(271 days)
No
The device description and performance studies focus on the mechanical properties and surgical technique of a physical intramedullary nail system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the alignment, stabilization, and fixation of long bones following surgical preparation or trauma, which directly addresses medical conditions and supports healing.
No
The SLIM System is intended as a temporary implant for alignment, stabilization and fixation of long bones, not for diagnosing conditions.
No
The device description clearly states it is an intramedullary fixation system made of medical grade Stainless Steel, which is a hardware implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "temporary implant for alignment, stabilization and fixation of long bones" during surgical procedures. This describes a surgical implant used directly on the patient's body.
- Device Description: The description details the physical components of the implant (rods, threads, locking holes, etc.) and its material (Stainless Steel). This aligns with a surgical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status based on such testing.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes:
- Femur and tibia in the pediation (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.
. Humerus, ulna, fibula in all patient populations
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Simple Locking Intra-Medullary (SLM) system consists of intramedullary fixation devices for use in long bones. The solid shaft, bevelled point, and pre-determined or blank length options is designed for easy insertion in the medullar canal. Anchorage of the device is achieved through a conical thread to obtain a stable fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, are designed for capture and guidance during insertion and retrieval. Additional proximal and distal locking holes allow pinning to ensure fixation with locking pegs when required, and the Bullet screws allow fixation of smaller diameter shafts that cannot be cross-pinned due to their size. The SLIM implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0.2.6.3.2. 4.0. 4.8. 5.6 and 6.4 mm, from 80mm up to 400 mm in length allows end user to customize the length of the rod.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur and tibia, Humerus, ulna, fibula
Indicated Patient Age Range
pediation (child and adolescent), and small-stature adults, all patient populations
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)
No additional testing was considered necessary for the SLIM Blanks, pins or pegs.
- SLIM blanks have the identical diameters and material as previously cleared SLIM rods; . therefore, they will have the same mechanical resistance.
- o The added pins and pegs have the same or larger diameter and the same material than previously cleared pins, therefore they will have the same or higher mechanical resistance.
Additional testing was conducted for the addition of the Bullet screw to the system. In four-point static and fatigue testing, the Bullet screws were found equivalent for their intended uses. In comparison to the previously cleared locking pins, it was considered that the locking pegs perform equivalently than simple locking pin that is bent against the cortex rather than threaded into the cortex in terms of torsion, drive torque and axial pull-out.
A list of the tests carried for this application can be found below:
- Static four-point bending bench testing;
- Fatigue four-point bending bench testing;
- Pull-out & Push-out strength;
- Surgical technique validation on animal model;
- Evaluation of a Shaft to Bullet assembly and instrumentation: migration resistance of the ● assembly under static loading:
- o Evaluation of a Shaft to Bullet assembly and instrumentation: migration resistance of the assembly under cyclic loading (fatigue);
- Static four-point bending bench test of the Bullet;
- Fatigue four-point bending bench test of the Bullet;
- Surgical technique validation of the SLIM and Bullet; .
- . Comparative loading in physiological relevant setting of the SLIM and Bullet against predicate;
- . Functional testing of the cutting operation of the Intro-OP Implant Cutter (ICON) Prototype on a SLIM blank.
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.
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
June 24, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Pega Medical Inc. Ariel R. Dujovne President and CEO 1111 Highway Chomedey Laval, Quebec, Canada H7W 5J8
Re: K192710
Trade/Device Name: The Simple Locking IntraMedullary (Slim) System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 21, 2020 Received: May 26, 2020
Dear Ariel 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. 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 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
1
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 medical devices and radiation-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,
Michael Owens Acting 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
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
The Simple Locking IntraMedullary (SLIM) System
Indications for Use (Describe)
The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes:
- Femur and tibia in the pediation (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.
. Humerus, ulna, fibula in all patient populations
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) SUMMARY
Applicant : Pega Medical Inc. 1111 Highway Chomedey Laval, Quebec, Canada, H7W 5J8 Phone : 1-877-739-5175 Fax: +1 450 233-6358 Contact Person : Ariel R. Dujovne Proprietarv Name : The Simple Locking IntraMedullary (SLIM) System Common Name : SLIM Rod Device Classification : Class II Panel: Orthopedic Classification Name : 21 CFR-888.3020 Intramedullary fixation rod Device Product Code : HSB Establishment Registration Number : 9048931
Intended Use:
The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes:
- · Femur and tibia in the pediatric population (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.
- · Humerus, ulna, fibula in all patient populations
Description:
The Simple Locking Intra-Medullary (SLM) system consists of intramedullary fixation devices for use in long bones. The solid shaft, bevelled point, and pre-determined or blank length options is designed for easy insertion in the medullar canal. Anchorage of the device is achieved through a conical thread to obtain a stable fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, are designed for capture and guidance during insertion and retrieval. Additional proximal and distal locking holes allow pinning to ensure fixation with locking pegs when required, and the Bullet screws allow fixation of smaller diameter shafts that cannot be cross-pinned due to their size. The SLIM implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0.2.6.3.2. 4.0. 4.8. 5.6 and 6.4 mm, from 80mm up to 400 mm in length allows end user to customize the length of the rod.
4
Basis for substantial equivalent:
The Simple Locking IntraMedullary (SLM) System is claimed to be substantially equivalent in design, indicated use and function to the following devices:
Primary predicate:
-
0 The Simple Locking IntraMedullary (SLIM) System, K143355, Pega Medical Inc.
References: -
0 GAP Endo-Exo Medullary System, K160545, Pega Medical Inc.
-
0 Stainless Steel Elastic Intramedullary Nail System, K081452, Synthes (USA)
Summary of Technologies:
The technological characteristics of the Simple Locking IntraMedullary (SLIM) System are the same or similar to the predicate devices.
Non-clinical Performance Data:
No additional testing was considered necessary for the SLIM Blanks, pins or pegs.
- SLIM blanks have the identical diameters and material as previously cleared SLIM rods; . therefore, they will have the same mechanical resistance.
- o The added pins and pegs have the same or larger diameter and the same material than previously cleared pins, therefore they will have the same or higher mechanical resistance.
As per the findings of the bench testing and the performance of the data supports the use of this product as substantially equivalent to the predicate device; the anticipated benefits of such a system clearly outweigh the possible residual risks.
Additional testing was conducted for the addition of the Bullet screw to the system. In four-point static and fatigue testing, the Bullet screws were found equivalent for their intended uses. In comparison to the previously cleared locking pins, it was considered that the locking pegs perform equivalently than simple locking pin that is bent against the cortex rather than threaded into the cortex in terms of torsion, drive torque and axial pull-out.
A list of the tests carried for this application can be found below:
- Static four-point bending bench testing;
- Fatigue four-point bending bench testing;
- Pull-out & Push-out strength;
- Surgical technique validation on animal model;
5
- Evaluation of a Shaft to Bullet assembly and instrumentation: migration resistance of the ● assembly under static loading:
- o Evaluation of a Shaft to Bullet assembly and instrumentation: migration resistance of the assembly under cyclic loading (fatigue);
- Static four-point bending bench test of the Bullet;
- Fatigue four-point bending bench test of the Bullet;
- Surgical technique validation of the SLIM and Bullet; .
- . Comparative loading in physiological relevant setting of the SLIM and Bullet against predicate;
- . Functional testing of the cutting operation of the Intro-OP Implant Cutter (ICON) Prototype on a SLIM blank.
Clinical Performance Data:
No clinical testing is provided as a basis for substantial equivalence.
Conclusion:
Based on the similarities in the intended use, design, materials, manufacturing methods, and packaging, The Simple Locking IntraMedullary (SLIM) System has been established as substantially equivalent to the previously cleared predicate device. Furthermore, mechanical evaluation results demonstrate that the proposed SLIM System is substantially equivalent to the predicate devices.