(208 days)
No
The device description and performance studies focus on mechanical properties and substantial equivalence to predicate devices, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
Yes
The device is intended to repair a fracture, mal-union, or non-union of the clavicle, which aligns with the definition of a therapeutic device as it directly treats a medical condition.
No
This device is an intramedullary device for fracture fixation, not a diagnostic tool.
No
The device description explicitly states it consists of a physical titanium device and a screw, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to repair fractures of the clavicle, which is a surgical procedure performed in vivo (within the body).
- Device Description: The device is an intramedullary implant and screw, designed to be surgically inserted into bone.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The AOS Clavicle Intramedullary Device is intended to be used to repair an acute fracture, mal-union, or the Clavicle.
Product codes (comma separated list FDA assigned to the subject device)
HSB, JDW
Device Description
The system consists of an intramedullary titanium device and a fully threaded 2.7mm cortical screw for Clavicle fracture fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle
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)
PRECLINICAL TESTING: The AOS Clavicle Intramedullary Device was subjected to comparative mechanical testing per a four point bend test based on ASTM F1264-03. The results demonstrate that the AOS Clavicle Intramedullary Device and accessories are substantially equivalent to the predicate.
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.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(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 border 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, resembling a bird-like shape.
June 3, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Incorporated Ms. Anna Hwang Regulatory Associate 3203 Kashiwa Street Torrance, California 90505
Re: K143204
Trade/Device Name: AOS Clavicle Intramedullary Device Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDW Dated: April 27, 2015 Received: April 29, 2015
Dear Ms. Hwang:
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
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Page 2 - Ms. Anna Hwang
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/Resourcesfor You/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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Indications for Use
510(k) Number (if known) K143204
Device Name AOS Clavicle Intramedullary Device
Indications for Use (Describe)
The AOS Clavicle Intramedullary Device is intended to be used to repair an acute fracture, mal-union, or the Clavicle.
| 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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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 a darker blue color and the "O" and "S" in a lighter blue color. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font.
5. TRADITIONAL 510(K) SUMMARY
| DATE PREPARED: | May 19, 2015 |
|---|---|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc. |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| CONTACT PERSON: | Anna Hwang |
| Advanced Orthopaedic Solutions, Inc. | |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| DEVICE NAME: | AOS Clavicle Intramedullary Device |
| COMMON NAME: | Clavicle Nail |
| CLASSIFICATION: | Class II, 21 CFR 21 CFR 888.3020, Intramedullary |
| fixation rod | |
| 888.3040, Smooth or Threaded Metallic Bone | |
| Fixation Fastener | |
| DEVICE CODE: | HSB and JDW |
| SUBSTANTIALLY | |
| EQUIVALENT DEVICES: | Primary Predicate: DePuy Orthopaedics Rockwood |
| Clavicle Pin (510(k): K103001, Cleared February 17, | |
| 2011); | |
| Reference Device: Sonoma Orthopedic EnsplintCMx | |
| Clavicle Pin (510(k): K081832, Cleared October 10, | |
| 2008); and | |
| Reference Device: Synthes Elastic Intramedullary | |
| Nail (EIN) System: K971783, Cleared July 18, 1997. | |
| DEVICE DESCRIPTION: | The system consists of an intramedullary titanium |
| device and a fully threaded 2.7mm cortical screw for | |
| Clavicle fracture fixation. | |
| INDICATIONS FOR USE: | The AOS Clavicle Intramedullary Device is intended |
| to be used to repair an acute fracture, mal-union, or | |
| non-union of the Clavicle. | |
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial |
| equivalence of the AOS Clavicle Intramedullary | |
| Device to the predicate devices. The proposed |
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system has the same indications for use, is similar in shape, design and material, and has the same fundamental technology.
PRECLINICAL TESTING: The AOS Clavicle Intramedullary Device was subjected to comparative mechanical testing per a four point bend test based on ASTM F1264-03. The results demonstrate that the AOS Clavicle Intramedullary Device and accessories are substantially equivalent to the predicate.