(26 days)
Not Found
No
The document describes a mechanical external fixation device and explicitly states that the fundamental scientific technology has not changed. There are no mentions of AI, ML, or related concepts.
Yes
The device is used for the "treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality," which clearly indicates a therapeutic purpose.
No
The device is described as an external fixation device used for treating bone conditions, not for diagnosing them. Its function involves attaching to bone via screws and a frame to stabilize or lengthen bones, consistent with therapeutic intervention rather than diagnosis.
No
The device description explicitly states it consists of "external fixation components and implantable bone screws," which are hardware. The submission is for a change in a hardware component (carbon fiber bar).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the EBI® XFIX® Access™ Pelvic Fixator is an external fixation device used for treating bone conditions by being attached to bone screws inserted into the patient's body. This is a surgical/implantable device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use describes the treatment of bone conditions, not the diagnosis of them.
Therefore, this device 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® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Product codes
KTT
Device Description
The EBI® XFIX® Access™ Pelvic Fixator 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® Access™ Pelvic Fixator is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI® XFIX® Access™ Pelvic Fixator is attached to the shanks of the bone screws. This submission is for the use of a carbon fiber bar that will replace the current titanium bar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EBI® XFIX® DFS® System - Electro-Biology, Inc.
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
JUN 2 7 2001
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® Access™ Pelvic Fixator is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.
- Submitter: EBI, L.P. 1. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Jon Caparotta, RAC Telephone: (973) 299-9022
Date prepared: May 31, 2001
-
- Proprietary Name: Common Name: Classification Names:
EBI® XFIX® Access™ Pelvic Fixator External Fixation Device Single Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030.
- Proprietary Name: Common Name: Classification Names:
-
Predicate or legally marketed devices that are substantially equivalent: 3.
· EBI® XFIX® DFS® System - Electro-Biology, Inc. -
Description of the device: The EBI® XFIX® Access™ Pelvic Fixator has not changed 4. 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® Access™ Pelvic Fixator is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI® XFIX® Access™ Pelvic Fixator is attached to the shanks of the bone screws. This submission is for the use of a carbon fiber bar that will replace the current titanium bar.
-
Intended Use: The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are ર. unilateral external fixation devices intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
-
Materials: The components of the system are manufactured from materials such as Ti-6A1-4V 6. ELI, Aluminum, Stainless Steel, and Carbon Fiber.
22
1
- Comparison of the technological characteristics of the device to predicate devices: There are 7. no significant differences between the EBI® XFIX® Access™ Pelvic Fixator m and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
*Any statement made in conjunction with this submission of substantial equivalial equivalence to any of the product is not * Any statement made in conjunction with uns submitted without re-markt and to reclassified ion and is not intended only to relate to when the product on the research infringened fities one thit one (Establishment Registration intended to be interpreted as an admission of any outer type of evidence in packs and any works.
and Premarket Notification Procedures, Final Regulation, Preamble, August 23,
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2001
Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054-1079
Re: K011697
Trade Name: EBI XFIX Access Pelvic Fixator Regulation Number: 888.3030 Regulatory Class: II Product Codes: KTT Dated: May 31, 2001 Received: June 1, 2001
Dear Mr. Caparotta:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally it (x) is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the cherosure) to device Amendments, or to devices that have been reclassified in enacificili dato of the Fredical Food, Drug, and Cosmetic Act (Act). You may, accordance with the device, subject to the general control provisions of the Act. The general therefore, market the do rece sacjes to quirements for annual registration, listing of devices, control provisions or the fire, 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 (1 Chiarket Approval), it they of Sale, Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good A substantially equirement, 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 mispections, the Food and Dation may result in regulatory action. In addition, FDA may publish comply with the Criti regular 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.
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.
3
Page 2 -- Mr. Jon Caparotta, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific as a vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m The classicstions on the promotion and advertising of your device, (2017) 594-4639 f 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 Information on your responsionally tree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Michlberger
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
Page 1 of of 1
510(k) Number (if known):
Device Name: EBI® XFIX® Access ™ Pelvic Fixator
Indications For Use:
The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
tj
Psmhulelcoms for CAUI
(Division Sign-Off) (Division Bigger Crail, Restorative Divisiourological Devices
510(k) Number_401027