(55 days)
Not Found
Not Found
No
The summary describes a mechanical implant for fracture fixation and does not mention any AI or ML components or functions.
Yes
Explanation: The device is intended for "temporary stabilization of types of fractures of the proximal and distal femur," which is a therapeutic purpose.
No
The device is described as a system for temporary stabilization and fixation of fractures, which are treatment functions, not diagnostic ones.
No
The device description explicitly states it is a "compression screw system" and a "Supracondylar Plate," which are hardware components used for fracture fixation. The performance studies also focus on "mechanical testing," further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "temporary stabilization of types of fractures of the proximal and distal femur." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description confirms it's a "compression screw system designed to treat various types of fractures of the distal femur." This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are available sterile and non-sterile intended for use in the temporary stabilization of fractures of the proximal and distal femur. The indications for use for the Omega™ 3 System are provided below.
The Omega™ Plus, Omega™ 2, and Omega™ 3 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to:
- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
- Subtrochanteric fractures .
- Supracondylar fractures .
- Intracondylar fractures .
- Osteotomies for patients with diseases or deformities of the hip .
- . Hip arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Omega™ 3 Supracondylar Plate is a compression screw system designed to treat various types of fractures of the distal femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal and distal femur
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)
Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.
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.
Not Found
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
K070454 182
APR 1 2 2007
Summary of Safety and Effectiveness Omega™ 3 Supracondylar Plate
Proprietary Name:
Common Name:
Classification Name and Reference
Device Product Code:
For Information Contact:
Omega™ 3 Supracondylar Plate
Compression Screw System
Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030
87 KTT
Francisco Haro, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5493 Fax: (201) 831-6038
Date Summary Prepared:
February 9, 2007
Description:
The Omega™ 3 Supracondylar Plate is a compression screw system designed to treat various types of fractures of the distal femur.
Intended Use:
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are available sterile and non-sterile intended for use in the temporary stabilization of fractures of the proximal and distal femur. The indications for use for the Omega™ 3 System are provided below.
Indications for Use:
The Omega™ Plus, Omega™ 2, and Omega™ 3 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to:
1
K070454 zg2
- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
- Subtrochanteric fractures .
- Supracondylar fractures .
- Intracondylar fractures .
- Osteotomies for patients with diseases or deformities of the hip .
- . Hip arthrodesis
Substantial Equivalence:
The subject Omega™ 3 Supracondylar Plates shares the same intended use, and basic design concepts as that of the currently available Omega™ Plus System and Omega™ 2 System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.
2
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 depiction of an eagle with its wings spread, positioned to the right. To the left of the eagle is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
APR 1 2 2007
Re: K070454
Trade/Device Name: Omega™ 3 Supracondylar Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 27, 2007 Received: March 28, 2007
Dear Mr. Haro:
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. Francisco Haro
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Barbary Poucelin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Omega™ 3 Supracondylar Plate
Indications for Use:
The Omega™ Plus, Omega™ 2, and Omega™ 3 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to:
- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
- Subtrochanteric fractures ◆
- . Supracondylar fractures
- Intracondylar fractures
- Osteotomies for patients with diseases or deformities of the hip �
- Hip arthrodesis .
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Signature, Office of Device Evaluation (ODE)
(Division Sign-Off) MXM
Division of General, Restorative,
and Neurological Devices
510(k) Number K070454
45