(65 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description is purely mechanical.
No
The device is described as a graft fixation device for surgeries, which is a structural component and not a device that directly provides therapy or treatment to a condition.
No
The device is described as a "graft fixation device" intended for "fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries." Its purpose is to fix grafts, not to diagnose a condition or disease.
No
The description clearly states "Endoflip graft fixation device," implying a physical device used for fixation, not a software-only application.
Based on the provided information, the Endoflip graft fixation device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of ligament and tendon grafts in vivo (within the body) during surgical procedures.
- Device Description: The device is described as a tool for femoral fixation of grafts, again indicating use within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Endoflip device does not involve any such activity.
Therefore, the Endoflip graft fixation device is a surgical implant/device used directly on the patient during surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Endoflip graft fixation device is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.
Product codes
MBI
Device Description
Endoflip graft fixation device for femoral fixation of hamstrings grafts in cruciate ligament reconstruction.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Mr. Nick Woods Director of Quality Systems Atlantech Medical Devices Ltd. Atlantech House Freemans Way Harrogate Business Park Harrogate, North Yorkshire, HG3 1DH United Kingdom
Re: K013334
Trade/Device Name: Endoflip Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: MBI Dated: October 3, 2001 Received: October 9, 2001
Dear Mr. Woods:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the cholosure) to regars actment date of the Medical Device Amendments, or to commence prior to May 20, 1970, are excordance with the provisions of the Federal Food, DNA A devices mat have been roomstilled in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercetore, market the act include requirements for annual registration, listing of general controls provisions of vactice, 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 IT your device is classified (500 a00 roy als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations o may or subject to back adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oe advisou that i Dr bration that your device complies with other requirements of the Act that I Dr has Intact a and regulations administered by other Federal agencies. You must
1
Page 2 - Mr. Nick Woods
comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 11et 6 requirements, with 801); good manufacturing practice requirements as set CITY art 807); adomig (21 OF RT Part 820); and if applicable, the electronic forth in and quality by believes (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) I mis letter will anow you to organ finding of substantial equivalence of your device to a legally premarket notification: "The PDF 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 If you desire specific advices for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP at 3659. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 1 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 Oiner general 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. Millhiser
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
2
3. Indications for Use
510(k) Number (if known): tba
- Endoflip graft fixation device for femoral fixation of hamstrings Device Name: grafts in cruciate ligament reconstruction.
- Indications for Use: The Endoflip graft fixation device is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.
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)
(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number
Mark A. Millerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Endoflip 510(K) Rev A
K013334 510(k) Number.