(62 days)
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.
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.
The provided text describes a medical device, the i[phi]s External Fixation Device, and its clearance through the 510(k) pathway. This pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than independent proof of safety and effectiveness through clinical trials with specific acceptance criteria and performance data.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device.
The information that can be extracted relates to the substantial equivalence determination:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided text as the device followed the 510(k) pathway, which focuses on substantial equivalence to a predicate device rather than direct proof against pre-defined acceptance criteria for performance. The text only states:
| Criterion | Reported Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Established based on similarities in intended use, materials, design, and mechanical performance to K031919 – EBI XFIX DFS system. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The 510(k) summary does not detail a "test set" in the context of a new efficacy study with human subjects. The substantial equivalence was demonstrated through "mechanical performance" (likely bench testing) and comparison to the predicate, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No such clinical "test set" requiring expert ground truth establishment is described for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical "test set" requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is an external fixation system, not an AI or imaging diagnostic device that would typically involve MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware medical device (external fixator), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the substantial equivalence claim, the "ground truth" was implicitly the performance and characteristics of the predicate device (K031919 – EBI XFIX DFS system) and the mechanical properties (e.g., strength, durability) of the i[phi]s fixator itself, assessed through engineering principles and testing. No clinical "ground truth" for efficacy in human subjects is described.
8. The sample size for the training set:
Not applicable. No "training set" in the context of an algorithm or AI model development is mentioned.
9. How the ground truth for the training set was established:
Not applicable. No "training set" is mentioned.
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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 MetallicBone 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
Page 1 of 2
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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.
Page 2 of 2
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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
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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
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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
Page 1 of 1
510(k) Number K070724
D-2
N/A