(67 days)
Intended Use: The ACE® A/R Humeral Nail is a single use device intended for fixation of humeral fractures.
Indications for Use: The ACE® Antegrade Retrograde Humeral Nail System is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.
The ACE® Antegrade Retrograde (A/R) Humeral Nail System includes an intramedullary nail, cancellous and cortical screws, and end caps and is intended for the firsting of humeral fractures. The nail is available in diameters of 7, 8, and 9 millimaters and lengths of 200-300mm, in 20mm increments. The nail incorporates anterior/posterior and lateral/medial screw holes, distal and proximal bends, a distal locking screw postcho may be inserted antegrade as well as retrograde.
The provided text describes a 510(k) Summary for the DePuy ACE® Antegrade Retrograde Humeral Nail System. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria. As such, the document does not contain the information requested regarding acceptance criteria, a study that proves the device meets them, or details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The "Basis of Substantial Equivalence" section explicitly states:
"Based on the same intended use, indications for use, design features, materials, and sterilization processes, DePuy ACE® believes that the subject Antegrade Rotrograde Humeral Nail System is substantially equivalent to the previously cleared DePuy ACE® AIM Humeral Nail System (K934643) and the Howmedica Osteonics Corp T2™ Humeral Nail System (K011529)."
This indicates that the submission relies on demonstrating similarity to already approved devices rather than presenting novel performance data against pre-defined acceptance criteria for the new device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
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FEB 2 0 2004
033878
page 1 of 2
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy ACE®700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration Number: 1818910 |
|---|---|
| 510(K) CONTACT: | Rhonda MyerRegulatory AffairsTelephone: (574) 371-4944Facsimile: (574) 371-4987Electronic Mail: Rmyer@dpyus.jnj.com |
| DATE PREPARED: | December 12, 2003 |
| PROPRIETARY NAME: | ACE® Antegrade Retrograde Humeral Nail System |
| COMMON NAME: | Intramedullary Nail |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3020:Intramedullary Fixation Rod |
| DEVICE PRODUCT CODE: | 87 HSB |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy ACE® AIM Humeral Nail, K934643Howmedica Ostconics Corp T2™ Humeral NailSystem, K011529 |
DEVICE DESCRIPTION:
The ACE® Antegrade Retrograde (A/R) Humeral Nail System includes an intramedullary nail, cancellous and cortical screws, and end caps and is intended for the firsting of humeral fractures. The nail is available in diameters of 7, 8, and 9 millimaters and lengths of 200-300mm, in 20mm increments. The nail incorporates anterior/posterior and lateral/medial screw holes, distal and proximal bends, a distal locking screw postcho may be inserted antegrade as well as retrograde.
INTENDED USE AND INDICATIONS:
Intended Use:
The ACE® A/R Humeral Nail is a single use device intended for fixation of humeral fractures.
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033878
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Indications for Use:
The ACE® A/R Humeral Nail is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Based on the same intended use, indications for use, design features, materials, and sterilization processes, DePuy ACE® believes that the subject Antegrade Rotrograde Humeral Nail System is substantially equivalent to the previously cleared DePuy ACE® AIM Humeral Nail System (K934643) and the Howmedica Osteonics Corp T2™ Humeral Nail System (K011529).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Ms. Rhonda Myer Regulatory Affairs DePuy Ace 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K033878
Trade/Device Name: DePuy ACE® Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 12, 2003 Received: December 15, 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 may or saily of 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 I'DA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I citial battler and securitements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice 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 CFR 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 prested 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,
Sincerely yours,
Mark A. McMullen
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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Image /page/4/Picture/0 description: The image shows the logo for DePuy ACE, a Johnson & Johnson company. The logo features a black circle to the left of the text "DePuy ACE". A line is present under the text. The text "A Johnson & Johnson company" is present under the line.
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DePuy ACE
PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA Tel: +1 (574) 267 8143 Fax: +1 (574) 267 7098
Indications for Use Statement
510 (k) Number (if known): K033878
Device Name: DePuy ACE® Antegrade Retrograde Humeral Nail System
Indications for Use:
The ACE® Antegrade Retrograde Humeral Nail System is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.
Mark N. Millman
Division of General, Restorative, and Neurological Devices
510(k) Number K033878
(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-The-Counter-Use: ાર
§ 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.