(29 days)
Not Found
No
The document describes a mechanical external fixation system and explicitly states that the fundamental scientific technology has not changed from the previously cleared system. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as an "external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions." This directly implies a therapeutic purpose.
No
The device is described as an external fixation device used for treating bone conditions, not for diagnosing them. Its function is to fix bones, not to identify or assess a condition.
No
The device description explicitly states that the system consists of external fixation components and implantable bone screws, which are hardware. The submission is for modifications to a hardware component (Ankle Clamp).
No, 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 provided description clearly states that the EBI® XFIX® DFS® System is an external fixation device used for treating bone conditions by being attached to bone screws inserted into the patient's body.
- Intended Use: The intended use is for surgical procedures related to bone conditions, not for analyzing biological samples.
The device is a surgical implant/external fixation system, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The EBI® XFIX® DFS® System is 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® DFS® System is a 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.
Product codes
KTT
Device Description
The EBI® XFIX® DFS® System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® DFS® 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® DFS® System is attached to the shanks of the bone screws. This submission is for the modifications to the Ankle Clamp of the EBI® XFIX® DFS® System.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI XFIX® DFS® System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
- Contact Person: Frederic Testa, RAC 1. Submitter: EBI, L.P. Telephone: (973) 299-9300, x2208 100 Interpace Parkway Parsippany, NJ 07054
April 3, 2002 Date prepared:
| 2. Proprietary Name: | EBI® XFIX® DFS® System |
|---|---|
| Common Name: | External Fixation Device |
| Classification Names: | Single/Multiple Component Metallic Bone |
| Fixation | |
| Appliances and Accessories, 21 CFR 888.303 |
3. Predicate or legally marketed devices that are substantially equivalent:
-
- EBI® XFIX® DFS® System EBI, L.P. (K953406)
-
- Description of the device: The EBI® XFIX® DFS® System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® DFS® 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® DFS® System is attached to the shanks of the bone screws. This submission is for the modifications to the Ankle Clamp of the EBI® XFIX® DFS® System.
- The EBI® XFIX® DFS® System is intended for use in the treatment of bone 5. Intended Use: conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
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Koo1091
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- Materials: The components of the System may be manufactured from materials such as titanium, stainless steel, and aluminum.
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- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI® XFIX® DFS® Fixation System and other currently marketed external fixation systems. It is substantially equivalent* to the predicate device 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 marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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 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 three wavy lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Re: K021091
Trade/Device Name: EBX® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 3, 2002 Received: April 4, 2002
MAY 0 3 2002
Dear Mr. Caparotta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jon Caparotta, RAC
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 vours,
Mach N. Millener
Celia 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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STATEMENT OF INDICATIONS FOR USE
Page 1 of __ 1
510(k) Number (if known): KO2 / O9 /
Device Name: EBI® XFIX® DFS® System
Indications For Use:
The EBI® XFIX® DFS® System is a 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______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
fo Mark H. Milleson
Division of General, Restorative and Neurological Devices
510(k) Number_