(176 days)
Not Found
No
The device description and intended use clearly describe a physical, non-software-based implant used in orthopedic surgery. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device is a cement restrictor used in orthopedic surgeries, not a therapeutic device designed to treat a medical condition or ailment. It serves a mechanical function during surgery.
No
Explanation: The device is described as a "cement restrictor" used during orthopedic surgeries to physically restrict cement. Its function is not to diagnose any condition or disease.
No
The device description clearly states it is a "hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1 mm toothed spikes on opposite sides," indicating it is a physical hardware device.
Based on the provided information, the RABEATM Cement Restrictor Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use in orthopedic surgeries as a cement restrictor. This is a surgical implant/device used in vivo (within the body) during a procedure.
- Device Description: The description details a physical device made of titanium, designed to be used with PMMA cement during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test or examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a physical implant used during surgery.
N/A
Intended Use / Indications for Use
The RABEA™ Cement Restrictor Device is intended for use as a cement restrictor 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.
Product codes
JDK
Device Description
The RABEA™ Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1 mm 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™ 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 issues of safety and effectiveness 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
JUL 30 1999
.
¥990345
Attachment 2
510(k) Summary
510(K) SUMMARY
| SUBMITTER: | SIGNUS Medizintechnik GmbH
Rannenbergring 54
D-63755 Alzenau
Germany |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mr. Thomas Hoghaug
Newport Medical International
27660 Woodside Road
Shorewood, MN 55331
Phone: 612-470-9545
Fax: 612-470-6985 |
| DATE PREPARED: | April 30, 1999 |
| TRADE NAME: | RABEATM Cement Restrictor Device |
| CLASSIFICATION NAME
and NUMBER:
PRODUCT CODE: | Surgical Mesh
Class II, 21 CFR 878.3300
JDK |
| PREDICATE DEVICE(S): | The RABEA™ Cement Restrictor Device is substantially
equivalent to the Osteonics PTII Cement Spacer which was
cleared via premarket notification K914406 on December 20,
1991, and the Motech Surgical Mesh which was cleared for use
as a cement restrictor via premarket notification K900138 on
March 20, 1990. |
| DEVICE DESCRIPTION: | The RABEATM Cement Restrictor Device is a hollow, titanium,
rounded rectangular frame with fenestrated surfaces on all sides
and 1 mm toothed spikes on opposite sides. The device is
intended to be used in conjunction with standard PMMA cement. |
| INTENDED USE: | The RABEATM Cement Restrictor Device is intended for use as a
cement restrictor 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. |
| FUNCTIONAL &
SAFETY TESTING: | Functional and safety testing of the RABEA™ 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 |
1
results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device.
CONCLUSION:
The RABEA™ Cement Restrictor Device is substantially equivalent to the Osteonics PTII Cement Spacer which was cleared via premarket notification K914406 on December 20, 1991, and the Motech Surgical Mesh which was cleared for use as a cement restrictor via premarket notification K900138 on March 20, 1990, based upon the devices' similarities in functional design, materials and indications for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2001
Mr. Thomas Hoghaug Newport Medical International 27660 Woodside Road Shorewood, Minnesota 55331
Re: K990345
Tradc Namc: RABEATM Cement Restrictor Regulation Number: 878.3350 Regulatory Class: II Product Code: JDK Dated: April 30, 1999 Received: May 3, 1999
Dear Mr. Hoghaug:
This letter corrects our substantially equivalent letter of July 30, 1999.
We have reviewed your Section 510(k) 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). 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 p. visions of equirements 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely vours
H. Ehlers
E. Statland, M.D., Ph.D. Bernard Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Page
K990345. 510(k) Number (if known):
Device Name:
RABEA™ Cement Restrictor Device
ALUUESI INC
Indications for Use:
Indications for Use.
The RABEAT* Cement Restrictor Device is intended for use as a cement restrictor in orthopedic The RABEATK Cement Restricter Device is intended for use as a cement results are and total provention
surgeries such as those involving the femoral canal and tibial placeries Inc. 11:22:00
surgeries such as those involving the femoral canal and tions. Included in the surgeries.
replacement. This device is not appropriate for acctabular cup surger
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990345 |
Prescription Use
(Per 21 CFR 801.109)
C