The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Device Description

The Mondeal® Distal Radius System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.

AI/ML Overview

This submission describes a medical device, the Mondeal® Distal Radius System, which is a set of plates and screws for fixing distal radius fractures. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a previously cleared device. Therefore, the "study" conducted is a comparison to a predicate device, rather than a clinical trial or a performance study with acceptance criteria in the typical sense for an AI/software device.

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Acceptance Criteria and Study for Mondeal® Distal Radius System

The "acceptance criteria" and "study" for the Mondeal® Distal Radius System are based on demonstrating substantial equivalence to a predicate device (Mondeal® Radius HO System, K050655), as per 510(k) requirements. There is no performance study against specific, quantified acceptance criteria in the context of an AI/software device. Instead, the "performance" here refers to material and mechanical properties, as well as intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Demonstrates Equivalence to Predicate)	Reported Device Performance (Mondeal® Distal Radius System)
Indications for Use	Identical to predicate device	The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect. (Identical to predicate)
Technology	Identical to predicate device	Titanium plates and screws (Identical to predicate)
Application	Identical to predicate device	Internal Fixation of small bones of hand and foot (Identical to predicate)
Design / Components	Comparable to predicate device	CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws (Predicate uses Ti-6Al-4V ELI Anodized Type II plates and screws)
Corrosion Resistance	Identical to predicate device	Identical
Mechanical Properties	Similar to predicate device	Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content
Sterilization Method	Identical to predicate device	Steam Autoclave (Identical to predicate)
Packaging	Identical to predicate device	Tempered plastic and/or stainless steel trays for steam sterilization; plates and screws also packaged individually, all non-sterile (Identical to predicate)

Note: The "acceptance criteria" are implied by the 510(k) process, which requires demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This means the new device must have the same intended use, and the same technological characteristics, or, if different, any differences must not raise new questions of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This is not a study involving a "test set" of patients or data in the typical sense. The evaluation is a comparison of device specifications and characteristics against a predicate device.
Data Provenance: Not applicable. The data is descriptive information about the device's design, materials, and performance specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. There is no "ground truth" in the context of expert consensus on patient data or images. The "ground truth" for this submission would be industry standards for material properties and manufacturing, as well as the specifications of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication process as described in the context of clinical studies or AI algorithm evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an MRMC study. It is a comparison of a new medical device to a predicate device based on its physical and mechanical properties.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" is based on accepted engineering and material science standards, as well as the specifications and regulatory clearance of the predicate device (Mondeal® Radius HO System, K050655). The submission relies on the established safety and effectiveness of the existing predicate device as the benchmark for comparison.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary

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Mondeal® Distal Radius System 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is Kon1798 . This Summary was prepared on August 27, 2007

GENERAL INFORMATION

Manufacturer and Applicant Information:

Mondeal Medical Systems GmbH Moltkestr. 39 Tuttlingen, GERMANY 78532 Contact: Jay Evans Telephone: 858-901-4123 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: 858-225-0311

Trade Name:

Device Name: Mondeal® Distal Radius System Common Name: Screw, Fixation, Bone and Plate, Fixation, Bone Classification Name: Plate, Fixation, Bone, Class II and Regulation: 21 CFR 888.3030, 87HRS

Substantial Equivalence:

Mondeal Medical Systems GmbH, claims substantial equivalence to the Mondeal® Radius HO System, K050655.

Indications for Use:

The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Description of the Device

SEP 17 2007

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ATTACHMENT III - 510(k) SUMMARY, REVISED

Characteristic	Mondeal® Distal Radius System	Mondeal® Radius HO System
Names	Mondeal® Distal Radius System	Mondeal® Radius HO System
510(k) number	TBD	K050655
Indications for use	The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.	The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
Design and Device Characteristics
Technology	Titanium plates and screws	Titanium plates and screws
Application	Internal Fixation of small bones of hand and foot	Internal Fixation of small bones of hand and foot
Design / Components	CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws	Ti-6Al-4V ELI Anodized Type II plates and screws
Performance Specifications
Corrosion resistance	Identical	Identical
Mechanical properties	Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content	Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content
Sterilisation Method	Steam Autoclave	Steam Autoclave
Packaging	Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser	Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser

Device Comparison

Conclusions

Mondeal Medical Systems GmbH considers the Mondeal® DISTAL RADIUS System to be substantially equivalent to the aforementioned predicate devices with regard to intended use, materials, biocompatibility, and overall performance characteristics in accordance with the above comparison summary.

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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 three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mondeal Medical Systems, GmbH % Mr. Jay Evans Mondeal North America, Inc. 13566 Freeport Road San Diego, California 92133

SEP 1 7 2007

Re: K071798

Trade/Device Name: Mondeal® Distal Radius 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: August 28, 2007 Received: September 4, 2007

Dear Mr. Evans:

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 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, RDA over 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); good manufacturing practice requirements as set

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Page 2 - Mr. Jay Evans

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Barbara buelin
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Mondeal® Distal Radius System

Indications For Use:

The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dalvara Buchen
(Division Sign-Off)

Division of Ge eral, Restorative. and Neurological Devices

510(k) Number K07196

Page 1 of _

Mondeal® Distal Radius System Mondeal Medical Systems, GmbH. Traditional 510(k) Application Page 37 of 63

Regulation Number and Section

§ 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.