(54 days)
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No
The summary describes a purely mechanical implant (intramedullary rod) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is an intramedullary rod that addresses supracondylar fractures, which is a therapeutic intervention.
No
The device described is an intramedullary rod used to treat supracondylar fractures, which is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is an "intramedullary rod" made of titanium, which is a physical hardware 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 description clearly states the device is an "intramedullary rod" used to address "supracondylar fractures." This is a surgical implant used to stabilize bone fractures.
- Intended Use: The intended use is to address supracondylar fractures, which is a structural repair within the body, not a diagnostic test performed on a sample outside the body.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures. The nail is available in six different sizes with diameters of 11 mm, 12 mm, and 13 mm and lengths of 150 mm and 220 mm. The nail is used in conjunction with 5 mm interlocking screws. The Acumed Supracondylar Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 106. Information regarding implantation, packaging, and labeling have been provided.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
supracondylar
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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/0 description: The image shows the word "ACUMED" in a bold, sans-serif font. The letters are black, and there is a horizontal line underneath the word. To the right of the word is the trademark symbol, "TM", in a smaller font.
Ouality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Acumed Supracondylar Nail is an intramedullary rod which addresses supracondylar fractures. The nail is available in six different sizes with diameters of 11 mm, 12 mm, and 13 mm and lengths of 150 mm and 220 mm. The nail is used in conjunction with 5 mm interlocking screws.
The Acumed Supracondylar Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 106. Information regarding implantation, packaging, and labeling have been provided.
The Acumed Supracondylar Nail is similar to Smith & Nephew Richards' Intramedullary Supracondylar Nail System in design, function, indications, and surgical technique and is expected to perform as well as similar devices.