(84 days)
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of tapered plates, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.
This looks like a 510(k) summary for a medical device (HTO Plating System), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance as would be seen for AI/ML devices. Therefore, much of the requested information (like effect size for MRMC studies, ground truth establishment, training set details) is not applicable or unavailable in this type of document.
However, I will extract what is available regarding performance and equivalence.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: Similar performance to previously cleared high tibial osteotomy systems with similar indications. | Met: Biomechanical testing of the subject device (HTO Maxi Plate and screws) found it to be similar in performance to previously cleared high tibial osteotomy systems with similar indications. Fatigue testing was performed to support this. |
2. Sample Size Used for the Test Set and Data Provenance:
This document describes a biomechanical test, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable. Ground truth, in the context of device performance for this type of submission, refers to the physical properties and mechanical behavior of the device itself, usually measured in a lab setting by engineers or technicians, not by medical experts establishing diagnostic ground truth from patient data.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this was a biomechanical test, not a clinical study with adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of clinical data, not for an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI/ML algorithm or diagnostic device.
7. The Type of Ground Truth Used:
For this type of device, the "ground truth" would be established through objective engineering measurements in a lab setting, such as:
- Material properties (e.g., tensile strength, yield strength, fatigue limit)
- Dimensional accuracy
- Biomechanical performance determined by standardized tests (e.g., fatigue testing, static loading)
The document specifically mentions "Fatigue testing" as the performance data.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that undergoes training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the Study:
The study referenced in the document is a biomechanical performance study, specifically fatigue testing, of the new HTO Maxi Plate. The purpose of this testing was to demonstrate that the new components (HTO Maxi Plate and screws) are substantially equivalent in performance to the predicate device and other legally marketed high tibial osteotomy systems. The document states that the testing "found [the device] to be similar in performance" to these predicates. This type of testing is standard for orthopedic implants to ensure mechanical integrity and durability.
Key takeaway: This 510(k) submission is for an orthopedic implant, where the focus is on mechanical and material performance to prove substantial equivalence, rather than a diagnostic AI/ML device where clinical efficacy and reader performance are assessed through complex clinical studies.
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| B. | 510(k) SUMMARY (as required by 21 CFR 807.92) | ||
|---|---|---|---|
| High Tibial Osteotomy (HTO) Plating SystemNovember 15, 2010 | NOV 2 4 •2010 | ||
| COMPANY: | Aesculap Implant Systems, LLC3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 | ||
| CONTACT: | Kathy A. Racosky(610) 984-9291 (phone)610-791-6882 (fax) | ||
| TRADE NAME: | HTO Plating System | ||
| COMMON NAME: | High Tibial Osteotomy (HTO) Plating System | ||
| CLASSIFICATION NAME: | Plate, Fixation, Bone (HRS)Screw, Fixation, bone (HWC) | ||
| REGULATION NUMBER: | 888.3030, 888.3040 |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the new HTO Maxi plate and screws are substantially equivalent to the existing plate and screws of the High Tibial Osteotomy (HTO) Plating System cleared under K080992.
DEVICE DESCRIPTION
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of tapered plates, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.
INDICATIONS FOR USE
There have been no changes to the Indications for Use. It remains as follows:
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
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PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the new HTO Maxi Plate and screws which are being added to the Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
The Aesculap Implant Systems HTO Plating 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 high tibial osteotomy systems with similar indications.
PERFORMANCE DATA
Fatigue testing of the Position HTO Maxi Plate was performed to support substantial equivalence.
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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 or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Aesculap Implant Systems, LLC % Ms. Kathy Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
NOV 2 4 2010
Re: K102505
Trade/Device Name: Aesculap Implant Systems High Tibial Osteotomy (HTTO) 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 Dated: November 15, 2010 Received: November 17, 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 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
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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.
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.htm1 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/ReportalProblem/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,
Sincerely yours,
Mark A. Milken
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.
NOV 2 4 2010
510(k) Number: K102505
Device Name: Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System
Indications for Use:
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
Prescription Use
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)
Spate for mxm
(Dwision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K.102505
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