(159 days)
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No
The device description focuses on the material, dimensions, and mechanical properties of a physical implant (a nail for bone fractures). There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is an orthopedic implant for fixing bone fractures, which is a structural support device, not a therapeutic device designed for treating disease or restoring health through non-surgical means.
No
The device is described as a surgical implant (Retrograde Pediatric Nail) used for fixing fractures, not for diagnosing conditions. Its description focuses on material, dimensions, and mechanical properties (bending and torsional stiffness).
No
The device description clearly states it is a physical nail made of wrought Ti-6Al-4V, indicating it is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a "Retrograde Pediatric Nail" made of Ti-6Al-4V. It's a physical implant designed to fix bone fractures.
- Intended Use: The intended use is for "fractures of the femur, tibia and humerus with retrograde applications." This is a surgical procedure involving the direct treatment of a physical condition within the body.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.
Product codes
HTY
Device Description
The Retrograde Femoral Nail is made of wrought Ti-6Al-4V conforming to ASTM F136. The diameter of the nail tapers from 4.0 mm to 3.6mm with 6 lengths ranging from 19 to 29 cm. Both the proximal and distal ends are bent to provide 3 point fixation. The entire nail is fluted for rotational stability. One end of the nail is threaded to allow for an axial end screw or smooth attachment cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femur, tibia, humerus
Indicated Patient Age Range
pediatric
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 nail is designed with a bending stiffness of 1451b-in2 and a torsional stiffness of 1121b-in2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
AUG | | | |998
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Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: Retrograde Pediatric Nail
Common Name: Femoral Nail
Classification Name: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030.
The Retrograde Femoral Nail is made of wrought Ti-6Al-4V conforming to Description: ASTM F136. The diameter of the nail tapers from 4.0 mm to 3.6mm with 6 lengths ranging from 19 to 29 cm. Both the proximal and distal ends are bent to provide 3 point fixation. The entire nail is fluted for rotational stability. One end of the nail is threaded to allow for an axial end screw or smooth attachment cap.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include same indications for use and similar geometry.
Test Results: The nail is designed with a bending stiffness of 1451b-in2 and a torsional stiffness of 1121b-in2.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 11 1998
Ms. Debbie De Los Santos Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
Re: K980854 Retrograde Pedicatric Nail Requlatory Class: II Product Code: HTY Dated: July 9, 1998 Received: July 13, 1998
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 controls provisions The general controls provisions of the Act 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. ਜ 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 requlation may result in requlatory 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 requlations.
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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,
Stephen Rhodes
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):
Retrograde Pediatric Nail Device Name: Indications For Use:
Retrograde Pediatric Nail Indications For Use
The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.
(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)
Stipt Rhodes
Division Sign Off Division of General Restorative Devices (980854 510(k) Number.