(17 days)
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement, ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to indications for intramedullary nails, devices that utilize a retrograde femoral surgical approach {i.e. Retrograde/Tibial and Supracondy|ar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.
intramedullary locking nails (i.e. TriGen® Nails) are for single use only.
The subject devices are line additions to the TriGen® Intramedullary Nail System. These line additions are comprised of retrograde femoral, supracondylar, and tibial intramedullary nails and a nail cap. All described components are manufactured from titanium material.
The provided text is a 510(k) summary for a medical device (intramedullary nails). It focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study demonstrating the device's performance against specific acceptance criteria.
Therefore, many of the requested categories for a study that proves device performance cannot be answered from the provided document. The document explicitly states: "There are no changes in intended use, performance specifications or method of operation." and "A review of the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure." This confirms that no new performance study was conducted to establish new acceptance criteria.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific device performance metrics in the way a clinical or technical performance study would. The basis for clearance is "substantial equivalence" to predicate devices, implying that the performance is considered acceptable because it is equivalent to already marketed devices.
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. No new test set data was generated for a performance study. The evaluation was based on a comparison to existing predicate devices.
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. No ground truth establishment was conducted in the context of a new performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication was used.
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. This device is an intramedullary nail, not an AI-based diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an intramedullary nail, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for this submission. The "ground truth" for regulatory clearance is the established performance and safety profile of the predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Acceptance:
The acceptance of the TriGen® Retrograde Femoral, Supracondylar, and Tibial Nails by the FDA is based on a Substantial Equivalence (SE) determination. This means the device was found to be as safe and effective as a legally marketed predicate device. The primary "study" or evaluation performed was a comparison of the new device to existing predicate devices based on:
- Indications for Use: The new nails have similar indications to the predicate devices.
- Design Features: The design is comparable.
- Operational Principles: The way the nails function is the same as the predicates.
- Material Composition: The nails are manufactured from titanium, similar to the referenced predicates.
The text explicitly states: "There are no changes in intended use, performance specifications or method of operation. A review of the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure." This statement acts as the "reported device performance" and the unstated "acceptance criteria" is that it should be equivalent to the predicate devices in these aspects, ensuring similar safety and effectiveness.
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051557
510(k) Summary of Safety and Effectiveness TriGen® Retrograde Femoral, Supracondylar, and Tibial Nails
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116 | Date: June 8, 2005JUN 3 0 2005 |
|---|---|---|
| Contact Person: | David Henley, Senior Regulatory Affairs Specialist | |
| Proprietary Name: | TriGen® Retrograde Femoral, Supracondylar and Tibial Nails | |
| Common Name: | Intramedullary Nail | |
| Classification Name and Reference: | 21 CFR 888.3020 – Intramedullary Fixation Rod, Class II | |
| Device Product Code and Panel Code: | JDS / Orthopaedics / 87 |
Device Description:
The subject devices are line additions to the TriGen® Intramedullary Nail System. These line additions are comprised of retrograde femoral, supracondylar, and tibial intramedullary nails and a nail cap. All described components are manufactured from titanium material.
Indications for Use:
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement, ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to indications for intramedullary nails, devices that utilize a retrograde femoral surgical approach {i.e. Retrograde/Tibial and Supracondy|ar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.
intramedullary locking nails (i.e. TriGen® Nails) are for single use only.
Technological Characteristics:
The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. A review of the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information:
Substantial equivalence for TriGen® Retrograde Femoral, Supracondylar and Tibial Nails is based on its similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: K981529, Smith & Nephew Titanium (TriGen®) Intramedullary Hip System; K983942, Smith & Nephew Intramedullary Nail System; K032722, TriGen® Straight Humeral Nail; and K040212, TriGen® InterTAN Nails.
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Image /page/1/Picture/1 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 agency's mission of providing health and human services to the nation. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2005
Mr. David Henley Smith and Nephew Incorporated Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K051557
Trade/Device Name: TriGen® Retrograde Femoral, Supracondylar, and Tibial Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: JDS Dated: June 10, 2005 Received: June 13, 2005
Dear Mr. Henley:
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 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 - Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loket notification. The FDA finding of substantial equivalence of your device to a legally premated 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 If you t the Office of Compliance at (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
A. Hypt Rurder
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement
510(k) Number (if known): _
TriGen® Retrograde Femoral, Supracondylar, and Tibial Nails Device Name:
Indications for Use:
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting, supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) are indicated for the fotlowing: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.
Intramedullary locking nails (i.e. TriGen® Nails) are for single use only.
and/or Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (Per 21 CFR 801, 109)
Over-the-Counter Use (Optional Format 1-2-96)
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt. Quade
Division of General, Restorative, and Neurological Devices
510(k) Number_
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.