(84 days)
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No
The device description is for a purely mechanical intramedullary rod and associated screws, with no mention of software, image processing, or AI/ML terms.
Yes
The device is used to address humeral fractures, which is a therapeutic function.
No
The device description clearly states it is an "intramedullary rod" used to address "humeral fractures," indicating it is a therapeutic implant for treatment, not for diagnosis.
No
The device description clearly states it is an intramedullary rod made of titanium, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended to address humeral fractures. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a physical implant (intramedullary rod, screws) used to stabilize a bone fracture. This is a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Acumed Retrograde Humeral Nail is an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws. The Acumed Retrograde Humeral Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterlity is achieved by gamma radiation.
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
humeral fractures
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.
0
Image /page/0/Picture/1 description: The image shows the word "ACUMED" in a bold, sans-serif font. The letters are large and blocky, with a slightly rounded appearance. To the right of the word "ACUMED" is the superscript "TM", indicating a trademark. A thick, black line underlines the entire word, adding emphasis to the brand name.
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Quality Orthopaedic Instruments and Implants
OCT 28 1996 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 Retrograde Humeral Nail is an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws.
The Acumed Retrograde Humeral Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterlity is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 104. Information regarding implantation, packaging, and labeling have been provided.
The Acumed Retrograde Humeral Nail is similar to Smith & Nephew Richards' Russell-Taylor Humeral Interlocking Nail in design, function, indications, and surgical technince and is expected to perform as well as similar devices. .