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.

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.

AI/ML Overview

The provided 510(k) summary for the ACE® Nancy Nail™ (K032687) is a substantial equivalence submission, not a study demonstrating performance against specific acceptance criteria.

In substantial equivalence submissions, the "acceptance criteria" are generally that the new device is as safe and effective as a legally marketed predicate device. The "study" isn't a performance study with numerical results, but rather a comparison to a predicate device.

Therefore, many of the requested fields are not applicable to this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance / Evidence Provided
Design Similarity (ACE® Nancy Nail™ vs. Predicate)	* Materials: Both devices are made of titanium alloy.
	* Geometric Design: The Nancy Nail™ is a titanium alloy pin, available in two lengths (450mm with 5 diameters, 100mm with 1 diameter). While specific dimensions of the predicate aren't detailed, the overall design type (elastic intramedullary nail) is common.
Mechanisms of Action Similarity	Implicitly, as both are "Elastic Intramedullary Nails" used for long bone fracture fixation, their biomechanical function would be considered similar.
Indications for Use Similarity	* Predicate: Synthes Elastic Intramedullary Nail System (K971783) had existing clearance for upper extremity fractures in all patients.
	* ACE® Nancy Nail™: Original indications included long bone fractures in children above four years of age and patients below 65 kg (450mm nail), and small long bones (100mm nail). This submission adds the indication for use in upper extremity fractures in all patients, aligning it with the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission is based on a comparison to a predicate device, not on a new performance study with a test set. There are no patient samples or data provenance details provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No test set or ground truth established by experts is mentioned, as this is a substantial equivalence submission.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. An MRMC study was not conducted or presented in this 510(k) summary. This type of study is not typically required for substantial equivalence for a device like an intramedullary nail.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (intramedullary nail), not an algorithm or AI solution. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

Not applicable. No specific "ground truth" in the clinical study sense (e.g., pathology, outcomes data) was used or provided in this submission to demonstrate new device performance. The "ground truth" for the regulatory decision is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for this type of device.

Summary of the 510(k) Submission:

The DePuy ACE® Nancy Nail™ (K032687) sought to expand its indications for use to include upper extremity fractures in all patients. This was achieved through a substantial equivalence claim to the Synthes Elastic Intramedullary Nail System (K971783), which already had clearance for this specific indication.

The basis for substantial equivalence was "similarities of design, materials, and indications for use." The submission states that the new indication (upper extremity fractures in all patients for the 450 mm Nancy Nail™) had been previously cleared for the Synthes predicate device. The FDA's letter confirmed that the device was found substantially equivalent for the stated indications for use.

Therefore, the "proof" the device meets acceptance criteria is the successful demonstration of its substantial equivalence to a legally marketed predicate device, rather than explicit numerical performance data from a new clinical study.

Summary

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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 DriveWarsaw, Indiana 46581-0988Est. Reg. No.1818910
510(k) Contact:	Rhonda MyerRegulatory AffairsPhone: (574) 371-4944FAX: (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 EquivalentDevices:	DePuy ACE® Nancy Nail™ K960642Synthes Elastic Intramedullary Nail System K971783
Device Description:	The Nancy Nail™ is a titanium alloy pin that is implantedto facilitate the fixation of long bone fractures. The NancyNail™ is available in two lengths; the 450 mm is availablein five diameters (2.0, 2.5, 3.0, 3.5, 4.0 mm), and the 100mm is available in 1.0 mm diameter. The Nancy Nail™ isa single-use device intended for temporary implantation. Itis 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.

21
7

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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:

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

್ತಿ

Prescription Use ાર Over-The-Counter Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 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.