(103 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical design and materials of the interbody fusion device.
Yes
The device is intended for "anterior intervertebral body fusion of the lumbar spine" to treat "lumbar degenerative disc disease (DDD)," which involves addressing a medical condition to alleviate symptoms or restore function.
No
The Incite Interbody Fusion Device is an implantable device used for spinal fusion, which is a treatment for degenerative disc disease, not a tool for diagnosing medical conditions.
No
The device description clearly states it is an implant made from physical materials (PEEK, titanium alloy, and tantalum) and is intended for surgical implantation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Incite Interbody Fusion Device is a physical implant designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or the generation of diagnostic information from patient samples.
Therefore, the Incite Interbody Fusion Device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Incite Interbody Fusion Device is intended for anterior intervertebral body fusion of the lumbar spine at one or two contiguous levels from L2-S1. The device is indicated for patients with lumbar degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients treated should be skeletally mature and have received a minimum of six months of non-operative treatment. The Incite Interbody Fusion Device is designed for use with additional supplemental fixation and with autograft to facilitate fusion.
Product codes
OVD
Device Description
The Incite Interbody Fusion Device (IBFD) is an ALIF implant that incorporates the benefit of a radiolucent interbody spacer equipped with internal fixation anteriorly through the use of an integrated anchoring mechanism. The implant is made from materials with a long history of use in this type of application which include PEEK, titanium alloy, and tantalum. The implant has two chambers to accommodate autograft.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K082262, K072253, K081395, P950002
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.
0
r
Image /page/0/Picture/3 description: The image shows a logo for "INCITE INNOVATION". The logo features a stylized symbol above the word "INCITE", with the word "INNOVATION" placed below it in a smaller font size. The symbol consists of a curved shape with a dot in the middle, resembling an eye or a stylized letter. The text is in a bold, sans-serif font, giving the logo a modern and professional appearance.
MAR 2 4 2010
510k Summary
| As required by section 807.92(c) | |
|---|---|
| Company Name | Incite Innovation LLC |
| Address | 1350 Main Street |
| Springfield, MA 01103 | |
| 413-382-0210 Phone | |
| 413-382-0211 Fax | |
| Contact Person | John Kirwan |
| Date | March 1, 2010 |
| Trade Name | Incite Interbody Fusion Device |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device, 21 CFR Part 888.3080, MAX |
| Class | II, Special Controls |
| Predicate Devices | LDR ROI - A™ ALIF Cage with Vertebridge™ Technology and LDR ROI-T TLIF |
| Cage (K082262) | |
| Synthes Synfix™-LR System (K072253) | |
| Biomet Solitaire™ PEEK-Optima® Anterior Spinal System (K081395) | |
| Spine-Tech BAK™ Interbody Fusion System (P950002) | |
| Device Description | The Incite Interbody Fusion Device (IBFD) is an ALIF implant that incorporates |
| the benefit of a radiolucent interbody spacer equipped with internal fixation | |
| anteriorly through the use of an integrated anchoring mechanism. The implant is | |
| made from materials with a long history of use in this type of application which | |
| include PEEK, titanium alloy, and tantalum. The implant has two chambers to | |
| accommodate autograft. | |
| Intended Use | The Incite Interbody Fusion Device is intended for anterior intervertebral body |
| fusion of the lumbar spine at one or two contiguous levels from L2-S1. The | |
| device is indicated for patients with lumbar degenerative disc disease (DDD) with | |
| up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back | |
| pain of discogenic origin with degeneration of the disc confirmed by history and | |
| radiographic studies. Patients treated should be skeletally mature and have | |
| received a minimum of six months of non-operative treatment. The Incite | |
| Interbody Fusion Device is designed for use with additional supplemental fixation | |
| and with autograft to facilitate fusion. | |
| Substantial | |
| Equivalence | The intended use, device design, materials, and mechanical performance data |
| demonstrate that the proposed Incite Interbody Fusion Device is substantially | |
| equivalent to the predicate devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the agency's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 12 2011
Incite Innovation, LLC % Mr. John Kirwan 1350 Main Street, Suite 1506 Springfield, Massachusetts 01103
Re: K093808
Trade/Device Name: Incite Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 1, 2010 Received: March 2, 2010
Dear Mr. Kirwan:
This letter corrects our substantially equivalent letter of March 24, 2010.
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 (FMA). 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.
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
2
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.
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 yours,
Sincerely yours,
Mark A. Millkern
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
1-Mar 2010
INDICATIONS FOR USE
510(k) Number (if known): K(y 9 3 8C) {
Device Name: Incite Interbody Fusion Device
Indications for Use:
The incite Interbody Fusion Device is intended for anterior intervertebral body fusion of the lumbar spine at one or two contiguous levels from L2-S1. The device is indicated for patients with lumbar degenerative disc disease (DDD) with up to Grade I spondylolistian familed level(s). DISEase defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients treated should be skeletally mature and have received a minimum of six months of nonoperative treatment. The Incite Interbody Fusion Device is designed for use with additional supplemental fixation and with autograft to facilitate fusion.
Prescription Use X
AND/OR
Over-The_Counter Use
(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, Divisionalive Devices
510(k) Number