(77 days)
The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
The Biomet Variable Locking Plate System is an internal fixation system comprised of Ti-6Al-4V and consisting of various-sized plates and screws.
The provided 510(k) summary for the Biomet Variable Locking Plate System (K071325) indicates that no clinical testing was performed to establish substantial equivalence. Instead, the device's substantial equivalence was based on non-clinical engineering analyses comparing it to predicate devices. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and human reader performance is not applicable to this submission.
The summary specifically states:
- "Non-Clinical Testing: Engineering analyses comparing the Biomet Variable Locking Plate System to a predicate device were conducted to determine substantial equivalence. The results indicated that the Biomet Variable Locking Plate System was functional within its intended use."
- "Clinical Testing: None provided as a basis for substantial equivalence."
This means the device's performance was evaluated through engineering tests, not clinical studies involving human or even animal subjects to assess clinical efficacy or safety against specific performance metrics for diagnosis or treatment.
Therefore, for each of your requested points, the answer is "Not Applicable" or "None".
- A table of acceptance criteria and the reported device performance: Not Applicable (no clinical study with performance metrics).
- Sample sized used for the test set and the data provenance: Not Applicable (no clinical test set).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (no clinical test set requiring expert ground truth).
- Adjudication method for the test set: Not Applicable (no clinical test set).
- 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 (no MRMC study; this is a medical device, not an AI/imaging diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable (this is a medical device, not an AI/algorithm-based diagnostic tool).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Applicable (no clinical study with ground truth).
- The sample size for the training set: Not Applicable (no training set as this is not an AI/machine learning device).
- How the ground truth for the training set was established: Not Applicable (no training set).
{0}------------------------------------------------
JUL 26 2007
510(k) Summary
| Preparation Date: | July 10, 2007 |
|---|---|
| Applicant/Sponsor: | Biomet Trauma (formerly known as EBI Trauma)100 Interpace ParkwayParsippany, NJ 07054 |
| Contact Person: | Debra L. BingDirector, Requlatory AffairsBiomet Trauma973.299.9300 |
| Proprietary Name: | Biomet Variable Locking Plate System |
| Common Name: | Metallic bone plates and screws |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories,21 CFR $888.3030 |
| Product Code(s): | HRS, HWC |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| EBI Anterior Cervical Plate System (Cyprus) | K060379 | EBI, L.P. |
|---|---|---|
| IQL Stainless Steel Bone Plates and Screws | K020221 | Biomet Orthopedics, Inc |
Device Description: The Biomet Variable Locking Plate System is an internal fixation system comprised of Ti-6Al-4V and consisting of various-sized plates and screws.
Indications for Use: The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fraction and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
Summary of Technologies: The technological characteristics of the Biomet Variable Locking Plate System are the same as, or similar to, the predicate devices.
Non-Clinical Testing: Engineering analyses comparing the Biomet Variable Locking Plate System to a predicate device were conducted to determine substantial equivalence. The results indicated that the Biomet Variable Locking Plate System was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. unless otherwise noted.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2007
Biomet Trauma % Ms. Susan Alexander Senior Regulatory Specialist P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K071325
Trade/Device Name: Biomet Variable Locking Plate 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: May 9, 2007 Received: May 10, 2007
Dear Ms. Alexander:
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 such 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); good manufacturing practice requirements as set
{2}------------------------------------------------
Page 2 - Ms. Susan Alexander
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Harbare Muchimp
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
5:10(k) Number (if known): K07 | 325
Device Name: Biomet Variable Locking Plate System
Indications For Use:
The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aarbai bonem
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K021324
Page 1 of 1
§ 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.