(301 days)
Not Found
No
The 510(k) summary describes a physical, bioresorbable pin used for stabilizing membranes. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No
The device is intended to stabilize membranes during healing, not to treat a disease or condition itself.
No
The IMTEC BioPin is described as a device to "fixate and stabilize bioresorbable barrier membranes" and provides an "attachment mechanism" to avoid "a second stage surgery." Its function is mechanical stabilization and reabsorption, not diagnosis.
No
The device description clearly states it is a physical pin fabricated from a bioresorbable copolymer, indicating it is a hardware device, 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 to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment mechanism. This is a surgical/implantable device used directly on the patient's tissue.
- Device Description: The description details a physical pin fabricated from a bioresorbable copolymer, designed to be implanted in the oral cavity to anchor membranes to bone. This is consistent with a surgical device.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
The resorbable IMTEC BioPin pin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment. Its use is intended to avoind a second stage surgery required to remove nonresorbable tacks and pins.
Product codes
DZL
Device Description
The IMTEC BioPin is a bioresorbable pin designed to fixate and stabilize bioresorbable barrier membranes in the oral cavity during the healing process following dental surgery. The pin provides an anchoring mechanism to resident and adjacent bone at the surgical site. The pin is fabricated from a bioresorable copolymer of L and DL lactide. The pin has a low profile, round, lens shaped head an a shaft with two circular ribs. It is provided in a sterile vial.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
JUN 21 1999
510 (k) SUMMARY
SUBMITTED BY:
M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 (580) 223-4456
F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407
Date Submitted: August 20,1998
CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:
Classification Name: Screw, fixation, intraosseous (ref: 21 CFR 8722.4880); Product Code: DZL Common/ Usual Name: Membrane fixation pin.
Proprietary Name: IMTEC BioPin.
PREDICATE DEVICE:
LEADfix Bioresorbable Membrane Pin ( K974392) 3I Bioresorbable Fixation Tack (K972480) Synthes Fixation System (K974554)
DEVICE DESCRIPTION:
The IMTEC BioPin is a bioresorbable pin designed to fixate and stabilize bioresorbable barrier membranes in the oral cavity during the healing process following dental surgery. The pin provides an anchoring mechanism to resident and adjacent bone at the surgical site. The pin is fabricated from a bioresorable copolymer of L and DL lactide. The pin has a low profile, round, lens shaped head an a shaft with two circular ribs. It is provided in a sterile vial.
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INDICATIONS FOR USE:
The resorbable IMTEC BioPin pin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment. Its use is intended to avoind a second stage surgery required to remove nonresorbable tacks and pins.
PRINCIPLES OF OPERATION:
The IMTEC BioPin is a bioresorbable pin used to fix commercially available bioresorbable guided tissue regeneration membranes.
CONTRAINDICATIONS:
Contraindications customary to the use of bone grafts and membrane techniques should be observed. These include but are not limited to, current local infection, vascular impairment at the surgical site, uncontrolled diabetes, chronic high dose steroid therapy, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which affect bone or wound healing. Specifically if allergies to polylactid and lactic acid is known
COMPLICATIONS:
Possible complications with any oral reconstructive surgery include infection, closure perforation, abcess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with anesthesia and dental surgery. Specific to this surgery is augmentation material perforation or exfoliation.
MATERIALS OF CONSTRUCTION:
IMTEC BioPin is molded from PURASORB PL, a 70/30 copolymer of L( - ) Lactide/ DL-Lactide ( Molecular Weight: 152.000) by IMTEC-SWISS, Ardmore, OK.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The design, material, configuration, method of sterilization and other technological characteristics of IMTEC BioPin are similar to the currently marketed predicate devices.
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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 21 1999
M.K. Patterson, Jr., Ph.D. Sr. Vice President Requlatory Affairs IMTEC Corporation 2401 North Commerce P.O. Box 1562 Ardmore, Oklahoma 73402 U.S.A
K982951 Re : IMTEC BioPin Trade Name: Regulatory Class: II Product Code: DZL Dated: March 22, 1999 Received: March 23, 1999
Dear Dr. Patterson:
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, Druq, 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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 Reqister.
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Page 2 - Dr. Patterson
this response to your premarket notification Please note: 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.
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) 594-4692. 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,
Timothy A. Ulatowski
Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1___ of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:IMTEC BioPin
Indications For Use:
The resorbable IMTEC BioPin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment mechanism.Its use is intended to avoid a second stage surgery required to remove nonresorbable tacks and pins.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------ | -------------------------------------------- | ---- | -------------------------------------------------- |
|---|
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K982951 |