(113 days)
Not Found
No
The description focuses on the chemical composition and physical properties of a self-curing resin for cranial repair, with no mention of AI or ML.
No
The device is a material for repairing cranial defects, which is a structural rather than a functional or therapeutic intervention.
No
Explanation: The device, Visioplast Acrylic Resin, is described as a material for repairing cranial defects, indicating a therapeutic or reconstructive purpose rather than a diagnostic one. Its function is to harden and fill defects, not to detect, diagnose, or monitor a medical condition.
No
The device is a physical material (acrylic resin) used for cranial repair, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "repairing cranial defects." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "resinous material" that is "self-curing" and "hardens within 20 minutes." This describes a material used for physical reconstruction within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The Visioplast Acrylic Resin is a surgical implant/material used for cranioplasty.
N/A
Intended Use / Indications for Use
Visioplast Acrylic Resin is a resinous material for repairing cranial defects.
Product codes
GXP
Device Description
Visioplast Acrylic Resin is a self-curing resin which is intended for the repair of cranial defects. Like the predicate model, the proposed acrylic resin is provided sterile and contains a liquid and powder component. Visioplast Acrylic Resin is designed for manual mixing technique. When the two components are mixed together, a viscous paste is obtained which hardens within 20 minutes with a cold-curing polimerisation. The chemical constituents are substantially equivalent to those in the predicate apart from the presence of barium sulphate in the powder which provides radiopacity for imaging purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial defects
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)
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
K.042414
DEC 2 9 2004
Visioplast Acrylic Resin Traditional 510(k)
Company confidential
Summary of Safety and Effectiveness
TECRES S.p.A Via Andrea Doria 10. 37066 Sommacampagna, Verona, Italia Phone: +39 045 9217311 Fax: +39 045 9217330
Contact person:
Massimo Grazioli General Manager
Official Correspondent
Christine Brauer, Ph.D. Regulatory Affairs Consultant One Democracy Plaza 6701 Democracy Boulevard, Suite 700 Bethesda, MD 20817 tel: 301-545-1990 fax: 301-545-1992 E-MAIL: chrisbrauer@earthlink.net
- Proposed Propietary Trade Name:
Visioplast Acrylic Resin
-
- Classification Name:
Methyl methacrylate for cranioplasty.
- Classification Name:
3. Equivalent Device:
The subject device is substantially equivalent to Codman Cranioplastic TM, Acrylic Cranioplasty Material (#K873689)
4. Product Description:
Visioplast Acrylic Resin is a self-curing resin which is intended for the repair of cranial defects. Like the predicate model, the proposed acrylic resin is provided sterile and contains a liquid and powder component. Visioplast Acrylic Resin is designed for manual mixing technique. When the two components are mixed together, a viscous paste is obtained which hardens within 20 minutes with a cold-curing polimerisation.
The chemical constituents are substantially equivalent to those in the predicate apart from the presence of barium sulphate in the powder which provides radiopacity for imaging purposes.
5. Indications
Visioplast Acrylic Resin is a resinous material for repairing cranial defects.
Section 4 Page 1/2
1
Summary of Safety and Effectiveness
6. Substantial Equivalence
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 2004
Christine Brauer, Ph.D. Regulatory Affairs Consultant One Democracy Plaza 6701 Democracy Boulevard, Suite 700 Bethesda. Maryland 20817
Re: K042414
Trade Name: Visioplast Acrylic Resin Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: December 20, 2004 Received: December 21, 2004
Dear Dr. Brauer:
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Christine Brauer, Ph.D.
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 (240) 276-0120. 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,
b. Mark N. Milburn
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
Indications for Use
510(k) Number:
K0124/4
Device Names:
Visioplast Acrylic Resin
INDICATIONS FOR USE
Visioplast Acrylic Resin is a resinous material for repairing cranial defects.
Mark A. Millerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K042414 510(k) Number
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
×
or
Over the Counter Use
Section 3 Page 1/1