(23 days)
Not Found
Not Found
No
The summary describes a mechanical implant for fracture stabilization and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "compression screw system designed to treat various types of fractures," which aligns with the definition of a therapeutic device that is intended to treat a medical condition.
No
The device is described as a system for temporary stabilization and fixation of fractures, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "compression screw system," which is a hardware implant. The intended use also describes the stabilization of fractures, which is a mechanical function performed by hardware.
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 is a surgical intervention for treating bone fractures, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a "compression screw system designed to treat various types of fractures of the proximal femur." This describes a physical implant used in surgery.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing diagnostic information.
Therefore, the Omega™ Plus, Omega™ 2, and Omega™ 3 Systems are medical devices used for surgical treatment, not in vitro diagnostics.
N/A
Intended Use / 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:
- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
- Subtrochanteric fractures .
- Supracondylar fractures .
- Intracondylar fractures t
- 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 Trochanteric Stabilizing Plate is a compression screw system designed to treat various types of fractures of the proximal femur.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Proximal and distal femur, hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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.
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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.
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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
K081278 (pg 192)
MAY 29 2008
Omega™ 3 Trochanteric Stabilizing Plate Proprietary Name: Compression Screw System Common Name: Single/multiple component metallic bone Classification Name and fixation appliances and accessories, 21 CFR Reference: 888.3030 87 KTT Device Product Code: Andrea Dwyer, Regulatory Affairs Associate For Information Contact: Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6250 Fax: (201) 831-6038 May 5, 2008 Date Summary Prepared:
Summary of Safety and Effectiveness Omega™ 3 Trochanteric Stabilizng Plate
Description:
The Omega™ 3 Trochanteric Stabilizing Plate is a compression screw system designed to treat various types of fractures of the proximal 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:
- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
1
K081278(pg2g2)
- Subtrochanteric fractures .
- Supracondylar fractures .
- Intracondylar fractures t
- Osteotomies for patients with diseases or deformities of the hip ●
- Hip arthrodesis .
Substantial Equivalence:
The subject Omega™ 3 Trochanteric Stabilizing Plate shares the same intended use, and basic design concepts as that of the currently available Omega™ 3 System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. 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
MAY 2 9 2008
Howmedica Osteonics Corp. % Ms. Andrea Dwyer Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
K081278 Trade/Device Name: Omega™ 3 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: May 5, 2008 Received: May 6, 2008
Dear Ms. Dwyer:
Re:
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.
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Page 2 - Ms. Andrea Dwyer
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 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 N Millican
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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510(k) Number (if known):
510(k) Number (if known):
Device Name: Omega™ 3 System
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:
- . 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 X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) | Neil R. Ogden for MAM |
---|---|
(Division Sign-Off) | |
Division of General, Restorative, | |
and Neurological Devices | |
510(k) Number | K081278 |
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