(67 days)
The RABEATM Spinal Implant is indicated 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 thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. This device is intended to be implanted in pairs.
The supplemental internal fixation systems that may be used with the RABEATM Spinal Implant are the same as those used with the Curved PEEK Tetris™ Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
The RABEATM Spinal implant is a rectangular frame. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies.
The frame is forged from PEEK (PEEK-OPTIMATM LT1), which is radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker pins so the device can be located within the body. The marker pins meet ASTM F-136 and ISO 5832/3.
The RABEATM Spinal Implant is available in a variety of sizes ranging from 5mm to 30mm. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The RABEATM is implanted in pairs.
This document is a 510(k) summary for the RABEA™ Spinal Implant. It outlines the device description, intended use, and a comparison to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in an AI/ML device submission. Instead, it demonstrates substantial equivalence to a previously cleared device.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This document describes a traditional medical device (spinal implant) seeking 510(k) clearance based on substantial equivalence to a predicate device. It does not present acceptance criteria or reported performance data in the context of an AI/ML device study. Performance is implicitly tied to demonstrating the same materials, design, indications for use, and operating principles as a cleared predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document is not a study report for an AI/ML device. It's a 510(k) summary for a physical implant.
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):
- Not Applicable. Ground truth creation in the context of expert review for AI/ML models is not relevant to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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:
- Not Applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this device's clearance would be its physical and mechanical properties, material biocompatibility, and functional equivalence to the predicate, as tested through engineering methods, not clinical data and expert consensus in the way an AI/ML device would be.
8. The sample size for the training set:
- Not Applicable.
9. How the ground truth for the training set was established:
- Not Applicable.
Summary of what can be gathered from the provided text:
- Device Name: RABEA™ Spinal Implant
- Submitter: SIGNUS Medizintechnik GMBH
- Predicate Device: Curved PEEK Tetris™ (cleared under K041888 on 8/10/04)
- Device Description: A rectangular frame made from PEEK (PEEK-OPTIMATM LT1) with spikes for anchorage and small Titanium alloy (TiAl6V4) marker pins. Available in sizes from 5mm to 30mm and intended to be implanted in pairs.
- Intended Use: To replace a vertebral body resected or excised due to tumor or trauma/fracture in the thoracolumbar spine (T1 to L5). Intended for use with supplemental internal fixation, similar to the predicate device's compatible systems (e.g., DePuy AcroMed titanium plate or rod systems like Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
- Substantial Equivalence Claims (Statements of Technological Comparison):
- Same indication for use
- Same operating principle
- Same basic design
- Same materials
- Implanted using the same surgical techniques and equipment
Conclusion:
The provided 510(k) summary is for a physical spinal implant and relies on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting a study with acceptance criteria and performance metrics for an AI/ML algorithm.
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ારબ્ધરૂડી ૯
510(k) Summary
:
| Submitter: | SIGNUS Medizintechnik GMBH |
|---|---|
| Brentanostr. 9 | |
| Alzennau, Germany D-63755 | |
| 49-6023 9166-0 | |
| Contact Person: | Tracy L. Gray, RN, BS RAC |
| Principal Consultant | |
| Alquest, Inc. | |
| Phone: (763) 588-9873 Fax: (763) 287-3836 | |
| Date Prepared: | November 22, 2004 |
| Trade Name: | RABEATM |
| ClassificationName andNumber: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device | Curved PEEK Tetris™ cleared under K041888 on 8/10/04. |
| Device Description: | The RABEATM Spinal implant is a rectangular frame. The upper andlower aspects of the implant are open and the walls feature spikes whichassist in the positive anchorage and seating of the implant between thesuperior and inferior vertebral bodies. |
| The frame is forged from PEEK (PEEK-OPTIMATM LT1), which isradiolucent, and incorporates small Titanium alloy (TiAl6V4) markerpins so the device can be located within the body. The marker pinsmeet ASTM F-136 and ISO 5832/3. | |
| The RABEATM Spinal Implant is available in a variety of sizes rangingfrom 5mm to 30mm. This enables the surgeon to choose the size suitedto the individual pathology and anatomical condition. The RABEATM isimplanted in pairs. | |
| Intended Use: | The RABEATM Spinal Implant is indicated for use to replace a vertebralbody that has been resected or excised due to tumor or trauma/fracture.The device is intended for use as a vertebral body replacement in thethoracolumbar spine (from T1 to L5) and is intended for use withsupplemental internal fixation. This device is intended to be implantedin pairs. |
| The supplemental internal fixation systems that may be used with theRABEATM Spinal Implant are the same as those used with the CurvedPEEK Tetris™ Spinal Implant and include, but are not limited to,DePuy AcroMed titanium plate or rod systems (Kaneda SR, UniversityPlate, M2, ISOLA, VSP, Moss, TiMX, and Profile). | |
| Statement ofTechnologicalComparison | The subject device and predicate device have the following similarities: |
| • The same indication for use; | |
| • The same operating principle; | |
| • The same basic design; | |
| • The same materials; | |
| • Implanted using the same surgical techniques and equipment; |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol consisting of three parallel lines that curve and taper towards the right, with a wavy line beneath them.
FEB - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Signus Medizintechnik GMBH C/o Ms. Tracy Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Hwy, Suite 350 Minneapolis, Minnesota 55422
Re: K043316
Trade/Device Name: RABEA™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 29, 2004 Received: December 2, 2004
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) 70 ttg ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . conninered prior to that 2011-17-19, in accordance with the provisions of the Federal Food, DNIg, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Free (110) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mantes of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is clusified (600 as a votrols. Existing major regulations affecting your device can may or saterial 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 I lease be advised that I Drimination that your device complies with other requirements of the Act that I Dri has Intatutes and regulations administered by other Federal agencies. You must or any I catal statuated and regisments, including, but not limited to: registration and listing (21 Comply with an the Her 621 CFR Part 801); good manufacturing practice requirements as set CI It I art 6077, naouing (21 CFR Part 820); and if applicable, the electronic forth in the quality Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Tracy Gray
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematice notification: "The stassification 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 If you desire specific auropliance 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 other general information on Jour Copsumer 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. Milkenn
Celia M. Witten, Ph.D., M.D. 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 Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
RABEA™ Spinal Implant Device Name:
Indications for Use:
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The supplemental internal fixation systems that may be used with the RABEA™ Spinal Implant The suppliemental internal triality of the Spinal Implant and include, but are not limited to, are the same as the Curved I ELES Teths - Spania - Spania - Spania - Spania - M2, ISOLA, VSP, Moss, TiMX, and Profile).
Prescription Use ____________ (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
S10(k) Number K043316
§ 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.