(325 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to aid in the healing of fractures and malunions, directly addressing a medical condition and promoting recovery.
No
The device description clearly states it is a "telescopic rod for use in fixation of long bone fractures" and an "implant." Its purpose is to aid in healing and prevent further fractures, which are therapeutic functions, not diagnostic.
No
The device description clearly describes a physical, implantable medical device (telescopic rod) made of hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the Fassier-Duval Pediatric IM System is a "telescopic rod for use in fixation of long bone fractures." It is an implantable device used within the body to provide structural support and aid in healing.
- Intended Use: The intended use describes the device's function in treating bone fractures and deformities, which is a surgical intervention, not a diagnostic test performed on a sample.
The device described is a surgical implant, not an IVD.
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. 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
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)
Clinical data submitted with the current application demonstrated that in the operative treatment of OI, the Fassier-Duval Pediatric IM System produces a 3fold reduction in the re-operation rate and a 2 to 3-fold reduction in the complication rate, compared to the predicate device #1. For predicated devices #2, 3 and 4, substantial equivalence was demonstrated by preclinical data according to ASTM F 1264 (four point bending).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Dubow-Bailey Intramedullary Nail, Zimmer, Inc. Warsaw, IN (510(k) number - Not available, pre-amendment device), K980854, K971783, K813371
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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K020885 P i/2
Image /page/0/Picture/1 description: The image shows the logo for Pega Medical. The logo consists of the words "Pega Medical" in a sans-serif font, with "Pega" in a larger, bolder font than "Medical". Above the text is a stylized graphic of a person with curved lines emanating from their head, resembling motion or energy. The logo is in black and white.
9260 Viau Blvd. Montreal Quebec H1R 2V8
FEB 0 6 2003
phone: (514) 322-8560 ax: (514) 328-9548 il: pegamedical@pegamedical.c website www.pegamedical.com
Montreal, January 23, 2003
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Contact Person: Ariel R. Dujovne, M.Sc
Pega Medical Inc. 9260 boul Viau, Montreal Ouebec. 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: 9048931
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. 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
Basis for substantial equivalent:
The Fassier-Duval Pediatric IM System is claimed to be substantially equivalent in design and function to the following predicate devices:
-
- Dubow-Bailey Intramedullary Nail, Zimmer, Inc. Warsaw, IN (510(k) number - Not available, pre-amendment device)
-
- Retrograde Pediatric Nail, Encore Orthopedics, Inc., Austin, TX (K980854)
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- Intramdedullary Fixation Rod/Pin, Synthes (USA), Paoli, PA (K971783)
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- The Grosse & Kempf Intramedullary Nail, Howmedica, Rutherford, NJ (K813371)
The intended uses of these devices are the same as the Fassier-Duval Pediatric IM System.
The technological characteristics of the Fassier-Duval Pediatric IM System are identical to the ones of the Dubow-Bailey Intramedullary Nail except for the method of fixation. Clinical data submitted with the current application demonstrated that in the operative treatment of OI, the Fassier-Duval Pediatric IM System produces a 3fold reduction in the re-operation rate and a 2 to 3-fold reduction in the complication rate, compared to the predicate device #1.
For predicated devices #2, 3 and 4, substantial equivalence was demonstrated by preclinical data according to ASTM F 1264 (four point bending). Although there are several design differences with the predicate devices, they do not raise new questions of safety and effectiveness.
KO208BS
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, representing health and well-being. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2003
Mr. Ariel R. Dujovne, Ing., M.Sc. Pega Medical, Inc. 9260 Viau Boulevard St-Leonard, (Montreal) Quebec. Canada H1R 2V8
Re: K020885
Trade/Device Name: Fassier Duval Telescopic IM Nail System Regulation Number: 21 CFR $888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 4, 2002 Received: December 6, 2002
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
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Page 2 -- Mr. Ariel R. Dujovne, Ing., M.Sc.
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (301) 594-4659. 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 Division of Small 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 M Millman
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS ENCLOSURE
510(k) Number (if known):
Device Name: Fassier-Duval Pediatric Intramedullary Nail 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.
for Mark N. Millman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO20885 10(k) Number _________________________________________________________________________________________________________________________________________________________________