(20 days)
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No
The document describes a mechanical external fixation device and explicitly states that the fundamental scientific technology has not changed from the previous cleared system. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is used for the treatment of bone and soft tissue conditions, including fractures and joint stiffness, which are therapeutic applications.
No
Explanation: The device description states it is an "external fixation device" used for "treatment of bone and soft tissue conditions," consistent with a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the system consists of "external fixation components and implantable bone screws," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The EBI XFIX DFS® OptiROM™ Elbow Fixator is an external fixation device that is surgically attached to bone using screws. It is used to stabilize and treat bone and soft tissue conditions.
- Intended Use: The intended use clearly describes a surgical intervention and mechanical support for the elbow joint, not the analysis of biological samples.
Therefore, based on the provided information, the EBI XFIX DFS® OptiROM™ Elbow Fixator is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EBI XFIX DFS® OptiROM™ Elbow Fixator external fixation device is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:
- Fracture dislocation with ligamentos instability.
- Comminuted intra-articular fractures.
- Post traumatic reconstruction for joint stiffness.
Product codes
KTT
Device Description
The EBI XFIX DFS OptiROM Elbow 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 DFS OptiROM Elbow Fixator 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 OptiROM Elbow Fixator is attached to the shanks of the bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity, elbow
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
EBI XFIX DFS Joint Fixator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K992515_{1of2}
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI XFIX DFS® OptiROM™ Elbow Fixator is provided as required per Section 513(I)(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: July 25, 1999 | | |
| 2. Proprietary Name: | EBI XFIX DFS® OptiROM™ Elbow
Fixator | |
| 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:
- EBI XFIX DFS Joint Fixator Electro-Biology, Inc. 트
- Description of the device: The EBI XFIX DFS OptiROM Elbow Fixator 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 DFS OptiROM Elbow Fixator 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 OptiROM Elbow Fixator is attached to the shanks of the bone screws.
-
- Intended Use: The EBI XFIX DFS® OptiROM Elbow Fixator external fixation device is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:
Fracture dislocation with ligamentos instability Comminuted intra-articular fractures Post traumatic reconstruction for joint stiffness
- Materials: The components of the system may be manufactured from materials such as 6. Aluminum, Stainless Steel, Pyromet® 718, and Ti-6A1-4V ELI.
1
K99 2515 20f2
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- Comparison of the technological characteristics of the device to predicate devices:
- The EBI XFIX DFS OptiROM™ Elbow Fixator is substantially equivalent to the . following predicate EBI and competitive devices. The components of the EBI XFIX DFS OptiROM Elbow Fixator are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS Joint Fixator.
- The bone screw clamps of the EBI XFIX DFS OptiROM Elbow Fixator, like the . bone screw clamps currently marketed EBI XFIX DFS Joint Fixator, are designed for attachment to the bone screws.
- . The Distractor of the EBI XFIX DFS OptiROM Elbow Fixator, like the currently marketed EBI XFIX DFS Joint Fixator, is designed to provide the surgeon the ability to compress or distract the bone of the patient for optimal treatment.
The EBI XFIX DFS OptiROM Elbow Fixator like the currently marketed EBI XFIX DFS Joint Fixator is provided non-sterile. There are no significant differences between the EBI XFIX DFS OptiROM Elbow Fixator 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 intigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 17 1999
Mr. Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054-1079
Re: K992515
Trade Name: EBI XFIX DFS® OptiRom™ Elbow Fixator Regulatory Class: II Product Code: KTT Dated: July 25, 1999 Received: July 28, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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. A 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 regulation may result in regulatory 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 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.
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Page 2 - Mr. Jon Caparotta
If you desire specific advice for your device on our labeling regulation (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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell J. Sayre
C. Lin McWhirter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use:
The EBI XFIX DFS® OptiROM™ Elbow Fixator external fixation device is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:
- Fracture dislocation with ligamentos instability. 1.
-
- Comminuted intra-articular fractures.
-
- Post traumatic reconstruction for joint stiffness.
Russell S. Ayres Jr.
Prescription Use
(Per 21 CFR 801.109)