(152 days)
The Aesculap Implant Systems Targon FN System is intended to be used for splinting, stabilization and fixation of the proximal femur.
The Aescular Implant Systems Targon FN System consists of a single tapered plate and screws (cancellous and bicortical design) in various sizes. The plate in this system accepts 6.5 mm cancellous screws proximally and 4.5 mm bicortical screw distally. The Aesculab Implant Systems Targon FN System is manufactured from Titanium Allov and will be provided sterile.
This document describes a 510(k) premarket notification for the Targon FN System, an internal fracture fixation device. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and a study proving those criteria are met for the Targon FN System itself in a clinical performance context.
Therefore, many of the requested details, such as specific acceptance criteria for a clinical study, reported device performance against those criteria, sample sizes for test sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, are not present in the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria for clinical performance or report specific device performance results against such criteria. The "Performance Data" section broadly states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It also states, "Biomechanical testing of the subject device was found to be similar in performance to previously cleared proximal femoral fixation systems with similar indications." This implies that the acceptance criteria are based on equivalence to the predicate device's biomechanical performance, but no specific metrics or thresholds are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance | "Biomechanical testing of the subject device was found to be similar in performance to previously cleared proximal femoral fixation systems with similar indications." |
| Likely based on performance equivalent to predicate device (Synthes Titanium Limited Contact Dynamic Hip Screw Plate [TILC-DHS] (K953607)) in biomechanical tests. | No specific quantitative results provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document refers to "biomechanical testing" rather than clinical test sets with patient data. No sample sizes, data provenance, or study design (retrospective/prospective) are mentioned.
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. This device underwent biomechanical testing for substantial equivalence, not clinical evaluation with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set with expert adjudication is described.
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. This is not an AI/imaging device. The notification is for an internal fracture fixation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable to the presented information, as the performance data cited is biomechanical testing demonstrating similarity to a predicate device, not clinical ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is a physical medical device, not an AI or data-driven software product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Tarqon FN Svstem July 15, 2010
DEC 21 2010
COMPANY: Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Vallev, PA 18034 Establishment Registration Number: 2916714
- CONTACT: Kathy A. Racosky (610) 984-9291 (phone) 610-791-6882 (fax)
TRADE NAME: Targon FN System
COMMON NAME: Internal fracture fixation device
- CLASSIFICATION NAME: Device, Fixation, Proximal Femoral, Implant (JDO)
REGULATION NUMBER: 888.3030
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC, believes that the Targon FN System is substantially equivalent to the Synthes Titanium Limited Contact Dynamic Hip Screw Plate ITILC-DHS] (K953607).
DEVICE DESCRIPTION
The Aescular Implant Systems Targon FN System consists of a single tapered plate and screws (cancellous and bicortical design) in various sizes. The plate in this system accepts 6.5 mm cancellous screws proximally and 4.5 mm bicortical screw distally. The Aesculab Implant Systems Targon FN System is manufactured from Titanium Allov and will be provided sterile.
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the Aesculap Implant Systems Targon FN System.
INDICATIONS FOR USE
The Aesculap Implant Systems Targon FN System is intended to be used for splinting, stabilization and fixation of the proximal femur.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Implant Systems Targon FN System is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared proximal femoral fixation systems with similar indications.
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PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems, LLC c/o Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
DEC 2 1 2010
Re: K102057
Trade/Device Name: Targon FN System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: December 14, 2010 Received: December 16, 2010
Dear Ms. Racosky:
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 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
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. Page 2 -- Ms. Kathy A. Racosky
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
A. B. R.t.
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 STATEMENT A.
DEC 21 2010
K102057 510(k) Number:
Device Name: Aesculap Implant Systems Targon FN System
Indications for Use:
The Aesculap Implant Systems Targon FN System is intended to be used for splinting, stabilization and fixation of the proximal femur.
| Prescription Use | X | and/or Over-the-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 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. Mckerson
mopedic, and Restorativ
510(k) Number K102057
§ 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.