(279 days)
Not Found
No
The 510(k) summary describes a resinous material for cranial repair and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "resinous material for repair of cranial defects," which indicates it is used for medical treatment or correction of a health condition.
No
Explanation: The device, Parallax Cranioset, is described as a "resinous material for repair of cranial defects," indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device is described as a "resinous material" and its performance is compared to another material, 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 "repair of cranial defects." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "resinous material for repair of cranial defects." This is a material implanted or used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body, not to directly repair or treat the body itself.
N/A
Intended Use / Indications for Use
Parallax Cranioset is a resinous material for repair of cranial defects.
Product codes
GXP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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 Parallax Cranioset is substantially equivalent to Cranioplastic 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.
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.
Not Found
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
AUG 3 1 2000
Section 3 - 510(k) Summary
k 99 4022 510(k) Number:
Date Prepared: June 21, 2000
Applicant Information:
- Applicant: Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, CA 94043
- Brvan M. Barr Contact: Senior Materials Scientist
- (650) 934-6969 Phone: Fax: (650) 934-6965
Device Information:
Trade Name: Parallax Cranioset
Common Name: Methyl methacrylate for cranioplasty
Equivalent Devices:
The subject device is substantially equivalent to Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689).
Intended Use:
Parallax Cranioset is a resinous material for repair of cranial defects.
Comparison to Predicate Devices:
This device has the same intended use and functional characteristics as the predicate device. The materials contained within Parallax Cranioset are all materials that appear in the predicate device.
Non-clinical Test Results:
Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Mr. Bryan Barr Senior Materials Scientist Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, California 94043
Re: K994022 Trade Name: Parallax Cranioset Regulatory Class: II Product Code: GXP Dated: June 21, 2000 Received: June 22, 2000
Dear Mr. Barr:
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 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.
AUG 3 1 2000
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 -- Mr. Bryan Barr
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 additionally 607.10 for m This alagilestions on the promotion and advertising of your device, (201) 594-1037. Traditionally, 107-4639. Also, please note the regulation prease contact the Office of Complexion researce notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnes and 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,
Dune R. bochner.
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
Section 4 - Statement of Indications for Use
Indications for Use
994022 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Parallax Cranioset
Indications for Use:
Parallax Cranioset is a resinous material for repair of cranial defects.
(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_199 Prescription Use OR Over-The Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)