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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for a medical device called the Fassier-Duval Telescopic IM System. It is a submission to the FDA regarding a change to an already cleared device, specifically the addition of gamma sterilized stainless steel components.

Based on the provided information, there is no study to prove the device meets acceptance criteria in the traditional sense of an AI/software performance study for which the specified information (sample sizes, ground truth experts, etc.) would be provided.

Instead, this document describes a renewal/modification to an existing device (K020885 & K041393) where the primary change is the sterilization method and packaging for certain components. The "acceptance criteria" here relate to the successful validation of this new sterilization and packaging process, and adherence to established regulatory and engineering standards.

Here's a breakdown of the requested information based on the provided text, while noting that most of the requested parameters are not applicable to this type of submission:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (for new sterilization/packaging)	Reported Device Performance (Summary)
Gamma sterilization validation	Performed (successfully implied for clearance)
Sterile packaging validation	Performed (successfully implied for clearance)
Integrity of the sterile barrier over time validation	Performed (successfully implied for clearance)
Rinsing validation	Performed (successfully implied for clearance)
Bacterial Endotoxin Testing (according to ANSI/AAMI ST72:2019)	Conducted (successfully implied for clearance within acceptable limits)

Notes:

The "device performance" in this context refers to the validated efficacy and safety of the new sterilization and packaging process, not clinical outcomes or algorithmic performance.
The primary "acceptance criteria" for the original device are related to its mechanical properties, biocompatibility, and functionality as an intramedullary fixation rod, which are not explicitly detailed in this document but were part of the previous 510(k) clearances (K020885 & K041393).

2. Sample size used for the test set and the data provenance:

Not applicable (N/A) in the context of an AI/software performance study. For sterilization validation, the "sample size" would refer to the number of devices or test units subjected to the sterilization and packaging validation tests. This specific number is not provided in the document.
Data Provenance: The tests for sterilization and packaging would have been conducted internally by Pega Medical Inc. or by a contracted laboratory. The document does not specify country of origin for these test results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This information pertains to studies where human experts establish ground truth for clinical data, which is not applicable here. Sterilization validations are typically performed by qualified microbiologists and technicians following established protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. Adjudication methods are used for resolving disagreements among multiple human readers of clinical data. This is not relevant to sterilization validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This device is a physical medical implant, not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This device is a physical medical implant, not an AI/software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

N/A. In the context of sterilization and packaging, the "ground truth" would be established by validated scientific and regulatory standards (e.g., successful sterilization to a defined sterility assurance level, successful package integrity, acceptable endotoxin levels).

8. The sample size for the training set:

N/A. This is a physical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

N/A. (See point 8)

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K211292

Device Name The Fassier-Duval Telescopic IM System

Indications for Use (Describe)

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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K211292

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:

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). ●

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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.

Regulation Number and Section

§ 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.