(70 days)
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No
The device description focuses on the material, design, and mechanical properties of a surgical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "Nail System" used to stabilize fractures of the femur and for arthrodesis of the hip, which are therapeutic medical interventions.
No
Explanation: The device is an UltiMax Haig II Nail System, which is described as an implant used to stabilize bone fractures and for hip arthrodesis. It is a surgical implant designed for treatment, not for diagnosing medical conditions.
No
The device description clearly details a physical implantable medical device made of titanium, including nails, plates, and screws, used for stabilizing bone fractures. It does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The UltiMax Haig II Nail System is a surgical implant designed to stabilize bone fractures in the femur and hip. It is a physical device implanted inside the body.
- Intended Use: The intended use is to stabilize fractures and perform arthrodesis, which are surgical procedures performed directly on the patient's body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition through testing of bodily fluids or tissues.
The UltiMax Haig II Nail System is a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The UltiMax Haig II Nail System is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity, and arthrodesis of the hip.
Product codes
LXT
Device Description
The UltiMax Haig II Nail System is manufactured from titanium (6AI-4V ELI) per ASTM F136 and is light weight. Drawings are provided in Exhibit II.
The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), and is available in 130 ° 135 ° 140 ° 145 ° and 150 ° angles. These are manufactured and tested per ASTM specifications F787. The bone screw hole pattern is offset and 5.0mm cortical screws are used. The most proximal hole accepts a large diameter (7.0mm) cannulated screw. The plates are available in 3 hole, 5 hole, 6 hole, 8 hole, 10 hole, 12 hole and 14 hole lengths.
The UltiMax Haig II Nails are available in 65-125mm (5 mm increments) lengths. The nails are tri-flanged with a series of holes in the proximal end. These holes serve as an enhancement to cement delivery. The Haig II Nail is implanted by direct impaction. Once implanted an adaptor is threaded on the distal end of the nail. A syringe containing a low viscosity bone cement is inserted into the adaptor and cement is delivered into the nail. The cement is pushed through the holes in the proximal end of the nail and dispersed into the femoral head.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
neck of the femur, hip
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The UltiMax Haig II Nail System has been tested by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida. Based upon ASTM test standards for metallic nail-plate applicances (F787), test results proved the device to be of sound design.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: UltiMax Haig II Nail System
Common Name: Compression Hip/Supracondylar Screw
Classification Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (Product Code 87LXT)
The UltiMax Haig II Nail System is manufactured from titanium (6AI-4V Device Description: ELI) per ASTM F136 and is light weight. Drawings are provided in Exhibit II.
The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), and is available in 130 ° 135 ° 140 ° 145 ° and 150 ° angles. These are manufactured and tested per ASTM specifications F787. The bone screw hole pattern is offset and 5.0mm cortical screws are used. The most proximal hole accepts a large diameter (7.0mm) cannulated screw. The plates are available in 3 hole, 5 hole, 6 hole, 8 hole, 10 hole, 12 hole and 14 hole lengths.
The UltiMax Haig II Nails are available in 65-125mm (5 mm increments) lengths. The nails are tri-flanged with a series of holes in the proximal end. These holes serve as an enhancement to cement delivery. The Haig II Nail is implanted by direct impaction. Once implanted an adaptor is threaded on the distal end of the nail. A syringe containing a low viscosity bone cement is inserted into the adaptor and cement is delivered into the nail. The cement is pushed through the holes in the proximal end of the nail and dispersed into the femoral head.
Intended Use:. The Haig Nail system is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weightbearing and against more than sedentary activity; and arthrodesis of the hip.
Comparable Features to Predicate Device(s): Based on the materials, intended uses, design, testing, and manufacturing, the UltiMax Haig II Nail System is equivalent to the referenced legally marketed comparison devices.
Test Results: The UltiMax Haig II Nail System has been tested by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida. Based upon ASTM test standards for metallic nail-plate applicances (F787), test results proved the device to be of sound design.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Ms. Debbie De Los Santos Regulatory and Clinical Specialist Encore Orthopedics, Incorporated 9800 Metric Boulevard Austin. Texas 78758
Re: K991889 Trade Name: UltiMax Haig II Nail System Regulatory Class: II Product Code: LXT Dated: June 2, 1999 Received: June 3, 1999
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
Indications For Use:
UltiMax Haig II Nail System Indications For Use
The UltiMax Haig II Nail System is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity, and arthrodesis of the hip.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)_
biolley
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K991889