(237 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a bone plate system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an orthopedic implant (plate and screws) used to stabilize fractures and treat other bone conditions in the proximal humerus, which serves a restorative rather than therapeutic function.
No
The device is a fracture plate system designed to treat fractures and reattach bones, not to diagnose medical conditions.
No
The device description clearly states it is a "Proximal Humeral Fracture Plate System" composed of physical implants (plates and screws) made from stainless steel. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Integra Proximal Humeral Fracture Plate System is a surgical implant made of stainless steel, designed to fix fractures in the proximal humerus (the upper part of the arm bone).
- Intended Use: Its intended use is to mechanically stabilize bone fractures and related conditions. It does not involve testing biological samples.
The description clearly indicates a surgical implant used for structural support, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Integra Proximal Humeral Fracture Plate System is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone
- Pseudoarthroses in the proximal humerus
- Osteotomies in the proximal humerus
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Integra Proximal Humeral Fracture Plate System is composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The GT plate is designed to cover the greater tuberosity and is available in four-hole, seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system features 3.5mm locking, non-locking and lag screws, in addition to, 2.7mm locking screws.
The Integra Proximal Humeral Fracture Plate System is a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws are made from stainless steel (SS 316L).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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)
The subject system was determined to be equivalent to the predicate devices by comparing the section moduli of the original design (K110700), the subject devices, and the predicate devices (Synthes LCP, K011815). Because the designs included in this 510(k) do not represent a worst case plate, additional testing was not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 1 3 2013
| SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| SPONSOR | Ascension Orthopedics, Inc. |
| A wholly owned division of Integra LifeSciences, Inc. | |
| 8700 Cameron Road | |
| Austin, TX 78754-3832 | |
| 510(k) CONTACT: | Susan Walton |
| susan.walton@integralife.com | |
| Phone: (512) 836-5001 x1591 | |
| FAX (512) 836-6933 | |
| DATE PREPARED: | February 12, 2013 |
| TRADE NAME: | Integra Proximal Humeral Fracture Plate System |
| COMMON NAME: | Plate, Fixation, Bone |
| CLASSIFICATION: | 21 CFR 888.3030 - Single/Multiple component metallic bone fixation |
| appliances and accessories | |
| PRODUCT CODE: | HRS |
| PANEL: | Orthopedic |
| PREDICATE DEVICE: | K011815 - Synthes LCP Proximal Humerus Plate |
| K010700 - ATLAS Humeral Plate System | |
| DEVICE DESCRIPTION: | The Integra Proximal Humeral Fracture Plate System is composed of |
| left and right humeral reconstruction plate implants in two options, | |
| GT Plate and LP Plate. The GT plate is designed to cover the greater | |
| tuberosity and is available in four-hole , seven-hole, and ten-hole | |
| lengths or sizes. The LP plate is designed to sit lower on the greater | |
| tuberosity and is available in three-hole, six-hole, and nine-hole | |
| lengths or sizes. The system features 3.5mm locking, non-locking and | |
| lag screws, in addition to, 2.7mm locking screws. | |
| The Integra Proximal Humeral Fracture Plate System is a single | |
| component made from stainless steel (SS 316L). The non-locking, | |
| locking and lag screws are made from stainless steel (SS 316L). | |
| INTENDED USE: | The Integra Proximal Humeral Fracture Plate system is designed for |
| fractures and fracture dislocations, osteotomies and non-unions of | |
| the proximal humerus. Indications include: | |
| ● Dislocated two-, three-, and four-fragment fractures of the | |
| proximal humerus, including fractures involving osteopenic | |
| bone | |
| ● Pseudoarthroses in the proximal humerus | |
| ● Osteotomies in the proximal humerus | |
| SUMMARY OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | The technological characteristics for the Integra Proximal Humeral |
| Fracture Plate System were compared to the predicate devices. The | |
| characteristics were defined to be device material, dimensional | |
| characteristics such as plate length, number and | |
| location of holes as well as screw sizes and packaging/sterilization | |
| methods. These characteristics were determined to be the same or | |
| similar between the subject and predicate devices. | |
| NONCLINICAL TESTING | The subject system was determined to be equivalent to the predicate |
| devices by comparing the section moduli of the original design (K110700), | |
| the subject devices, and the predicate devices (Synthes LCP, K011815). | |
| Because the designs included in this 510(k) do not represent a worst case | |
| plate, additional testing was not required. | |
| CLINICAL PERFORMANCE | |
| DATA: | Clinical performance data were not necessary to support substantial |
| equivalence. | |
| BASIS OF SUBSTANTIAL | |
| EQUIVALENCE: | Ascension Orthopedics believes that this system is substantially |
| equivalent to the legally marketed predicate devices based on similarities | |
| in design, materials and indications. |
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K121826
and the control control control of the control of
:
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Letter dated: February 13, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ascension Orthopedics, Incorporated % Ms. Susan Walton Director 8700 Cameron Road Austin, Texas 78754
Re: K121826
Trade/Device Name: Integra Proximal Humeral Fracture Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HRS Dated: January 31, 2013 Received: February 6, 2013
Dear Ms. Walton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
3
Page 2 – Ms. Susan Walton
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Niji Kerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Indications for Use Statement
K121826 510(K) Number:
Integra Proximal Humeral Fracture Plate System Device Name:
Indications for Use:
The Integra Proximal Humeral Fracture Plate System is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures . involving osteopenic bone
- Pseudoarthroses in the proximal humerus .
- Osteotomies in the proximal humerus .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens
Division of Orthopedic Devices