(119 days)
The tangoRS Polyaxial System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine. When used as a posterior spine thoracic/lumbar system, the tangoRS Polyaxial System is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, and spinal tumor.
The tangoRS Polyaxial System includes screws (preassembled), a locking screw, rod and cross links.
The provided text is a 510(k) summary for the tangoRS Polyaxial System, a pedicle screw spinal fixation system. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic or AI-based performance.
The document describes the device, its intended use, and its classification, and confirms that the FDA found it substantially equivalent to predicate devices. It mentions that "Performance data were submitted," but does not detail what that performance data entailed, what the acceptance criteria were, or the results of any specific studies related to its performance characteristics against predefined criteria.
Therefore, I cannot provide the requested information for the following reasons:
- Acceptance Criteria and Reported Device Performance: This information is not present in the provided text. The document is about regulatory clearance, not a performance evaluation against specific metrics.
- Sample Size for Test Set and Data Provenance: Not applicable as no diagnostic or AI-based performance study is described.
- Number of Experts and Qualifications: Not applicable as no ground truth establishment for a test set is described.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance Study: Not applicable.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
The document focuses on the regulatory approval process (510(k) clearance) for a medical device that provides immobilization and stabilization of spinal segments. The "Performance Data" mentioned likely refers to mechanical testing, biocompatibility, and other engineering-related assessments required for spinal implants, rather than clinical performance data in the way one might evaluate a diagnostic AI device.
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Ko52385
tangoRS Polyaxial System 510(k) Application
DEC 2 7 2005
PREMARKET NOTIFICATION 510(K) SUMMARY
| Company: | Ulrich GmbH & Co. KGBuchbrunnenweg 12D-89081 UlmGermany+49 (0) 731 9654-110/225 (phone)+40 (0) 731 9654-2702 (fax) |
|---|---|
| Company Contact: | Christoph Ulrich |
| Date: | August 26, 2005 |
| Trade Name: | tangoRS Polyaxial System |
| Common Name | Pedicle Screw Spinal Fixation System |
| ClassificationCode: | Orthopedics, 888.3070, MNI, MNH, NKB |
| Device Description: | The tangoRS Polyaxial System includes screws(preassembled), a locking screw, rod and cross links. |
| Intended Use: | The tangoRS Polyaxial System is intended to provideimmobilization and stabilization of spinal segments asan adjunct to fusion of the thoracic, lumbar and sacralspine. When used as a posterior spine thoracic/lumbarsystem, the tangoRS Polyaxial System is intended forthe following indications: degenerative disc disease (asdefined by back pain of discogenic with degeneration ofthe disc confirmed by patient history and radiographicstudies), spinal stenosis, spondylolisthesis, spinaldeformities (i.e., degenerative scoliosis, kyphosis,and/or lordosis), fracture, and spinal tumor. |
| Predicate Device: | Predicate device information is included. |
| Performance Data: | Performance data were submitted. |
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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 seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
Ulrich GmbH & Co. KG c/o Ian Gordon Senior Vice President EmergoGroup, Inc. 2519 McMullen Booth Rd. Clearwater, Florida 33761
Re: K052385
Trade/Device Name: tangoRS Polyaxial System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: August 26, 2005 Received: August 30, 2005
Dear Mr. Gordon:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we have reviewed your Section 910(x) premained 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 clediosure fo regally manatise possible in the Medical Device Amendments, or to commerce prior to May 26, 1776, the enaecential with the provisions of the Federal Food. Drug. devices that have been recatismed in acceraaned who f a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merclore, mance the device, belyer is the most
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the free from the read.
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 If your device is classified (soc aborto) als. Existing major regulations affecting your device can inay be subject to such additional consoler Lines. Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs of Pounts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial cquivalence determination does not mean Please be advised that I DA s issualite of a backaria. I miles with other requirements of the Act that 117A has made a dolorimation administered by other Federal agencies. You must of any rederal statutes and regulations administry, but not limited to: registration and listing (21 Comply with an the Her STequirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Ian Gordon
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (seting your device as described in your Section 510(k) This letter will anow you to oegin mailteans your device of your device of your device to a legally premarket notincation: "The PDF intelling of 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 11 you desire specific at Compliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Colline 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 responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
z
Co Mark N. Metkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number (if known): KOS23 8S
Device Name: tangoRS Polyaxial System
Indications for Use:
The tangoRS Polyaxial System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine. When used as a posterior spine thoracic/lumbar system, the cater a problem is intended for the following indications:
- degenerative disc disease (as defined by back pain of discogenic with . degeneration of the disc confirmed by patient history and radiographic studies),
- spinal stenosis, .
- spondyloiisthesis, .
- spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or . lordosis),
- fracture, and .
- spinal tumor. .
Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ X or (21 CFR 807 Subpart C) (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard S
eral, Rest rative,
510(k) Number K062385
N/A