(111 days)
Not Found
No
The device description and intended use focus on mechanical reduction and fixation. There is no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML-powered devices.
Yes
The device is described as an "external fixation system used for reduction and fixation of distal radius fractures," indicating it directly treats, mitigates, or prevents a disease or condition (fracture).
No
The "Intended Use / Indications for Use" states the device is for "Fracture reduction and external fixation for treatment of distal radius fractures," which describes a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states that the system includes hardware components such as an adjustable reduction frame, application instrumentation, and skeletal fixation pins, constructed from various materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Fracture reduction and external fixation for treatment of distal radius fractures." This describes a surgical procedure performed directly on a patient's body to treat a physical condition.
- Device Description: The device is an external fixation system with pins and instruments used to manipulate and stabilize bone fractures. This is a mechanical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on such analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Fracture reduction and external fixation for treatment of distal radius fractures.
Product codes (comma separated list FDA assigned to the subject device)
JEC
Device Description
The WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction frame (fixator), application instrumentation and skeletal fixation pins.
The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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)
Not Found
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.
Agee WristJack Fracture Reduction System (sterile), Item No. CFD-147, K984442
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUN 1 0 2003
Image /page/0/Picture/1 description: The image shows the logo for the Hand Biomechanics Lab. On the left side of the logo is a black silhouette of a hand with a curved line above it. To the right of the hand is the text "Hand Biomechanics Lab", with each word on a separate line. The text is in a simple, sans-serif font.
510(k) Summary
030519
page 1 of 1
Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 Sacramento, CA 95825-6209 Contact: Timothy R. Stallings (916) 923-5073 Phone: (916) 920-2215 Fax: Email: tstallings@handbiolab.com
Prepared February 18, 2003
Name of Device:
| Regulatory Classification: | Class II |
|---|---|
| Classification Name: | Component, Traction, Invasive [888.3040] |
| Common Name: | External Fixator System |
| Trade Name/Proprietary Name: | WristJack System (remanufactured), sterile, Item No. CFD-147-RS |
| WristJack System (remanufactured), non-sterile, Item No. CFD-147-RNS | |
| Performance Standards: | No performance standards exist for this device. |
Predicate Device:
Agee WristJack Fracture Reduction System (sterile), Item No. CFD-147, K984442
Description of Device:
The WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction frame (fixator), application instrumentation and skeletal fixation pins.
The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.
Intended Use:
Fracture reduction and external fixation for treatment of distal radius fractures.
Technological Characteristics Compared to Predicate Device:
All device components and materials of the WristJack System (remanufactured) are identical to the device components and materials of the predicate device. The subject device is reprocessed and delivered to the customer in either sterile form. In the non-sterile model, the customer is responsible for sterilization before use. The predicate device is supplied sterile.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, with three parallel lines forming a wave-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2003
Mr. Timothy R. Stallings Manufacturing Manager Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 Sacramento, California 95825
Re: K030519
Trade/Device Name: WristJack System (remanufactured) sterile and non-sterile Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JEC Dated: May 23, 2003 Received: May 29, 2003
Dear Mr. Stallings:
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.
2
Page 2 - Mr. Timothy R. Stallings
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Miriam 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
3
510(k) Number (if known): _KO30519 Device Name: WristJack System (remanufactured) _______________________________________________________________________________________________________________________________ Indications For Use:
Fracture reduction and external fixation for treatment of distal radius fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030579
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)