(67 days)
No
The summary describes a radiopaque additive for bone cement and does not mention any AI or ML components or functions.
No
The device is an opacifier added to bone cement for imaging purposes; it does not directly treat or diagnose a medical condition.
No
The device is an opacifier used to make bone cement visible under imaging, not to diagnose a condition itself. Its purpose is to assist in placement and visualization of an implant material, which is a treatment aid, not a diagnostic function.
No
The device is a physical additive (powder and disks) intended to be mixed with bone cement, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide radiopacity to bone cement for imaging purposes during surgical procedures. This is a function related to the visualization of an implant within the body, not the diagnosis of a condition based on in vitro analysis of biological samples.
- Device Description: The device is an additive to bone cement, comprised of materials that enhance visibility under imaging. It is used in vivo (within the body) as part of a surgical implant procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
Therefore, the TRACERS® Ta Bone Cement Opacifier is a medical device used in a surgical context for imaging purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour Acrylic Resin to provide radiopacity for imaging purposes.
Product codes (comma separated list FDA assigned to the subject device)
MYU
Device Description
TRACERS® Ta Bone Cement Opacifier is an additive to be used with Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of the implant material. The TRACERS® Ta Bone Cement Opacifier is added to the Secour polymer (powder) prior to mixing with the Secour monomer (liquid). TRACERS Bone Cement Opacifier is comprised of USP Barium Sulfate and unalloyed Tantalum disks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
IV. 510(k) Summary
This summary of safety and effectiveness is being submitted in accordance with This Sammary of Salesy and Medical Devices Act of 1990 and 21 CFR §807.92.
Date Prepared A.
October 3, 2003
General Information B.
| Manufacturer: | Parallax Medical, Inc.
940 Disc Drive
Scotts Valley, CA 95066-4544 |
|---------------|--------------------------------------------------------------------------|
| Contact: | Linda Paul
Manager, Regulatory and Clinical |
ager, Regulatory and Clinical Affairs (831) 439-0130, ext 251 (phone) (831) 439-1725 (fax)
C. Device Information
| Trade Name: | TRACERS® Ta Bone Cement Opacifier |
|---|---|
| Common Name: | Barium Sulfate with Tantalum |
| Device Classification: | II |
| Classification Name: | Accessory, Barium Sulfate, Methyl Methacrylate for Cranioplasty |
| Product Code(s): | MYU |
Predicate Device Identification D.
The subject device is substantially equivalent to TRACERS® Bone Cement Opacifier (K023445).
Intended Use E.
TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour Acrylic Resin to provide radiopacity for imaging purposes.
F. Product Description
TRACERS® Ta Bone Cement Opacifier is an additive to be used with Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of the implant material. The TRACERS® Ta Bone Cement Opacifier is added to the Secour polymer (powder) prior to mixing with the Secour monomer (liquid). TRACERS Bone Cement Opacifier is comprised of USP Barium Sulfate and unalloyed Tantalum disks.
Substantial Equivalence G.
The subject device is equivalent in intended use, design, and technological characteristics to TRACERS® Bone Cement Opacifier (K023445).
1
Summary H.
Based on the information provided in this notification, the subject device is Based on the information provided in the notinstilling with the nechnological characteristics, and design.
Signature of Preparer l.
The 510(k) summary was prepared and submitted by the following Parallax Medical employee.
Medical employee
Kolo Paul
Linda Paul Manager, Regulatory and Clinical Affairs
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 stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEC 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Paul Manager, Regulatory and Clinical Affairs Parallax Medical, Inc. 940 Disc Drive Scotts Valley, CA 95066
Re: K033230
Trade Name: TRACERS® Ta Bone Cement Opacifier Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: MYU Dated: November 26, 2003 Received: November 28, 2003
Dear Ms. Paul:
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.
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 (OS) regulation (21 CFR Part 820); and if
3
Page 2 -- Ms. Linda Paul
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you deente specifical of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melleman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use lll.
Indications for Use
510(k) Number (if known): K033230
TRACERS® Ta Bone Cement Opacifier Device Name:
Indications for Use:
TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin to provide radiopacity for imaging purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
✓
OR
Over-The Counter Use __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Post Restorative
K033230
Concurrence of CDRH, Office of Device Evaluation (ODE)