(28 days)
The AxSOSTM Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
This Special 510(k) submission is a line extension to address modifications made to the AxSOSTM Locking Plate System which was cleared in K061012. This line extension is to add humeral long plates to the existing size range of the AxSOSTM Locking Plate System. These monoaxial long plates will be known as AxSOSTM Proximal Lateral Humerus TS (Threaded Shaft) Long Plates and will be available in 6 length sizes in left and right configurations.
The provided text describes a 510(k) submission for a medical device, the "AxSOS™ Locking Plate System," specifically focusing on a line extension called "AxSOS™ Proximal Lateral Humerus TS Long Plates." This document primarily addresses the substantial equivalence of the new device to a predicate device based on its design, materials, and intended use, supported by non-clinical mechanical testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found in a clinical trial or performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering design and mechanical testing. The performance is assessed against the predicate device, not against specific numerical clinical outcomes.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | "Fractures of the Proximal Humerus" - Equivalent to Predicate Device |
| Design Equivalence | "Monoaxial Plates" - Equivalent to Predicate Device |
| Material Equivalence | "Stainless Steel" - Equivalent to Predicate Device |
| Mechanical Strength (Static) | Testing performed to demonstrate equivalence to predicate device. (Specific values not provided, only that testing was performed and demonstrated equivalence). |
| Mechanical Strength (Fatigue) | Testing performed by evaluating median fatigue limits and dynamic stiffness to demonstrate equivalence to predicate device. (Specific values not provided, only that testing was performed and demonstrated equivalence). |
| Risk Analysis | Performed according to ISO 14971:2007. (Records retained in design history file). |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing (static strength and fatigue strength testing) of the device. It does not mention a "test set" in the context of patient data or clinical samples. Therefore, there is no information about the sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The testing would have involved physical samples of the plates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes non-clinical mechanical testing, not a clinical study involving experts establishing ground truth for patient outcomes.
4. Adjudication method for the test set
This information is not applicable as the document describes non-clinical mechanical testing.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this document pertains to a medical device's mechanical properties and equivalence, not an AI-assisted diagnostic tool or an evaluation of human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a bone plate system, not an algorithm or software device.
7. The type of ground truth used
The "ground truth" in this context is the mechanical performance (static and fatigue strength) of the predicate device, which the subject device aims to be equivalent to. The performance parameters were established through engineering mechanical testing methods.
8. The sample size for the training set
This information is not applicable as the document describes non-clinical mechanical testing of a bone plate, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned. The ground truth for comparison was the established mechanical performance of the predicate device, determined through standard engineering test methods.
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110476 # '।
| 510(k) Summary of Safety and EffectivenessAxSOS™ Locking Plate System | MAR 18 2011 | |
|---|---|---|
| Proprietary Name: | AxSOS™ Locking Plate System | |
| Common Name: | Bone plates | |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliances andaccessories, 21 CFR §888.3030 | |
| Regulatory Class: | Class II | |
| Product Codes: | 87 HRS: Plate, Fixation, Bone | |
| Predicate Devices: | AxSOS™ Locking Plate System | |
| For Information contact: | Estela Celi, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6461 Fax: (201) 831-6038estela.celi@stryker.com | |
| Date Prepared: | February 16th, 2011 |
Description
ﺰ
This Special 510(k) submission is a line extension to address modifications made to the AxSOSTM Locking Plate System which was cleared in K061012. This line extension is to add humeral long plates to the existing size range of the AxSOSTM Locking Plate System. These monoaxial long plates will be known as AxSOSTM Proximal Lateral Humerus TS (Threaded Shaft) Long Plates and will be available in 6 length sizes in left and right configurations.
Intended Use
The AxSOS™ Proximal Lateral Humerus TS Long Plates line extension does not alter the intended use of the predicate AxSOS™ Locking Plate System as cleared in K061012. The indications for use for the subject plates are provided below.
Indications
The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
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Substantial Equivalence:
The AxSOS™ Proximal Lateral Humerus TS Long Plates are substantially equivalent to the AxSOS™ Proximal Lateral Humerus TS Plates of the AxSOSTM Locking Plate System cleared under K061012 in regards to intended use, design, materials, and operational principles as a bone fixation device.
| AxSOS TM Locked Plating Comparison of Subject to Predicate | ||
|---|---|---|
| Subject DeviceAxSOSTM Proximal LateralHumerus TS Long Plates | Predicate DeviceAxSOSTM Proximal LateralHumerus TS Plates | |
| 510(k) | Pending | K061012 |
| Intended Use | Fractures of the Proximal Humerus | Fractures of the Proximal Humerus |
| Design | Monoaxial Plates | Monoaxial Plates |
| Material | Stainless Steel | Stainless Steel |
| Plate Sizes | 6 lengths/10-20 hole plates | 3 lengths/3-8 hole plates |
Summary of Non-Clinical Testing and Evaluation
Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Testing has been performed to demonstrate equivalence of the subject device to its predicate device. The testing included static strength testing using combined axial and torsional loading as well as fatigue strength testing by way of evaluating median fatigue limits and dynamic stiffness.
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Corp. % Howmedica Osteonics Corp. Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430
MAR 1 8 2011
Re: K110476
Trade/Device Name: AxSOS™ Locking Plate 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 Dated: February 16, 2011 Received: February 18, 2011
Dear Ms. Celi:
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
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Page 2 - Ms. Estela Celi
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A. B. A
for
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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APPENDIX E-1
Indication for Use Statement
Indications for Use
510(k) Number (if known): K110476
Device Name: AxSOS™ Proximal Lateral Humerus TS Long Plates
Indications for Use:
The AxSOSTM Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mulletron
(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices
510(k) Number
§ 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.