(38 days)
Not Found
No
The description focuses solely on the physical characteristics and intended use of a titanium alloy pin for bone fracture fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone fractures, directly providing a therapeutic effect by facilitating fixation and healing.
No
The device is described as a temporary implant (titanium alloy pin) used to facilitate the fixation and healing of long bone fractures, not to diagnose medical conditions.
No
The device description explicitly states that the Nancy Nail™ is a "titanium alloy pin that is implanted," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Nancy Nail™ Function: The Nancy Nail™ is a physical implant used to stabilize bone fractures within the body. It does not analyze biological specimens.
The provided information clearly describes a surgical implant for bone fixation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of age and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.
Product codes (comma separated list FDA assigned to the subject device)
87 HTY
Device Description
The Nancy Nail™ is a titanium alloy pin that is implanted to facilitate the fixation of long bone fractures. The Nancy Nail™ is available in two lengths; the 450 mm is available in five diameters (2.0, 2.5, 3.0, 3.5, 4.0 mm), and the 100 mm is available in 1.0 mm diameter. The Nancy Nail™ is a single-use device intended for temporary implantation. It is intended to be removed once the bone has healed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone (tibia, humerus, femur, etc.), carpal or tarsal bones, upper extremity
Indicated Patient Age Range
children above four years of age and in any patient below 65 kg.
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): 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.
DePuy ACE® Nancy Nail™ K960642, Synthes Elastic Intramedullary Nail System K971783
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.
Not Found
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
§ 888.3040 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.
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510(k): ACE® Nancy Nail™ K032687
510(k) Summary 10-6-03
510(k) Summary
| Name of Sponsor: | DePuy ACE®, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No.1818910 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Rhonda Myer
Regulatory Affairs
Phone: (574) 371-4944
FAX: (574) 371-4987 |
| Trade Name: | ACE® Nancy Nail™ |
| Common Name: | Intramedullary Elastic Nail |
| Classification: | Class II Device per 21 CFR 888.3040:
Smooth or threaded metallic bone fixation fastener |
| Device Product Code: | 87 HTY |
| Substantially Equivalent
Devices: | DePuy ACE® Nancy Nail™ K960642
Synthes Elastic Intramedullary Nail System K971783 |
| Device Description: | The Nancy Nail™ is a titanium alloy pin that is implanted
to facilitate the fixation of long bone fractures. The Nancy
Nail™ is available in two lengths; the 450 mm is available
in five diameters (2.0, 2.5, 3.0, 3.5, 4.0 mm), and the 100
mm is available in 1.0 mm diameter. The Nancy Nail™ is
a single-use device intended for temporary implantation. It
is intended to be removed once the bone has healed. |
న్ని మొత్తమైన సామానికి చెందిన గ్రామం నుండి 10 కి.మీ. దూర
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510(k) Summary (continued)
Indications for use:
The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of age and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.
This submission covers the additional indication for use in upper extremity fractures in all patients.
This indication has been cleared previously for the Synthes Elastic Intramedullary Nail System, K971783. . . .
Substantial equivalence:
Based on similarities of design, materials, and indications for
use, DePuy believes the ACE® Nancy Nail™ is substantially equivalent to the Synthes Elastic Intramedullary Nail System, K971783.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
OCT - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rhonda Myer Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw. Indiana 46581-0988
Re: K032687
Trade/Device Name: ACE® Nancy Nail™ Regulation Number: 21 CFR 3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: August 28, 2003 Received: August 29, 2003
Dear Ms. Myer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 not 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); good manufacturing proctice requirements as set 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 CPR 1000-1050.
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Page 2 - Ms. Rhonda Myer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N. Melker
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K060654
510(k) Number: K032687
Device Name: ACE® Nancy Nail TM
Indications for Use:
The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of sge and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.
Concurrence of CDRH, Office of Device Evaluation
for Mark A. Millicus
Division Sign-Off) Dision of General, Re rative and Neurological Devic
(k) Number K032687
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Prescription Use ાર Over-The-Counter Use (Per 21 CFR 801.109)