(147 days)
K8736989, K994022
No
The device is a radiopaque additive for bone cement, with no mention of AI/ML in its description, intended use, or performance studies.
No.
The device is an additive to provide radiopacity for imaging purposes and does not directly treat or diagnose a disease or condition.
No
The device is an additive to provide radiopacity for imaging purposes, assisting in visualization and placement of material. It does not diagnose any condition itself.
No
The device is a physical additive (powder) 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 a medical procedure. This is an in-vivo application, not an in-vitro test performed on samples outside the body.
- Device Description: The description confirms it's an additive to be mixed with bone cement for use in the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is to enhance the visibility of bone cement during imaging, which is a supportive role in a surgical or medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
TRACERS Bone Cement Opacifier is intended for use as an additive to Secour Acrylic Resin or Codman Cranioplastic™ (Type I - Slow Set) to provide radiopacity for imaging purposes.
Product codes
MYU
Device Description
TRACERS Bone Cement Opacifier is an additive to be used with Codman Cranioplastic (K8736989) or Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of material. The TRACERS Bone Cement Opacifier is added to the Cranioplastic or Secour monomer (powder) prior to mixing with the Cranioplastic or Secour polymer (liquid). The end product (Cranioplastic or Secour and Tracer particles) is substantially equivalent to Cranioplastic and Secour alone.
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)
Reference Device(s)
K8736989, K994022
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KC0234Y5
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.
Date Prepared A.
October 11, 2002
MAR 11 2003
B. General Information
Manufacturer: Parallax Medical. Inc. 940 Disc Drive Scotts Valley, CA 95066-4544
Contact: Linda Bradley Manager, Regulatory and Clinical Affairs (831) 439-0130, ext 251 (phone) (831) 439-1725 (fax)
C. Device Information
| Trade Name: | TRACERS Bone Cement Opacifier |
|---|---|
| Common Name: | Barium Sulfate |
| Device Classification: | II |
| Classification Name: | Accessory, Barium Sulfate, Methyl Methacrylate for Cranioplasty |
| Product Code(s): | MYU |
D. Predicate Device Identification
The subject device is substantially equivalent to TRACERS Bone Cement Opacifier (K991893).
E. Intended Use
TRACERS Bone Cement Opacifier is intended for use as an additive to Secour Acrylic Resin or Codman Cranioplastic™ (Type I - Slow Set) to provide radiopacity for imaging purposes.
Product Description E
TRACERS Bone Cement Opacifier is an additive to be used with Codman Cranioplastic (K8736989) or Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of material. The TRACERS Bone Cement Opacifier is added to the Cranioplastic or Secour monomer (powder) prior to mixing with the Cranioplastic or Secour polymer (liquid). The end product (Cranioplastic or Secour and Tracer particles) is substantially equivalent to Cranioplastic and Secour alone.
1
Substantial Equivalence G.
The subject device is equivalent in intended use, design, and technological characteristics to TRACERS Bone Cement Opacifier (K991893).
H. Summary
Based on the information provided in this notification, the subject device is substantially equivalent to the predicate devices in intended use, technological characteristics, and design.
l. Signature of Preparer
The 510(k) summary was prepared and submitted by the following Parallax Medicanemployee
Medical employee:
Linda Bradley
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
MAR 11 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Bradley Manager, Regulatory and Clinical Affairs Parallax Medical. Inc. 940 Disc Drive Scotts Valley, CA 95066
Re: K023445
Trade/Device Name: Tracers Bone Cement Opacifier Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: MYU Dated: February 13, 2003 Received: February 14, 2003
Dear Ms. Bradley:
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. Insting 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 (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.
3
Page 2 - Ms. Linda Bradley
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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), please contact the Office of Compliance at (301) 594-4659. 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 McMillan
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 III.
Indications for Use
510(k) Number (if known): K023445
Device Name: TRACERS Bone Cement Opacifier
Indications for Use:
TRACERS® Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin or Codman Cranioplastic™ (Type I -- Slow Set) to provide radiopacity for imaging purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K023445 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |