(111 days)
Not Found
Not Found
No
The summary describes a physical implant (cage) used for spinal fusion and vertebral body replacement. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is used to treat degenerative disc disease, spinal instability due to tumor or trauma, and aid in spinal fusion, all of which address medical conditions.
No
The device is an intervertebral body fusion cage and a vertebral body replacement, used in surgical procedures to restore spinal stability and height. It is a therapeutic device, not a diagnostic one, as it does not diagnose or detect a disease or condition.
No
The device description explicitly states the device is manufactured from Ti6Al4V and stainless steel, indicating it is a physical implant and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Innvotec Surgical SEC IBF Cage is an implantable device used for intervertebral body fusion and vertebral body replacement. It acts as a spacer and provides structural support to the spine.
- No Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the patient. Its function is entirely mechanical and structural within the body.
Therefore, based on the provided information, the Innvotec Surgical SEC IBF Cage is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intervertebral Body Fusion Device: The Innvotec Surgical SEC IBF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC IBF Cage is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the Innvotec Surgical SEC IBF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC IBF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC IBF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC IBF Cage may be used with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MOP
Device Description
The SEC IBF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The SEC IBF Cage is manufactured from Ti6Al4V and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1, thoracolumbar spine (T1 to L5)
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)
Testing performed on this device indicates that the SEC IBF Cage is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
MAR 1 8 2010
| Contact: | Justin Eggleton
Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | SEC IBF Cage |
| Manufacturer: | Innvotec Surgical, Inc.
150 North Hill Drive, Suite 1
Brisbane, CA 94005 |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Code: | MAX, MOP |
Indications For Use:
Intervertebral Body Fusion Device: The Innvotec Surgical SEC IBF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC IBF Cage is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the Innvotec Surgical SEC IBF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC IBF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC IBF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC IBF Cage may be used with bone graft.
1
Device Description:
The SEC IBF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The SEC IBF Cage is manufactured from Ti6Al4V and stainless steel.
Predicate Device(s):
The SEC IBF Cage was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used.
Performance Standards:
Testing performed on this device indicates that the SEC IBF Cage is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR 1 8 2010
Innvotec Surgical, Inc. % Musculoskeletal Clinical & Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street, NW - 12th Floor Washington, District of Columbia 20005
Re: K093669
Trade/Device Name: SEC IBF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: March 01, 2010 Received: March 02, 2010
Dear Mr. Eggleton:
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
3
Page 2 - Mr. Justin Eggleton
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Barbara Buehr
Mark N. Melke Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K093669
Device Name: SEC IBF Cage
Intervertebral Body Fusion Device: The Innvotec Surgical SEC IBF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC IBF Cage is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the Innvotec Surgical SEC IBF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC IBF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC IBF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC IBF Cage may be used with bone graft.
ﮨﮯ 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ KO93669