(29 days)
The ATHLET™ System 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 ATHLET™ System is intended for use with supplemental fixation and should be implanted in pairs.
The ATHLET™ VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
Here's the analysis of the provided text regarding the ATHLET™ VBR device, focusing on acceptance criteria and supporting studies:
This document ([K081332](https://510k.innolitics.com/search/K081332)) is a 510(k) summary, which is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device. Therefore, it does not typically contain information about detailed acceptance criteria or standalone clinical studies demonstrating performance against specific metrics. Instead, the primary "study" is the demonstration of substantial equivalence to previously cleared devices.
Based on the provided text, many of the requested categories either do not apply or the information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The document explicitly states: "Documentation was provided which demonstrated the ATHLET™ VBR to be substantially equivalent to previously cleared vertebral body replacement devices. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites and performance."
This means the "performance" is implicitly deemed acceptable because it is equivalent to already-approved devices, rather than being measured against new, explicit acceptance criteria in this submission. No specific numerical performance metrics are reported.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. There is no "test set" in the context of a performance study for this 510(k) submission. The submission relies on demonstrating equivalence to predicate devices, not on a new clinical or performance study with a distinct test dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. As no specific performance study with a test set is described, the concept of establishing ground truth by experts is not relevant to this 510(k) summary.
4. Adjudication Method for the Test Set
Not Applicable. No test set or corresponding adjudication method is mentioned in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance?
Not Applicable. This device is a physical spinal implant (vertebral body replacement system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm. Standalone performance studies in the context of AI are not applicable here.
7. The Type of Ground Truth Used
Not Applicable. For a 510(k) submission demonstrating substantial equivalence of a physical implant, the "ground truth" is typically the established safety and efficacy profiles of the predicate devices, as recognized by the FDA through their previous clearances. There isn't a new dataset with an independent "ground truth" established for this specific device's performance in the context of this submission.
8. The Sample Size for the Training Set
Not Applicable. This 510(k) summary does not describe an AI/ML device, and thus there is no concept of a "training set" in this context. The manufacturing process and materials are described, but not in terms of data training.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set mentioned, this section is not applicable.
Summary of the K081332 Submission:
The provided document K081332 is a 510(k) premarket notification for the ATHLET™ VBR (Vertebral Body Replacement) system. The core of this submission is demonstrating substantial equivalence to already legally marketed predicate devices. This means that instead of conducting new performance studies that establish acceptance criteria and collect extensive data, the sponsor (SIGNUS Medizintechnik GmbH) provided documentation showing their device is equivalent in basic design, intended use, indications, anatomic sites, materials (PEEK-OPTIMA® LT1 and Titanium alloy), and overall performance to existing FDA-cleared devices. The FDA's issuance of a substantial equivalence determination allows the device to be marketed.
{0}------------------------------------------------
K0812330
・
7. 510(k) Summary
:
:
JUN 1 0 2008
| Sponsor: | SIGNUS Medizintechnik GmbIICarl-Zeiss-Strasse 2D-63755 Alzenau, GERMANYTel. + 49 (0) 6023 9166-136Fax + 49 (0) 6023 9166-161Url: http://www.signus-med.de |
|---|---|
| Contact Person: | Jörg Degen, Regulatory Affairs, QM |
| Proposed Trade Name: | ATHLET™ VBR |
| Device Classification | Class II |
| Classification Name: | Spinal vertebral body replacement device |
| Regulation: | 888.3060 |
| Device Product Code: | MQP |
| Device Description: | The ATHLET™ VBR System is a lordotic, modular vertebral bodyreplacement system. Caudal and cranial components are offered in a varietyof heights and are assembled to create a device construct. An intermediatecomponent is also available and is used between one caudal and one cranialcomponent. The device construct comprises a central cannula for bone graftand lateral fenestrations for bony in-growth. |
| Intended Use: | The ATHLET™ VBR is indicated for use to replace a vertebral body thathas been resected or excised due to tumor or trauma/fracture. The device isintended for use as a vertebral body replacement in the thoracolumbar spine(from T1 to L5). The ATHLET™ System is intended for use withsupplemental fixation and should be implanted in pairs. |
| Materials: | The ATHLET™ VBR components are manufactured frompolyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described byASTM F2026. Integral marker pins are manufactured from titanium alloy(Ti-6Al-4V) as described by ASTM F136. |
| SubstantialEquivalence: | Documentation was provided which demonstrated the ATHLET™ VBR tobe substantially equivalent to previously cleared vertebral body replacementdevices. The substantial equivalence is based upon equivalence in basicdesign, intended use, indications, anatomic sites and performance. |
{1}------------------------------------------------
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SIGNUS Medizintechnik GmbH % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026
JUN 1 0 2008
Re: K081332
Trade/Device Name: ATHLET™ VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 12, 2008 Received: May 12, 2008
Dear Dr. Warden:
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.
{2}------------------------------------------------
Page 2 - Karen E. Warden, Ph.D.
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-frec number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use Statement
510(k) Number: K081332
Device Name: ATHLETIM VBR
Indications for Use:
The ATHLET™ System 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 ATHLET™ system is intended for use with supplemental internal fixation and intended to be implanted in pairs.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden for mkm
Division of General. Re and Neurological Devices
510(k) Number K081332
§ 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.