(27 days)
The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® system are unilateral external fixation device 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.
The EBI® XFIX® Access™ Pelvic Fixator 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® Access™ Pelvic Fixator System 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 System is attached to the shanks of the bone screws. This submission is for the use of a Break-Away pelvic screw (clamp screw).
The provided text is a 510(k) Summary for the EBI® XFIX® Access™ Pelvic Fixator. This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel diagnostic or AI-driven device.
Based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements Met ("device complies with applicable standards and meets all of its functional requirements") | Testing comparing modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements. |
| Technological Characteristics Substantially Equivalent ("no significant differences between the EBI® XFIX® Access™ Pelvic Fixator with breakaway clamp screw and other currently marketed external fixation systems... substantially equivalent to the predicate devices in regards to intended use, materials and function") | The device was found to be substantially equivalent to predicate devices in regards to intended use, materials, and function. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes no clinical test set in the way typically seen for performance studies of AI or diagnostic devices. The testing mentioned appears to be engineering or functional testing of the device itself and its modifications, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth based on expert review of a test set is mentioned.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this mechanical external fixator.
6. Standalone Performance Study (Algorithm Only):
No standalone performance study of an algorithm was conducted or reported. This device is a mechanical external fixation system.
7. Type of Ground Truth Used:
Not applicable. The "ground truth" for this device's acceptance seems to be adherence to applicable standards and successful functional testing of its mechanical properties, rather than diagnostic accuracy against a clinical reference standard.
8. Sample Size for the Training Set:
Not applicable. This document pertains to a mechanical medical device, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is relevant to this device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states: "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements."
This indicates that the "study" was likely engineering or functional testing to confirm that the changes (specifically the "Break-Away pelvic screw (clamp screw)") did not negatively impact the device's performance and that it continued to meet established requirements for external fixation devices. No clinical study with patient data or expert review is described as part of this 510(k) submission for substantial equivalence. The primary evidence for acceptance is the demonstration of substantial equivalence to a legally marketed predicate device through engineering and functional testing.
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K013540
page 1 of 2
NOV 2 0 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.
- Contact Person: Frederic Testa Submitter: EBI, L.P. 1. Telephone: (973) 299-9022 100 Interpace Parkway Parsippany, NJ 07054
Date prepared: October 23, 2001
| 2. | Proprietary Name: | EBI® XFIX® Access™ Pelvic Fixator |
|---|---|---|
| Common Name: | External Fixation Device | |
| Classification Names: | Single Multiple Component Metallic BoneFixation Appliances and Accessories, 21 CFR888.3030. |
Predicate or legally marketed devices that are substantially equivalent: 3.
· EBI® XFIX® Access™ Pelvic Fixator -- Electro-Biology, Inc.
- Description of the device: The EBI® XFIX® Access™ Pelvic Fixator System has not 4. 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 System 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 System is attached to the shanks of the bone screws. This submission is for the use of a Break-Away pelvic screw (clamp screw).
- Intended Use: The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFLX® DFS® System are న్. unilateral external fixation device 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.
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3540
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re
- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI® XFIX® Access™ Pelvic Fixator with breakaway clamp screw 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 regarding a determination of substantial equivalence to any other product is intended only to relate to whether markets without pre-market without pre-market approval or reclassification and is not intended to be interneted as an admission or any other type of evidence in patent informati litigation (Establishment) Registerial on included to be the procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. Frederick Testa Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K013540
Trade/Device Name: EBI® XFIX® Access™ Pelvic Fixator Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 23, 2001 Received: October 24, 2001
Dear Mr. Testa:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becared on and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) is etgans and the Medical Device Amendments, or to conninered pror to that 20, 1977, in eccordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, afterere, marris of the Act include requirements for annual registration, listing of general voltarely pro resuring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is oldshired (controls. Existing major regulations affecting your device can may be subject to back academal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I vaturer statutes are requirements, including, but not limited to: registration and listing (21 compy with an the Fee orequirements) (1); good manufacturing practice requirements as set CI It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of bections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Frederick Testa
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark N. Millen
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
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NOV 2 0 2001
STATEMENT OF INDICATIONS FOR USE
Page __ 1__ 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 device 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 ✗
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K013546
§ 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.