(62 days)
Not Found
No
The device description and performance studies focus on mechanical fixation and material equivalence, with no mention of AI/ML terms or functionalities.
Yes
The device is described as being used in the "treatment of bone conditions including fracture fixation and other bone conditions," which aligns with the definition of a therapeutic device designed for medical treatment.
No
Explanation: The device description states its use is for "fracture fixation and other bone conditions," which are treatment rather than diagnostic functions. There is no mention of it gathering data, analyzing images, or providing any form of diagnosis.
No
The device description clearly details physical components like a main body, holes, screw sleeves, bone screws, and grub screws, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation." This describes a therapeutic device used directly on the patient's body for treatment.
- Device Description: The description details a physical device (fixator, screws, sleeves) used to stabilize bone fragments. This is consistent with a surgical or orthopedic device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ids fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The ids fixator construct comprises of a main body which incorporates a central portion with larger ends with three 10mm diameter holes in each to accommodate bone screws. It is available in two lengths - 70 mm and 110mm. A screw sleeve fits into each hole and the bone screw is passed through each sleeve and into the bone fragment through the skin. The bone screw is secured to the fixator using a grub screw (passing through the sleeve) and tightening onto the screw directly. The ids fixator is a single use device.
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): 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
K070724 Page 15
MAY 16 2007
Image /page/0/Picture/2 description: The image shows a symbol that resembles the Greek letter phi (Φ, φ) with a dot above it. The symbol consists of a circle with a vertical line passing through its center. The dot is positioned directly above the vertical line, creating a distinct visual element. The symbol is rendered in black against a white background.
PO Box 2681 Steke on Tient STA 988
T: +44 (0) 17 82 84 78 40 F: +44 (0) 17 82 54 60 46 www.intelligent.orthopaedics.co.uk
E) 510(k) Summary or 510(k) Statement
Submitted by
Peter Ogrodnik Managing Director Intelligent Orthopaedics Limited Building 103 Campbell Road Stoke on Trent Staffordshire ST4 4DE United Kingdom
Date
8 February 2007
Contact person
Julio Gonzalez BSN medical Inc 5285 Carnegie Blvd Charlotte NC
| Proprietary Name | i[phi]s External Fixation Device |
|---|---|
| Common Name | External Fixation Systems |
| Classification / Reference | Class II – 888.3030 Single / Multiple Component Metallic |
| Bone Fixation Appliances and Accessories | |
| Product Code & Panel | KTT / Orthopedic |
Device Description
The ids fixator construct comprises of a main body which incorporates a central portion with larger ends with three 10mm diameter holes in each to accommodate bone screws. It is available in two lengths - 70 mm and 110mm. A screw sleeve fits into each hole and the bone screw is passed through each sleeve and into the bone fragment through the skin. The bone screw is secured to the fixator using a grub screw (passing through the sleeve) and tightening onto the screw directly. The ids fixator is a single use device.
Intended Use
The ids fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation
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Technological characteristics
The components of the iφs fixator are made from titanium alloy and stainless steel
Substantial Equivalence
The components of the ids fixator are substantially equivalent to K031919 – EBI XFIX DFS system.
Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the 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 an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intelligent Orthopaedics Ltd. % Mr. Neil McLachlan BSN Medical Ltd. Brierfield Mill Brierfield, Nelson Lancashire BB9 5NJ United Kingdom
MAY 16 2007
K070724 Re:
Trade/Device Name: I�S External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: KTT Dated: April 30, 2007 Received: May 4, 2007
Dear Mr. McLachlan:
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
3
Page 2 - Mr. Neil McLachlan
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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buechner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K070724
Device Name:
Indications for Use:
The IQS fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation.
Prescription Use X (Part 21 CFR 801 Subpart D)
APC FESS AS TOLES FREE PARTER PLUS PERSONAL POST COLLECTION COLLECTION CONSECTION CONNECT
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
barbare buehum
Division Sion-( Division of General. Restorative. and Neurological Devices
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510(k) Number K070724
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