N/A
Intended Use / Indications for Use
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Incite Anchored Cervical Interbody (ACI) Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Device is manufactured from PEEK and Ti 6A1 4V titanium alloy with tantalum radiopaque markers.
The purpose of this submission is to add the updated ACI II Inserter to the ACI System. The ACI II Inserter is used with the Incite Innovation Anchored Cervical Interbody Device. The inserter places the implant in the surgical site, deploys the anchor and detaches from the implant. The patient contacting material of the inserter is stainless steel (SS 17-4). The ACI II Inserter has been modified to be smaller, lighter in weight and easier to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, disc level from 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation was conducted for the ACI II Inserter. Design Verification included verification of the ACI II Inserter component dimensions performed through Device Interface Analysis (DIA). This analysis ensures that the interfacing components fit and function as specified for the components of the instrument as well as, the instrument with the implant. Design Validation was based on products requirements for the ACI II Inserter and on the previous inserter user validation methodology (ACI Inserter, K122008 & K130306). Design validation using a human cadaver demonstrated that the instrument met the user's needs in terms of overall use by attaching, placing, deploying and detaching from the implant.
Verification and validation data demonstrate that the performance and functionality of the ACI II Inserter is substantially equivalent to the ACI Inserter.
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.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2015
Incite Innovation % Ms. Renee Murphy Senior Regulatory Affairs Specialist Alphatec Spine, Incorporated 5818 El Camino Real Carlsbad, California 92008
Re: K150913
Trade/Device Name: Incite Anchored Cervical Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: April 3, 2015 Received: April 6, 2015
Dear Ms. Murphy:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Renee Murphy
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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Mark N. Melkerson -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150913
K150913 Page 1 of 1
Device Name
Incite Anchored Cervical Interbody Device
Indications for Use (Describe)
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
I. SUBMITTER
John Kirwan, President Incite Innovation, LLC 1500 Main Street, Suite 2410 Springfield, MA 01115 Phone: (413) 382-0210
Date Prepared: April 3, 2015
II. DEVICE
Name of Device: Incite Anchored Cervical Interbody Device Common or Usual Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: OVE
III. PREDICATE DEVICES
Incite Anchored Cervical Interbody Device, K130306, Primary Predicate Incite Anchored Cervical Interbody Device, K122008, Additional Predicate
IV. DEVICE DESCRIPTION
The Incite Anchored Cervical Interbody (ACI) Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Device is manufactured from PEEK and Ti 6A1 4V titanium alloy with tantalum radiopaque markers.
Purpose of this 510(k) submission: The purpose of this submission is to add the updated ACI II Inserter to the ACI System. The ACI II Inserter is used with the Incite Innovation Anchored Cervical Interbody Device. The inserter places the implant in the surgical site, deploys the anchor and detaches from the implant. The patient contacting material of the inserter is stainless steel (SS 17-4). The ACI II Inserter has been modified to be smaller, lighter in weight and easier to use.
V. INDICATIONS FOR USE
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with
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degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody
Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The technological design features of the ACI II Inserter are similar to the previous version of the inserter. The design of the implant/device (ACI fusion device) has not changed since the predicate submission. Both versions of the ACI Inserter:
- . Attach and detach from the Incite Innovation implant/anchor,
- Place the Incite Innovation implant into the surgical site and
- Deploy the anchor. .
VII. PERFORMANCE DATA
The following performance information is being provided in support of a substantial equivalence determination.
Design verification and validation was conducted for the ACI II Inserter. Design Verification included verification of the ACI II Inserter component dimensions performed through Device Interface Analysis (DIA). This analysis ensures that the interfacing components fit and function as specified for the components of the instrument as well as, the instrument with the implant. Design Validation was based on products requirements for the ACI II Inserter and on the previous inserter user validation methodology (ACI Inserter, K122008 & K130306). Design validation using a human cadaver demonstrated that the instrument met the user's needs in terms of overall use by attaching, placing, deploying and detaching from the implant.
Verification and validation data demonstrate that the performance and functionality of the ACI II Inserter is substantially equivalent to the ACI Inserter.
CONCLUSION VIII.
Based upon the information provided in this Special 510(k) submission, it has been determined that the ACI II Inserter is substantially equivalent to the previous version of the inserter in regards to the Indications for Use, fundamental scientific technology, materials, labeling, packaging, and performance characteristics.
The subject and predicate ACI fusion device submissions, which include the two different ACI Inserter designs, were demonstrated to be substantially equivalent.