(28 days)
Not Found
No
The 510(k) summary describes a purely mechanical implant for bone fixation and growth accommodation. There is no mention of software, data processing, or any technology that would involve AI or ML. The changes described relate to sterilization and packaging.
Yes
The device is a temporary implant used to aid in the healing of fractures and prevent further fractures, which aligns with the definition of a therapeutic device.
No
This device is an implantable surgical system used for fixation of long bone fractures, aid in healing, and prevent further fractures. It is a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical implant (telescopic rod) made of stainless steel components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to aid in the healing of bone fractures and prevent further fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a telescopic rod designed for bone fixation. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Focus on mechanical function: The description emphasizes the mechanical function of the device in supporting bone healing and growth.
IVD devices are used to perform tests on specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Fassier-Duval Telescopic 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 Peqa Medical Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates.
This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized Ø3.2 – Ø6.4 stainless steel Fassier-Duval implant components. All subject components have previously been cleared as non-sterile implants. All other components of the Fassier-Duval Telescopic IM System will remain non-sterile to be sterilized by end-user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, humerus
Indicated Patient Age Range
pediatric patients, pediatric or small stature 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)
Non-clinical Performance Data:
No significant design changes have been made since the previous submission. Gamma sterilization validation, sterile packaging validation, integrity of the sterile barrier over time validation, and rinsing validation were performed to qualify the new packaging and sterilization method for the Fassier-Duval Telescopic IM system. Bacterial Endotoxin Testing was conducted in accordance with ANSI/AAM ST72:2019.
Clinical Performance Data:
No clinical testing is provided as a basis for substantial equivalence.
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.
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.
0
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Pega Medical Inc. Enrique Garcia Vice President of Operations 1111 Autoroute Chomedey Laval. Quebec H7W 5J8 Canada
Re: K211292
Trade/Device Name: Fassier-Duval Telescopic IM System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 23, 2021 Received: April 28, 2021
Dear Enrique Garcia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
May 26, 2021
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K211292
Device Name The Fassier-Duval Telescopic IM System
Indications for Use (Describe)
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Page 1 of 2
510(k) SUMMARY
| Applicant: | Pega Medical Inc. |
|---|---|
| 1111 Autoroute Chomedey | |
| Laval, Quebec, Canada, H7W 5J8 | |
| Phone: 1-877-739-5175 | |
| Contact Person: | Enrique Garcia |
| Proprietary Name: | Fassier-Duval Telescopic IM System |
| Common Name: | FD Telescopic Nail, FD Rod |
| Device Classification: | Class II |
| Panel: | Orthopedic |
| Regulation Number: | 21 CFR 888.3020 |
| Device Classification Name: | Intramedullary fixation rod |
| Device Product Code: | HSB |
| Establishment Registration Number: | 9048931 |
| Date Prepared: | May 18, 2021 |
Indications for Use:
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, ostectomies, 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 stature patients with limb length discrepancy.
Description:
The Fassier-Duval Telescopic 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 Peqa Medical Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates.
This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized Ø3.2 – Ø6.4 stainless steel Fassier-Duval implant components. All subject components have previously been cleared as non-sterile implants. All other components of the Fassier-Duval Telescopic IM System will remain non-sterile to be sterilized by end-user.
Basis for substantial equivalence:
The technological characteristics (materials, design, sizing) of the Fassier-Duval Telescopic IM System are identical to the predicate Pega Medical Fassier-Duval Telescopic IM System (K020885 & K041393).
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The intended use is identical to the predicate (K020885 & K041393). ●
- Indications for Use: Indications for Use are identical to the predicate (K020885 & K041393). ●
4
- Materials: Materials are identical to the predicate (K020885 & K041393). ●
- Design Features: Design features are identical to the predicate (K020885 & K041393). ●
- . Function: The function is identical to the predicate (K020885 & K041393).
- . Sterilization: The proposed Fassier-Duval Telescopic IM System seeks to add sterile packaged nails for distribution. All subject components have previously been cleared as non-sterile implants. All other components will remain non-sterilized by end-user.
Non-clinical Performance Data:
No significant design changes have been made since the previous submission. Gamma sterilization validation, sterile packaging validation, integrity of the sterile barrier over time validation, and rinsing validation were performed to qualify the new packaging and sterilization method for the Fassier-Duval Telescopic IM system. Bacterial Endotoxin Testing was conducted in accordance with ANSI/AAM ST72:2019.
Clinical Performance Data:
No clinical testing is provided as a basis for substantial equivalence.
Conclusion:
Pega Medical has established that the Fassier-Duval Telescopic IM System is substantially equivalent to the legally marketed predical Fassier-Duval Telescopic IM System (K020885 & K041393) based on the similarities of design, intended use, materials, sizing. Risk analysis and design control activities including verification activities were conducted to mitigate identified new risks associated with packaged sterile devices.