(48 days)
Not Found
No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or any technology related to AI/ML.
Yes
The device description and intended use clearly state that it is an external fixation device used for treating various bone conditions like limb lengthening, fracture fixation, and corrective osteotomies, which are therapeutic applications.
No
The device is described as an external fixation device for treating bone conditions, not for diagnosing them. It is used to fix bones, not to provide diagnostic information.
No
The device description explicitly states it consists of "fixation components and implantable bone screws," which are hardware. The submission is for the addition of a carbon fiber rail, also a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the treatment of bone conditions through external fixation. This involves physically interacting with the patient's body to stabilize and manipulate bone.
- Device Description: The description details components like fixation components, implantable bone screws, and a fixator frame that are attached to the patient's bone. This is a mechanical device used for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The EBI XFIX DFS Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction, and other bone conditions amenable to treatment by use of the external fixation modality.
Product codes
KTT
Device Description
The system consists of fixation components and implantable bone screws. The EBI XFIX DFS Rail 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 Rail System is attached to the shanks of the bone screws. This submission is for the addition of a carbon fiber (radiolucent) Rail to the System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
K991941, K000083, K010437, K993886, K014194, K020141
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
Traditional 510(k) Premarket Notification EBI® XFIX® DFS® Rail System
510(k) Summary
This 510(k) Summary for the EBI XFIX DFS Rail System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.
| 1. Sponsor: | Contact Person: |
|---|---|
| EBI, L.P. | |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | Patricia Flood, RAC |
| Telephone: (973) 299-9300, ext.3318 | |
| Date Prepared: | March 28, 2002 |
| 2. Proprietary Name: | EBI XFIX DFS Rail System |
| Common Name: | External Fixation Device |
| Classification Name: | Single Multiple Component Metallic Bone Fixation |
| Appliances and Accessories, 21 CFR 888.3030. |
3. Predicate or Legally Marketed Devices:
- EBI XFIX DFS Rail System (K991941, K000083, K010437) .
- EBI XFIX Vision Fixation System (K993886, K014194, K020141) .
4. Description of Device:
The system consists of fixation components and implantable bone screws. The EBI XFIX DFS Rail 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 Rail System is attached to the shanks of the bone screws. This submission is for the addition of a carbon fiber (radiolucent) Rail to the System.
5. Intended Use:
The EBI XFIX DFS Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction, and other bone conditions amenable to treatment by use of the external fixation modality.
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6. Materials:
The components of the System may be manufactured from materials such as titanium alloy, stainless steel, aluminum, carbon fiber reinforced epoxy, and Pyromet® 718.
7. Comparison of the technological characteristics of the device to predicate devices:
The proposed EBI XFIX DFS Rail System is substantially equivalent to the following predicate EBI devices:
EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141)
- The proposed EBI XFIX DFS Rail System and the currently marketed EBI . XFIX DFS Rail System are both indicated for the treatment of bone conditions, including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.
- The proposed EBI XFIX DFS Rail System, like the currently marketed ● EBI XFIX DFS Rail System and the EBI XFIX Vision Fixation System, is provided non-sterile.
- The components of the proposed EBI XFIX DFS Rail System are . fabricated from the same materials as the components of the currently marketed EBI XFIX DFS Rail System and the EBI XFIX Vision Fixation System.
- There are no significant differences between the proposed EBI XFIX DFS . Rail System and the currently marketed EBI XFIX DFS Rail System. It is substantially equivalent* to the predicate device with regard to intended use, materials, function, and mechanical integrity.
- 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 interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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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 symbol that resembles three abstract, curved shapes stacked on top of each other, possibly representing human figures or a stylized eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Re: K021031
Trade/Device Name: EBI® XFIX® DFS® Rail System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 28, 2002 Received: March 29, 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 (QS) 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
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" (21 CFR 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,
iriam C. Provost
for 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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Statement of Indications for Use
Page 1 of
510(k) Number (if known): K02103 |
Device Name: EBI® XFIX® DFS® Rail System
Indications For Use:
The EBI XFIX DFS Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction 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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K 02103/