(94 days)
Not Found
No
The summary describes a mechanical external fixation device and explicitly states that the fundamental scientific technology has not changed from the predicate device. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is used for the treatment of bone conditions such as leg lengthening, osteotomies, arthrodesis, and fracture fixation, which are direct medical treatments.
No
The device, an external fixation device, is used for treatment of bone conditions, not for diagnosis.
No
The device description explicitly states it is a "unilateral external fixation device" and describes physical components like "external fixation components and implantable bone screws." This indicates it is a hardware device, not software-only.
Based on the provided information, the EBI® XFIX® OptiROM® Knee Fixator 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 (inserting bone screws and attaching a frame) to stabilize and manipulate bone.
- Device Description: The description reinforces this by detailing the components (external fixation components and implantable bone screws) and how they are used in a surgical/treatment setting.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the EBI® XFIX® OptiROM® Knee Fixator is a medical device used for surgical and orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EBI® XFIX® OptiROM® Knee Fixator 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.
Product codes
KTT
Device Description
The EBI® XFIX® OptiROM® Knee Fixator is a module which is used in conjunction with the currently marketed EBI® XFIX® DFS® System. The EBI® XFIX® OptiROM Knee Fixator has not changed the Indications for Use or the fundamental scientific technology of the previously cleared System. The System consists of external fixation components and implantable bone screws. The 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 System 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
Knee, 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)
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
JUL 1 0 2003
K031093
page 1 of 2
510(k) Summary
This 510(k) Summary for the EBI® OptiROM® Knee Fixator is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
- Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Frederic Testa, RAC Phone: (973)299-9300, ext. 2208
April 3, 2003 Date prepared:
| 2. Proprietary Name: | EBI® XFIX® OptiROM® Knee Fixator |
|---|---|
| Common Name: | External Fixation Device |
| Classification Names: | Single/Multiple Component Metallic Bone |
| Fixation | |
| Appliances and Accessories, 21 CFR 888.3030 |
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® OptiROM® Knee Fixator is a module which is used in conjunction with the currently marketed EBI® XFIX® DFS® System. The EBI® XFIX® OptiROM Knee Fixator has not changed the Indications for Use or the fundamental scientific technology of the previously cleared System. The System consists of external fixation components and implantable bone screws. The 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 System is attached to the shanks of the bone screws.
1
K031093
page 2 of 2
-
- Intended Use: The EBI® XFIX® OptiROM® Knee Fixator 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.
-
- Materials: The components of the System may be manufactured from materials such as titanium, stainless steel, aluminum, and Delrin®.
-
- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI® XFIX® OptiROM® Knee Fixator and the currently marketed EBI® XFIX® DFS® System. 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 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
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health & Human Services. The logo is a stylized image of an eagle with three stripes across its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2003
Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K031093
Trade/Device Name: EBI XFIX OptiROM Knee Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 3, 2003 Received: April 7, 2003
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
3
Page 2 - Mr. Jon Caparotta, RAC
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. 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
uriam C. Provost
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 _ l
510(k) Number (if known): KO31C 93
Device Name: EBI® XFIX® OptiROM® Knee Fixator
Indications For Use:
The EBI® XFIX® OptiROM® Knee Fixator 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)
Muriam C. Provost
ivision of General. Restorative and Neurological Devices
510(k) Number K031093