(14 days)
Not Found
No
The device description focuses on mechanical components (screws, plates, instruments) and their intended use for bone fixation. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used for internal fixation of bones and securing cranial flaps, which are structural and mechanical functions, not therapeutic.
No
Explanation: The device description states its purpose is for "internal fixation of bone fragments" and "to cover burr holes and to secure cranial flaps," which are therapeutic or surgical functions, not diagnostic ones.
No
The device description explicitly lists hardware components such as titanium screws, plates, and reusable instruments (screwdrivers, handles, etc.).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Integra Bone Fixation System is a system of implants (screws and plates) and instruments used for the internal fixation of bones. This is a surgical procedure performed inside the body.
- Intended Use: The intended use is for fixing bones affected by trauma, reconstruction, or arthrodesis, and covering burr holes. These are all surgical applications, not diagnostic tests performed on specimens.
The description clearly indicates a surgical device used for structural support and fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Integra Bone Fixation System includes titanium self-tapping and /or self-drilling screws and plates along with instruments for the internal fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra's various designs of fixation plates, including mesh plates, and burr hole covers. The Integra Bone Fixation System includes reusable instruments such as screwdrivers, handles and blades, plates holders, benders and cutters, drill bits, and instrument trays. The single use fixation plates and screws, and reusable instruments are provided nonsterile and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones affected by trauma; Burr holes; Cranial flaps
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Confidential
Integra Bone Fixation System 510(k) Summary
Submitter's name and address:
MAR 1 4 2005
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536
Contact person and telephone number:
Donna R. Wallace Director Regulatory Affairs 609-275-0500
Date prepared: February 25, 2005
Name of device:
.
Proprietary Name: Common Name: Classification Name:
Integra Bone Fixation System Bone Fixation Plates and Screws Bone Fixation Plates Burr Hole Covers Metal Mesh Bone Fixation Screws
Substantial Equivalence:
The Integra Bone Fixation System is substantially equivalent in function and intended use to the unmodified Integra Bone Fixation System which has been cleared to market under Premarket Notificaiton 510(k) K040860.
Intended Use:
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
Device Description:
The Integra Bone Fixation System includes titanium self-tapping and /or self-drilling screws and plates along with instruments for the internal fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra's various designs of fixation plates, including mesh plates, and burr hole covers. The Integra Bone Fixation System includes reusable instruments such as screwdrivers, handles and blades, plates holders, benders and cutters, drill bits, and instrument trays. The single use fixation plates and screws, and reusable instruments are provided nonsterile and must be sterilized prior to use.
Conclusion:
The modified Integra Bone Fixation System is substantially equivalent to the unmodified Integra Bone Fixation System. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows a circular seal with an eagle-like bird in the center. The bird is stylized with three thick, curved lines forming its body and wings. The bird's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle. The seal appears to be a logo or emblem for a health-related organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 스 2005
Ms. Donna Wallace Director Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K050492
Trade/Device Name: Integra Bone Fixation System Regulation Numbers: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: March 25, 2005 Received: March 30, 2005
Dear Ms. Wallace:
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.
2
Page 2 – Ms. Donna Wallace
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ovejn mailoning of substantial equivalence of your device to a legally premarket notification: "The PDF mising of cassification 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 If you desire spochie at (240) 276-0120. Also, please note the regulation entitled, Colliation of Comptimes w (21 the stimes w (21CFR Part 807.97). You may obtain Misoranding by reference to premainter novilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
O. Clarke H. Millican
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Integra Bone Fixation System
Indications For Use: The Integra Bone Fixation System is intended for use in internal fixation fiftheations I of Oser the moga, for reconstruction, or arthrodesis. Burr Hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
Prescription Use X_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mark M Milkerer | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K050497 |
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