(203 days)
Not Found
No
The summary describes a mechanical implant for fracture fixation and does not mention any AI/ML components or capabilities.
Yes
The "Intended Use / Indications for Use" section states that the device is used for "fixation of unstable distal radius fractures," which is a therapeutic intervention.
No
Explanation: The device is described as an "implant manufactured from stainless steel" intended for the "fixation of unstable distal radius fractures." This indicates it is a therapeutic device used for treatment, not for diagnosis.
No
The device description explicitly states it consists of a flexible implant manufactured from stainless steel, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of distal radius fractures. This is a surgical procedure performed on the patient's body.
- Device Description: The device is described as a flexible implant manufactured from stainless steel. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens like blood, urine, tissue, etc., or to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used to treat a physical injury.
N/A
Intended Use / Indications for Use
The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- . Osteotomy and repair of distal radius malunion with or without bone graft;
- Non-displaced fractures.
- Transverse fractures of the distal radius with or without comminution (e.g. AO . classifications A2 and A3);
- . Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);
- Failed fracture fixation with or without bone graft for the types of fractures above; .
- The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, t C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
Product codes
HRS, HSB
Device Description
The WavEon™ WRx configuration consists of a flexible implant manufactured from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
distal radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Equivalent to the predicate, the WavEon™WVRx device meets the requirements of ASTM 1264. Further, cadaver studies demonstrate that the implant can be safely inserted, reduce and fixate C2 fractures. Therefore, the WavEon™WRx is substantially equivalent to the predicate and Safe and Effective for the extended application.
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
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
Ko90304 '/2
Sonoma Orthopedic Products, Inc. 650 Larkfield Center, Suite C Santa Rosa, CA 95403
Ph: 707-526-1335 Fax: 707-540-6001
510(k) Summary
AUG 2 8 2009
| Submitter's name | Sonoma Orthopedic Products, Inc. |
|---|---|
| Address | 650 Larkfield Center, Suite C |
| Santa Rosa, CA 95403 | |
| Phone Number | 707-526-1335 ext. 255 |
| Fax Number | 707-540-6001 |
| Name of contact person | Carlos Gonzalez |
| Date summary was prepared | January 14, 2008 |
| Proprietary name/Trade name | WavEon™ WRx |
| Common Name | Intramedullary Distal Radius Fixation |
| Device | |
| Classification Name | Plate, Fixation, Bone 21 CFR 888.3030, HRS |
| Predicate Device | Sonoma Orthopedic Products Inc. |
| Ensplint Rx, K071809 | |
| Description of device | The WavEon™ WRx configuration consists |
| of a flexible implant manufactured from stainless | |
| steel. | |
| Intended use of device | The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be |
| used for the fixation of unstable distal radius fractures in which closed reduction | |
| is not suitable: Joint destruction and/or subluxation visible on x-ray;Osteotomy and repair of distal radius malunion with or without bone graft;Non-displaced fractures.Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3);Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);Failed fracture fixation with or without bone graft for the types of fractures above;The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator. | |
| Comparison to Predicate Device | The WavEon™ WRx is the new trade name, |
| for the Ensplint predicate device. This submission | |
| extends the indications for use to C2 Distal Radius | |
| Fractures (AO classification). Only minor | |
| differences are incorporated in this model that do |
1
Sonoma Orthopedic Products, Inc. 650 Larkfield Center, Suite C Santa Rosa, CA 95403 Ph: 707-526-1335 Fax: 707-540-6001
not affect safety or effectiveness. Extended indications is requested to include C2 Distal Radius fractures.
Performance Data (Non clinical)
Equivalent to the predicate, the WavEon™WVRx device meets the requirements of ASTM 1264. Further, cadaver studies demonstrate that the implant can be safely inserted, reduce and fixate C2 fractures. Therefore, the WavEon™WRx is substantially equivalent to the predicate and Safe and Effective for the extended application.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Sonoma Orthopedic Products, Inc. % Mr. Carlos Gonzalez 650 Larkfield Center, Suite C Santa Rosa, CA 95403
Re: K090304
. Trade/Device Name: WavEon WRx Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
AUG 2 8 2009
Regulatory Class: II Product Code: HRS, HSB Dated: July 15, 2009 Received: July 21, 2009
Dear Mr. Gonzalez:
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 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 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.
3
Page 2 - Mr. Carlos Gonzalez
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K090304
Device Name: WavEon™ WRx
Indications for Use:
The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- . Osteotomy and repair of distal radius malunion with or without bone graft;
- Non-displaced fractures.
- Transverse fractures of the distal radius with or without comminution (e.g. AO . classifications A2 and A3);
- . Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);
- Failed fracture fixation with or without bone graft for the types of fractures above; .
- The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, t C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
X 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)
Souther for MXM
(Division Sign off)
(DKision Sign-6 Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K090304