(90 days)
Not Found
Not Found
No
The summary describes a mechanical implant (wrist fusion plate) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a wrist fusion plate intended to restore alignment and stability, reduce pain, and address damage to the wrist joint, which are all therapeutic actions.
No
The device is a "Carpal Engaging Wrist Fusion Plate," which is an implant used in surgery for conditions like wrist deformities, instabilities, and pain. It is a therapeutic device, not one that identifies or analyzes a disease or condition.
No
The device description clearly states "Carpal Engaging Wrist Fusion Plate," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a surgical procedure (wrist arthrodesis) to treat various wrist conditions. This is a therapeutic intervention performed on a patient's body.
- Device Description: The device is a "Carpal Engaging Wrist Fusion Plate," which is a surgical implant used to stabilize the wrist bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include:
- rheumatoid wrist deformities requiring restoration of alignment and stability
- carpal instabilities
- severe unremitting wrist pain related to motion of the carpus
- other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.
Product codes
HRS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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.
Not Found
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
§ 888.3030 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The agency's name is written around the logo in a circular fashion. The text reads, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1998
Ms. Teal Renals · Quality Assurance Manager Terray Corporation Jackson Lane Pine Grove Industrial Park Arnprior, Ontario K7S 3G8 CANADA
K974030 Re: Terray Carpal Engaging Wrist Fusion Plate Trade Name: Requlatory Class: II Product Code: HRS October 8, 1997 Dated: Received: October 23, 1997
Dear Ms. Renals:
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, Drug, 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. A 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 Register. 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 regulations.
1
Page 2 - Ms. Teal Renals
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (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,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and ___ ____ Radiological Health
Enclosure
2
"510 (K) Notification"
510(k) Number (if known)
Device Name:
Carpal Engaging Wrist Fusion Plate
INDICATIONS FOR USE:
The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include:
- rheumatoid wrist deformities requiring restoration of alignment and stability
- carpal instabilities
- severe unremitting wrist pain related to motion of the carpus
- other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.
Concurrence of CDRH, Office of Device Evaluation (ODE)
peelle
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
ない。
Image /page/2/Picture/20 description: The image shows the logo for Terrav Corporation. The logo consists of a stylized, bold, black symbol on the left, resembling the letters 'TC' or a geometric design. To the right of the symbol is the text "Terrav Corporation" in a serif font, with "Terrav" appearing above "Corporation". The text is also in black, complementing the symbol.