(66 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description does not mention any AI/ML components or functionalities.
Yes
Explanation: The device is intended for use in treating PIP joint flexion contractures and increasing range of motion, which are considered therapeutic applications.
No
The device is described as an external fixation system for treating joint flexion contractures to regain, maintain, or increase range of motion, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components made of plastic, metal, neoprene, and nylon, and describes a mechanical traction mechanism and fixation pins. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Digit Widget function: The Digit Widget is an external fixation system applied directly to the finger to treat a physical condition (PIP joint flexion contractures). It does not analyze any biological samples.
The description clearly indicates it's a mechanical device used for physical therapy and rehabilitation, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Hand Biomechanics Lab, Inc. Digit Widget is intended for use in treating PIP joint flexion contractures with an associated loss of range of motion.
Product codes
87JDW
Device Description
The Digit Widget is an external fixation system designed to effect rotation of an injured or diseased finger, to help regain, maintain, or increase the range of motion of the proximal interphalangeal (PIP) joint. It utilizes standard small diameter bone pin (Kirschner wire) fixation techniques and procedures for placement. The device acts about the PIP joint and allows some adjustability to permit fine tunive to the joint's axis. During treatinent, the surgeon or hand therapist (under order from the physician) may be required to periodically adjust the torque provided by the traction mechanism, by changing or adding orthodontic elastic can be removed temporarily to permit active range of motion exercise. The Digit Widget traction device is made from plastic and materials. Fixation pins (Kirschner wires) are made from implant grade stainless steel. An included wrist splint is made of neoprene and nylon, with Velcro attachment provisions. All components are designed for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
PIP joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon or hand therapist
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
None
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV - 8 1996
Image /page/0/Picture/2 description: The image shows the logo for Hand Biomechanics Lab, Inc. On the left side of the logo is a black silhouette of a hand with a curved line extending from the wrist area. To the right of the hand is the word "HAND" in large, bold, black letters. Below the word "HAND" is the word "BIOMECHANICS" in smaller, black letters. Below that is a black rectangle with the words "LAB, INC." in white letters.
510(k) Summary
| Contact Information: | Hand Biomechanics Lab. Inc.
77 Scripps Drive, Suite 104
Sacramento, CA 95825
Telephone: 1(916) 920-0484
Facsimile: 1(916) 920-2215
Contact Person: Jeff Woodhouse |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Digit Widget |
| Common Name: | PIP Joint External Fixation Device |
| Classification Name: | Pin, Fixation, Threaded |
| Device Product Code: | 87JDW |
| Regulation Number: | 888.3040 |
Substantial Equivalence: The Hand Biomechanics Lab, Inc. Digit Widget is substantially equivalent in material, function, performance, and design to the Proximal Interphalangeal (PIP) Joint External Fixation device (Compass® Proximal Interphalangeal Joint Hinge) marketed by Smith Nephew Richards. The products have comparable indications for use.
Device Description: The Digit Widget is an external fixation system designed to effect rotation of an injured or diseased finger, to help regain, maintain, or increase the range of motion of the proximal interphalangeal (PIP) joint. It utilizes standard small diameter bone pin (Kirschner wire) fixation techniques and procedures for placement. The device acts about the PIP joint and allows some adjustability to permit fine tunive to the joint's axis. During treatinent, the surgeon or hand therapist (under order from the physician) may be required to periodically adjust the torque provided by the traction mechanism, by changing or adding orthodontic elastic can be removed temporarily to permit active range of motion exercise. The Digit Widget traction device is made from plastic and materials. Fixation pins (Kirschner wires) are made from implant grade stainless steel. An included wrist splint is made of neoprene and nylon, with Velcro attachment provisions. All components are designed for single use only.
Indications For Use: The Hand Biomechanics Lab, Inc. Digit Widget is intended for use in treating PIP joint flexion contractures with an associated loss of range of motion
Predicate Devices: The Proximal Interphalangeal (PIP) Joint External Fixation devices marketed by BIOMET, Inc. (K980370) and Smith Nephew Richards (K970713) represent predicate devices relative to the Hand Biomechanics Lab, Inc. Digit Widget .
Clinical Tests: None
Adverse S&E Information: None
John M. Agee, M.D.
President & C.E.O.
9-1-99
Date
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an emblem of an eagle with three stylized lines representing its wings and body. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 1999
John M. Agee, M.D. President and CEO Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 95825 Sacramento, California
Re: K992970 Trade Name: Digit Widget Regulatory Class: II Product Code: JDW September 1, 1999 Dated: Received: September 3, 1999
Dear Dr. Agee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - John M. Agee, M.D.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. one regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number (if known): | K992970 |
|---|---|
| --------------------------- | --------- |
Device Name: Digit Widget
Indications For Use:
The Hand Biomechanics Lab, Inc. Digit Widget is intended for the following indication:
PIP joint flexion contractures with an associated loss of range of motion. 1.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number . 1992970
ア Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__
(Optional Format 1-2-96)