(154 days)
P950002, P970015, P950019, P960025
P950002, P970015, P950019, P960025
No
The summary describes a physical interbody fusion cage and associated instrumentation, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "interbody fusion device" intended to treat "Degenerative Disc Disease (DDD)" by enabling fusion procedures, clearly indicating a therapeutic purpose.
No
The provided text explicitly states that the DIANA™ Fusion Cage is "intended for interbody fusion procedures" and "is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1." This describes a therapeutic, implantable device used in surgery, not a device used to diagnose a medical condition.
No
The device description explicitly states that the DIANA™ Fusion Cage is comprised of implantable components manufactured from medical grade titanium alloy and associated instrumentation, indicating it is a physical medical device, not software-only.
Based on the provided information, the DIANA™ Fusion Cage is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- DIANA™ Fusion Cage Function: The DIANA™ Fusion Cage is an implantable medical device designed for surgical insertion into the spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a surgical procedure for treating Degenerative Disc Disease, not for analyzing biological samples.
- Device Description: The description focuses on the material and physical characteristics of the implant, not on any components or processes related to analyzing biological specimens.
Therefore, the DIANA™ Fusion Cage falls under the category of a surgical implant or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DIANA™ Fusion Cage is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes
MAX
Device Description
The DIANA™ Fusion Cage is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
Indicated Patient Age Range
skeletally mature patients
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)
The pre-clinical testing performed indicated that the DIANA™ Fusion Cage is substantially equivalent to the predicate devices and is adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P950002, P970015, P950019, P960025
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
SEP 1 8 2009
4. 510(k) Summary according to 807.92(c)
Contact:
Thomas Hoghaug Signus Medical 18888 Lake Drive East Chanhassen, MN 55317 952-294-8700
Trade Name: Product Class: Classification: Product Codes: Panel Code:
DIANATM Fusion Cage Class II 21 CFR §888.3080 Orthosis, intervertebral fusion MAX 87
Indications for Use:
The DIANA™ Fusion Cage is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Device Description:
The DIANA™ Fusion Cage is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Predicate Device(s):
The DIANA™ Fusion Cage was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. . The four formerly Class III predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025).
Performance Testing:
The pre-clinical testing performed indicated that the DIANA™ Fusion Cage is substantially equivalent to the predicate devices and is adequate for the intended use.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). 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 symbol that resembles three overlapping human figures or abstract shapes. The symbol is positioned to the right of the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 1 8 2009
Signus Medical % MCRAPPD Medical Device Rich Jansen, Pharm.D. 1331 H Street Northwest, Suite 1200 Washington, District of Columbia 20005
Re: K091122
Trade/Device Name: The DIANA™ Fusion Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 27, 2009 Received: August 5, 2009
Dear Mr. Jansen:
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.
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
2
Page 2 - Rich Jansen, Pharm.D.
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Harbare Buckins
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3. Statement of Indications for Use
510(k) Number (if known): _KO91122
Indications for Use:
The DIANA™ Fusion Cage is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
1 Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Kareem S. Roney for MXM
(Division Sign-Off)
Division of Stagical, Orthopedic, and Restorative Devices
510(k) Number K091122
Concurrence of CDRH, Office of Device Evaluation (ODE)