(54 days)
The PEEK Tetris™ 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). The PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the PEEK Tetris™ Spinal Implant 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 PEEK Tetris™ Spinal Implant is a hollow, rectangular frame with lateral fenestrations. The upper and lower aspects of the implants are open and the walls feature spikes, which assist in the positive anchorage and seating of the implants between the superior and inferior vertebral bodies. The frame is forged from PEEK which is radiolucent and incorporates Titanium alloy marker pins so the device can be located within the body. The PEEK Tetris™ Spinal Implant is available in a variety of sizes and a wedge shaped option. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition.
The provided text describes a 510(k) submission for the PEEK Tetris™ Spinal Implant and focuses on demonstrating its substantial equivalence to a predicate device, the Titanium Tetris™.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance results. Instead, it relies on demonstrating comparable functional and performance characteristics to the predicate device through testing. The key acceptance criterion is that the PEEK Tetris™ must perform equivalently or superiorly to the Titanium Tetris™ regarding its intended use as a vertebral body replacement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable functional design | Demonstrated as comparable |
| Comparable performance characteristics | Demonstrated as comparable |
| Biocompatibility | Fulfilled by analogy to predicate devices using identical patient contact materials and processing |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Representative samples of the device underwent testing to demonstrate comparable functional and performance characteristics to the predicate device."
- Sample Size: "Representative samples" implies a test set was used, but the exact number of devices or experimental units is not specified.
- Data Provenance: The document does not specify the country of origin for the data. It's safe to assume the testing was conducted in a controlled lab environment. It is a prospective study in the sense that the testing was performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a physical medical implant, and its "performance" for regulatory purposes is evaluated through mechanical testing, material characterization, and comparison to a predicate device, not through expert assessment of clinical outcomes or images in a diagnostic context. Ground truth, in this context, would be established by direct physical measurements and material properties obtained from laboratory tests, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where conflicting interpretations need to be resolved. For mechanical testing of an implant, the results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. An MRMC study is relevant for AI-powered diagnostic or decision-support systems that influence human interpretation. The PEEK Tetris™ is a surgical implant and does not involve AI assistance or human readers in its direct use or regulatory evaluation for this 510(k).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The PEEK Tetris™ is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for evaluating the PEEK Tetris™ (in comparison to the predicate) would be based on:
- Physical and Mechanical Testing: Direct measurements of properties like strength, stiffness, fatigue resistance, and geometric conformity.
- Material Characterization: Verification of the PEEK material composition and its properties.
- Biocompatibility Standards: Compliance with established biocompatibility standards, demonstrated by analogy to other legally marketed devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical implant. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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K031757
Pi of 2
PEEK Tetris™
SIGNUS Medical LLC Special 510(k)
JUL 3 0 2003
Appendix F
510(k) Summary
| Submitter: | SIGNUS Medical LLC |
|---|---|
| 6713 Lakeway Drive | |
| Chanhassen, MN 55317 | |
| Contact Person: | Mr. Thomas Hoghaug |
| Managing Director | |
| Phone: (952) 974-9456 | |
| Fax: (952) 975-0465 | |
| Date Prepared: | June 3, 2003 |
| Trade Name: | PEEK Tetris™ |
| Classification Nameand Number: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate DeviceName and 510(k)Number | Titanium Tetris™K022793 |
| Device Description: | DEVICE DESCRIPTIONThe PEEK Tetris™ Spinal Implant is a hollow, rectangularframe with lateral fenestrations. The upper and lower aspects ofthe implants are open and the walls feature spikes, which assistin the positive anchorage and seating of the implants betweenthe superior and inferior vertebral bodies. The frame is forgedfrom PEEK which is radiolucent and incorporates Titaniumalloy marker pins so the device can be located within the body.The PEEK Tetris™ Spinal Implant is available in a variety ofsizes and a wedge shaped option. This enables the surgeon tochoose the size suited to the individual pathology andanatomical condition. |
| Intended Use: | The PEEK Tetris™ Spinal Implant is indicated for use toreplace a vertebral body that has been resected or excised due totumor or trauma/fracture. The device is intended for use as avertebral body replacement in the thoracolumbar spine (from T1to L5). |
| The PEEK TETRIST™ Spinal Implant is intended for use withsupplemental internal fixation. | |
| The supplemental internal fixation systems that may be usedwith the PEEK Tetris™ Spinal Implant include, but are notlimited to, DePuy AcroMed titanium plate or rod systems(Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX,and Profile). | |
| Statement ofTechnologicalComparison | Representative samples of the device underwent testing todemonstrate comparable functional and performancecharacteristics to the predicate device. |
| The patient contact materials of the PEEK Tetris™ areprocessed in the same manner and are identical to those used inother legally marketed predicate devices from SIGNUS thathave undergone appropriate biocompatibility testing. Thereforebiocompatibility testing of the PEEK Tetris™ has been fulfilledby analogy to those devices. | |
| Conclusion: | The PEEK Tetris™ is substantially equivalent to the TitaniumTetris™. This conclusion is based upon the fact that this deviceis substantially equivalent to the predicate device in terms offunctional design, indications for use, principles of operationand test performance characteristics. |
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PEEK Tetris™
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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 representation of three human figures, possibly representing individuals or families, under a protective wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Mr. Thomas Hoghaug Managing Director SIGNUS Medical LLC 6713 Lakeway Drive Chanhassen, MN 55317
Re: K031757
Trade Name: PEEK Tetris™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 7, 2003 Received: July 8, 2003
Dear Mr. Hoghaug:
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 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 - Mr. Thomas Hoghaug
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark A. Mellar
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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Image /page/4/Picture/0 description: The image shows a sequence of characters and a trademarked name. The characters "K O 3 1 7" are followed by a stylized "5" and a "7". Below the characters, the text "PEEK Tetris™" is visible, indicating a product or brand name.
SIGNUS Medical LLC Special 510(k)
Appendix B
Indications for Use Statement
TBD 510(k) Number (if known)
Device Name PEEK Tetris™
The PEEK Tetris™ Spinal Implant is indicated for use to replace a Indications vertebral body that has been resected or excised due to tumor or for Use trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5).
The PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the PEEK Tetris™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)
OR Over-The-Counter Use
[signature]
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number
Appendix B Page 1
06/03/03
CONFIDENTIAL
§ 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.