(105 days)
No
The description focuses on the mechanical properties and materials of a bone screw, with no mention of AI or ML.
No
The device is described as a cannulated bone screw for internal fixation of fractures, which is a structural implant, not a device used to treat or manage a disease or condition for therapeutic purposes in the medical sense.
No
The device is a cannulated bone screw used for internal fixation of fractures; it is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical bone screw made of Ti-6Al-4V ELI alloy, intended for internal fixation of fractures. 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 for "internal fixation of fractures of the proximal humerus." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a "cannulated bone screw" made of a specific alloy. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used to stabilize a fracture.
N/A
Intended Use / Indications for Use
The Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.
Product codes
HWC, HRS
Device Description
The Miami Device Solutions (MDS) Cannulated Screw is a cannulated bone screw intended for use with the MDS Proximal Humerus Plating System cleared in K141493. The MDS cannulated bone screw is 3.5 mm in diameter, 30 to 60 mm in length in 3 mm increments, fully cannulated and threaded, and can interface with MDS Proximal Humerus Plates and Locking Caps cleared in K141493. The MDS device is supplied not sterile and is single-use only.
Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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)
Characterization of the subject MDS Cannulated Screw and Predicate Zimmer Cannulated Screw was performed per consensus standard ASTM F543. More specifically, the subject MDS and predicate Zimmer cannulated screws were evaluated for torsional strength, torque-out, and axial pull out strength. The results of these tests showed the MDS device to possess similar performance properties as the Zimmer predicate device, and the Arthrex predicate device (K041965), and therefore do not raise new questions of safety when used per the products labeling.
The results of the performance testing per ASTM F543 indicate the MDS Cannulated Screw to be substantially equivalent to the predicate Zimmer cannulated screw and the predicate Arthrex screw, and to be safe when used per the products labeling and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K141493, K041965, K040593, K042598, K043227, K043560, K050121, K051098
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
Miami Device Solutions. LLC % Robert Poggie, Ph.D. President Biovera Incorporated 65 Promenade Saint Louis Notre-dame-de-l'ile-perrot. OC J7V7P2 Canada
Re: K161058
Trade/Device Name: Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: June 13, 2016 Received: June 15, 2016
Dear Dr. Poggie:
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
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Page 2 - Dr. Robert Poggie
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 of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161058
Device Name
Cannulated Screw
Indications for Use (Describe)
The Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.
Image /page/2/Picture/8 description: The image appears to be a textured, light gray surface. The texture is subtle and consistent throughout the image, giving it a slightly mottled appearance. There are no distinct objects or features visible, and the overall impression is one of a neutral, uniform background. The lighting seems even, with no strong shadows or highlights.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Line Extension - Cannulated Screw for the Proximal Humerus Plating System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following is a summary of safety and effectiveness of the Cannulated Screw.
A. SUBMITTERS INFORMATION, DEVICE IDENTIFICATION, AND MANUFACTURER
| Name: | Miami Device Solutions, LLC |
|---|---|
| Address: | 7620 NW 25th Street, Unit 3, Miami, FL 33122, USA |
| Registration Number: | 3009222247 |
| Contact Name: | Markku Biedermann |
| Title: | President |
| Device Trade Name: | Cannulated Screw |
| Device Common Name: | Bone screw |
| Classification Name: | Plate, fixation, bone; and Screw, fixation, bone |
| Classification Codes: | HWC and HRS - Class II |
| Classification Panel: | Orthopedic |
| Requlation Number: | 21 CFR section 888.3040 and 888.3030 |
B. CORRESPONDENT INFORMATION
| Name: | BioVera, Inc. |
|---|---|
| Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Québec, |
| J7V 7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796; (973) 738-6097 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | July 28, 2016 |
C.1. PREDICATE DEVICES
| K141493 | Miami Device Solutions, LLC Proximal Humerus Plating System |
|---|---|
| K041965 | Arthrex Inc., Arthrex Humeral Fracture Plates & Screws |
| K040593, K042598, | |
| K043227, K043560, | |
| K050121, K051098 | Zimmer, Inc. Proximal Humeral Plating System |
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C.2. REFERENCE DEVICES
K151418 Paragon 28, Inc.; the Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments
D. DEVICE DESCRIPTION
The Miami Device Solutions (MDS) Cannulated Screw is a cannulated bone screw intended for use with the MDS Proximal Humerus Plating System cleared in K141493. The MDS cannulated bone screw is 3.5 mm in diameter, 30 to 60 mm in length in 3 mm increments, fully cannulated and threaded, and can interface with MDS Proximal Humerus Plates and Locking Caps cleared in K141493. The MDS device is supplied not sterile and is single-use only.
Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.
E. INTENDED USE
The Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject device is a titanium alloy, fully threaded, polyaxial, cannulated bone screw for use with the MDS Proximal Humerus Plating System. It is available in one diameter, 3.5 mm, and length options of 30 to 60 mm in 3 mm increments, and can be used with MDS plates and locking caps cleared in K141493. The subject Cannulated Screw is a line extension to the cleared MDS Proximal Humerus Plating System for the purpose of providing surgeons the option to guide the screw with a K-wire.
The material (Ti-6Al-4V ELI), indications for use, diameter, drive-interface detail, and polyaxial cone of angulation of the subject Cannulated Screw are identical to MDS noncannulated screws cleared in K141493 for the MDS Proximal Humerus Plating System. Performance testing of the MDS and Zimmer devices per ASTM F543 showed the subject cannulated screw to possess similar strength and performance characteristics as the predicate Zimmer cannulated screw, and the Arthrex predicate device (K041965). The MDS Cannulated Screw was determined to be substantially equivalent to the Zimmer and Arthrex predicate devices.
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G. PERFORMANCE DATA
Characterization of the subject MDS Cannulated Screw and Predicate Zimmer Cannulated Screw was performed per consensus standard ASTM F543. More specifically, the subject MDS and predicate Zimmer cannulated screws were evaluated for torsional strength, torque-out, and axial pull out strength. The results of these tests showed the MDS device to possess similar performance properties as the Zimmer predicate device, and the Arthrex predicate device (K041965), and therefore do not raise new questions of safety when used per the products labeling.
The results of the performance testing per ASTM F543 indicate the MDS Cannulated Screw to be substantially equivalent to the predicate Zimmer cannulated screw and the predicate Arthrex screw, and to be safe when used per the products labeling and intended use.
H. CONCLUSION
The Miami Device Solutions Cannulated Screw is substantially equivalent to the predicate devices cited in this 510(k) application.