(126 days)
No
The device description and intended use describe a purely mechanical device for restricting cement flow during orthopedic surgery. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
No
A therapeutic device is one that treats or mitigates a disease or condition. This device is a cement restrictor used during orthopedic surgeries, which assists in the surgical procedure but does not directly treat a disease or condition itself.
No
Explanation: The NBD Cement Restrictor Device is described as a surgical tool used to restrict cement during orthopedic procedures. Its function is mechanical (a physical barrier) rather than providing information for diagnosis.
No
The device description explicitly states it is a "hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides," indicating it is a physical hardware device.
Based on the provided information, the NBD Cement Restrictor Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for a surgical procedure (orthopedic surgeries) and involves a physical device used within the body to restrict cement flow. IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
- Device Description: The description details a physical implantable device made of titanium. IVD devices are typically reagents, instruments, or systems used for testing specimens.
- Anatomical Site: The device is used within the femoral canal and tibial plateau, which are internal anatomical sites. IVD testing is performed on specimens collected from the body.
- Lack of IVD Characteristics: The description does not mention any aspects related to specimen collection, analysis, or diagnostic information derived from testing biological samples.
Therefore, the NBD Cement Restrictor Device is a surgical implant/accessory, not an IVD.
N/A
Intended Use / Indications for Use
The NBD 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.
The NBD Cement Restrictor is NOT intended for any spinal indications.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The NBD Cement Restrictor Device is a hollow, titanium, 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, tibial plateau, hip stem, total knee replacement
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 saftey testing of the NBD 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 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): 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.
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
§ 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
OCT 0 4 2002
510(k) Summary of Safety and Effectiveness
In Accordance with SMDA of 1990
NBD Cement Restrictor
May 15, 2002
Company:
NBD, LLC 605 Industrial Court Woodstock, GA 30189
Trade Name: NBD Cement Restrictor
Common Name: Cement Restrictor
Product Code and Regulatory Classification:
JDK: 878.3300 Surgical Mesh
Product Classification:
Class II
Intended Use:
The NBD 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.
1
Device Description:
The NBD Cement Restrictor Device is a hollow, titanium, 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.
Performance Data:
No applicable performance standards have been promulgated under Section 514 of the Food. Drug, and Cosmetic Act for this device. However, the material is subjected to ISO 5832-3 Implants for surgery - Wrought titanium 6-aluminum 4 vanadium alloy 1996-07-01.
Functional & Safety Testing:
Functional and saftey testing of the NBD 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 were successful and did not raise any issues of safety and effectiveness of the device.
Substantial Equivalence:
The NBD Cement Restrictor Device is substantially equivalent to RA-BEATM Cement Restrictor Device which was cleared for premarket notification K990345 on July 30, 1999. The NBD Cement Restrictor is equivalent in design, function, material, and indications for use.
Osteonics PTII Cement Spacer, K914406 Motech Surgical Mesh, K900138
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" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
OCT 0 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tim B. Lusby President New Business Development, LLC -605 Industrial Court Woodstock, GA 30189
Re: K021788
Trade/Device Name: NBD Titanium Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: August 13, 2002 Received: August 15, 2002
Dear Mr. Lusby:
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.
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
3
Page 2 - Mr. Tim B. Lusby
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,
Daniel Schacter, M.D.
Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1.
510(K) Number:
Device Name:
NBD Cement Restrictor
Indications For Use:
The NBD 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.
The NBD Cement Restrictor is NOT intended for any spinal indications.
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Millhurn
(Div. Off
Restorative
510(k) Number: K021788
(Optional Format 3-10-98)