(49 days)
The KIMBA™ 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™ is intended to be implanted singularly.
The supplemental internal fixation systems that may be used with the KIMBA™ spinal implant include, but are not limited to, SIGNUS Coklusion rod system, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).
The KIMBATM is a hollow, curved frame spinal implant with tapered edges. The upper and lower aspects of the implant are open and the walls feature spikes and ridges which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies.
The KIMBA®implant is available in a variety of sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition and will be implanted individually.
The SIGNUS Medizintechnik GMBH KIMBA™ Spinal Implant (K052533) is a vertebral body replacement device. The provided text describes design verification tests for the device, but it does not specify quantitative acceptance criteria or detailed study results in a format that would allow for a table of device performance against such criteria.
Here's an analysis based on the provided text, addressing the requested information:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria and detailed performance results are not explicitly stated. The document mentions that "Design verification tests were performed in compliance with the FDA Guidance document issued May 3, 2004 titled Guidance for Industry and FDA Staff Spinal System 510(k)s. Testing on the subject device included compression, torsion, and expulsion testing." This indicates that tests were conducted according to FDA guidelines for spinal systems, but it doesn't provide the pass/fail criteria or the actual numerical results of the tests.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the mechanical "test set" (i.e., the number of devices tested for compression, torsion, and expulsion). It also does not mention data provenance in terms of country of origin or whether the study was retrospective or prospective, as these terms are typically relevant for clinical studies involving patient data, not mechanical testing of implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the type of testing described. The "ground truth" concept is relevant for studies involving human interpretation (e.g., medical imaging, clinical diagnosis), where expert consensus helps establish a reference. The KIMBA™ device underwent mechanical design verification tests (compression, torsion, expulsion), which involve engineering measurements, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in studies where multiple human readers or evaluators provide subjective assessments, and a system is needed to resolve discrepancies. Mechanical testing involves objective measurements rather than subjective assessment and adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor is there any mention of AI assistance. This type of study and AI involvement are entirely outside the scope of the design verification tests (compression, torsion, expulsion) described for the KIMBA™ Spinal Implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The KIMBA™ is a physical surgical implant, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the described mechanical tests (compression, torsion, expulsion), the "ground truth" would be established by the engineering specifications and standards against which the device's performance is measured. For example, a certain force would be applied, and the device would need to withstand that force without failure, or deform within specified limits. These are objective physical measurements, not expert consensus, pathology, or outcomes data, which apply to clinical or diagnostic studies.
8. The sample size for the training set
This question is not applicable. The concept of a "training set" refers to data used to train machine learning models. The KIMBA™ is a physical medical device undergoing mechanical validation, not an AI or software product.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
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SECTION 2. SUMMARY AND CERTIFICATION
| 510(k) SummaryA. | |
|---|---|
| Submitter: | SIGNUS Medizintechnik GMBH |
| Brentanostra 9 | |
| Alzenau, Germany D-63755 | |
| Contact Person: | Tracy L. Gray RN, BS, RAC |
| Principal Consultant | |
| Alquest, Inc | |
| Ph: 763-588-9873 Fax: 763-287-3836 | |
| tracyg@alquest.com | |
| Date Prepared: | 09-August-2005 |
| Trade Name: | KIMBATM |
| Classification | Vertebral Body Replacement |
| Name/Number: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate | Curved PEEK TETRIS™ cleared under K041888; the RABEAT™ cleared |
| Device(s): | under K043316; and the PEEK Tetris™ cleared under K031757. |
| Device | The KIMBATM is a hollow, curved frame spinal implant with tapered |
| Description: | edges. The upper and lower aspects of the implant are open and the walls |
| feature spikes and ridges which assist in the positive anchorage and seating | |
| of the implant between the superior and inferior vertebral bodies. | |
| The KIMBA®implant is available in a variety of sizes. This enables the | |
| surgeon to choose the size suited to the individual pathology and anatomy | |
| and condition and will be implanted individually. | |
| Intended Use: | The KIMBATM 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 | |
| KIMBATM is intended to be implanted singularly. | |
| The supplemental internal fixation systems that may be used with the | |
| KIMBATM spinal implant include, but are not limited to, SIGNUS | |
| Coklusion rod system, DePuy AcroMed titanium plate or rod systems | |
| (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and | |
| Profile). | |
| Functional and | Design verification tests were performed in compliance with the FDA |
| Safety Testing: | Guidance document issued May 3, 2004 titled Guidance for Industry and |
| FDA Staff Spinal System 510(k)s. Testing on the subject device included | |
| Conclusion: | compression, torsion, and expulsion testing. |
| SIGNUS GMBH considers the KIMBATM to be substantially equivalent to | |
| the predicate devices listed above. This conclusion is based upon the | |
| devices' similarities in functional design, materials, indications for use, and | |
| principles of operation. |
CONFIDENTIAL
Page
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2005
Signus Medizintechnik GMBH c/o Tracy L. Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Highway, Suite 350 Minneapolis, Minnesota 55422
Re: K052533
Trade/Device Name: KIMBA™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 9, 2005 Received: September 15, 2005
Dear Ms. Gray:
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. Iisting 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 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,
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Page 2-Tracy L.Gray
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082533
KIMBA™ Spinal Implant Device Name:
Indications for Use:
The KIMBA™ 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™ is intended to be implanted singularly.
The supplemental internal fixation systems that may be used with the KIMBA™ spinal implant include, but are not limited to, SIGNUS Coklusion rod system, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).
Prescription Use X (Per 21 CFR 801.109) Or
Over-the-Counter Use -------
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052533
CONTIDENTIAL
§ 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.