(56 days)
Not Found
No
The device description focuses on the material, design, and mechanical properties of bone screws, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The devices are indicated for fixation of bone fractures and bone reconstruction, which are therapeutic interventions.
No
The device description clearly states its purpose is for "fixation of bone fractures and bone reconstruction," and it is detailed as a "screw" for surgical use, not for diagnosis.
No
The device description clearly states the device is made of titanium alloy and is a physical screw intended for bone fixation. It does not mention any software component.
No, 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.
- Device Description: The provided text describes a surgical implant (screws) made of titanium alloy, designed for the physical fixation of bone fractures and reconstruction.
- Intended Use: The intended use is clearly for surgical procedures to stabilize bones, not for analyzing biological samples.
The device described is a surgical implant/orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to:
· Fixation of bone fragments in long or small bone fractures
· arthrodesis in hand or foot surgery
· mono or bi-cortical osteotomies in the foot or hand
· distal or proximal metatarsal or metacarpal osteotomics
· fixation of osteotomies for hallux valgus treatment (such as Scarf, Chevron, etc.)
Product codes
HWC
Device Description
The ARS and SLANT Screws are made of titanium alloy (Ti6A14V) according to ISO 5832-3 and ASTM F 136. They are self-drilling, self-tapping and designed with a double thread for better grip on tissue. The ARS and SLANT Screws are intended for single use only.
The titanium ARS and SLANT SCREWs are cannulated for use with a guide wire and have double-threading and different pitch for the proximal and distal threads. The headless screws can be completely embedded in the bone thus avoiding any protrusion that could cause irritation to the tissue. The double-thread design assures compression and stability of the fractures. Both screws have reverse-cutting flutes in the head threaded portion to facilitate removal of the screw.
The code to clearly identify each product is laser-marked on the unthreaded cylindrical screw part. The screws are color coded (anodized) to be easily recognized ARS (blue) from SLANT (green).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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
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.
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K130954 page 1 of 2
ATTACHMENT E
510(k) SUMMARY
MAY 3 1 2013
Trade Name: BRM ARS AND SLANT SCREWS
Advanced Interventional Technology LLC Sponsor: 6703 NW 167 Street, Suite C-9 Miami, Fla 33015
E. March Contact: 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 |
Product Description:
The ARS and SLANT Screws are made of titanium alloy (Ti6A14V) according to ISO 5832-3 and ASTM F 136. They are self-drilling, self-tapping and designed with a double thread for better grip on tissue. The ARS and SLANT Screws are intended for single use only.
The titanium ARS and SLANT SCREWs are cannulated for use with a guide wire and have double-threading and different pitch for the proximal and distal threads. The headless screws can be completely embedded in the bone thus avoiding any protrusion that could cause irritation to the tissue. The double-thread design assures compression and stability of the fractures. Both screws have reverse-cutting flutes in the head threaded portion to facilitate removal of the screw.
The code to clearly identify each product is laser-marked on the unthreaded cylindrical screw part. The screws are color coded (anodized) to be easily recognized ARS (blue) from SLANT (green).
1
Indications for Use:
The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to:
· Fixation of bone fragments in long or small bone fractures
· arthrodesis in hand or foot surgery
· mono or bi-cortical osteotomies in the foot or hand
· distal or proximal metatarsal or metacarpal osteotomies
· fixation of osteotomies for hallux valgus treatment (such as Scarf, Chevron, etc.)
Predicate Devices
Substantial Equivalence Information
Based on available 510k information including engineering analyses, AIT bone fixation screws (BRM ARS and Slant) are deemed substantially equivalent to the predicate devices in terms of indications for use, material, technology and design specifications.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Interventional Technology LLC % GAMA Associates LLC Mr. Eduardo March 7000 Cashell Manor Court Derwood, Maryland 20855
Letter dated: May 31, 2013
Re: K130954
Trade/Device Name: BRM ARS and SLANT Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 2, 2013 Received: May 3, 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-ofdevices, 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,
Mark N.J.Mielkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices_ Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of ___________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K130954
Device Name: BRM ARS and SLANT SCREWS
Indications for Use:
The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to:
- · Fixation of bone fragments in long or small bone fractures
·arthrodesis in hand or foot surgery
·mono or bi-cortical osteotomies in the foot or hand
· distal or proximal metatarsal or metacarpal osteotomics
· fixation of ostcotomies for hallux valgus treatment (such as Scarf. Chevron, etc.)
Prescription Use × 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
CONFIDENTIAL
29 April 2013
Elizabeth L. Frank -S
Division of Orthopedic Devices