(105 days)
The APTUS® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.
The APTUS® 2.0 Radial Head System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones.
This is a 510(k) premarket notification for a medical device called the "APTUS® 2.0 Radial Head System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel device performance against acceptance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, and performance metrics (like sensitivity, specificity, or reader improvement with AI) is not explicitly present in a standard 510(k) summary for a device like a bone fixation system.
However, I can extract and infer some contextual information based on the provided text, particularly concerning the device's equivalence to predicate devices, which serves as a proxy for "meeting acceptance criteria" in the context of a 510(k).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a bone fixation system, the "acceptance criteria" revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices. The performance is assessed by comparing key attributes of the new device to those of the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate) | Reported Device Performance (APTUS® 2.0 Radial Head System) |
|---|---|
| Same Intended Use | The APTUS® 2.0 Radial Head System has the same intended use as the predicate devices: for use in proximal radial fractures and osteotomies. |
| Same Operating Principle | The APTUS® 2.0 Radial Head System uses the same operating principle as the predicate devices: internal fixation of small bones using plates and screws. |
| Same Basic Design | The APTUS® 2.0 Radial Head System incorporates the same basic design as the predicate devices: small titanium fixation plates, conventional screws, and locking screws. |
| Same Materials | The APTUS® 2.0 Radial Head System incorporates the same materials as the predicate devices: titanium for plates and screws. |
| Similar Packaging and Sterilization | The APTUS® 2.0 Radial Head System has similar packaging and is sterilized using the same materials and processes as the predicate devices. |
| Safety and Efficacy (implied by substantial equivalence) | The FDA's substantial equivalence determination implies that the device is as safe and effective as the predicate devices. The K090053 letter confirms this determination, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission for this type of device. There isn't a "test set" of patients or images used to evaluate its diagnostic or predictive performance in the way described for AI/software devices. The evaluation is primarily based on a comparison of device characteristics.
- Data Provenance: Not applicable. The "data" here refers to the specifications and materials of the device and the predicate device, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" established by experts for a test set in a 510(k) for a bone fixation system. The assessment is a regulatory review comparing the physical and functional aspects of the device to predicates.
4. Adjudication method for the test set:
- Not applicable. No test set requiring adjudication in this context.
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. This is a physical orthopedic implant (plate, screws), not an AI/software device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical orthopedic implant, not an algorithm or software.
7. The type of ground truth used:
- Not applicable in the typical sense of clinical ground truth (e.g., pathology, outcomes). The "ground truth" for a 510(k) in this context is the established safety and effectiveness of the predicate devices to which the new device is compared. The FDA has already determined these predicate devices to be safe and effective.
8. The sample size for the training set:
- Not applicable. No "training set" is used for a bone fixation system in a 510(k) submission.
9. How the ground truth for the training set was established:
- Not applicable. No "training set" or corresponding ground truth establishment in this context.
In summary:
The provided document is a 510(k) summary for a physical medical device (bone fixation system). The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to already approved predicate devices across several key characteristics (intended use, operating principle, design, materials, manufacturing processes). This type of submission relies on comparing the device's specifications and characteristics to those of legally marketed devices, rather than conducting new clinical performance studies that define specific acceptance thresholds for metrics like sensitivity or specificity.
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510(k) Summary
KO4005 3 2
APTUS® 2.0 Radial Head System
510(k) Summary
APR 2 3 2009
Medartis AG APTUS® 2.0 Radial Head System
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Medartis AGAustrasse 24CH-4051 Basel, SwitzerlandTelephone: +41 (0) 61 228 18 18Fax: +41 (0) 61 228 18 00 . |
|---|---|
| Official Contact: | Rosina CifelliRegulatory Affairs Manager, Medartis AG |
| Representative/Consultant: | Kevin A. Thomas, PhDFloyd G. Larson· PaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236email: kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | APTUS® 2.0 Radial Head System |
|---|---|
| Common Name: | Plate, fixation, bone |
| Classification Regulations: | Single/multiple component metallic bone fixation appliancesand accessories21 CFR 888.3030Class II |
| Product Code: | HRS |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INTENDED USE
The APTUS® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.
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510(k) Summary
DEVICE DESCRIPTION
The APTUS® 2.0 Radial Head System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS® 2.0 Radial Head System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. Overall, the APTUS® 2.0 Radial Head System has the following similarities to the predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- . incorporates the same basic design,
- . incorporates the same materials, and
- has similar packaging and is sterilized using the same materials and processes. .
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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2009
Medartis AG % Kevin A. Thomas, PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130
Re: K090053
Trade/Device Name: APTUS 2.0 Radial Head 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: March 20, 2009 Received: March 23, 2009
Dear Dr. Thomas:
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 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 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.
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Page 2 - Kevin A. Thomas, PhD
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
For Pete Nmn
Des Dr
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APTUS® 2.0 Radial Head System
Indications for Use
510(k) Number (if known): K090053
·
APTUS® 2.0 Radial Head System Device Name:
Indications for Use:
The APTUS® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative,
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices
| 510(k) Number | 4090083 |
|---|---|
| Page 1 of |
Page 21 of 40
§ 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.