(93 days)
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Not Found
No
The summary describes a simple titanium alloy pin for fracture fixation and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is described as an "aid in the healing of lor fractures," which indicates a therapeutic purpose.
No
The device is described as a temporary implant (titanium alloy pin) to aid in the healing of fractures, which classifies it as a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "titanium alloy pin," which is a physical hardware component, 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 described as a "temporary ant to aid in the healing of lor fractures." This is a therapeutic purpose, directly treating a medical condition within the body.
- Device Description: The device is a "titanium alloy pin" intended for implantation into bone. This is a surgical implant, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used in vitro (outside the body) to analyze specimens and provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The intended use for the 450mm Nancy Nail™ is as a temporary implant to aid in the healing of long bone fractures. It is for children above 10 kg, up to 30 kg and up to 65 kg. The 100mm Nancy Nail™ is for small long bones with a long diaphysis, such as carpal or tarsal bones.
Product codes
ODB
Device Description
The Nancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm. The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Long bone, carpal bone, tarsal bone
Indicated Patient Age Range
Children above 10 kg, up to 30 kg and up to 65 kg. (Implied age range: pediatric)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kirschner's Wire, Steinman Pin, Howmedica's Rush Nail
Reference Device(s)
Not Found
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 a logo with a stylized letter 'L' inside a partial circle. The 'L' is formed by two thick, parallel lines that create the shape. The circle is incomplete, with a gap at the top left, giving the impression that the 'L' is emerging from or connecting to the circle. The logo is in black and white, with the 'L' and circle being solid black against a white background.
A SUBSIDIARY OF GIROUP LANDANGER CAMUS
MAY 1 7 1996
8 - SUMMARY OF SAFETY & EFFECTIVENESS
| MANUFACTURER
IDENTIFICATION | Landanger-Landos
Z.I. La Vendue BP 88
52003 Chaumont Cedex France |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 9007981 |
| SPONSOR IDENTIFICATION | Jean-Paul Burtin, C.E.O.
Landos, Inc.
100 Lindenwood Drive
Malvern, PA 19355
Phone: (610) 644-4670
Fax: (610) 644-4429 |
| SPONSOR ESTABLISHMENT
REGISTRATION NUMBER | 2530066 |
| OFFICIAL CONTACT
PERSON | Norman F. Estrin, Ph.D., RAC
President
Estrin Consulting Group, Inc.
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Fax: (301) 294-0126 |
| PROPRIETARY NAME | Nancy Nail™ |
| COMMON NAME | Intramedullary Elastic Nail |
1