(88 days)
Not Found
Not Found
No
The device description focuses on the material properties and mechanical function of the anchors, with no mention of AI or ML.
No
The device aids in anchoring soft tissue during brow lift procedures and is not intended to treat or ameliorate a disease, injury, or medical condition.
No
The device, Craniofacial Anchors, is described as assisting suture in anchoring soft tissue during brow lift procedures, indicating it is a surgical implant rather than a diagnostic tool. Its mechanism of action involves physical placement and resorption, not the detection or analysis of medical conditions.
No
The device description explicitly states the devices are made of LactoSorb® material, which is a physical, bioresorbable material, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Craniofacial Anchor" used in "open and endoscopic brow lift procedures." It is placed into bone to anchor soft tissue. This is an implantable device used within the body (in vivo).
The function of this device is to provide physical support and anchoring during surgery, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Craniofacial Anchors are indicated for use with resorbable suture in open and endoscopic brow lift procedures. The device is placed into a preditiled, tapped bone hole and assists the suture in anchoring soft tissue. These devices are not designed for use in the mandible and/or full load bearing procedures.
Product codes
79 GAN, MBI, HWC
Device Description
The devices are made of LactoSorb® material, which based on animal studies, completely resorbs by 12 months In Vivo. The devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs In Vivo by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLAPGA material has been well documented since the early 1970's when FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip and safety and effectiveness has been studied in two different clinical trials. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue and maintains its strength for soft tissue reattachment and fracture healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brow
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)
Not Found
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 of Safety and Effectiveness
SUBMITTER: Biomet, Inc. Airport Indutrial Park P. O. Box 587 Warsaw, IN 46581-0587
CONTACT PERSON: Mary L. Verstynen (219) 267-6639 ext. 1343
PRODUCT CODE: 79 GAN Device Name: Craniofacial Anchors
SUMMARY
The Craniofacial Anchors are indicated for use with resorbable suture in open and endoscopic brow lift procedures. The device is placed into a preditiled, tapped bone hole and assists the suture in anchoring soft tissue. These devices are not designed for use in the mandible and/or full load bearing procedures.
The devices are made of LactoSorb® material, which based on animal studies, completely resorbs by 12 months In Vivo. The devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs In Vivo by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLAPGA material has been well documented since the early 1970's when FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip and safety and effectiveness has been studied in two different clinical trials. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue and maintains its strength for soft tissue reattachment and fracture healing.
As demonstrated in this submission, the Craniofacial Anchors are safe and effective for use in brow lift procedures.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three wavy lines extending from the head, resembling hair or a flowing garment. The figure is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 0 1998 : 1
Ms. Mary Verstynen ·Clinical Research Manager Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K974136 Craniofacial Anchor Trade Name: Regulatory Class: II Product Codes: MBI, HWC, and GAN Dated: October 31, 1997 Received: November 3, 1997
Dear Ms. Verstynen:
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.
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 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 Requlation (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.
2
Page 2 - Ms. Mary Verstynen
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 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.qov/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
Enclosure
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510 (k) NUMBER (IF KNOWN) : K974136 DEVICE NAME: Craniofacial Anchors
INDICATIONS FOR USE:
5 -
The Craniofacial Anchors are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.
(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 | 1979136 |
Prescription Use
(Per 21 CFR 801.109) X OR Over-The-Counter-Use
(Optional Format 1-2-96)