(28 days)
Not Found
No
The 510(k) summary describes a physical spinal implant and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended to replace a vertebral body that has been removed due to tumor or trauma/fracture, which is a therapeutic intervention.
No
Explanation: The device is a spinal implant intended to replace a vertebral body, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "hollow, curved frame spinal implant" and mentions physical characteristics like "upper and lower surfaces" and "variety of heights," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a spinal implant used to replace a vertebral body. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details a physical implant designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant.
N/A
Intended Use / Indications for Use
The KIMBAT™ mini Spinal Implant is intended for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the lumbar spine and is intended for use with supplemental internal fixation. The KIMBAT™ mini is intended to be implanted singularly. The supplemental internal fixation systems that may be used with the KIMBAT™ mini spinal implant include, but are not limited to, SIGNUS Conklusion rod system, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).
Product codes
MQP
Device Description
The KIMBAT™ mini is a hollow, curved frame spinal implant. The upper and lower aspects of the implant are open and the upper and lower surfaces of the implant provide a surface feature which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The KIMBAT™ mini implant is available in a variety of heights. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine
Indicated Patient Age Range
Not Found
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)
To verify that device design met its functional and performance requirements, representative samples of the device underwent testing in accordance with applicable industry standards or FDA guidance documents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KIMBAT™ Spinal Implant K052533
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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K080349
Page 1 of 1
MAR 1 0 2008
Section 5 – 510(k) Summary
| Submitter: | SIGNUS Medizintechnik GmbH
Carl-Zeiss-Str. 2
63755 Alzenau Germany |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alan A. Alexander
Executive Vice President
Alquest, Inc.
Ph: 763-287-3830 Fax: 763-287-3836
ala@alquest.com |
| Date Prepared: | February 8, 2008 |
| Trade Name: | KIMBAT™ mini |
| Classification: | Vertebral Body Replacement
21 CRF 888.3060 |
| Product Code: | MQP |
| Predicate Device(s): | The subject device is equivalent to the following devices:
KIMBAT™ Spinal Implant K052533 |
| Device Description: | The KIMBAT™ mini is a hollow, curved frame spinal implant. The upper and
lower aspects of the implant are open and the upper and lower surfaces of the
implant provide a surface feature which assist in the positive anchorage and
seating of the implant between the superior and inferior vertebral bodies.
The KIMBAT™ mini implant is available in a variety of heights. This enables
the surgeon to choose the size suited to the individual pathology and anatomy
and condition of the patient. |
| Intended Use: | The KIMBAT™ mini Spinal Implant is intended for use to replace a vertebral
body that has been resected or excised due to tumor or trauma/fracture. The
device is intended for use as a vertebral body replacement in the lumbar spine
and is intended for use with supplemental internal fixation. The KIMBAT™
mini is intended to be implanted singularly.
The supplemental internal fixation systems that may be used with the
KIMBAT™ mini spinal implant include, but are not limited to, SIGNUS
Conklusion rod system, DePuy AcroMed titanium plate or rod systems
(Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile). |
| Functional and Safety
Testing: | To verify that device design met its functional and performance requirements,
representative samples of the device underwent testing in accordance with
applicable industry standards or FDA guidance documents. |
| Conclusion: | SIGNUS GMBH considers the KIMBAT™ mini to be equivalent to the
predicate devices listed above. This conclusion is based upon the devices'
similarities in principles of operation, technology, materials and indications
for use. |
Special 510(k) for the SIGNUS Medizintechnik GMBH KIMBA™ mini CONFIDENTIAL
1
Image /page/1/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 the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. (USA)" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Signus Medizintechnik GmbH % Alquest, Incorporated Mr. Alan Alexander Executive Vice President 4050 Olson Memorial Highway, Suite 350 Minneapolis, MN 55422
K080349 Re:
Trade/Device Name: Kimba™ mini Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: February 8, 2008 Received: February 11, 2008
Dear Mr. Alexander:
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.
MAR 1 0 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. Alan Alexander
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K080349
Page 1 of 1
Section 4 -- Indications For Use Statement
510(k) Number (if known): K-TBD Device Name: KIMBA™ mini Indications for Use:
The KIMBA™ mini Spinal Implant is intended for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the lumbar spine and is intended for use with supplemental internal fixation. The KIMBA TM mini is intended to be implanted singularly. The supplemental internal fixation systems that may be used with the KIMBA™ mini spinal implant include, but are not limited to, SIGNUS Conklusion rod system, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Wilkerson
Division of Gener storative. and Neurological Devices
510(k) Number K080349