(166 days)
Not Found
No
The description focuses on the mechanical properties and surgical application of a bone screw, with no mention of AI or ML capabilities.
No.
The device is an orthopedic screw used for surgical fixation of bone fractures and osteotomies, which is a structural implant, not a therapeutic device.
No
The device is a surgical screw used for fixation of bone fractures, osteotomies, and bone reconstruction. Its purpose is to provide stable fixation, not to diagnose a condition.
No
The device description clearly states the device is a physical screw made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "surgical fixation of bone fractures, osteotomies and bone reconstruction". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a screw made of titanium alloy, designed for physical implantation into bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with biological samples in this way.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The AIT BRM SWING-OFF SCREW is indicated for surgical fixation of bone fractures, osteotomies and bone reconstruction in order to position and maintain bony fragments in a desired orientation and to provide stable fixation of the osteotomy site until a stable bony union occurs.
Examples include but are not limited to:
-Fixation of small bone fragments
-Weil osteotomy
-Mono-cortical fixation
-Osteotomies and fractures fixation in foot and hand
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The BRM SWING OFF Screw is made of titanium alloy (Ti6A14V- ELI) according to ISO 5832-3 and ASTM F 136. It is self-drilling and self-tapping and consists of a screw with a flat thin head which is integrated with a short round shaft. The shaft is fixed on a standard surgical shaft and separates from the screw when the head comes in contact with cortical bone.
The screw is available in two different diameters (2.0 and 2.7 mm) and in length from 10 to 15 mm for Ø 2.0 mm and from 10 to 17 mm for Ø 2.7 mm. The screws are anodized and color-coded (yellow) to be easily recognized. The head design facilitates maximum loading and compression. The self-drilling tip easily penetrates the cortical shell. A Swing-Off Terminal Screw Driver is offered for ease of use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
§ 888.3040 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
ATTACHMENT E
ﺮ ﺍﻟﻤ
510(k) SUMMARY
| Trade Name: | BRM SWING-OFF SCREW |
|---|---|
| Sponsor: | Advanced Interventional Technology LLC |
| 6703 NW 167 Street, Suite C-9 | |
| Miami, Fla 33015 | |
| Contact: | E. March |
| GAMA Associates LLC | |
| Ph- 240.506.3212 | |
| Email- edogama@comcast.net | |
| Device Generic Name: | Bone Fixation Screw |
| Classification: | CFR 888.3040 Class II |
| Product Code: | HWC |
AUG 2 1 2013### Product Description
The BRM SWING OFF Screw is made of titanium alloy (Ti6A14V- ELI) according to ISO 5832-3 and ASTM F 136. It is self-drilling and self-tapping and consists of a screw with a flat thin head which is integrated with a short round shaft. The shaft is fixed on a standard surgical shaft and separates from the screw when the head comes in contact with cortical bone.
The screw is available in two different diameters (2.0 and 2.7 mm) and in length from 10 to 15 mm for Ø 2.0 mm and from 10 to 17 mm for Ø 2.7 mm. The screws are anodized and color-coded (yellow) to be easily recognized. The head design facilitates maximum loading and compression. The self-drilling tip easily penetrates the cortical shell. A Swing-Off Terminal Screw Driver is offered for ease of use.
Indications for Use:
The AIT BRM SWING-OFF SCREW is indicated for surgical fixation of bone fractures, osteotomies and bone reconstruction in order to position and maintain bony fragments in a desired orientation and to provide stable fixation of the osteotomy site until a stable bony union occurs.
Examples include but are not limited to:
-Fixation of small bone fragments
Date Prepared: 21 Aug. 2013
1
-Weil osteotomy
-Mono-cortical fixation
-Osteotomies and fractures fixation in foot and hand
Predicate Devices
/
ど
Substantial Equivalence Information
Based on available 510k information including engineering analyses and insertion testing, AIT bone fixation (screw) devices are deemed substantially equivalent to the predicate devices in terms of indications for use, material, technology and design specifications.
2
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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2013
Advanced Interventional Technology LLC % Mr. Eduardo March GAMA Associates LLC 7000 Cashell Manor Court Derwood, Maryland 20855
Re: K130627
Trade/Device Name: BRM Swing-Off Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 19, 2013 Received: July 22, 2013
Dear Mr. March:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Eduardo March
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin | Meith
For
Mark N. Melkerson Director Division of Orthopedic 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): K130627
Device Name: BRM Swing-Off Screw
Indications for Use:
The BRM SWING-OFF SCREW is indicated for surgical fixation of bone fractures, osteotomies and bone reconstruction in order to position and maintain bony fragments in a desired orientation and to provide stable fixation of the osteotomy site until a stable bony union occurs.
Examples include but are not limited to:
- -Fixation of small bone fragments
- -Weil osteotomy
- -Mono-cortical fixation
- -Osteotomies and fractures fixation in foot and hand
Prescription Use __ X_ AND / OR (PART 21 CFR 801.Subpart D)
Over-the -Counter Use (PART 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, OFFICE OF DEVICE EVALUATION
б
Elizabeth L. Frank -S
Division of Orthopedic Devices