(420 days)
Not Found
No
The description focuses on a mechanical bone anchor and surgical procedure, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is a bone anchor system used in cosmetic surgical procedures (forehead or brow lift) to fix elevated soft tissue; it is not for treating a disease or disorder.
No
Explanation: The device is described as a "bone anchor device" used to fix elevated soft tissue during an endoscopic forehead or brow lift procedure. Its function is to provide physical support and fixation, not to diagnose a condition or disease.
No
The device description clearly describes a physical bone anchor device (partially threaded bone screw) and its intended use in a surgical procedure, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (endoscopic forehead or brow lift) to fix soft tissue to bone. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a bone anchor screw, a physical implant used during surgery.
- 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 samples, 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 CSCO Forehead Fixation System is intended for use in an endoscopic forehead or brow lift procedure. This procedure is performed endoscopically through several small openings rather than through a trans-coronal incision, resulting in reduced scarring and blood loss for patients. The soft tissue is elevated off the underlying bone endoscopically and fixed in the higher position by tying sutures attached to the tissue of the scalp to the CSCO Forehead Fixation System anchored in the outer table of the skull. The CSCO Forehead Fixation System is attached to the skull through a small incision in the scalp. It is recommended that the CSCO Forehead Fixation System be removed after approximately 10-14 days to allow adherence of the newly elevated soft tissues to the underlying frontal bone.
Product codes
MBI
Device Description
This submission describes a bone anchor device intended for use in endoscopic forehead or brow lift procedures. The CSCO Forehead Fixation System is a partially threaded bone screw 2.0 mm in diameter and available in either 12, 14 or 16 mm lengths. The distal 4 mm of each screw is threaded. The remainder of the shaft is smooth. The screw head is hexagonal and has a small groove just inferior to it for attachment of the suture. It is recommended that the CSCO Forehead Fixation System be removed after approximately 10-14 days to allow adherence of the newly elevated soft tissues to the underlying frontal bone. The device can be removed without anesthesia in the doctor's office.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead, brow, skull, frontal bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctor's office
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)
K926384, K953531, K912932, K961094, K961120
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
Bone Anchor
ОСТ 2 8 1997
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
Staple, Fixation, Bone Appliance for Reconstruction of Bone to Soft Tissue. 888.3030
CSCO Forehead Fixation System
Howmedica Leibinger Inc.
Contact Person:
Kristyn R. Waski QA/RA Engineer Howmedica Leibinger Inc. 14540 Beltwood Pkwy., East Dallas, TX 75244 (972) 392-3636 Telephone: (972) 392-7258 Fax:
Date Prepared: Date Revised:
August 30, 1996 July 28, 1997
Summary:
This submission describes a bone anchor device intended for use in endoscopic forehead or brow lift procedures. The CSCO Forehead Fixation System is a partially threaded bone screw 2.0 mm in diameter and available in either 12, 14 or 16 mm lengths. The distal 4 mm of each screw is threaded. The remainder of the shaft is smooth. The screw head is hexagonal and has a small groove just inferior to it for attachment of the suture. It is recommended that the CSCO Forehead Fixation System be removed after approximately 10-14 days to allow adherence of the newly elevated soft tissues to the underlying frontal bone. The device can be removed without anesthesia in the doctor's office.
Equivalence for this device is based upon similarities in intended use, material, design and operational principle to the Zimmer Statak Anchors (K926384), the Howmedica Mainstay Anchor (K953531), the Synthes Cortical Bone Screw (K912932), the Mitek® Threaded 2.0 mm Anchor (K961094), and the Marker System for Stereotaxic Navigation (K961120). The Statak, Mainstav and Mitek anchor devices are intended for use in reattachment of soft tissue to bone; the Cortical Bone Screw and Mitek anchor are used in endoscopic forehead lift procedures. The Statak, Mainstay and Mitek anchors are manufactured from Ti6Al4V, while the Cortical Bone Screw is manufactured from commercially pure titanium. The basic operational principle is similar for the anchor devices and the bone screw device. The Marker System for Stereotaxic Navigation relies on the principle of temporary percutaneous screw fixation for attachment to the skull.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 28 1997
Ms. Kristyn R. Waski Quality Assurance/Regulatory Affairs Engineer Howmedica Leibinger, Inc. Pfizer Hospital Products Group 14540 Beltwood Parkway East Dallas, Texas 75244
K963502 Re: CSCO Forehand Fixation System Regulatory Class: II Product Code: MBI Dated: July 28, 1997 Received: July 30, 1997
Dear Ms. Waski:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 53through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Kristyn R. Waski
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.
If you desire specific advice for your device on our labeling requlation (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,
Colia M. Witton, Ph.D.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K963502
Device Name: CSCO Forehead Fixation System
Indications for Use:
The CSCO Forehead Fixation System is intended for use in an endoscopic forehead or brow lift procedure. This procedure is performed endoscopically through several small openings rather than through a trans-coronal incision, resulting in reduced scarring and blood loss for patients. The soft tissue is elevated off the underlying bone endoscopically and fixed in the higher position by tying sutures attached to the tissue of the scalp to the CSCO Forehead Fixation System anchored in the outer table of the skull. The CSCO Forehead Fixation System is attached to the skull through a small incision in the scalp. It is recommended that the CSCO Forehead Fixation System be removed after approximately 10-14 days to allow adherence of the newly elevated soft tissues to the underlying frontal bone.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of General Restorative |
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
96550