(55 days)
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The APTUS® Foot 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 in the foot.
The provided text is a 510(k) summary for the Medartis AG APTUS® Foot System, which is a device for internal fixation in small bones. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical or technical study as might be done for novel devices or software.
Therefore, many of the requested details, particularly those related to performance studies, acceptance criteria, sample sizes, and ground truth establishment, are not applicable to this submission. The 510(k) summary explicitly states that the equivalence is based on "the same intended use," "same operating principle," "same basic design," "same or very similar materials," and "similar packaging and is sterilized using the same materials and processes." It does not describe any new performance studies with specific acceptance criteria.
Below is a response outlining what information can be gleaned from the provided text and indicating where the requested information is not present.
Acceptance Criteria and Study for the Medartis AG APTUS® Foot System
The provided 510(k) summary for the Medartis AG APTUS® Foot System (K091479) focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about specific acceptance criteria or an independent study to prove the device meets such criteria in the way that would be described for a novel medical device, especially an AI-powered one. The approval is based on the device's similarity to existing, legally marketed implants.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as performance criteria for this device) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use: (Implied: To be suitable for use in small bones, fractures, osteotomies, arthrodesis of tarsals, metatarsals, phalanges) | Same Intended Use as predicate devices: The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges. This is demonstrated by conceptual equivalence to predicate devices with the same indications. |
| Operating Principle: (Implied: To provide internal fixation for bones) | Same Operating Principle as predicate devices: Provides internal fixation using plates and screws. |
| Basic Design: (Implied: To be a system of plates and screws for small bone fixation) | Same Basic Design as predicate devices: Consists of small titanium fixation plates, conventional screws, and locking screws. |
| Materials: (Implied: Materials suitable for surgical implantation and bone fixation) | Same or Very Similar Materials as predicate devices: Titanium. |
| Sterilization & Packaging: (Implied: To be sterile and packaged appropriately for medical devices) | Similar Packaging and Sterilization using the same materials and processes as predicate devices. |
Explanation: The "acceptance criteria" here are not performance metrics from a new study, but rather the points of comparison used to establish substantial equivalence to predicate devices. The device "meets" these criteria by being sufficiently similar.
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 provided 510(k) summary does not describe a performance study with a test set. Substantial equivalence was demonstrated through comparison to predicate devices, not through new clinical or performance data generation.
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. No test set or ground truth establishment by experts is described in this 510(k) summary. This type of information is typically relevant for diagnostic AI/ML devices or novel therapies requiring new clinical evidence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method 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 device is a physical bone fixation system, not an AI software or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical bone fixation system, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No ground truth is described. The basis for approval is substantial equivalence to predicate devices, meaning the safety and effectiveness are inferred from devices already on the market with a similar design, materials, and intended use, whose performance has been established over time.
8. The sample size for the training set
- Not Applicable. No training set is described. This device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for it is described.
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510(k) Summary
510(k) Summary
JUL 1 3 2009
Medartis AG APTUS® Foot System
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Medartis AG Austrasse 24 CH-4051 Basel, Switzerland Telephone: +41 (0) 61 228 18 18 Fax: +41 (0) 61 228 18 00
Official Contact:
Rosina Cifelli Regulatory Affairs Manager, Medartis AG
Representative/Consultant:
Linda K. Schulz Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 email: lschulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name : Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
APTUS® Foot System Plate, fixation, bone Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030/21 CFR 888.3040 Class II HRS/HWC Orthopedic Products Panel Orthopedic Devices Branch
INTENDED USE
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
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510(k) Summary
K091479 2/2
APTUS® Foot System
DEVICE DESCRIPTION
The APTUS® Foot 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 in the foot.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS® Foot System is substantially equivalent to previously cleared devices. The APTUS® Foot 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 or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. .
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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1-3 2009
Medartis AG % Ms. Linda K. Schulz PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130
Re: K091479
Trade/Device Name: APTUS Foot 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: May 18, 2009 Received: May 19, 2009
Dear Ms. Schulz:
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 - Ms. Linda K. Schulz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrb/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Obalar Buenno
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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APTUS® Foot System
Indications for Use
510(k) Number (if known): K091479
APTUS® Foot System Device Name:
Indications for Use:
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
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Division of Surgical, Orthopedic, and Resiorative Devices
510(k) Number K091479
§ 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.