(272 days)
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No
The 510(k) summary describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for spinal fusion procedures to treat cervical disc disease, which addresses a medical condition and aims to restore proper function and alleviate symptoms.
No
The device is an implant for spinal fusion procedures, specifically a cervical cage system. Its purpose is to physically fuse vertebrae, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is comprised of implants and instruments made of Titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a surgical implant, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, reagents, or laboratory procedures typically associated with IVDs.
This device falls under the category of a surgical implant or medical device used in a surgical procedure.
N/A
Intended Use / Indications for Use
The Rhausler RT2 Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment.
This device is intended to be used with supplemental spinal fixation systems.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a cervical intervertebral body fusion device. The system is comprised of implants and instruments. The instruments are utilized for the implantation procedure. All implants are manufactured from medical grade Titanium alloy (Ti6 Al 4V). The implant is rectangular in shape with lordotic configuration, i.e., with 4 degree profiles. It is offered in two cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The center of the implant has a hollow cylindrical shape fenestration for placement of autogenous bone. Trabeculite Titanium Cervical Cage implant is provided sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical (C3-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing has been performed on the RT2 Trabeculite Titanium Cervical Cage System in accordance to the FDA recommendation entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", which included Compression tests (Static and Dynamic) and Torsion tests (Static and Dynamic) per ASTM F2077-11, Subsidence testing per ASTM F2267-04 and Expulsion test. The results of testing and analyses conducted, demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance.
Biocompatibility tests for the RT2 Trabeculite Titanium Cervical Cage were selected in accordance with blue book memorandum G95-1 entitled Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing". Biocompatibility tests were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR 58. All tests conducted passed biocompatibility requirements.
Sterilization validation of the RT2 Trabeculite Titanium Cervical Cage implant is to be based on the requirements of ANSI/AAMI/ISO 11137-1:2006 (R) 2010 and 11137-2:2013 with a minimum Sterility Assurance Level of 1X10-6
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2015
Rhausler, Incorporated % Ms. Dionicia Reblando Regulatory Consultant 837 Industrial Road, Unit E San Carlos, California 94070
Re: K150455
Trade/Device Name: RT2 Trabeculite Titanium Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 21, 2015 Received: October 23, 2015
Dear Ms. Reblando:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
RT2 Trabeculite Titanium Cervical Cage System
Indications for Use (Describe)
The Rhausler RT2 Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least of nonoperative treatment.
This device is intended to be used with supplemental spinal fixation systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) Summary
| Assigned 510(k) number: | K150455 |
|---|---|
| Company: | Rhausler Inc. |
| 837 Industrial Road, Unit E | |
| San Carlos, CA 94070 USA | |
| Phone: 650-631-4515 | |
| Fax: 650-631-4555 | |
| Contact: | Dionicia B. Reblando |
| Email: joann.reblando@yahoo.com | |
| Date Prepared: | October 17, 2015 |
| Proprietary Names: | RT2 Trabeculite Titanium Cervical Cage System |
| Classification Name: | Intervertebral body fusion device |
| Classification: | 21 CFR 888.3080, Class II, Product Code ODP |
| Predicate Device: | Primary predicate device-Nubic and Rabea Device (K082848) Interbody |
| Fusion device with bone graft, cervical. | |
| Other predicate device: The Rhausler Plage Anterior Cervical | |
| Fusion System (K111272) | |
| Device Description: | The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a |
| cervical intervertebral body fusion device. The system is comprised | |
| of implants and instruments. The instruments are utilized for the | |
| implantation procedure. All implants are manufactured from | |
| medical grade Titanium alloy (Ti6 Al 4V). | |
| The implant is rectangular in shape with lordotic configuration, i.e., | |
| with 4 degree profiles. It is offered in two cross sectional sizes and | |
| is available in various height options to accommodate variations in | |
| patient anatomy. The center of the implant has a hollow cylindrical | |
| shape fenestration for placement of autogenous bone. Trabeculite | |
| Titanium Cervical Cage implant is provided sterile. | |
| Indications For Use: | The Rhausler RT2 Trabeculite Titanium Cervical Cage System is |
| intended for spinal fusion procedures at one level (C3-T1) in | |
| skeletally mature patients with cervical disc disease (defined as | |
| neck pain of discogenic origin with degeneration of the disc | |
| confirmed by history and radiographic studies). Implants are to be |
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| implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment. | |
|---|---|
| This device is intended to be used with supplemental spinal fixation systems. | |
| Technological | |
| Comparison to Predicate | |
| Device: | The Rhausler RT2 Trabeculite Titanium Cervical Cage System is equivalent to the predicate devices. Both are intervertebral body fusion devices that attach to the anterior portion of the cervical spine during the development of spinal fusion. Additionally, both use the same fundamental scientific technology, principle of operation, and materials. Performance test results confirm that design differences do not pose new issues of safety or effectiveness. |
| Performance Testing: | Mechanical testing has been performed on the RT2 Trabeculite Titanium Cervical Cage System in accordance to the FDA recommendation entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", which included Compression tests (Static and Dynamic) and Torsion tests (Static and Dynamic) per ASTM F2077-11, Subsidence testing per ASTM F2267-04 and Expulsion test. The results of testing and analyses conducted, demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance. |
| Biocompatibility tests for the RT2 Trabeculite Titanium Cervical Cage were selected in accordance with blue book memorandum G95-1 entitled Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing". Biocompatibility tests were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR 58. All tests conducted passed biocompatibility requirements. | |
| Sterilization validation of the RT2 Trabeculite Titanium Cervical Cage implant is to be based on the requirements of ANSI/AAMI/ISO 11137-1:2006 (R) 2010 and 11137-2:2013 with a minimum Sterility Assurance Level of 1X10-6 | |
| Conclusion: | Based upon the design, technology, performance, and intended use, the Rhausler RT2 Trabeculite Titanium Cervical Cage System is substantially equivalent to the predicate device/s currently marketed under the Food, Drug and Cosmetic Act. |