(81 days)
Not Found
No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used to treat degenerative disc disease and facilitate spinal fusion, which are therapeutic interventions.
No
The Opticage Interbody Fusion Device is described as an implant used for spinal fusion in patients with degenerative disc disease, not for diagnosing conditions.
No
The device description explicitly states it is composed of "lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy," which are physical 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.
- Device Description: The Opticage Interbody Fusion Device is a physical implant made of titanium alloy that is surgically placed in the lumbar spine. It is used to facilitate bone fusion.
- Intended Use: The intended use is to provide structural support and promote bone growth in the spine, not to analyze biological samples for diagnostic purposes.
The provided text clearly describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
Product codes
MAX
Device Description
The Opticage™ Expandable Interbody Fusion Device, Model Series 9070 is composed of lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy and ranging in widths from 9 mm x 12 mm and lengths from 21 x 30 mm. Each implant consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the construct from a minimum of 9 mm to a maximum of 14 mm. The top and bottom plates are fenestrated and contain a window to enhance bony in-growth. A cavity internal to the device is intended to hold autogenous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary performance testing was completed for the previously cleared Opticage Expandable Interbody Fusion Devices in Model Series 9070. A Finite Element Analysis (FEA) model was developed and validated to show that the additional sizes perform at least equivalently to the previously cleared devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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510(k) SUMMARY
FEB 1 0 2014
Submitter Information
| Address: | Interventional Spine, Inc.
13600 Alton Parkway, Ste. 160
Irvine, CA 92618 |
|-----------------|---------------------------------------------------------------------------------|
| Telephone: | (949) 472-0006 |
| Contact Person: | Jane Metcalf |
| Date prepared: | November 19, 2013 |
Name of Device
| Trade name: | Opticage™ Expandable Interbody Fusion Device, Model
Series 9070 |
|-----------------|--------------------------------------------------------------------|
| Common name: | Intervertebral Body Fusion Device |
| Classification: | Class II (Special Controls) per 21 CFR 888.3080 |
| Product Code: | MAX |
Purpose of Submission
The purpose of this submission is to gain market clearance for additional sizes of implants utilizing the technology of the Opticage Expandable Interbody Fusion Device, Model Series 9070.
Substantially Equivalent To
The additional sizes described in this submission are substantially equivalent to the Opticage Expandable Interbody Fusion Device, Model Series 9070, cleared under K113527 and K132479.
Description of the Device Subject to Premarket Notification
The Opticage Expandable Interbody Fusion Device, Model Series 9070 is composed of lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy and ranging in widths from 9 mm x 12 mm and lengths from 21 x 30 mm. Each implant consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the construct from a minimum of 9 mm to a maximum of 14 mm. The top and bottom plates are fenestrated and contain a window to enhance bony in-growth. A cavity internal to the device is intended to hold autogenous bone graft.
1
510(k) SUMMARY (continued)
Indication for Use
The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
Technical Characteristics
The Opticage Expandable Interbody Fusion Device, Model Series 9070 is designed to hold bone graft, to be expanded after implantation, and to allow bony ingrowth through-out the device. Expansion of the device is accomplished by rotating a central shaft that moves the side wedges inward, increasing the distance between the top and bottom plates.
Performance Data
All necessary performance testing was completed for the previously cleared Opticage Expandable Interbody Fusion Devices in Model Series 9070. A Finite Element Analysis (FEA) model was developed and validated to show that the additional sizes perform at least equivalently to the previously cleared devices.
Basis for Determination of Substantial Equivalence
The additional sizes of the Opticage Expandable Interbody Fusion Device, Model Series 9070, are determined to be substantially equivalent to the Opticage Expandable Interbody Fusion Devices from Model Series 9070, previously cleared under K113527 and K132479 based on comparisons to device design, indications for use, technological characteristics, and FEA analysis.
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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 stylized eagle with its wings spread, and three lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2014
Interventional Spine, Incorporated Ms. Jane Metcalf Vice President, Quality Assurance, Regulatory and Clinical Affairs 13700 Alton Parkway, Suite 160 Irvine, California 92618
Re: K133583
Trade/Device Name: Opticage™ Expandable Interbody Fusion Device. Model Series 9070 Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 11, 2014 Received: January 13, 2014
Dear Ms. Metcalf
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Jane Metcalf
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Vincent JiDevlin -S
for
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
510(k) Number (if known) K133583
Device Name
Opticage(TM) Expandable Interbody Fusion Device, Model Series 9070
Indications for Use (Describe)
The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sudies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
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)
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FOR FDA USE ONLY ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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