(68 days)
No
The summary does not mention AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on the physical design and material properties.
No
The device, an external fixator, is used for fracture fixation and correction of bone deformities, which are therapeutic interventions.
No
The device is an external fixator used for fracture fixation and correction of bone deformities; its purpose is therapeutic, not diagnostic.
No
The device description explicitly details a physical hardware component made of carbon fiber composite, intended for external fixation of bone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is an External Fixator used for the mechanical fixation and manipulation of bone segments in the body. It is applied externally to the limb to stabilize fractures, correct deformities, and aid in bone healing.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing bodily fluids, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.
Product codes
KTT, LXT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone segments, limb
Indicated Patient Age Range
Human of any gender and at the advanced walking age
Intended User / Care Setting
hospitals and in patients surroundings and environments
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)
Comparatively tested, indicating 15%-20% superiority.
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
SEP 2 2 2003
510(K) SUMMARY (as required by 807.92(c))
032169
page 1 of 3
| Submitter of 510(k): | Cyber Orthology, Inc.
6301 Hughes Dr.
Sterling Heights, MI 48312
Phone: 586-264-9544
Fax: 586-264-9566 | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Dr. Djoldas Kuldjanov | |
| Date of Summary: | June 30, 2003 | |
| Trade Name: | CyberOrthology Carbon Fiber Composite Circular Fixation
(CIRfix) Device (Half Ring) | |
| Classification Name: | APPLIANCE, FIXATION, NAIL/BLADE/PLATE
COMBINATION, MULTIPLE COMPONENT | |
| Classification Product Code: | KTT | |
| Predicate Device: | Ilizarov External Fixation System | K962808 |
| | External Fixation System | K870961 |
| Intended Use: | | |
Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.
Conclusion:
This device has equivalent intended use, has similar promotional claims, conforms to similar standards, and has equivalent technological characteristics to predicate devices.
1
Device Comparison Chart
Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K032169", and the text below reads "page 2 of 3". The handwriting is in black ink and appears to be cursive.
| Comparison Items | CyberOrthology Carbon
Fiber Composite Circular
Fixation (CIRfix) device | Ilizarov External Fixation
System K962808 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Part of external fixator aiding
trophism in the correction of
bone deformities/defects. | Same |
| Target population | Human of any gender and at
the advanced walking age | Same |
| Design | Same physical design, except
aesthetically and tactual more
pleasing with improved
impression of superior
strength and safe mobility | Circular half-ring with
overlapping ends to form a
perfect ring when
joined together by bolts and
nuts |
| Material | Radiolucent Carbon Fiber
Composite utilizing
Randomly orientated, pre-
impregnated carbon
strands resulting in a
carbon fiber content of
better than 62%. | Radiolucent Carbon Fiber
Composite featuring
pre-determined fiber
orientations and typically 55%
carbon fiber content. |
| Performance | Comparatively tested,
indicating 15%-20%
superiority. | Compression Stiffness,
(ASTM F-1746). 3-Point
Bending. Cantilever Bending.
Wire Pull-out Test. |
| Sterility | Shipped none-sterile & device
may be sterilized as required
by any method. | Same |
| Biocompatibility | The component is a none
invasive external device and
will not be used for
implantation or contact with
skin or soft tissues. | Same |
| Mechanical Safety | The test procedure
&requirements allow for the
appropriate amount of rigidity
and stability. | Same |
| Chemical Safety | The device is indicated for use
in clinical and common patient
living environment not being
exposed to
harmful chemical elements | Same |
| Compatibility with other
Devices | Compatible with all
appropriate predicate devices | Compatible with specially
designed frames, clamps, rods,
couplings, pins, posts, bolts,
washers, nuts, & others for the
management of appropriate
orthopedic surgeries |
2
Device Comparison Chart
Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The top line reads 'K032169', with the 'k' being lowercase and the other characters being numbers. The second line reads 'page 3 of 3', indicating that this is the third page of a three-page document.
| Where used | The device is being used in hospitals and in patients surroundings and environments |
|---|---|
| Same |
.
3
Image /page/3/Picture/1 description: The image is a black and white seal. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized lines that resemble a bird in flight. The lines are thick and curved, and they are arranged in a way that suggests movement.
Public Health Service
SEP 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CyberOrthology, Inc. c/o Mr. Arthur Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572
Re: K032169
Trade/Device Name: CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 30, 2003 Received: July 21, 2003
Dear Mr. Ward:
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.
4
Page 2 - Ms. Lisa M. Boyle
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.
Mark M. Wilkerson
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
5
510(k) Number (if known):
Device Name: CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring)
Indications For Use:
Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkman
(Division of General, Restorative and Neurological I
Number K032169
510(k) Number -
OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)