(56 days)
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
- Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
- Arthrodesis of the foot, wrist and elbow.
- Small and long bone osteotomies.
- Fracture fixation of small bones, small bone fragments and long bones.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
- Fixation of fractures in long bones and long bone fragments.
- Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
- Arthrodesis and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
- Slipped capital femoral epiphysis
- Pediatric femoral neck fractures
- Tibial plateau fractures
- SI joint disruptions
- Intercondylar femur fractures
- Subtalar arthrodesis
- Fixation of pelvis and iliosacral joint.
The Biomet Cannulated Screw System consists of bone screws, associated washers, which are manufactured from Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), and corresponding instruments are used to aid in the alignment and stabilization of fractures to the skeletal system.
Here's an analysis of the provided text regarding the Biomet Cannulated Screw System's acceptance criteria and study proving its efficacy:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by Predicate Devices) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Design similar to predicate devices | Similar design to predicate devices. |
| Dimensions similar to predicate devices | Similar dimensions to predicate devices. |
| Material identical/similar to predicate devices | Fabricated from Ti-6Al-4V alloy per ASTM F136 (a commonly used material in orthopedic implants and used in predicate devices K082874, K903810, K926047, K872859). |
| Meets mechanical standards (ASTM F543) | Performed torsional, axial pullout, and driving torque mechanical tests per ASTM F543. Results indicate substantial equivalence to legally marketed devices. |
| Safe and effective performance | No new issues of safety or efficacy have been raised. Results indicate the device will perform within the intended use. |
| MRI compatibility/justification | MRI justification performed. |
| Cadaver evaluation | Cadaver evaluation performed. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. The evidence for substantial equivalence is based on non-clinical performance testing (mechanical tests, cadaver evaluation, MRI justification) and comparison to predicate devices, rather than a clinical "test set" in the context of human data.
The data provenance is non-clinical (laboratory and cadaveric testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as there was no clinical "test set" in the traditional sense that required expert interpretation for ground truth. The evaluation focused on material properties, mechanical performance, and design equivalence to established predicate devices.
4. Adjudication Method for the Test Set
This is not applicable as there was no clinical "test set" requiring adjudication or multi-reader reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information: None provided as a basis for substantial equivalence." This indicates that no clinical studies, including MRMC studies, were performed to compare the performance of human readers with and without AI assistance for this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The device is a physical medical implant (a cannulated screw system), not an AI algorithm. Therefore, a standalone performance study for an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established through:
- Engineering specifications and standards: Adherence to ASTM F136 (material) and ASTM F543 (mechanical testing).
- Performance of predicate devices: The Biomet Cannulated Screw System's characteristics (design, dimensions, material) and performance were compared to those of legally marketed predicate devices, which implicitly serve as the "ground truth" for acceptable safety and effectiveness.
- Non-clinical testing results: Specifically, the outcomes of torsional, axial pullout, and driving torque mechanical tests, and MRI justification, demonstrated "substantial equivalence."
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device (cannulated screw system), there is no 'training set' in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above (not an AI/ML device).
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JUN 0 3 2014
Section 5 - 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitted by: | Biomet Manufacturing Corp. |
|---|---|
| 56 East Bell Drive | |
| PO Box 587 | |
| Warsaw, IN 46581 | |
| Phone: (574) 372-6801 | |
| Fax: 574.372.1683 |
Victoria Scheitlin, Regulatory Affairs Specialist Contact Person:
April 2, 2014 Date Prepared:
Biomet Cannulated Screw System Proprietary Name:
Common Name: Screw, Fixation, Bone
Smooth or threaded metallic bone fixation fastener. (21 CFR § Classification Name: 888.3040/HWC)
Predicate Devices: Biomet's Cannulated Screw System is substantially equivalent to currently marketed BioDrive Cannulated Screw System (K082874), DePuy/Ace 8.0mm Cannulated Cancellous Bone Screw (K926047), DePuy/Ace Cannulated Self Tapping Cancellous Bone Screw (K903810), Ace/DePuy Ace Cancellous Bone Screw (K872859), Synthes Sterile 4.5mm Cannulated Screws (K963172), Synthes Sterile 3.5mm and 4.0mm Cannulated Screws (K963192), Synthes 6.5mm Cannulated Screw (K021932), Synthes 7.3mm Cannulated Slipped Capital Femoral Epiphysis Screws (K092909).
Device Description: The Biomet Cannulated Screw System consists of bone screws, associated washers, which are manufactured from Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), and corresponding instruments are used to aid in the alignment and stabilization of fractures to the skeletal system.
{1}------------------------------------------------
Indications for Use:
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
-
Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
-
Arthrodesis of the foot, wrist and elbow.
-
Small and long bone osteotomies.
-
Fracture fixation of small bones, small bone fragments and long bones.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
-
- Fixation of fractures in long bones and long bone fragments.
-
- Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
- Arthrodesis- and fracture fixation of the foot and ankle, such as 3. Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
-
- Slipped capital femoral epiphysis
-
- Pediatric femoral neck fractures
- Tibial plateau fractures 3.
-
- SI joint disruptions
-
- Intercondylar femur fractures
- Subtalar arthrodesis 6.
-
- Fixation of pelvis and iliosacral joint.
The technological characteristics of the Biomet Cannulated Screw System are similar to the predicate devices including design, dimensions, and material. The Biomet Cannulated Screw System screws and washers are fabricated from Ti-6Al-4V alloy per ASTM F136. Ti-6Al-4V alloy is a commonly used material in orthopedic implants, and is a material that was used in predicate devices cleared in K082874, K903810, K926047, and K872859.
The Biomet Cannulated Screw System is substantially equivalent to currently marketed devices. No new issues of safety or efficacy have been raised.
Non-clinical performance testing included cadaver evaluation and MRI justification. Mechanical tests per ASTM F543 that were performed to determine substantial equivalence of the Biomet Cannulated Screws including torsional, axial pullout and driving torque. Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
Technological Characteristics:
Summary of Substantial Equivalence:
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence:
{2}------------------------------------------------
. . . . . . . .
:
.
| Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information: | None provided as a basis for substantial equivalence. |
|---|---|
| Conclusions Drawn From Non-Clinical And Clinical Data | The Biomet Cannulated Screw System has been shown to be substantially equivalent to the predicate devices. Results of preclinical tests/engineering justification and the similarities with legal marketed predicated devices indicate the device will perform within the intended use and no new issues of safety or effectiveness have been raised. |
.
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2014
Biomet Manufacturing Corporation Ms. Victoria Scheitlin Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K140891
Trade/Device Name: Biomet Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 15, 2014 Received: April 16, 2014
Dear Ms. Scheitlin:
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 advisers good a mease 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 or any I edolar statution and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cr K r art 607), adoning (21 OFF 803); good manufacturing practice requirements as set Gevice-related adverse overlis) (2) CFR Part 820); and if applicable, the electronic forth in the quality of the (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Ms. Victoria Scheitlin
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" (21 CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -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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Section 4 - Indications for Use Statement
510(k) Number:
Device Name:
Biomet Cannulated Screw System
Indications For Use:
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
-
- Fixation of small bones, Including those in the foot, patella, ankle, wrist and elbow.
-
- Arthrodesis of the foot, wrist and elbow.
- Small and long_bone osteotomies. 3.
- Fracture fixation of small bones, small bone fragments and long bones. 4.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
- Fixation of fractures in long bones and long bone fragments. 1.
- Long bone osteotomies (femur, tibia, foot, ankle, olecranon). 2.
- Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth ന് metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
-
- Slipped capital femoral epiphysis
- Pediatric femoral neck fractures 2.
- Tibial plateau fractures 3.
- SI joint disruptions 4.
- Intercondylar femur fractures ડ.
- Subtalar arthrodesis દ.
- Fixation of pelvis and iliosacral joint. 7.
× AND/OR Over-the-Counter_ Prescription Use_ (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D}
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth D. Frank -S
Division of Orthopedic Devices
Biomet Cannulated Screw System Traditional 510(k)
§ 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.