(149 days)
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Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes.
The device is intended for intervertebral body fusion to treat degenerative disc disease and is used with autogenous bone graft material and supplemental fixation, indicating a therapeutic purpose.
No
The device is a fusion device intended for intervertebral body fusion, which is a treatment, not a diagnostic process. It is used to join vertebrae together, not to identify or determine a medical condition.
No
The device description clearly states it is comprised of physical PEEK spacers, which are hardware components.
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.
- Binder Fusion System Function: The Binder Fusion System is an implantable device designed to be surgically placed in the spine to facilitate bone fusion. It is a physical device used within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "intervertebral body fusion" in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test.
- Device Description: The description details a physical implant made of PEEK material with ridges for fixation. This is consistent with a surgical implant, not a diagnostic device.
The information provided describes a surgical implant used for treatment, not a device used for diagnosis based on testing biological samples.
N/A
Intended Use / Indications for Use
The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is intended to be used for intervertebral body fusion.
The Binder Intervertebral Body Fusion Device is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.
Product codes
MAX
Device Description
The Binder Fusion System is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Binder Fusion System also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Binder Fusion System is provided non-sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04. In all instances, the Binder Fusion System functioned as intended and specified requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
FEB 2 5 2010
V. 510(K) SUMMARY
Binder Biomedical, Inc.'s Intervertebral Body Fusion Device
Submitted by:
Binder Biomedical, Inc. 2385 NW Executive Center Dr, Suite 100 Boca Raton, FL 33431 Phone: (561) 981-2682 Facsimile: (561) 962-2710 Contact Person: Lawrence Binder
Date Prepared: September 27, 2009
Device Name and Address of Sponsor
Binder Intervertebral Body Fusion Device Binder Biomedical, Inc. 2385 NW Executive Center Dr, Suite 100 Boca Raton, FL 33431
Common Name
Intervertebral Body Fusion Device
Classification
Orthosis, Spinal Intervertebral Fusion
Predicate Devices
| DePuy AcroMed, Inc. | Lumbar I/F Cage with VSP Spine System |
|---|---|
| Globus Medical, Inc. | PATRIOT Spacers |
| Lanx, Inc. | Lanx Intervertebral Body Fusion Device |
Intended Use / Indications for Use
The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is intended to be used for intervertebral body fusion.
The Binder Intervertebral Body Fusion Device is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is
1
defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.
Technological Characteristics
The Binder Fusion System is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Binder Fusion System also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Binder Fusion System is provided non-sterile.
Performance Data
Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04. In all instances, the Binder Fusion System functioned as intended and specified requirements were met.
Basis of Substantial Equivalence
The Binder Fusion System is as safe and effective as the predicate devices. The Binder Fusion System has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Binder Fusion System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Binder Fusion System is as safe and effective as the predicate devices. Thus, the Binder Fusion System is substantially equivalent.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 2 5 2010
Binder Biomedical, Inc. % Mr. Lawrence Binder President and CEO 2385 NW Executive Center Drive Suite 100 Boca Raton, Florida 33431
Re: K093015
Trade/Device Name: Binder Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 17, 2010 Received: February 19, 2010
Dear Mr. Binder:
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
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Page 2 - Mr. Lawrence Binder
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Cibava buchnb
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV. INDICATIONS FOR USE STATEMENT
K093015 510(k) Number (if known):
Device Name: Binder Intervertebral Body Fusion Device
Indications for Use:
The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X
(Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.M.
Page 1 of 1
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
K093015 510(k) Number_