(104 days)
The Hip Fracture 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, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
The Hip Fracture Nail System consists of an intramedullary nail, lag screw, distal screws, end cap and optional antirotation screw all manufactured from titanium allov and used to treat fractures in the proximal portion of the femur. The system offers 125° and 130° angle nails with 9-15mm distal diameters and a 180-460mm length range.
The provided text describes a 510(k) premarket notification for a medical device called the "Hip Fracture Nail System." It primarily focuses on demonstrating substantial equivalence to predicate devices through pre-clinical data (cyclical testing).
Here's an analysis of the requested information based on the provided text, noting where specific details are not available:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieved higher maximum loads prior to failure | "Cyclical testing demonstrated that the new Hip Fracture Nail System achieved higher maximum loads prior to failure when compared to both predicate devices successfully meeting the pre-defined acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The study describes "cyclical testing" of the Hip Fracture Nail System and two predicate devices, but the number of units tested for each is not explicitly mentioned.
- Data Provenance: Not specified. As this is a pre-clinical study involving mechanical testing rather than patient data, country of origin is less relevant than with clinical trials. It is implicitly a prospective study in the sense that the mechanical tests were designed and conducted specifically for this submission.
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)
- This question is not applicable to the provided context. The "ground truth" here is based on physical mechanical properties (maximum load prior to failure) measured during cyclical testing, not on expert interpretation of medical data or images. Therefore, clinical experts are not involved in establishing this "ground truth."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As noted above, the "test set" involves mechanical properties, not expert consensus or medical diagnosis.
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 is a submission for a mechanical implant (Hip Fracture Nail System), not an AI/imaging device. The study involves pre-clinical mechanical testing, not a clinical study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm device. The "standalone" performance here refers to the mechanical performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this pre-clinical study is defined by the objective measurement of mechanical failure points (maximum loads prior to failure) under cyclical stress testing. It's a physical, engineering-based ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set. The study compares the mechanical performance of the new device against predicate devices.
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI/machine learning device, there is no "training set" or "ground truth for the training set" in the conventional sense. The study's focus is on direct experimental comparison of mechanical properties.
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K1002-38
SECTION 5 - 510(K) SUMMARY
| Submitted by: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581 | MAY 11 2010 |
|---|---|---|
| Phone: (305) 269-6386Fax: (305) 269-6441US representative for Medos International SARL |
Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs
January 22, 2010 Date Prepared:
Hip Fracture Nail System Proprietary Name:
Intramedullary Fixation Rod Common Name:
Rod, Fixation, Intramedullary and accessories (21 CFR § Classification Name: 888.3020)
- The Hip Fracture Nail System is substantially equivalent to Predicate Devices: currently marketed devices: Trochanteric Nail System (K042325) and Gamma3 Nail System (K043431).
Device Description: The Hip Fracture Nail System consists of an intramedullary nail, lag screw, distal screws, end cap and optional antirotation screw all manufactured from titanium allov and used to treat fractures in the proximal portion of the femur. The system offers 125° and 130° angle nails with 9-15mm distal diameters and a 180-460mm length range.
Indications for Use: The Hip Fracture 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. including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas. impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions, malunions, revision procedures and turnor resections.
p. 1 of 2
Hip Fracture Nail System Traditional 510(k) DePuy Orthopaedics, Inc. for Medos International SARL
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| TechnologicalCharacteristics: | The technological characteristics of the Hip Fracture NailSystem are similar to the predicate devices including designand material. The Hip Fracture Nail system and predicatesystems are manufactured from titanium alloy. Dimensionalcharacteristics are similar among the systems includingproximal and distal nail diameters, nail angles and lengths.In addition to the material, the screws are similarlycomparable in major and minor OD and length. |
|---|---|
| Summary ofSubstantialEquivalence: | The Hip Fracture Nail System is substantially equivalent tocurrently marketed devices as demonstrated with pre-clinicaldata. Cyclical testing demonstrated that the new HipFracture Nail System achieved higher maximum loads priorto failure when compared to both predicate devicessuccessfully meeting the pre-defined acceptance criteria. Nonew issues of safety or efficacy have been raised. |
pizfer
Hip Fracture Nail System Traditional 510(K)
DePuy Orthopaedics, Inc. for Medos International SARL
Page 20 of 95
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
MAY 1 1 2010
Re: K100238
Trade/Device Name: Hip Fracture Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedu!lary fixation rod Regulatory Class: II Product Code: HSB Dated: April 28, 2010 Received: April 29, 2010
Dear Ms. Otaño:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Suzana Otaño
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Clara Bielup
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number:
Hip Fracture Nail System Device Name:
Indications For Use:
The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures iractures, intertroons of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anita for nym
(Division Sign-Off)
Division of Surgical. Othopedic. and Restorative Devices
510(k) Number K100238
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Hip Fracture Nail System Traditional 510(k) DePuy Orthopaedics, Inc. for Medos International SARL
§ 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.