(80 days)
The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.
Specifically:
- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
- Ligament reconstruction
- Osteochondritis dissecans
- Arthrodesis of the foot, ankle, wrist, elbow and hand
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal . osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
The Biomet BioDrive Micro Screw System consists of screws, a micro nail plate and ancillary instruments intended for surgery to aid in alignment and stabilization of fractures of small bones such as those in the foot, elbow, ankle, and hand.
The provided document is a 510(k) Premarket Notification for the Biomet BioDrive Micro Screw System. This type of notification is for medical devices that are substantially equivalent to a legally marketed predicate device, and it does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or AI-specific metrics like those requested.
The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications, technological characteristics (material, design, sizing), and principles of operation. It explicitly states: "The technological characteristics (material, design, and sizing) of the implants and instruments comprising the BioDrive Micro Screw System are the same as or similar to the predicate devices."
Therefore, most of the requested information regarding acceptance criteria, specific device performance studies, and AI-related metrics cannot be found in this document.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not describe specific performance criteria or a study with measured performance outcomes against those criteria. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, not on de novo performance testing against acceptance criteria in the way a novel AI device might.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not available. No clinical test set or data provenance is detailed in this 510(k) summary. Performance is inferred through equivalence to existing predicate devices, which would have undergone their own testing in the past.
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)
- Not applicable/Not available. As there is no specified test set described for this 510(k), there is no mention of experts establishing ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. Similar to above, this information is not relevant to the content of this 510(k) document, which does not describe a performance study with a test set requiring adjudication.
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
- Not applicable/Not available. This device is a bone screw system, not an AI image analysis or diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available. This device is a physical medical implant (screws and plates), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available. No ground truth is described as part of this 510(k) submission for performance evaluation, as it relies on substantial equivalence.
8. The sample size for the training set
- Not applicable/Not available. This device is not an AI/ML model, so there is no concept of a training set.
9. How the ground truth for the training set was established
- Not applicable/Not available. This device is not an AI/ML model, so there is no concept of a training set or its ground truth establishment.
In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical medical device, not a performance study for an AI/ML medical device. Therefore, the specific details requested regarding detailed performance evaluations, test sets, expert annotations, and AI-related metrics are not present.
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Biomet Trauma Traditional 510(k) Premarket Notification
Image /page/0/Figure/1 description: The image shows the logo for Biomet Trauma. The word "BIOMET" is in large, bold, sans-serif font. Below that, the word "TRAUMA" is in a smaller, sans-serif font. The logo is in black and white.
092670
NOV 1 9 2009
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93.
Submitter:
EBI LLC d/b/a Biomet Trauma 100 Interpace Parkway Parsippany, NJ 07054
Establishment Registration 2242816 Number:
Contact:
Shikha Gola Regulatory Affairs Specialist Biomet Trauma 100 Interpace Parkway Parsippany, NJ 07054 Tel .: 973-299-9300, ext. 2070 Fax: 973-257-0232 E-mail: shikha.gola@biomet.com
Contract Manufacturer/Sterilizer: Biotech International 305. Allees de Craponne 13300 Salon de Provence, France Tel: (33)4 90 44 60 60 Fax: (33)4 90 44 60 61
Date Prepared:
BioDrive Micro Screw System Trade/Proprietary Name:
Common/Usual Name:
Classification Name:
Plate, Fixation, Bone. 888.3030 Screw, Fixation, Bone 888.3040
Bone screw, Bone plate
November 17, 2009
Orthopedics HRS and HWC Device Panel/Product Code:
Page 52
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Biomet Trauma Traditional 510(k) Premarket Notification
Device Description:
The Biomet BioDrive Micro Screw System consists of screws, a micro nail plate and ancillary instruments intended for surgery to aid in alignment and stabilization of fractures of small bones such as those in the foot, elbow, ankle, and hand.
Indications for Use:
The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.
Specifically:
- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
- Ligament reconstruction �
- Osteochondritis dissecans .
- Arthrodesis of the foot, ankle, wrist, elbow and hand �
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal . osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Summary of Technology:
The technological characteristics (material, design, and sizing) of the implants and instruments comprising the BioDrive Micro Screw System are the same as or similar to the predicate devices.
Substantial Equivalence:
The Biomet BioDrive bone screw system is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safectiveness. Examples of predicates include the Omnitech System distributed by TriMed Inc (K050681), the Sclf Countersinking Bone Screw distributed by Biomet (K013534) and the DynaFix Compression Bone Screw distributed by Biomet Trauma (K030706).
Page. 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
EBI LLC D/B/A Biomet Trauma % Ms. Shikha Gola 100 Interpace Parkway Parsippany, New Jersey 07054
NOV 1 9 2009
Re: K092670
Trade/Device Name: BioDrive Micro Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 28, 2009
Received: August 31, 2009
Dear Ms. Gola:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Shikha Gola
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
en
Sincerely yours,
Oneta 3
Mark N. Miller
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: BioDrive Micro Screw System
The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.
Specifically:
- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
- Ligament reconstruction 아
- Osteochondritis dissecans 0
- Arthrodesis of the foot, ankle, wrist, elbow and hand 0
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal 0 osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Prescription Use X . (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonita for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092670
P2
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.