(59 days)
Not Found
Not Found
No
The summary describes a purely mechanical device (intra-medullary nail) and contains no mention of AI, ML, image processing, or any related concepts.
Yes
The "intra-medullary nail" is used to restore natural alignment and assist in the healing of fractured long leg bones, performing a therapeutic function.
No
This document describes an "intra-medullary nail" used as a scaffold to hold fractured bone sections in alignment for healing, which is a therapeutic device, not a diagnostic one.
Unknown
The provided text only describes the intended use of an intramedullary nail for long leg bone fractures. It does not contain any information about the device itself, specifically whether it is hardware, software, or a combination.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant (intra-medullary nail) used to stabilize bone fractures within the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
- Device Description: While the description is "Not Found," the intended use clearly points to a physical implant, not a diagnostic test.
- No Mention of Biological Specimens: There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cases of fracture of the long leg bones are not uncommon and are usually caused by trauma. The surgical re-construction of either the tibia or femur is necessary to restore the patient back their natural alignment and gait. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections in alignment until natural healing occurs. The nails creates a sound foundation for the partial, then when healed full load bearing.
Product codes
KTW
Device Description
Omnifix nailing system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long leg bones (tibia or femur)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed inside a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1999
Mr. Douglas W. Stuart President Surgical Implants, Inc. 962 South Tamiami Trail, Suite 203 Sarasota, Florida 34326
K990307 Re: Omni-Fix, Nail System Trade Name: Regulatory Class: II Product Code: KTW Dated: January 21, 1999 February 1, 1999 Received:
Dear Mr. Stuart:
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 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 (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. તે 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.
1
Page 2 - Mr. Douqlas W. Stuart
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
2
EXHIBIT 7
STATEMENT OF INTENDED USE
510(K) Number: Device Name: Omnifix nailing system
Indications For Use:
Statement of Intended Use
Cases of fracture of the long leg bones are not uncommon and are usually caused by trauma. The surgical re-construction of either the tibia or femur is necessary to restore the patient back their natural alignment and gait. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections in alignment until natural healing occurs. The nails creates a sound foundation for the partial, then when healed full load bearing.
Signed: __
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over The Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990307 |
: 上一篇: