(89 days)
Not Found
No
The summary describes a physical orthopedic implant (cement restrictor) and its intended use. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device, a cement restrictor, is used in orthopedic surgeries to restrict cement and does not directly treat a disease or condition. It's an accessory used during a surgical procedure.
No.
The RABEAT™ Cement Restrictor is described as a device used in orthopedic surgeries in conjunction with PMMA cement, specifically for femoral canal and tibial plateau in hip stem and total knee replacement, indicating a therapeutic or surgical support function rather than a diagnostic one.
No
The device description clearly states it is a physical device made of PEEK with a frame, fenestrated surfaces, and spikes, intended for use in orthopedic surgeries with PMMA cement. This is a hardware device, not software.
Based on the provided information, the RABEA™ Cement Restrictor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for orthopedic surgeries involving the femoral canal and tibial plateau in hip and knee replacements. This is a surgical implant/accessory, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical device made of PEEK with specific features for use with bone cement during surgery. It doesn't describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests on samples
The device is a surgical tool/implant designed to restrict cement flow during orthopedic procedures.
N/A
Intended Use / Indications for Use
The RABEAT™ Device is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.
Product codes
JDK
Device Description
The RABEAT™ Cement Restrictor is a hollow, PEEK rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal and tibial plateau
Indicated Patient Age Range
Not Found
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)
Functional and safety testing of the RABEA IM Cement Restrictor Device consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results of the examination and testing were successful and did not raise any issucs of safety and effectivencss of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the text "Page 1 of 2" written in a handwritten style. The words are spaced out, with "Page" on the left, "1 of" in the middle, and "2" on the right. The text appears to be written with a dark ink or pencil, and the paper has a slightly rough texture.
JUN 1 1 2002
510(k) Summary for the RABEA Cement Restrictor Device
| Submitter: | SIGNUS Medical LLC
7140 Derby Drive
Chanhassen, MN 55317 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Thomas Hoghaug
SIGNUS Medical LLC
7140 Derby Drive
Chanhassen, MN 55317 |
| Date Prepared: | June 3, 2002 |
| Trade Name: | RABEAT™ Cement Restrictor |
| Classification Name:
and Number: | Cement Restrictor
Class II, 21 CFR 878.3300 |
| Product Code: | JDK |
| Predicate Device(s): | The RABEAT™ Cement Restrictor is substantially
equivalent to:
RABEAT™ Titanium Cement Restrictor (K990345)Medtronic Sofamor Danek Cement Restrictor (K013663) |
| Device Description: | The RABEAT™ Cement Restrictor is a hollow, PEEK
rounded rectangular frame with fenestrated surfaces on all
sides and 1mm toothed spikes on opposite sides. The
device is intended to be used in conjunction with standard
PMMA cement. |
| Intended Use: | The RABEAT™ Device is intended to be used in orthopedic
surgeries, such as those involving the femoral canal and
tibial plateau in hip stem and total knee replacement. This
device is not appropriate for acetabular cup surgeries, nor is
it intended for any spinal indications. |
1
Functional and Safety Testing:
Functional and safety testing of the RABEA IM Cement Restrictor Device consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results of the examination and testing were successful and did not raise any issucs of safety and effectivencss of the device.
Conclusion:
The RABEA™ Cement Restrictor Device is substantially cquivalent to the RABEA™ Titanium Cement Restrictor (K990345) and the Medtronic Sofamor Danek Cement Restrictor (K013663) based upon the devices' similarities in functional design and indications for use.
KO20836
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2002
Mr. Thomas Hoghaug Managing Director SIGNUS Medical LLC 7140 Derby Drive Chanhassen, Minnesota 55317
K020836 RABEA™ Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: March 12, 2002 Received: March 14, 2002
Dear Mr. Hoghaug:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
3
Page 2 -- Mr. Thomas Hoghaug
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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Bernard E. Statland, M.D., Ph.D.
Director
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K02.0.836
page loft
Indications for Use Page
Device Name: RABEA™ Cement Restrictor
Indications for Use: The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millman
(Division Sign-Off Division of General, Restorative and Neurological Devi
510(k) Number_