(71 days)
K8736989
Not Found
No
The device is a radiopaque additive for a bone cement, intended for imaging purposes. There is no mention of AI/ML in the description, intended use, or performance studies.
No
The device is described as an additive to provide radiopacity for imaging purposes, not to treat a medical condition.
No
The device is an additive to provide radiopacity for imaging purposes, not to diagnose a condition. It facilitates imaging for diagnosis but does not perform the diagnosis itself.
No
The device is described as "Radiopaque Particles," which are a physical substance intended to be added to another material. This clearly indicates a hardware component, not a software-only device.
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 for imaging purposes when added to a cranioplastic material. This is a function related to imaging and visualization within the body, not for testing samples of human origin in vitro (outside the body) to provide information about a physiological state, health, or disease.
- Device Description: The device is described as "Radiopaque Particles," which are physical particles added to another material. This doesn't align with the typical nature of IVD devices, which are often reagents, kits, or instruments used for testing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Parallax™ Tracer Radiopaque Particles are intended for use as an imaging aid within a medical device (cranioplastic material) and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.
Product codes
MYU
Device Description
Not Found
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
Performance testing demonstrated that the end product (Cranioplastic and Tracer Particles) is substantially equivalent to Cranioplastic alone, with regards to functional characteristics.
Key Metrics
Not Found
Predicate Device(s)
K8736989
Reference Device(s)
Not Found
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
Section 3 - 510(k) Summary
510(k) Number:
991993
Date Prepared: June 2, 1999
Applicant Information:
Applicant: Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, CA 94043
| Contact: | Susan G. Marques |
|---|---|
| Manager, Regulatory Affairs |
| Phone: | (650) 934-6969 |
|---|---|
| Fax: | (650) 934-6965 |
Device Information:
Parallax™ Tracer Radiopaque Particles Trade Name:
Barium Sulfate Common Name:
Equivalent Devices:
The subject device is substantially equivalent to Codman Cranioplastic™, Acrylic Cranioplasty Material (K8736989).
Intended Use:
Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.
Comparison to Predicate Devices:
This device has the same functional characteristics as the predicate device.
Non-clinical Test Results:
Performance testing demonstrated that the end product (Cranioplastic and Tracer Particles) is substantially equivalent to Cranioplastic alone, with regards to functional characteristics.
Summary:
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.
1
Image /page/1/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 a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1999
Ms. Susan G. Marques Manager, Regulatory Affairs Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, California 94043
Re: K991893
Trade Name: Parallax Tracer Radiopaque Particles Regulatory Class: II Product Code: MYU Dated: July 16, 1999 Received: July 19, 1999
Dear Ms. Marques:
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 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 control provisions of the Act. The general control 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 (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 requirement, 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.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 – Ms. Susan G. Marques
If you desire specific advice for your device on our labeling regulation (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/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section 4 - Statement of Indications for Use
Indications for Use
..............................................................................................................................................................................
510(k) Number (if known): K 99189 3
Device Name: Parallax™ Tracer Radiopaque Particles
Indications for Use:
・
Parallax™ Tracer Radiopaque Particles are intended for use 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 IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K991893 | |
| Prescription Use | OR | Over-The Counter Use |
| (Per 21 CFR 801.109) X | (Optional Format 1-2-96) |