(149 days)
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 or retrolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.
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.
The provided text describes a 510(k) summary for a medical device, the Binder Intervertebral Body Fusion Device. It outlines the device's intended use, technological characteristics, and a statement about performance data. However, it does not contain the detailed acceptance criteria or a specific study proving the device met those criteria in the way a clinical or AI-based performance study would.
Instead, the document focuses on the regulatory submission process for substantial equivalence to predicate devices, primarily through mechanical testing.
Here's the breakdown of the information requested, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| Function as intended per ASTM F2077-03 | Met |
| Function as intended per ASTM F2267-04 | Met |
| Specified requirements (not detailed) | Met |
Note: The document states "In all instances, the Binder Fusion System functioned as intended and specified requirements were met." but does not provide the specific numerical acceptance criteria or the quantitative results from the tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or AI model evaluation. The "performance data" refers to mechanical testing.
- Sample Size for Mechanical Testing: Not specified.
- Data Provenance: Not applicable in the context of clinical patient data or AI data. The "data" refers to engineering test results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable to the information provided. The performance testing described is mechanical, not involving expert interpretation of patient data.
4. Adjudication Method for the Test Set
This is not applicable to the information provided, as there is no "test set" in the context of human or AI interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document describes mechanical performance testing, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" would be the engineering specifications and performance standards defined by ASTM F2077-03 and ASTM F2267-04.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of Missing Information in Relation to AI/Clinical Study Criteria:
The provided document is a 510(k) summary focusing on a physical medical device (intervertebral body fusion device) and its mechanical performance testing for regulatory clearance. It does not provide information relevant to the performance evaluation of an AI algorithm, clinical trials with human readers, or detailed patient data analysis that would typically involve many of the criteria you asked for (e.g., test set size, expert ground truth, adjudication, MRMC studies, training sets). The "acceptance criteria" discussed are for the physical properties of the implant based on recognized ASTM standards.
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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
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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.
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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_
§ 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.