(209 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "Anterior Cervical Fusion System" intended for spinal fusion procedures in patients with degenerative disc disease, indicating its use to treat a medical condition.
No
Explanation: The device is an implantable system for spinal fusion procedures, used in treatment rather than diagnosis.
No
The device description explicitly states that the system consists of titanium implants (plage, cage, screws) and instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. This is a therapeutic device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a titanium implant (plage and screws) designed to be surgically placed in the cervical spine. This is consistent with a surgical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. 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 had at least 6 weeks of nonoperative treatment.
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7)
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing has been performed on the Rhausler Plage Anterior Cervical Fusion System per ASTM F2077 (static and dynamic compression and torsion). Subsidence testing has been performed per ASTM F2267, and wear testing has been performed per ASTM F1877. Results of performance testing are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K071833 Mosaic™ by Spinal Elements Inc., K092521 Zuma-CTM by Seaspine Inc.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
NOV 2 9 2011
Abbreviated 510(k) Rhausler Plage Anterior Cervical Fusion System
Section 5: 510(k) Summary
Assigned 510(k) number: K11272 Company: Rhausler Inc. 837 Industrial Road, Unit E San Carlos, CA 94070 USA Phone: 650-631-4515 Fax: 650-631-4555 Contact: Barbara DeBiase Phone: 303-537-3311 Email: barbdebiase@mac.com November 28, 2011 Date Prepared: Rhausler Plage™ Anterior Cervical Fusion System Proprietary Names: Classification Name: Intervertebral body fusion device 21 CFR 888.3080, Class II, Product Code ODP Classification: K071833 Mosaic™ by Spinal Elements Inc. Predicate Devices: K092521 Zuma-CTM by Seaspine Inc. Device Description: The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile. Intended for spinal fusion procedures at one level (C3-C7) in Intended Use: skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. 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 had at least 6 weeks of nonoperative treatment. Technological Comparison to Predicate Device: The Rhausler Plage Anterior Cervical Fusion System is similar to the predicate device. Both are intervertebral body fusion devices
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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.
- Mechanical testing has been performed on the Rhausler Plage Performance Testing: Anterior Cervical Fusion System per ASTM F2077 (static and dynamic compression and torsion). Subsidence testing has been performed per ASTM F2267, and wear testing has been performed per ASTM F1877. Results of performance testing are substantially equivalent to the predicate devices.
- Based upon the design, technology, performance, and intended use, Conclusion: Rhausler Plage Anterior Cervical Fusion System is the substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 29 2011
Rhausler, Inc. % Ms. Barbara DeBiase 837 Industrial Road, Unit E San Carlos, California 94070
Re: K111272
Trade/Device Name: Rhausler Plage ** Anterior Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 10, 2011 Received: October 11, 2011
Dear Ms. DeBiase:
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
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Page 2 - Ms. Barbara DeBiase
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
ely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111272
Device Name: Rhausler Plage™ Anterior Cervical Fusion System
Indications for Use:
Intended for spinal fusion procedures at one level (C3-C7) in skcletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. 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 had at least 6 weeks of nonoperative treatment.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
. . .
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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