(45 days)
No
The summary describes a mechanical expandable interbody fusion device made of titanium alloy. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance testing is based on Finite Element Analysis (FEA), which is a simulation technique, not an AI/ML method.
Yes
The device is indicated for use in patients with degenerative disc disease to achieve intervertebral body fusion, which is a treatment for a medical condition.
No
The device is an expandable interbody fusion device designed for use in surgical procedures to fuse vertebrae. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is fabricated from titanium alloy and consists of physical components like plates, wedges, and a central shaft, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "posterior lumbar intervertebral body fusion device" used for surgical implantation in patients with degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy designed to be placed between vertebrae. This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status or disease
- Using reagents or assays
The device is a surgical implant intended to treat a condition by providing structural support and promoting fusion.
N/A
Intended Use / Indications for Use
The Opticage® Expandable 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, transforaminal or lateral 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 Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. They are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM F136. Each device consists of five components: an upper and lower titanium plate, two titanium wedges and a central shaft. The faces of the upper and lower plates of the devices contain teeth and fenestrations to enhance bony in growth. The two titanium wedges are connected by the central shaft. The shaft can be rotated clockwise to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated counter clockwise to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted through a range of 5mm. A cavity internal to each device is intended to hold autogenous bone graft. The Opticage is available in a variety of configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic studies
Anatomical Site
lumbar intervertebral body, 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
Design verification testing was conducted via Finite Element Analysis (FEA) to assess the device modification. The FEA results demonstrate that the performance of the device is substantially equivalent to that of the predicate.
Key Metrics
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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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.
April 4, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Interventional Spine, Incorporated Ms. Jane Metcalf Vice President, Quality Assurance, Regulatory and Clinical Affairs 13700 Alton Parkway, Suite 160 Irvine, California 92618
Re: K160464
Trade/Device Name: Opticage® Expandable Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 17, 2016 Received: March 18, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 yours,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson" in a large, bold font, followed by a hyphen. Below the name, there is a large letter "S" in a similar font. In the background, there is a faint, stylized FDA logo, which is partially obscured by the text.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160464
K160464 Page 1 of 1
Device Name
Opticage® Expandable Interbody Fusion Device
Indications for Use (Describe)
The Opticage® Expandable 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 at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. 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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510(k) Summary
| APPLICANT: | Interventional Spine, Inc. |
|---|---|
| DATE PREPARED: | February 17, 2016 |
| CONTACT PERSON: | Jane Metcalf |
| 13700 Alton Parkway, Ste 160 | |
| Irvine, CA 92618 | |
| Phone: 949.525.1493 | |
| Fax: 949.472.0016 | |
| TRADE NAME: | Opticage® Expandable Interbody Fusion Device |
| COMMON NAME: | Interbody Fusion Device |
| CLASSIFICATION NAME: | Intervertebral Body Fusion Device |
| DEVICE CLASSIFICATION: | Class II |
| REGULATION NUMBER | 888.3080 (product code: MAX) |
| PRIMARY PREDICATE | |
| DEVICE: | Opticage® Expandable Interbody Fusion Device (K152156) |
Purpose of Submission
The purpose of this special 510(k) submission is to obtain market clearance for twenty-four (24) additional models of the Opticage Expandable Interbody Fusion Device.
Indication for Use and Intended Use
The Opticage® Expandable 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, transforaminal or lateral 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.
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510(k) Summary
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).
Device Description
The Opticage Expandable Interbody Fusion Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. They are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM F136. Each device consists of five components: an upper and lower titanium plate, two titanium wedges and a central shaft. The faces of the upper and lower plates of the devices contain teeth and fenestrations to enhance bony in growth. The two titanium wedges are connected by the central shaft. The shaft can be rotated clockwise to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated counter clockwise to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted through a range of 5mm. A cavity internal to each device is intended to hold autogenous bone graft. The Opticage is available in a variety of configurations.
Technical Characteristics
The modified devices contain an 8 degree lordotic angle. Otherwise, they have the same physical and technological characteristics as the predicate devices.
Performance Tests
Design verification testing was conducted via Finite Element Analysis (FEA) to assess the device modification. The FEA results demonstrate that the performance of the device is substantially equivalent to that of the predicate.
Basis for Determination of Substantial Equivalence
The predicate and the modified devices have identical intended uses. They are fabricated from the same material, are supplied in the same manner, have identical operating mechanisms and similar technological characteristics. Differences between the predicate and modified device do not raise any additional issues of safety or effectiveness