(88 days)
Not Found
No
The description focuses on mechanical components and material modifications, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for 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." This describes a therapeutic purpose.
No
The device description clearly states its purpose as "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." It is an external fixation system used to stabilize bones, not to diagnose conditions.
No
The device description explicitly states that the system consists of "external fixation components and implantable bone screws," which are hardware components. The submission is for modifications to these hardware components (clamps and materials).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for 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." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details external fixation components and implantable bone screws used to stabilize bone. This is a mechanical device for surgical use.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests on biological samples.
The device described is an external fixation system, which is a type of surgical device used to stabilize bones.
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.
Product codes
KTT
Device Description
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. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of carbon fiber material for the Straight Clamps, modification to the Carbon Ankle Clamp, and modification to the Carbon T-Clamp.
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)
OrthoFix XCaliber Fixation System
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
040935
page 1 of 2
JUL - 6 2004
510(k) Summary
This 510(k) Summary for the modified EBI® XFIX® DFS® System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
| 1. Sponsor: | EBI, L.P.
100 Interpace Parkway
Parsippany, NJ 07054 | Contact Person: | Frederic Testa |
|----------------|------------------------------------------------------------|-----------------|----------------|
| Telephone: | (973) 299-9300, x2208 | | |
| Date prepared: | April 8, 2004 | | |
| 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 | |
| 888.3030 |
3. Predicate or Legally Marketed Device:
- EBI® XFIX® DFS® System EBI, L.P. (K953406) .
- EBI® XFIX® DFS® System EBI, L.P. (K031919) .
- OrthoFix XCaliber Fixation System .
4. Description of the device:
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. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of carbon fiber material for the Straight Clamps, modification to the Carbon Ankle Clamp, and modification to the Carbon T-Clamp.
5. Intended 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.
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K040935
page 2 of 2
6. Materials:
The components of the System may be manufactured from materials such as aluminum, stainless steel, titanium alloy, and carbon fiber.
7. Comparison of the technological characteristics of the device to predicate devices:
The modified EBI® XFIX® DFS® System is substantially equivalent to the following predicate device:
EBI XFIX DFS System (K953406, K031919)
- The modified EBI XFIX DFS System is fabricated from . the same materials as the components of the currently marketed EBI XFIX DFS Fixation System.
- The modified EBI XFIX DFS System and the currently marketed EBI . XFIX DFS System are both indicated for 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 bone screw clamps of the modified EBI XFIX DFS System, like the . bone screw clamps currently marketed in the EBI XFIX DFS System, are designed for attachment to the bone screws.
- The additional component of the EBI XFIX DFS System, like the . components of the currently marketed EBI XFIX DFS System, is provided non-sterile.
- . There are no significant differences between the modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS System. It is substantially equivalent* to the predicate device with regard to intended use, materials, and function.
- Any statement made in conjunction with this submission of substantial equivalence to any other product is intended only to relate 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2004
Frederic Testa, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K040935
Trade/Device Name: EBI® XFIX® DFS® System Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Regulatory Class: II
Product Codes: KTT Dated: April 8, 2004 Received: April 9, 2004
Dear Mr. Testa:
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.
3
Page 2 - Frederic Testa, 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), 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,
Miriam 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 __ 1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EBI® XFIX® DFS® System
Indications For Use:
The EBI® XFIX® DF5® 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 X
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| -------------------------------------------- | ---- | ---------------------- |
| Miriam C. Provost (Optional Format 1-2-96) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices |
| 510(k) Number | K640935 |
|---|---|
| --------------- | --------- |
510(k) Number
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