(61 days)
Not Found
No
The device description focuses on the mechanical properties and design of a fracture fixation system, with no mention of AI or ML capabilities.
No
Explanation: This device is a fracture fixation system designed to stabilize fractures, which falls under the category of a surgical implant rather than a therapeutic device that administers treatment or therapy directly.
No
The device is a fracture fixation system designed to stabilize fractures, not to diagnose medical conditions. Its function is to treat, not to identify or determine a disease or condition.
No
The device is a fracture fixation plating system made of titanium implants and screws, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description: The provided text describes a surgical implant used for stabilizing bone fractures. It is a physical device that is surgically placed within the patient's body.
- Intended Use: The intended use is to stabilize fractures of the distal humerus, which is a treatment for a physical injury, not a diagnostic test performed on a sample outside the body.
The device is a Class II medical device (based on the predicate devices listed, which are typically Class II orthopedic implants) used for fracture fixation.
N/A
Intended Use / Indications for Use
The intended use of the I.T.S. Distal Humeral Plates with Angular Stability is to stabilize fractures of the distal humerus in the elbow of a pediatric or adult patient.
Indications for use include intra-articular fractures, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient.
Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.
Product codes
HRS
Device Description
The I.T.S. GmbH Distal Humeral Plates with Angular Stability is a fracture fixation plating system for repairing factures located in the distal area of the humerus in the elbow (in the area of medial and lateral epicondyles of the distal humerus). The Distal Humeral Plates consist of two plate designs as a medial (8 hole) and dorsolateral (5 hole) left and right plate configuration - anatomically pre-contoured to fit the distal humerus human anatomy and manufactured from Commercialy Pure (CP) Titanium material for minor intra-operative forming by the surgeon. The offset opposite location of the plates on the medial and lateral epicondyles provide a girder-like construct for difficult bone fracture reconstruction stability. The added benefit of locking screws within each plate and up to a +- 15° angle position allows a fixed-angle contruct of screw-to-plate and offers angle-flexibility in screw positioning for further optimal fracture stability. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plates and introducing multiple sizes of locking/non-locking screws as needed for stabilizing the fracture(s) - when using optional x-ray fluroscopy. The system offers a 3.5mm locking and non-locking cortical screw and a 4.2mm locking cancellous screw in multiple lengths manufactured from High Strength 6-4 Alloyed Titanium material. All plates and screws are processed with a TIODIZE II surface treatment - which improves the material surface hardness and biocompatibility to adjacent tissues. The low-profile and contoured left and right plate design minimizes soft-tissue irritation for the patient. A full compliment of instrumentation is available for use with the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus in the elbow (in the area of medial and later epicondyles of the distal humerus)
Indicated Patient Age Range
pediatric or adult
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)
K033995, K012655, K063460, K071715, K040593
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
510(k) Summary of Safety and Effectiveness Section XII:
SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
MAR 2 6 2008
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.
Autal 28.
Lassnitzhoehe A-8301
AUSTRIA |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372 |
| TRADE NAME: | Distal Humeral Plates with Angular Stability |
| COMMON NAME: | Bone Plate System |
| CLASSIFICATION: | Plate, Fixation, Bone |
| | (see 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: | HRS |
| SUBSTANTIALLY
EQUIVALENT DEVICES | Synthes 3.5mm LCP Distal Humerus System (K033995)
Acumed Congruent Bone Plate System (K012655), (K063460),
(K071715)
Zimmer Periarticular Locking Plates and Screws (K040593) |
| DEVICE DESCRIPTION: | The I.T.S. GmbH Distal Humeral Plates with Angular Stability is a
fracture fixation plating system for repairing factures located in the
distal area of the humerus in the elbow (in the area of medial and
lateral epicondyles of the distal humerus). The Distal Humeral
Plates consist of two plate designs as a medial (8 hole) and
dorsolateral (5 hole) left and right plate configuration -
anatomically pre-contoured to fit the distal humerus human
anatomy and manufactured from Commercialy Pure (CP) Titanium
material for minor intra-operative forming by the surgeon. The
offset opposite location of the plates on the medial and lateral
epicondyles provide a girder-like construct for difficult bone
fracture reconstruction stability. The added benefit of locking
screws within each plate and up to a +- 15° angle position allows a
fixed-angle contruct of screw-to-plate and offers angle-flexibility
in screw positioning for further optimal fracture stability. Small
holes in the plate allow intermediate 'k-wire bone fracture segment
positioning' for reducing and aligning the fracture bone segments
while positioning the plates and introducing multiple sizes of
locking/non-locking screws as needed for stabilizing the fracture(s) |
| | - when using optional x-ray fluroscopy. The system offers a
3.5mm locking and non-locking cortical screw and a 4.2mm
locking cancellous screw in multiple lengths manufactured from
High Strength 6-4 Alloyed Titanium material. All plates and
screws are processed with a TIODIZE II surface treatment - which
improves the material surface hardness and biocompatibility to
adjacent tissues. The low-profile and contoured left and right plate
design minimizes soft-tissue irritation for the patient. A full
compliment of instrumentation is available for use with the system. |
| INTENDED USE: | The intended use of the I.T.S. Distal Humeral Plates with Angular
Stability is to stabilize fractures of the distal humerus in the elbow
of a pediatric or adult patient. |
| | Indications for use include intra-articular fractures, comminuted
supracondylar fractures, osteotomies, and non-unions of the distal
humerus. |
| BASIS OF SUBSTANTIAL
EQUIVALENCE: | The I.T.S. Distal Humeral Plates with Angular Stability is
substantially equivalent to the Synthes and Acumed distal humeral
bone plate systems. |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. Distal Humeral Plates with Angular Stability is shown
to be safe and effective for use in fracture fixation of the distal
humerus in the elbow. |
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2008
I.T.S. GmbH % Engineering Consulting Services, Inc. Mr. Al Lippincott Official Correspondent 3150 East 200th Street Prior Lake, MN 55372
Re: K080184 Trade/Device Name: Distal Humeral Plates with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 18, 2008 Received: January 25, 2008
Dear Mr. Lippincott:
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 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.
3
Page 2 - Mr. Al Lippincott
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) NUMBER: DEVICE NAME: DISTAL HUMERAL PLATES WITH ANGULAR STABILITY INDICATIONS FOR USE:
The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient.
Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.
Prescription Use
Over-The-Counter-Use AND/OR
(Per 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)
sion Sign-Off) Division of General, Restorative, and Neurological Devices
Section XI
510(k) Number K080184
I.T.S. Implantat-Technologie-Systeme GmbH part of the MED-HOLD GROUP Autal 28, 8301 Lassnitzhöhe, Austria
Tel.: +43 | 316 | 211 21 0 Fax: +43 | 316 | 211 21 20 office@its-implant.com www.its-implant.com
ATU43757109 FN 163966 b FBG LG Graz
DVR 0934704 ARA LN 5062 EN ISO 13485