(85 days)
Not Found
No
The device description and intended use focus on a mechanical implant for bone fixation and growth, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an implant aid in the healing of fractures, osteotomies, malunions, and nonunions, and to prevent further fractures, indicating a therapeutic purpose for treating these conditions.
No
The device is described as a "telescopic rod for use in fixation of long bone fractures" and acts as a "temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions". This indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly describes a physical, implantable medical device (a telescopic rod) made of hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used within the body to aid in bone healing and prevent fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (telescopic rod) designed for internal fixation of bones. This is consistent with a surgical implant, not a device used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro, or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.
Product codes
HSB
Device Description
The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation or a locking pin. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia and humerus
Indicated Patient Age Range
pediatric patients, pediatric or small statured patients
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)
Design changes have been validated via in-vitro biomechanical testing where deemed necessary. Addition of larges sizes do not raise new questions of safety and effectiveness.
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/0 description: The image contains the logo for Pega Medical, which includes the company name in bold font and a stylized graphic of a person. Above the logo, the text "AUG 17 2004" is printed in a simple, sans-serif font. The date appears to be a stamp or print, as the ink is slightly uneven.
9260 Viau Blvd Montreal Quebec HIR 2V8
0413923
page 1 of 2
phone: (514) 322-856 fax 1514: 328.9541 pegamedical@pegamedical con ww.pegamedical.com
Montreal, May 24, 2004
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Contact Person: Ariel R. Dujovne, M.Sc
Pega Medical Inc. 9260 boul Viau, Montreal Quebec, H1R 2V8 CANADA (514) 322-8560 ext. 241
Proprietary Name: Fassier-Duval Pediatric IM System
Common Name: Telescopic Nail
Device Classification: Class II
Classification Name: Intramedullary fixation rod - 21CFR 888.3020/888.3030/888.3040
Establishment Registration Number: 904893 l
Intended Use: This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.
Description: The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation or a locking pin. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.
1
K04/395
page 2 of 2
Basis for substantial equivalent: The Fassier-Duval Pediatric IM Syst to be substantially equivalent in design and function to itself as predicate device:
The intended uses remained unchanged from the original Fassier-Duval Pediatric IM System (K020885) to the modified device, subject of this application.
Design changes have been validated via in-vitro biomechanical testing where deemed necessary. Addition of larges sizes do not raise new questions of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows a logo with a circle around three curved lines that resemble a bird in flight. The lines are thick and black, and they are arranged diagonally within the circle. The logo has a simple and minimalist design, and it is likely used to represent an organization or company related to aviation, nature, or environmental protection.
AUG 1 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Mr. Ariel R. Dujovne, M.Sc President Pega Medical, Inc. 9260 boul. Viau, Montreal Quebec, H1R 2V8 Canada
Re: K041393
Trade/Device Name: Fassier-Duval Pediatric Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: May 24, 2004 Received: June 1, 2004
Dear Mr. 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.
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 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.
3
Page 2 – Mr. Ariel R. Dujovne, M.Sc
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and on. The FDA finding of substantial equivalence of your device to a legally premaince noticate 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 If you don't office of Compliance at (301) 594-4659. Also, please note the regulation entitled, Connect the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. Millman
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
4
Indications for Use
510(k) Number (if known): K041393 Device Name: Fassier-Duval Pediatric IM system Indications For Use:
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
State Auditor
Division City Office
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_ Kn41397