(88 days)
Parallax Tracer Radiopaque Particles
No
The 510(k) summary describes a simple additive for bone cement to make it radiopaque. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on the functional characteristics of the material itself.
No.
The device is described as an additive to provide radiopacity for imaging purposes, assisting in placement and visualization of material, rather than directly treating or preventing a disease or condition.
No
This device is an additive to provide radiopacity for imaging purposes, aiding in visualization and placement, not diagnosing a condition.
No
The device is described as an "additive" and "particles" to be mixed with bone cement, indicating it is a physical substance, not software.
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 a bone cement for imaging purposes. This is a function related to the physical properties of the material and its visualization during a medical procedure, not a diagnostic test performed in vitro on biological samples.
- Device Description: The description reinforces that it's an additive to a bone cement to aid in placement and visualization.
- 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 specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device's function is to make the bone cement visible under imaging, which is a procedural aid, not a diagnostic test.
N/A
Intended Use / Indications for Use
This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes.
Product codes (comma separated list FDA assigned to the subject device)
MYU
Device Description
The Bone Cement Radio-Opacifier is an additive to be used with Codman Cranioplastic (K873689) to provide radiopacity to the resin and assist in placement and visualization of material.
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)
Performance testing demonstrated that the end product Cranioplastic and Bone Cement Radio-Opacifier is substantially equivalent to currently marketed Cranioplastic with Radio-Opacifier from Parallax with regard to functional characteristics.
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.
Parallax Tracer Radiopaque Particles
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.
Codman Cranioplastic (K873689)
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
OCT 3 1 2003
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of several curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
Cardinal Health
1500 Waukegan Road McGaw Park, Illinois 60085-6787
847.473.1500
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Bone Cement Radio-Opacifier
| Sponsor: | Cardinal Health
1500 Waukegan Road - MPWM
McGaw Park, IL 60085 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sharon Nichols
Manager, Regulatory Affairs |
| Telephone: | (847) 785-3311 |
| Date Prepared: | July, 2003 |
| Product Trade Name: | Bone Cement Radio-Opacifier |
| Common Name: | Barium Sulfate, USP |
| Classification: | Class II per 21 CFR §8825300 |
| Predicate Device: | Parallax Tracer Radiopaque Particles |
| Intended Use: | This device is used as an additive to Codman Cranioplastic
(Type 1-slow set) to provide radiopacity for imaging
purposes. |
| Substantial Equivalence: | The Bone Cement Radio-Opacifier is substantially equivalent
to the Parallax Tracer Radiopaque Particles in that:
- Intended use is the same
- Performance attributes are the same |
| Description: | The Bone Cement Radio-Opacifier is an additive to be used
with Codman Cranioplastic (K873689) to provide radiopacity
to the resin and assist in placement and visualization of
material. |
| Summary of testing: | Based on the product performance information provided in
this notification, the subject device has been shown to be
substantially equivalent to the currently marketed predicate
device. |
| Non-clinical Test Results: | Performance testing demonstrated that the end product
Cranioplastic and Bone Cement Radio-Opacifier is
substantially equivalent to currently marketed Cranioplastic
with Radio-Opacifier from Parallax with regard to functional
characteristics. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1500 Waukegan Road McGraw Park, Illinois 60085-6787
Re: K032388
Trade Name: Bone Cement Radio-Opacifier Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: MYU Dated: July 31, 2003 Received: August 4, 2003
Dear Ms. Nichols:
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 (QS) regulation (21 CFR Part 820); and if
2
Page 2 - Ms. Sharon Nichols
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) 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) 594-4639. 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,
Sincerely yours,
R. Mark A. Milker
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
3
Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
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510(k) Number (if known):
Device Name:
Indications For Use:
Bone Cement Radio-Opacifier
This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Mark A Milkerso
(Division Sign-Off)
Division -General, Restornities and Neurological Devices
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