(86 days)
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No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on mechanical assistance for fracture reduction and screw targeting.
No
The device aids in fracture reduction and targeting screws, which are supportive functions for a procedure, not a direct therapeutic action on the patient.
No
The device is described as aiding in the reduction and positioning for femur fractures during intramedullary rod fixation, which is a therapeutic or surgical aid, not a diagnostic function.
No
The intended use describes a "System" that is an "adjunct to any intramedullary rod" and aids in "reduction of a femur fracture" and "targeting of the distal screws". This strongly implies a physical device or system interacting with surgical hardware and the patient's anatomy, not solely software. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only device.
Based on the provided information, the Euclid Reduction and Positioning System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery to aid in the reduction and positioning of a femur fracture and the targeting of screws. This is a surgical aid, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or other materials to perform a test on a sample.
The Euclid Reduction and Positioning System is a surgical instrument or system used to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
The Euclid Reduction and Positioning System is an adjunct to any intramedullary rod system. The Euclid Reduction and Positioning System is to aid in both the reduction of a femur fracture and the targeting of the distal screws placed across the rod. It is considered to aid in any type femur fracture for which intramedullary rod fixation is indicated.
Product codes
JDS
Device Description
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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
Femur
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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§ 888.3030 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three abstract human figures, possibly representing people or families.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Allen P. Schlein, M.D. President Modular Cutting Systems, Inc. 650 Clinton Avenue 06605 Bridgeport, Connecticut
Re: K991037 Euclid Reduction and Guidance System Trade Name: Requlatory Class: II Product Code: JDS Dated: March 24, 1999 Received: March 29, 1999
Dear Dr. Schlein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Allen P. Schlein, M.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinany of easone 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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The Euclid System
Indication Statement
The Euclid Reduction and Positioning System is an adjunct to any intramedullary The Bachd Roudenion as is to aid in both the reduction of a femur fracture rouding of on the targeting of the distal screws placed across the rod. It is considered and to are in any type femur fracture for which intramedullary rod fixation is indicated.
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices ( ۹ ۹ / 3 / 3 / 3 / 3 / 3 / 3 / 5 / 5 / 3 / 3 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 / 5 510(k) Number _