← Product Code [MYU](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU) · K991893 # PARALLAX TRACER RADIOPAQUE PARTICLES (K991893) _Parallax Medical, Inc. · MYU · Aug 13, 1999 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K991893 ## Device Facts - **Applicant:** Parallax Medical, Inc. - **Product Code:** [MYU](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU.md) - **Decision Date:** Aug 13, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5300 - **Device Class:** Class 2 - **Review Panel:** Neurology ## 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. ## Device Story Parallax Tracer Radiopaque Particles are barium sulfate particles added to Codman Cranioplastic (Type 1 - Slow Set) bone cement. The additive provides radiopacity to the cranioplastic material, allowing clinicians to visualize the implant during post-operative imaging. The device is used in a clinical or surgical setting by physicians performing cranioplasty. By enabling radiographic visibility, the particles assist in monitoring the placement and integrity of the cranioplastic implant. ## Clinical Evidence Bench testing only. Performance testing demonstrated that the end product (Cranioplastic and Tracer Particles) is substantially equivalent to Cranioplastic alone regarding functional characteristics. ## Technological Characteristics Barium sulfate particles; additive for acrylic cranioplasty material; provides radiopacity for imaging. ## Regulatory 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. ## Predicate Devices - Codman Cranioplastic™, Acrylic Cranioplasty Material (K8736989) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 {3}------------------------------------------------ 乐 # 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) | --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K991893](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K991893) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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