(28 days)
No
The 510(k) summary describes a standard orthopedic implant (plate and screws) for fracture fixation and does not mention any AI or ML components or functionalities.
No
The device is an orthopedic implant for internal fixation of fractures, not a therapeutic device that delivers therapy or treatment. Its function is mechanical support.
No
The device is described as an "open reduction internal fixation device" for temporary fixation of fractures, not for diagnosing them. It is used to treat a condition (fractures), not to identify or characterize it.
No
The device description explicitly states it consists of titanium plates and screws, which are hardware components.
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 information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the AOS Anterolateral Proximal Humeral Plate is an open reduction internal fixation device used for the temporary fixation of fractures of the humerus. This is a surgical implant used directly on the patient's bone.
- Intended Use: The intended use is for treating fractures, dislocations, osteotomies, and nonunions of the proximal humerus. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The information provided describes a surgical implant, which falls under the category of medical devices, but specifically not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AOS Anterolateral Proximal Humeral Plate is indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.
The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Product codes
KTW
Device Description
The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
AOS Proximal Humeral Plate (K080590, May 6, 2008)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Incorporated Kazu Mivahara Product Development Engineer 3203 Kashiwa Street Torrance, California 90505
March 15, 2016
Re: K160409 Trade/Device Name: AOS Anterolateral Proximal Humeral Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTW Dated: February 16, 2016 Received: February 17, 2016
Dear Kazu Miyahara:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (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 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 yours,
Mark N. Melkerson -S
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) K160409
Device Name
AOS Anterolateral Proximal Humeral Plate
Indications for Use (Describe)
The AOS Anterolateral Proximal Humeral Plate is indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in blue and the "O" and "S" in a lighter shade of blue. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is all in uppercase.
8. SPECIAL 510(K) SUMMARY
| SUMMARY PREPARED ON: | March 9, 2016 |
|---|---|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc. |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| CONTACT PERSON: | Kazu Miyahara |
| Advanced Orthopaedic Solutions, Inc. | |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| DEVICE NAME: | |
| COMMON NAME: | AOS Anterolateral Proximal Humeral Plate |
| Appliance, Fixation, Nail/Blade/Plate Combination, | |
| Single Component | |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiple |
| component metallic bone fixation appliances and | |
| accessories | |
| DEVICE CODE: | KTW |
| SUBSTANTIALLY | |
| EQUIVALENT DEVICE: | AOS Proximal Humeral Plate (K080590, May 6, |
-
|
| DEVICE DESCRIPTION: | The AOS Anterolateral Proximal Humeral plates are
open reduction internal fixation devices for the
temporary fixation of various types of fractures of the
humerus and are intended as load sharing devices
which may be removed once the fracture has healed.
The AOS Anterolateral Proximal Humeral System
consists of titanium plates, and proximal and distal
locking and non-locking screws. |
| INDICATIONS FOR USE: | The AOS Anterolateral Proximal Humeral Plate is
indicated for fractures, fracture dislocations,
osteotomies, and non-unions of the proximal
humerus. |
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial
equivalence of the Anterolateral Proximal Humeral
plate to the predicate device. The proposed plates
have the same indications for use, are similar in
geometry and design, have the same fundamental |
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scientific technology, and are made of the same material (Ti-6Al-4V, per ASTM F1472) as the predicate plates. As detailed in the submission, the proposed plates do not present a worst-case scenario with respect to strength characteristics and because of their similarity to the current plates, physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and predicate plates.