(21 days)
No
The summary describes a mechanical external fixation system and explicitly states that the fundamental scientific technology has not changed from previous cleared systems. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is used for the "reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities," which are therapeutic applications. It directly treats a medical condition.
No
Explanation: The device description states its purpose is for the "reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities," which are treatment functions, not diagnostic ones.
No
The device description explicitly states that the system consists of "external fixation components and implantable bone screws," which are hardware components.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The EBI XFIX DFS Wristfix System is described as an external fixation system with implantable bone screws used for the reduction, alignment, and stabilization of fractures and deformities in the upper extremity. This is a surgical device used directly on the patient's body, not for testing samples outside the body.
- Intended Use: The intended use clearly states its purpose is for treating fractures and deformities, which is a therapeutic and structural function, not a diagnostic one.
Therefore, the EBI XFIX DFS Wristfix System falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EBI XFIX DFS Wristfix System is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
Product codes
KTT
Device Description
The EBI XFIX DFS Wristfix System has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX DFS Wristfix System is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS Wristfix System is attached to the shanks of the bone screws. The components of the System may be manufactured from materials such as Aluminum, Stainless Steel, Pyromet® 718, Ti-6AI-4V ELI, and Carbon Fiber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Nov | 9 1999
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI XFIX DFS® Wristfix™ System is provided as required per Section 513(1)(3) of the Federal Food, Drug and Cosmetic Act.
| 1. Sponsor: | EBI, L.P.
100 Interpace Parkway
Parsippany, NJ 07054 | Contact Person: | Jonas Wilf
Telephone: (973) 299-9022 |
|---------------------------------|-----------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------|
| Date prepared: October 27, 1999 | | | |
| 2. Proprietary Name: | EBI XFIX DFS® Wristfix™ System | | |
| Common Name: | External Fixation Device | | |
| Classification Names: | Single Multiple Component Metallic
Bone Fixation Appliances and
Accessories, 21 CFR 888.3030. | | |
- Predicate or legally marketed devices that are substantially equivalent:
- 미 EBI XFIX DFS Small External Fixator - Electro-Biology, Inc. (K951357)
- Synthes Distal Radius Fixator -- Synthes USA (K963618) .
- Description of the device: The EBI XFIX DFS Wristfix System has not changed the 4. Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX DFS Wristfix System is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS Wristfix System is attached to the shanks of the bone screws.
- Intended Use: The EBI XFIX DFS Wristfix System external fixation system is intended ર્મ for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
- Materials: The components of the System may be manufactured from materials such as 6. Aluminum, Stainless Steel, Pyromet® 718, Ti-6AI-4V ELI, and Carbon Fiber.
- Comparison of the technological characteristics of the device to predicate devices: 7.
- The EBI XFIX DFS Wristfix™ System is substantially equivalent to the following . predicate EBI and competitive devices. The components of the EBI XFIX DFS
1
Wristfix System are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS Small External Fixator and Synthes Distal Radius Fixator.
- The bone screw clamps of the EBI XFIX DFS Wristfix System, like the bone screw . clamps currently marketed EBI XFIX DFS Small External Fixator, are designed for attachment to the bone screws.
- . The EBI XFIX DFS Wristfix System like the currently marketed Synthes Distal Radius Fixator is available preassembled and sterile.
There are no significant differences between the EBI XFIX DFS Wristfix System and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in itigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Mr. Jon Caparotta Manager, Requlatory Affairs EBI, L.P. 100 Interpace Parkway 07054-1079 Parsippany, New Jersey
Re: K993649 EBI XFIX DFS Wristfix System Trade Name: Regulatory Class: II Product Code: KTT Dated: October 27, 1999 Received: October 29, 1999
Dear Mr. Caparotta:
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, Druq, 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. ਜ਼ਿੰ 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.
3
Page 2 - Mr. Jon Caparotta
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 requlation (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,
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K993649
Device Name: EBI XFIX DFS Wristfix System
Indications For Use:
The EBI XFIX DFS Wristfix System is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99 3649
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use