(29 days)
Not Found
No
The summary describes a mechanical external fixator system and explicitly states that the fundamental scientific technology has not changed from previously cleared submissions, which predate the widespread use of AI/ML in medical devices. There are no mentions of AI, ML, image processing, or data sets for training/testing.
Yes
The device is described as an external fixator intended for the treatment of bone and soft tissue conditions, including fractures and joint stiffness, which are therapeutic applications.
No
Explanation: The device, an elbow fixator, is used for external treatment of bone and soft tissue conditions, such as fractures and joint stiffness. It is a therapeutic device that physically stabilizes and treats the conditions, rather than diagnosing them.
No
The device description explicitly states it consists of "external fixation components and implantable bone screws," which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The EBI® XFIX® DFS® OptiROM® Elbow Fixator is a surgical device that is implanted into the body (bone screws) and attached externally to stabilize and treat bone and soft tissue conditions. It directly interacts with the patient's anatomy.
- Intended Use: The intended use describes treating bone and soft tissue conditions through external fixation, not analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EBI® XFIX® DFS® OptiROM® Elbow Fixator 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 (comma separated list FDA assigned to the subject device)
KTT
Device Description
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's 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. This submission is for the addition of a carbon fiber ulnar bar, as well as components to allow for posterior bone screw placement in the humerus. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity (elbow, humerus, ulnar)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k) Device Modification: EBI® XFIX® DFS® OptiROM® Elbow Fixator
K000403
page 1 of 2
510(k) Summary
This 510(k) Summary 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.
- Contact Person: Patricia Flood, RAC 1. Sponsor: (973) 299-9300, ext.3318 Telephone: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Date Prepared: February 6, 2002
| 2. Proprietary Name: | EBI® XFIX® DFS® OptiROM® Elbow Fixator |
|---|---|
| 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 Device:
4. Description of Device:
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's 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. This submission is for the addition of a carbon fiber ulnar bar, as well as components to allow for posterior bone screw placement in the humerus. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
5. Intended Use:
The EBI XFIX DFS OptiROM Elbow Fixator 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
K020403
page 20fa
Comminuted intra-articular fractures. Post traumatic reconstruction for joint stiffness.
6. Materials:
The components of the System may be manufactured from materials such as Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy.
7. Comparison of the technological characteristics of the device to predicate devices:
The modified EBI XFIX DFS OptiROM Elbow Fixator is substantially equivalent to the following predicate device:
EBI XFIX DFS OptiROM Elbow Fixator (K981483, K992515)
- The additional EBI XFIX DFS OptiROM Elbow Fixator components . are fabricated from the same materials as the components of the currently marketed EBI XFIX DFS OptiROM Elbow Fixator, with the addition of carbon fiber.
- The modified EBI XFIX DFS OptiROM Elbow Fixator and the currently . marketed EBI XFIX DFS OptiROM Elbow Fixator are both 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.
- The bone screw clamps of the modified EBI XFIX DFS OptiROM Elbow ● Fixator, like the bone screw clamps currently marketed in the EBI XFIX DFS OptiROM Elbow Fixator, are designed for fixation of the bar and bone screw.
- The modified EBI XFIX DFS OptiROM Elbow Fixator, like the currently ● marketed EBI XFIX DFS OptiROM Elbow Fixator, is provided nonsterile.
There are no significant differences between the modified EBI XFIX DFS OptiROM Elbow Fixator and the currently marketed EBI XFIX DFS OptiROM Elbow Fixator. It is substantially equivalent* to the predicate device with regard 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 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Ms. Patricia Flood, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Re: K020403 Trade/Device Name: EBI® XFIX® DFS® OptiROM® Elbow Fixator Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: February 6, 2002 Received: February 7, 2002
Dear Ms. Flood:
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 rommerce 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 oney, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , answer , 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.
3
Page 2 - Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wy of a finding of substantial equivalence of your device to a legally promatics noticated. " 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 Ouvision 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,
Mark A. Miller
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 l
510(k) Number (if known): KOLL CS /03 EBI® XFIX® DFS® OptiROM® Elbow Fixator Device Name: Indications For Use:
The EBI® XFIX® DFS® OptiROM® Elbow Fixator 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.
(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 N Millam
/ (Division Sign-Off)
Division of General Restorative
510(k) Number K020403