(168 days)
The Comprehensive® Proximal Humeral Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus.
The Comprehensive® Proximal Humeral Plating System is comprised of anatomic plates in seven lengths and non-locking, locking and variable angle screws in multiple lengths. Plate sizing and contouring was developed through the use of Biomet's IntelliFIT Technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate sizing. (Note, the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates.)
The provided information indicates that the device is a Comprehensive® Proximal Humeral Plating System, a bone fixation device. The study performed is non-clinical, and primarily relies on engineering analysis to demonstrate substantial equivalence to predicate devices, rather than a clinical trial involving patient data or human reader evaluation. Therefore, many of the typical questions regarding clinical studies, human readers, and ground truth establishment are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance |
|---|---|---|
| Plate Strength | Equivalent to predicate | Equivalent to predicate |
| Plate Strength (Comparative) | Meet or exceed predicate | Met (vs. K062494) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of non-clinical engineering analysis. The "test set" would consist of the physical devices undergoing mechanical testing or computational models for engineering analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for mechanical properties in this context would be established through engineering principles, mechanical testing, and comparison to established predicate devices, rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data, which was not performed here.
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
No MRMC study was done, as this is a bone fixation system and not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The ground truth used for determining equivalence for "Plate Strength" was an engineering analysis and comparison to the performance of predicate devices (K062494, K082625). This likely involved mechanical testing of the physical properties and structural integrity of the plates and screws.
8. The Sample Size for the Training Set
Not applicable. There is no training set in the context of this device and study type. The "IntelliFIT Technology" mentioned for plate sizing used "contour analysis to map patterns in complex bone on cadaveric specimens", which could be considered a form of data used in the design process, but not a "training set" for an AI algorithm in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there was no training set. The "IntelliFIT Technology" used "contour analysis to map patterns in complex bone on cadaveric specimens" to determine pre-defined plate sizes. The "ground truth" for this design process would be anatomical data derived from cadaveric specimens.
Additional Information from the Document:
- Study Type: Non-clinical tests (Engineering Analysis)
- Clinical Studies: None were conducted.
- MR Environment: Studies performed on 316L Stainless Steel Plating Systems per ASTM F138 determined them to be MR Conditional according to ASTM F2503-08.
- Conclusion: "No mechanical or clinical testing was necessary for a determination of substantial equivalence. The results of engineering analysis indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices."
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<110320
Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is displayed in a stylized, blocky font above the words "MANUFACTURING CORP." The text is black and the background is white. The logo appears to be a scan or photocopy, as the edges of the letters are slightly pixelated.
JUL 2 1 2011
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell DriveWarsaw, IN 46581-0857 |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| EstablishmentRegistration Number | 1825034 |
| Name of contact person | Patricia Sandborn BeresSenior Regulatory Specialist |
| Date prepared | January 26, 2011 |
| Name of device | |
| Trade or proprietaryname | Comprehensive® Proximal Humeral Plating System |
| Common or usualname | plate, fixation, bone screw, fixation, bone |
| Classification name | Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3030 21 CFR 888.3040 |
| Product Code(s) | HRS HWC |
| Legally marketed device(s)to which equivalence isclaimed | K062494 - EBI OptiLock® Upper Extremity Plating SystemK082625 - Synthes (USA) 3.5mm LCP Periarticular Proximal Humeral Plates |
| Reason for 510(k)submission | New device |
| Device description | The Comprehensive® Proximal Humeral Plating System iscomprised of anatomic plates in seven lengths and non-locking,locking and variable angle screws in multiple lengths. Platesizing and contouring was developed through the use ofBiomet's IntelliFIT Technology which uses contour analysis tomap patterns in complex bone on cadaveric specimens todetermine plate sizing. (Note, the software was used todetermine a set of pre-defined plate sizes and is not used tocreate individual, patient matched plates.) |
| Intended use of the device | Bone fixation |
Malling Address:
P.O. Box 5811681
P.Oresaw, M.G.G.G.G.G.G.G.G.G.G.C.C.C.
Translaw, B000.3 AM.C.S.A.G.C.C.C.
Collice: Sp. 2007.37 A.C.T.C.T.C.
Main Fax: 574.767.8137 ww.blomet.com
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
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K 110320
510(k) Summary
Comprehensive® Proximal Humeral Plating System Page 2 of 2
く
:
| Indications for use | The Comprehensive® Proximal Humeral Plating System isindicated for fractures, fracture dislocations, osteotomies andnon-unions of the proximal humerus. | ||
|---|---|---|---|
| Summary of the technological characteristics of the device compared to the predicate | |||
| Characteristic | New Device | Predicate Device* | |
| Plate Design | Anatomic, precontoured | K062494, K082625 | |
| Plate Material | Stainless SteelASTM F138 & ASTM F139 | K062494, K082625 | |
| Plate Dimensions | Length: 75-255mmThickness: 3-4mm | K062494, K082625 | |
| Screw Design | Non-Locking, Locking and Variable Angle | K062494, K082625 | |
| Screw Material | Stainless SteelASTM F138, ASTM F139, ASTM F-2229 | K062494, K082625 | |
| Screw Dimensions | Diameter: 3.5mmLength: 10-40mm or 10-60mm | K062494, K082625 | |
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | |||
| Performance Test Summary-New Device | |||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| Plate Strength | Engineering Analysis | Equivalent to predicate | |
| Comparative Performance Information Summary | |||
| Characteristic | Requirement | New Device | Predicate Device* |
| Plate Strength | Meet or exceedpredicate | Meet | K062494 |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||
| Clinical Performance Data/Information: None | |||
| MAGNETIC RESONANCE (MR) ENVIROMENT | |||
| Biomet® has performed non-clinical Magnetic Resonance Imaging (MRI) studies on PlatingSystems manufactured of 316L Stainless Steel per ASTM F138. These Plating Systems aredetermined to be MR Conditional in accordance to ASTM F2503-08 Standard Practice forMarking Devices and Other Items for Safety in the Magnetic Resonance Environment. MRConditional refers to an item that has been demonstrated to pose no known hazards in aspecified MR environment with specified conditions of use. | |||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |||
| No mechanical or clinical testing was necessary for a determination of substantial equivalence. Theresults of engineering analysis indicated the devices performed within the intended use, did notraise any new safety and efficacy issues and were found to be substantially equivalent to thepredicate devices.*Any statement made in conjunction with this submission regarding and/or a determination of substantial equivalence to any other | |||
| product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or redassification and is |
not intended to be Interpreted as an admission or any other type of evident infingenent litigation. [Establishment
Registration and Premarket Notification Procedures, Final R
p. 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract design of an object with three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Ms. Patricia Beres Senior Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
JUL 2 1 2011
Re: K110320
Trade/Device Name: Comprehensive Proximal Humeral Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 27, 2011 Received: June 28, 2011
Dear Ms. Beres:
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.
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Page 2 - Ms. Patricia Beres
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerso 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):_ k 1) ωろ乙ム
Device Name: Comprehensive® Proximal Humeral Plating System
Indications For Use: The Comprehensive® Proximal Humeral Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus.
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)
for M. Melkerm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110320
§ 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.