(414 days)
MINIARS screw system is intended for fixation of intra-articular fractures, non-union and osteotomies of small bones and small bone fragments. Some examples include:
- arthrodesis of small joints (foot and hand surgery);
- intra-articular metatarsal and metacarpal fractures;
- osteotomies for hallux valgus treatment.
MINIARS screw system is intended for fixation of intra-articular and extra-articular fractures, non-union and osteotomies of small bones and small bone fragments. MINIARS screws are implants that will be in contact with body tissues for more than 30 days. Instrumentation used to assist in their implantation will be in temporary contact (inferior to 24 hours) with body tissues. The MINIARS screws are intended for single use only. The implant is a solid, one piece, cannulated and partially thread shaped design. MINIARS screws are available in two different external thread diameters: 2.2 mm e 2.6 mm. MINIARS screws are available in a range of lengths from 10mm to 30mm. All the screws sizes available are described in table 5.1. The screws are partially threaded: the proximal and distal parts are threaded while the middle part is cylindrical, as visible in figure 5.1. The thread shape has been designed to facilitate the compression of the bone fragments and the hold in cancellous bone thanks to the particular profile design: the wide thread pitch of the distal part penetrates in bone tissue faster than the thread of the proximal part, reducing and compressing the fracture through screw advance. Distal thread presents self-drilled and self-tapping grooves. The screws present a hexagonal torx 6 head which is conforming to ISO 10664 standard. All the MINIARS screws are supplied in a sterile state (beta rays); the single screw is packed into a double blister which allows the usage in surgery. The MINIARS Screws are made of Titanium Alloy (Ti6A14V ELI gr. 5) and is available in the range of sizes reported in the table below.
The provided document is a 510(k) premarket notification for the MINIARS Screws, a medical device for bone fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against predefined acceptance criteria for AI/diagnostic devices. Therefore, much of the requested information regarding AI/diagnostic device studies (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's physical and mechanical performance tests that were conducted to support its substantial equivalence.
Here's the breakdown of the information that can be extracted, and where applicable, a note indicating that the information is not provided or not applicable for this type of device submission:
1. A table of acceptance criteria and the reported device performance
The document states that "The results demonstrated that the performance of the subject device is substantially equivalent to the predicate devices." Implied acceptance criteria are that the performance of MINIARS screws must be comparable to the predicate devices in the specific tests conducted. The document does not provide specific numerical acceptance thresholds or detailed performance metrics from the predicate devices for direct comparison in a table.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to predicate devices for torsional load. | FEA analysis studied the maximum stress under a 300Ncm torsional load. |
| Performance comparable to predicate devices for pullout strength. | Pullout test measured the strength to extract a fully inserted screw. |
| Performance comparable to predicate devices for maximum torque. | Maximum screw torque test measured the maximum bearable torque before failure. |
| Performance comparable to predicate devices for bending strength. | Bending test measured the yield moment after a 2.5 mm displacement. |
| Dimensional comparability to other 510(k) cannulated screws. | Dimensional comparison was conducted. |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document as these are mechanical tests, not clinical studies in the typical sense for AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable for mechanical performance testing of a bone screw. Ground truth in this context would be physical measurements and engineering analyses, not expert medical opinion.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for mechanical performance testing of a bone screw.
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
This information is not applicable as this is not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be the established engineering and material science principles, physical measurements obtained from the tests (e.g., stress values, force measurements, torque values, displacement), and comparison against the known properties or performance of predicate devices. There is no expert consensus, pathology, or outcomes data used for these specific tests outlined.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI model requiring a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
Overmed S.r.l. Davide Pizzamiglio Legal Representative Via Lucania 23 Buccinasco Milan, 20090 ITALY
Re: K143596
Trade/Device Name: MINIARS Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 3, 2015 Received: December 24, 2015
Dear Mr. Pizzamiglio:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K143596
Device Name
MINIARS Screws
Indications for Use (Describe)
MINIARS screw system is intended for fixation of intra-articular fractures, non-union and osteotomies of small bones and small bone fragments. Some examples include:
-
arthrodesis of small joints (foot and hand surgery);
-
intra-articular metatarsal and metacarpal fractures;
-
osteotomies for hallux valgus treatment.
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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| Name of Submitter | Overmed S.r.l.Via Lucania 2320090 Buccinasco (MI)Italy |
|---|---|
| Name of Manufacurer | Overmed S.r.l.Via Lucania 2320090 Buccinasco (MI)Italy |
| Primary Contact Person | Ms. Rossella BalossinoQuality Assurance Responsiblebalossino@overmed.euPhone number: +39 02 45712909Mobile Phone number +39 334 6294462 |
| Secondary Contact Person | Mr. Davide PizzamiglioLegal representatived.pizzamiglio@overmed.euPhone number: +39 02 45712515Mobile Phone number : +39 3399178803 |
| Trade Name | MINIARS Screws |
| Device Common name | MINIARS Screws |
| Device Classification | Class II |
| Review Panel | Orthopedic |
| Product Code | HWC |
| CFR Section | 21CFR888.3040"Smooth or threaded metallic bone fixation fastener" |
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K143596
5.1 Identification of Predicate Devices:
| Predicate Device | 510(k) Number | Product Code |
|---|---|---|
| SBI AutoFix™ System | K052576 | HWC |
| Synthes 3.0 mm HeadlessCompression Screws | K050636 | HWC |
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5.2 Description:
The following is a brief description of the Overmed MINIARS Screws.
MINIARS screw system is intended for fixation of intra-articular and extra-articular fractures, non-union and osteotomies of small bones and small bone fragments.
MINIARS screws are implants that will be in contact with body tissues for more than 30 days. Instrumentation used to assist in their implantation will be in temporary contact (inferior to 24 hours) with body tissues.
The MINIARS screws are intended for single use only.
The implant is a solid, one piece, cannulated and partially thread shaped design.
MINIARS screws are available in two different external thread diameters: 2.2 mm e 2.6 mm.
MINIARS screws are available in a range of lengths from 10mm to 30mm.
All the screws sizes available are described in table 5.1.
The screws are partially threaded: the proximal and distal parts are threaded while the middle part is cylindrical, as visible in figure 5.1.
The thread shape has been designed to facilitate the compression of the bone fragments and the hold in cancellous bone thanks to the particular profile design: the wide thread pitch of the distal part penetrates in bone tissue faster than the thread of the proximal part, reducing and compressing the fracture through screw advance.
Distal thread presents self-drilled and self-tapping grooves.
Image /page/4/Picture/12 description: The image shows a long, silver-colored medical screw. The screw has threads on both ends and a smooth, cylindrical shaft in the middle. The threads appear to be designed for bone fixation, and the screw is likely used in orthopedic surgery to stabilize bone fractures or joints.
Fig. 5.1 MINIARS Screw
The screws present a hexagonal torx 6 head which is conforming to ISO 10664 standard.
All the MINIARS screws are supplied in a sterile state (beta rays); the single screw is packed into a double blister which allows the usage in surgery.
The MINIARS Screws are made of Titanium Alloy (Ti6A14V ELI gr. 5) and is available in the range of sizes reported in the table below.
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| MINIARS Screw Diameter | Code (STERILE) | Length [mm] |
|---|---|---|
| Ø2.2 | A0502210 | 10 |
| A0502212 | 12 | |
| A0502214 | 14 | |
| A0502216 | 16 | |
| A0502218 | 18 | |
| A0502220 | 20 | |
| A0502222 | 22 | |
| A0502224 | 24 | |
| A0502226 | 26 | |
| A0502228 | 28 | |
| A0502230 | 30 | |
| Ø2.6 | A0502610 | 10 |
| A0502612 | 12 | |
| A0502614 | 14 | |
| A0502616 | 16 | |
| A0502618 | 18 | |
| A0502620 | 20 | |
| A0502622 | 22 | |
| A0502624 | 24 | |
| A0502626 | 26 | |
| A0502628 | 28 | |
| A0502630 | 30 |
Table 5.1 MINIARS Screw sizes
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5.3 Indications for Use:
MINIARS screw system is intended for fixation of intra-articular and extra-articular fractures, non-union and osteotomies of small bones and small bone fragments. Some examples include:
- arthrodesis of small joints (foot and hand surgery);
- intra-articular metatarsal and metacarpal fractures;
- osteotomies for hallux valgus treatment.
5.4 Performance Testing:
To support the performance characteristics of MINIARS screws we conducted the following tests:
- FEA analysis, to study the maximum stress in the subject screw under a 300Ncm torsional load;
- Pullout test, to measure the strength to be employed in order to extract a screw . totally inserted into the bone;
- Maximum screw torque test, to measure the maximum torque bearable before the ● screw failure;
- Bending test, to measure the vield moment reached after a 2.5 mm displacement. ●
- . Dimensional comparison with other 510(k) cannulated screws
The results demonstrated that the performance of the subject device is substantially equivalent to the predicate devices.
5.5 Substantial equivalence:
Documentation is provided which demonstrates the Overmed MINIARS Screws to be substantially equivalent to other legally marketed devices. All the devices are "Smooth or threaded metallic bone fixation fastener" as defined in 21 CFR 888.3040, furthermore, the size, shape and materials for the subject devices are comparable to the predicate devices.
5.6 Conclusion:
Based upon the similarities in design, materials, performance testing and intended uses, the Overmed MINIARS Screw is substantially equivalent to the predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.