(73 days)
No
The document describes a mechanical compression screw system for fracture stabilization and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is described as a "compression screw system designed to treat various types of fractures of the proximal and distal femur," which indicates it is used for treatment.
No
The device is described as a "compression screw system designed to treat various types of fractures," not to diagnose them. Its intended use is for "temporary stabilization of types of fractures," which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a "compression screw system" and mentions "components," indicating it is a hardware device used for fracture fixation.
No, 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, not a diagnostic test performed on samples from the body.
- Device Description: The description details a "compression screw system designed to treat various types of fractures." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to fix bone fractures.
N/A
Intended Use / Indications for Use
The Omega™ Plus and 2 Systems are intended for use in the temporary stabilization 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
87 KTT
Device Description
The Omega™ 2 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur. The Omega™ 2 System is a modification to the existing Omega™ II, Omega™ Plus and Omega™ Systems. The subject Omega™ 2 System is a line extension to the predicate devices to modify and add new components to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal and distal femur, hip
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.
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 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
JUL 0 1 2004
K041001
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510(k) Summary of Safety and Effectiveness for the Omega™ 2 System
| Proprietary Name: | Omega™ 2 System |
|---|---|
| Common Name: | Compression Screw System |
| Classification Name and Reference | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| 21 CFR §888.3030 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 KTT |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | April 16, 2004 |
Description:
The Omega™ 2 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur. The Omega™ 2 System is a modification to the existing Omega™ II, Omega™ Plus and Omega™ Systems. The subject Omega™ 2 System is a line extension to the predicate devices to modify and add new components to the system.
Intended Use:
The Omega™ Plus and 2 Systems are intended for use in the temporary stabilization of fractures of the proximal and distal femur.
Substantial Equivalence:
The design and function of the Omega™ 2 System is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer different types of plates in varying lengths and angles for use with the other accessories in the system. This system is equivalent to other systems on the market in regards to design, materials, indications and operational principals. Mechanical testing demonstrated comparable mechanical properties to the predicate components.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes on its wing, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUL 01 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K041001 Trade/Device Name: Omega™ 2 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: April 16, 2004 Received: April 19, 2004
Dear Ms Kelly:
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. Iisting 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 - Vivian Kelly
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 (301) 594-4659. 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,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. 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 (if known): KO41001 Device Name: Omega™ 2 System
Indications for Use:
The Omega™ Plus and 2 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 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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________