(58 days)
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Not Found
No
The description focuses solely on the mechanical components and intended use of a bone fixation system, with no mention of AI or ML capabilities.
Yes
The device is used for fixation of fractures of the proximal femur, which is a therapeutic intervention.
No
The device is described as a plate system for the fixation of fractures, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components like plates, screws, and their dimensions, indicating it is a hardware-based medical device for fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures of the proximal femur". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates and screws designed to be implanted into bone.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
This device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The DHS/DCS Plate System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones.
Product codes (comma separated list FDA assigned to the subject device)
87 JDO, KTT, HWC
Device Description
The system makes up of DHS/DCS Plates, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5 mm Cortex Screw (self-tapping). The DHS Plates are available with barrel length 25 mm and 38 mm, and barrel angles 135°, 140°, 145°, and 150° . The standard barrel length is 38 mm. Otherwise, the self-tapping 4.5 mm Cortex Screw may be used to fix the DHS/DCS Plates to the femoral shaft.
The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26 mm and outer diameter 4.0 mm.
The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Screw is available with thread length 22 mm, total length from 50 to 145 mm, outer diameter 12.5 mm, and shaft diameter 8.0 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones
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
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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.
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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.
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510(k) Summary of Safety and effectiveness
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A Sponsor: Syntec-Taichung Medical Instruments Co., Ltd.
2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. 509 Phone / FAX: 886-4-7987099 / 886-4-7987077 Contact Person: Ted Y. Shi -
Proprietary Name : Syntec-Taichung Non-sterile DHS/DCS Plate System
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Common Name : Proximal Femoral Implant
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Classification Status : Class II, CFR 888.3030
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A Device Product Code : 87 JDO
A Material:
This device is manufactured from commercially 316 LS stainless steel and titanium alloy (Ti-6Al-4V).
A Indication for Use :
The DHS/DCS Plate System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones.
A Description of the Device :
The system makes up of DHS/DCS Plates, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5 mm Cortex Screw (self-tapping). The DHS Plates are available with barrel length 25 mm and 38 mm, and barrel angles 135°, 140°, 145°, and 150° . The standard barrel length is 38 mm. Otherwise, the self-tapping 4.5 mm Cortex Screw may be used to fix the DHS/DCS Plates to the femoral shaft.
The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26 mm and outer diameter 4.0 mm.
The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Screw is available with thread length 22 mm, total length from 50 to 145 mm, outer diameter 12.5 mm, and shaft diameter 8.0 mm.
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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 design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles or faces, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 30 1998
Mr. Ted Y. Shi President Syntec-Taichung (Taiwan) 2. Kung San Road Chuan Shing Industrial Zone Shen Kang, Chan Hua Taiwan 509
Re: K983873
Trade Name: Non-sterile DHS/DCS Plate System Regulatory Class: II Product Codes: KTT and HWC Dated: October 27, 1998 Received: November 2, 1998
Dear Mr. Shi:
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 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 (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 Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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.
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Page 2 - Ted Y. Shi
a mata mana mana mana mana mana mana mara mara mara mara mara mara mala sa t
יחידות המטע וביני הייתר המועד האירופי המו
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell P. Yagene
Company of Children Comments of
and the controlled on the comments of the states of the program and the first of the first of the first of
and the comments of the comment of the may be
for Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation
A Comments Beach Comments of Children
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Page 1 of 1
510(K) Number (if known): K983873
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The DHS/DCS Plate System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter-Use_ (Optional Format 1-2-96)
(Per 21 CFR 801.109)
Russell P. Reimer for Curer
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
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