(271 days)
Not Found
No
The document describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used to assure alignment, stabilization, and fixation of long bones to correct deformities or fractures caused by trauma or disease. These actions directly address a medical condition or promote healing, which fall under the definition of a therapeutic device.
No
The device is described as an implantable system for stabilization and fixation of long bones after surgical preparation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of physical components like an intramedullary cannulated nail, plates, and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the GAP Endo-Exo Medullary System is a temporary implant used for the surgical correction of bone deformities and fractures. It is a physical device implanted into the body to provide structural support and stabilization.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information about a patient's health status. Its function is purely mechanical and surgical.
Therefore, the GAP Endo-Exo Medullary System falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions:
- Diaphyseal fracture of the femur, tibia and humerus ●
- . Fractures of the femoral neck
- Subtrochanteric, intertrochanteric and combination fractures ●
- . Correction of deformities (OI, Coxa vara, Coxa valga)
- . Nonunions and malunions
Product codes
HSB
Device Description
The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via lag and/or mechanical screws creating a combined Endomedullary/ Exomedullary osteosythesis device. The nail is available is diameters ranging from 4.8 to 12.0mm in 0.8mm increments. Lengths available range from 160 to 320mm. 2.5, 3 and 4mm cortical screws are used to secure the nail to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, humerus, femoral neck
Indicated Patient Age Range
pediatric patients (child and adolescent) ages 2 to 21
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)
The proposed modification on the design of the distal holes of the 4.8 mm GAP Nail was tested through bench testing in static and fatigue loading with an offset axial compression test set-up. The results indicate that the new design increases mechanical resistance and fatigue life compared to the predicate Ø4.8mm GAP Nail design [K111232].
No Animal or Clinical testing was performed.
No clinical testing is provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
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 a stylized image of three human profiles facing to the right, forming a single, flowing shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2016
Pega Medical Inc. Ariel R. Dujovne President 1111 Autoroute Chomedey Laval, Quebec H7W 5J8 Canada
Re: K160545
Trade/Device Name: Gap Endo-Exo Medullary System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 18, 2016 Received: April 19, 2016
Dear Ariel R. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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/Safety/ReportaProblem/default.htm for the CDRH'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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Expiration Date: January 31, 2017
510(k) Number (if known
GAP Endo/Exo Medullary System Device Name
Indications for Use (Describe)
indicated for correction of the following conditions: si il .I və səsr (11925) və birin) sinfinin ədədi ilə bəsn si mərkiyyə yaşlıqların və ya ədə ədil əsasən və of o notisxil pur substility is internet is se temporary im sure aligniment, stabilization and filization and filization and filization and filization and filization and filizatio
- Diaphysess fracture of the femur, tibis and humerus
- Fractures of the femoral neck
- Subtrochanteric, intertrochanteric and combination fractures
- Correction of deformities (OI, Coxa vara, Coxa vara, Coxa valga
- Nounnious and malunions
Type of Use (Select one or both, as applicable)
2 Presscription Use (Fart 21 CFR 801 Suppart D
Over-The-Counter Use (2) CFR 801 Subpart C
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SEND YOUR SECTION HAPPENINGS TO:
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Paperwork Reduction Act (PRA) Staff
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Paperwork Reduction Act (PRA) Staff
Office of Chief Information Officer Food and Drug Administration
Department of Health and Human Services
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Approved: OMB No.0910-012
Diration Date: January 31, 2017
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Number (if known)
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Expiration Date: January 31,
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Wednesday, November 22nd, 2016
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant : Pega Medical Inc. 1111 Highway Chomedey Laval, Quebec, Canada, H7W 5J8 Phone :1-877-739-5175 Fax :1-888-258-0760 Contact Person : Ariel R. Dujovne Proprietary Name : GAP Endo-Exo Medullary System Common Name : Intramedullarv Nail Device Classification : Class II Classification Name : Rod, Fixation, Intramedullary And Accessories 21 CFR 888-3020 Device Product Code : нгв Establishment Registration Number : 9048931
Intended Use:
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions:
- Diaphyseal fracture of the femur, tibia and humerus ●
- . Fractures of the femoral neck
- Subtrochanteric, intertrochanteric and combination fractures ●
- . Correction of deformities (OI, Coxa vara, Coxa valga)
- . Nonunions and malunions
Description:
The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via lag and/or mechanical screws creating a combined Endomedullary/ Exomedullary osteosythesis device. The nail is available is diameters ranging from 4.8 to 12.0mm in 0.8mm increments. Lengths available range from 160 to 320mm. 2.5, 3 and 4mm cortical screws are used to secure the nail to the bone.
Basis for substantial equivalent:
The GAP Endo-Exo Medullary System is claimed to be substantially equivalent in design and function to the following predicate devices:
-
- The GAP Endo-Exo Medullary System, Pega Medical Inc. [K111232]
4
The intended use remains unchanged from the original GAP Endo-Exo Medullary System (K111232). Design changes have been validated via in-vitro biomechanical testing, when deemed necessary. The dimensional modification to the device maintains the effectiveness and increases the safety of the device.
Summary of Technologies:
The technological characteristics of the GAP Endo-Exo Medullary System are the same or similar to the ones of the predicate devices. The subject device uses the exact same lag and mechanical screws to fix onto the various plates at the level of the proximal femur. However, for distal locking of the subject device was redesigned for locking with Ø2.5mm unicortical pins instead of Ø3.0mm bicortical screws in the Ø4.8mm GAP Nail, which increases the mechanical resistance and fatigue life of the Ø4.8mm GAP Nail at the level of the distal pinning because of the reduction in the size of the locking holes when compared to the predicate device.
Non-clinical Performance Data:
The proposed modification on the design of the distal holes of the 4.8 mm GAP Nail was tested through bench testing in static and fatigue loading with an offset axial compression test set-up. The results indicate that the new design increases mechanical resistance and fatigue life compared to the predicate Ø4.8mm GAP Nail design [K111232].
No Animal or Clinical testing was performed.
Clinical Performance Data:
No clinical testing is provided as a basis for substantial equivalence.
Conclusion:
Based on the similarities of intended use, design, materials, manufacturing methods and packaging, the GAP Endo-Exo Medullary System has been established substantially equivalent to the previously cleared predicate devices. The literature supports the use of this product as safe and effective for its intended use; the anticipated benefits of such system outweigh any possible residual risks.