(180 days)
No
The description focuses on the mechanical design and function of a physical screw system for bone fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE), which aligns with the definition of a therapeutic device as something used to treat or manage a medical condition.
No
The device is a temporary implant for fixation of pediatric femoral neck fractures and slipped capital femoral epiphysis. It is a treatment device, not a diagnostic one.
No
The device description clearly details a physical implantable screw system with mechanical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Free-Gliding SCFE Screw System is a physical implant designed to stabilize bone fractures and slipped epiphysis. It is surgically inserted into the patient's body.
- Intended Use: The intended use is for the stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis, which is a direct treatment/stabilization of a physical condition within the body, not an analysis of a specimen outside the body.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.
Product codes
HWC
Device Description
The Free Glidinq SCFE Screw is a self-extending cannulated screw for use in fixation of slipped capital femoral epiphysis and femoral neck fractures. The design of the screw includes a male component (which is attached to the lateral cortex) and a female component (which is attached at the proximal epiphysis). Anchorage of the components is achieved through screw-type fixation. The screw has a built-in feature that allows for free extension of its length as the slipped capital physeal plate heals and normal patient growth continues. Stable fixation and rotational stability is created at the fracture (slip) site while avoiding compression forces thus avoiding premature closure of the physeal plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pediatric femoral neck, slipped capital femoral epiphysis (SCFE)
Indicated Patient Age Range
all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.
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
Biomechanical Testing: Static and Fatique four-point bending tests, based on the ASTM F1264 "Standard Specifications and Test Method for Intramedullary Fixation Devices" were performed in order to establish safety and effectiveness of the Free-Gliding SCFE Screw System. These tests demonstrated comparable mechanical performances of the Free-Gliding SCFE Screw System to the predicate device tested in direct side by side testing. Moreover, engineering analysis of torsional strength and screw pullout strength further demonstrated strengths that exceed those of the predicate device with a significant margin of safety.
Clinical Testing: No clinical testing is provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K021932, K964893, K033968, K092189, K080649
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 2 7 2013
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant:
Pega Medical Inc. 1111 Autoroute Chomedey Laval, Quebec H7W 5J8
Canada
Contact Person:
The Free-Gliding SCFE Screw System Proprietary Name:
Ariel R. Dujovne
SCFE screw Common Name:
Device Classification: Class II
21 CFR 888.3040 Smooth or threaded metallic bone Classification Name: fixation fastener
Device Product Code: HWC
Establishment Registration Number: 9048931
Intended Use:
The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.
Description:
The Free Glidinq SCFE Screw is a self-extending cannulated screw for use in fixation of slipped capital femoral epiphysis and femoral neck fractures. The design of the screw includes a male component (which is attached to the lateral cortex) and a female component (which is attached at the proximal epiphysis). Anchorage of the components is achieved through screw-type fixation. The screw has a built-in feature that allows for free extension of its length as the slipped capital physeal plate heals and normal patient growth continues. Stable fixation and rotational stability is created at the fracture (slip) site while avoiding compression forces thus avoiding premature closure of the physeal plate.
Basis for substantial equivalent:
The Free Gliding SCFE Screw System is claimed to be substantially equivalent in design and function to the following predicate devices:
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- Synthes 6.5 mm Cannulated Screw (Stainless Steel screws), Synthes 1. USA. (K021932)
- Hansson Pin System (Ti alloy nail and Stainless Steel screws & end 2. caps), Howmedica Osteonics Corporation. (K964893 & K033968)
The intended uses of these devices are the same as the Free Gliding SCFE Screw System
Summary of Technologies:
The technological characteristics of the Free Gliding SCFE Screw System are equivalent or similar to those of the predicate devices.
Biomechanical Testing:
Static and Fatique four-point bending tests, based on the ASTM F1264 "Standard Specifications and Test Method for Intramedullary Fixation Devices" were performed in order to establish safety and effectiveness of the Free-Gliding SCFE Screw System. These tests demonstrated comparable mechanical performances of the Free-Gliding SCFE Screw System to the predicate device tested in direct side by side testing. Moreover, engineering analysis of torsional strength and screw pullout strength further demonstrated strengths that exceed those of the predicate device with a significant margin of safety.
Clinical Testing:
No clinical testing is provided as a basis for substantial equivalence.
Conclusion:
Based on the similarities in the intended use, design, materials, manufacturing methods, and packaging, Free-Gliding SCFE Screw System has been established as substantially equivalent to the previously cleared predicate devices. Furthermore, mechanical test results demonstrate that the proposed Free-Gliding SCFE Screw System is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with its wings spread and body curving downwards. The bird is rendered in a thick, black line. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 27, 2013
Pega Medical Incorporated Ms. Ariel R. Dujovne President 111 Autoroute Chomedey Laval Quebec H7W 5J8 Canada
Re: K131591
Trade/Device Name: The Free-Gliding SCFE Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 1, 2013 Received: November 4, 2013
Dear Ms. Dujovne:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Ariel R. Dujovne
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetw/ReportaProblem/default.htm for the CDRI+'s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Lori A. Wigqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K131591 510(k) Number (if known): _
Device Name: The Free-Gliding SCFE Screw System
Indications for Use:
The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.
Over-The-Counter Use _ Prescription Use no × AND/OR (Part 21 CFR 801 Subpart D) (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)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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