(12 days)
No
The 510(k) summary describes a mechanical fixation system for craniotomy and does not mention any AI/ML components or capabilities.
No.
The device's intended use is to reattach and stabilize a cranial bone flap to the surrounding cranium after a craniotomy procedure, allowing for normal healing to occur. It is a fixation system, not a device that provides therapy.
No
The device is described as a fixation system used to reattach and stabilize a cranial bone flap after a craniotomy, allowing for normal healing. It is a surgical implant, not a tool for diagnosis.
No
The device description clearly states it consists of physical components (circular caps, internal serrated post) made of titanium and titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for reattaching a cranial bone flap to the surrounding cranium after a craniotomy procedure. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (caps and a post) used for mechanical fixation of bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Sterile Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.
Product codes
GXN
Device Description
The Bioplate ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques. The device will be packaged and provided Sterile ( by gamma radiation)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium, cranial bone flap
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
AUG 1 3 2008
Summary of Safety and Effectiveness VI.
Submitter's name, address, telephone number and contact person:
Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA, 90016 (310) 815-2100 (310) 815-2126 (fax)
Contact Person: Jesus Farinas
Trade name of Device:
Modified design of the Bioplate ZIP® Craniotomy Fixation System (K013050, K020088)
Common Name:
Bone Fixation Plates
Device Classification:
Class 2, 21 CFR 882-5330 GXN
Predicate Devices:
- (1) Bioplate, Inc. The Bioplate ZIP® Craniotomy Fixation System (K070901)
- (2.) Bioplate, Inc. The Bioplate ZIP® Craniotomy Fixation System (K013050)
- (3.) Bioplate, Inc. Device Modification of the Bioplate ZIP® Craniotomy Fixation System_(K020088)
1
Description of the Device:
The Bioplate ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques. The device will be packaged and provided Sterile ( by gamma radiation)
Intended Use of the Device:
The Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.
Comparison of the device's technological characteristics with those of the predicate devices
All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2008
Bioplate, Inc. % Mr. Jesus T. Farinas Director, OA/RA 3643 Lenawee Avenue Los Angeles, California 90016-4310
Re: K082175
Trade/Device Name: Bioplate ZIP® Craniotomy Fixation System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: July 31, 2008 Received: August 1, 2008
Dear Mr. Farinas:
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.
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Page 2 - Mr. Jesus T. Farinas
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use
K082175 510(k) Number (if known)
Device Name: Modified plate design for Bioplate ZIP® Craniotomy Fixation System.
Indication for Use:
The Sterile Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.
Prescription Use AND/OR × (Part 21 GFR-801 Subpart D)
Over-The Counter Use (21 GFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of the CDRH, Office of Evaluation (ODE)
eubare bucumo for mxa
(Division Sign-Off) Page 1 of Division of General, Restorative, and Neurological Devices
510(k) Number K082175