(77 days)
Not Found
No
The 510(k) summary describes a system of titanium plates and screws for bone fixation, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is used for internal fixation of fractured bones, which is a structural support function, not a therapeutic treatment for disease or a condition affecting the body's function.
No
The device is described as a system for internal fixation of small bones, consisting of plates and screws. Its intended use is for treatment (fixation), not for diagnosing conditions.
No
The device description explicitly details physical components such as titanium plates, screws, and surgical instruments, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "internal fixation of small bones including the hand and the foot." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "titanium plates" and "screws" used for "internal fixation." These are implants and surgical tools, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing information for diagnosis or treatment based on in vitro analysis.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is used within the human body for structural support.
N/A
Intended Use / Indications for Use
The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.
Product codes
HRS
Device Description
The Mondeal® Hand Contour System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile 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 straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones including the hand and the foot.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Mondeal® Hand Contour 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 K071797 . . 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 858-225-0311 Fax:
Trade Name:
Mondeal® Hand Contour System Device Name: Common Name: Screw, Fixation, Bone and Plate, Fixation, Bone Plate, Fixation, Bone, Class II Classification Name: and Regulation: 21 CFR 888.3030, 87HRS
Substantial Equivalence:
Mondeal Medical Systems GmbH, claims substantial equivalence to the Howmedica Profyle ® Hand and Small Fragment System, K961497.
Indications for Use:
The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.
Description of the Device
The Mondeal® Hand Contour System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile 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 straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation
SEP 1 7 2007
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ATTACHMENT III - 510(k) SUMMARY, REVISED
| Characteristic | Mondeal® Hand Contour System (subject of this 510(k)) | Howmedica Profyle Hand and Small Fragment System |
|---|---|---|
| Names | Mondeal® Hand Contour System | Howmedica Profyle Hand and Small Fragment System |
| 510(k) number | K071797 | K961497 |
| Indications for use | The Mondeal® Hand Contour System is intended to be used for the internal fixation of small bones of the hand and foot. | Howmedica Profyle Hand and Small Fragment System is intended for use in internal fixation of small bones including the hand, foot, and cranialmaxillofacial skeleton. |
| 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 | CP Titanium Grade 2 plates and Ti-6Al-4V ELI 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 |
| Sterilization 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 |
Conclusions
Mondeal Medical Systems GmbH considers the Mondeal® HAND CONTOUR 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 features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 17 2007
Mondeal Medical Systems, GmbH % Mr. Jay Evans Mondeal North America, Inc. 13566 Freeport Road San Diego, California 92133
Re: K071797
Trade/Device Name: Mondeal® Hand Contour 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, 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); 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 vours.
Barbara Buellm
Mark N. Melkerso 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® Hand Contour System
Indications For Use:
The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.
Prescription Use (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)
M
Pivision Sign.000
Division of General, Restorative, and Neurological Devices
510(k) Number K071797
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