(62 days)
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
The Trochanteric Long Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from Titanium (Ti-6Al-4V ELI) which are used to treat fractures of the femur.
The provided text describes a 510(k) premarket notification for a medical device called the "Long Trochanteric Nail System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested elements about acceptance criteria and study design are not available in the provided document. The document explicitly states:
- "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for intramedullary nails."
- "The Trochanteric Nail System has the same intended use, is manufactured from the same material and has the same design features as the predicate devices and is therefore substantially equivalent."
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The submission focuses on substantial equivalence based on intended use, materials, and design features compared to predicate devices, not on specific performance metrics or acceptance criteria for a new clinical study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No ground truth establishment is described as there is no clinical performance study in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is a bone fixation device (intramedullary nail), not an AI-powered diagnostic or imaging device, so an MRMC study is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth is described.
8. The sample size for the training set
- Not applicable / Not provided. No training set is described for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No ground truth for a training set is established.
Summary from the document:
The provided 510(k) summary for the "Long Trochanteric Nail System" relies on demonstrating substantial equivalence to existing legally marketed predicate devices for its clearance. This means the manufacturer presented evidence that their new device shares the same intended use, materials (Titanium (Ti-6Al-4V ELI)), and design features as the predicate devices. The listed predicate devices are:
- ACE Trochanteric Nail (K010780)
- ACE AIM Femoral Nail (K871539)
- Synthes Proximal Femoral Nail (K973240)
- Smith & Nephew TriGen Nail (K981529)
The basis for acceptance is this demonstration of substantial equivalence, rather than a clinical study with specific performance criteria for the new device.
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DEC 2 7 2001
K013563
page 1 of 2
510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910 | |
|---|---|---|
| 510(k) Contact: | Marcia J. ArentzSenior Regulatory AssociatePhone: (219) 371-4944FAX: (219) 371-4987 | |
| Trade Name: | Long Trochanteric Nail System | |
| Common Name: | Bone fixation device | |
| Classification: | Class II Device per 21 CFR 888.3020:Intramedullary fixation rodDescription: Rod, Fixation, Intramedullary andAccessories, Metallic and Non-collapsible | |
| Device Product Code: | Code: 87NDE or 87HSBNo performance standards have been establishedunder Section 514 of the Federal Food, Drug,and Cosmetic Act for intramedullary nails. | |
| Substantially Equivalent Device: | ACE Trochanteric NailACE AIM Femoral NailSynthes Proximal Femoral NailSmith & Nephew TriGen Nail | K010780K871539K973240K981529 |
| Device Descriptions: | The Trochanteric Long Nail System consists ofan intramedullary nail, lag screw, end cap, andoptional anti-rotation screw, all manufacturedfrom Titanium (Ti-6Al-4V ELI) which are usedto treat fractures of the femur. |
0000005
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KWI3563
page 2 of 2
510(k) Summary (continued)
| Indications for use: | The Trochanteric Nail System is intended to treatstable and unstable proximal fractures of the femurincluding pertrochanteric fractures, intertrochantericfractures, high subtrochanteric fractures andcombinations of these fractures. The TrochantericLong Nail system is additionally indicated to treatpertrochanteric fractures associated with shaftfractures, pathologic fractures in osteoporotic boneof the trochanteric and diaphyseal areas, longsubtrochanteric fractures, ipsilateral femoralfractures, proximal or distal non-unions andmalunions and revision procedures. |
|---|---|
| Substantial equivalence: | The Trochanteric Nail System has the sameintended use, is manufactured from the samematerial and has the same design features as thepredicate devices and is therefore substantiallyequivalent. |
0000000
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three flowing lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the figure in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2001
Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K013563
Trade Name: Trochanteric Long Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: October 21, 2001 Received: October 26, 2001
Dear Ms. Arentz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 of 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 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. Marcia J. Arentz
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Sincerely yours,
Mark N. Melhemor
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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K013563
page 1 of 1
510(k) Number (if known):
Device Name: Long Trochanteric Nail System
Indications for Use:
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures The frochanteric Nan Dystein is intenteric fractures, intertrochanteric fractures, high of the fremar fractures and combinations of these fractures. The Trochanteric Long Sublivenancere fractures and combinated to treat pertrochanteric fractures associated with Natt System is additionally marcures in osteoporotic bone of the trochanteric and shart fractures, paulonogro- nacteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
Concurrence of CDRH, Office of Device Evaluation
for Mark A. Milliken
(Division :11) Division c everal, Restorative and and ogical Devices
K 01356 510(k) Number _
000003
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.