(68 days)
Not Found
No
The summary describes a system of bone plates and screws for fracture fixation, which are purely mechanical devices. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is a non-active implantable plate system used for fracture fixation, which is a structural or mechanical support, not a therapeutic intervention in itself.
No
The device, SOLCO 4CIS® General Plate System, is described as a system for bone fracture fixations, consisting of plates used to stabilize fractures. Its intended use focuses on mechanical support rather than detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly states it consists of physical plates made from titanium material, indicating it is a hardware 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 states the device is for "pelvic, small, and long bone fracture fixations." This is a surgical implant used to stabilize bones, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details plates made of titanium, which are physical implants.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SOLCO 4CIS® General Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femur, pelvis, metacarpals, metatarsals, humerus, ulna, radius, hand and middle foot bones.
Product codes
HRS
Device Description
The SOLCO 4CIS & General Plate System consists of One-third Tubular plate, Small self compression plate, Reconstruction plate (Straight, Curved), Narrow self Small Sole Compression plate. SOLCO 4CIS® General Plate. SOLCO 4CIS® General Plate comproblem participants sizes of implants to accommodate the individual byother with from pure titanium material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small, and long bone (tibia, fibula, femur, pelvis, metacarpals, metatarsals, humerus, ulna, radius, hand and middle foot bones)
Indicated Patient Age Range
adult or pediatric patients
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)
Mechanical testing was conducted in accordance with ASTM F382 and Nicenames." (coming 10.
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 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
K05 1155 p 1/2
JUL 1 1 2005
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information
| Contact: | Seayoung Ahn
7612 Barnum Road, Bethesda, MD 20817 |
|----------------|----------------------------------------------------------------------------------------|
| Sponsor: | 34-6 Keumam-ri, Seotan-myeon,
Pyeongtaek, Gyeonggi-do, 451-852
Republic of Korea |
| Date Prepared: | May 03, 2005 |
Device Identification
| Trade Name: | SOLCO 4CIS® General Plate System |
|---|---|
| Common Name: | Bone Fixation Plate |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation |
| Appliances and Accessories(HRS), 21 CFR § 888.3030 |
Substantially Equivalent Predicate Legally Marketed Devices
The subject devices, SOLCO 4CIS" General Plate System, are substantially equivalent in function, design, composition, material and intended used to
- l ) Synthes Low Profile Reconstruction Plates (K042377) and
-
- Smith & Nephew Bonc Plate System (K993106).
Device Description
The SOLCO 4CIS & General Plate System consists of One-third Tubular plate, Small self compression plate, Reconstruction plate (Straight, Curved), Narrow self Small Sole Compression plate. SOLCO 4CIS® General Plate. SOLCO 4CIS® General Plate comproblem participants sizes of implants to accommodate the individual byother with from pure titanium material.
1
KOSILES PL
Indications for Use
The SOLCO 4CIS* General Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femur, pelvis, metacarpals, metatarsals, humerus, ulna, radius, hand and middle foot bones.
Performance Data
Mechanical testing was conducted in accordance with ASTM F382 and Nicenames." (coming 10.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2005
Solco Biomedical Company, Ltd. C/o Mr. Saeyoung Ahn KLA MedTech Incorporated 7612 Barnum Road Bethesda, Maryland 20817
Re: K051155
K031155
Trade/Device Name: SOLCO 4CIS® General Plate System Regulation Number: 21 CFR 888.3030 Regulation Number: 21 CFK 886.5030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 4, 2005 Received: May 9, 2005
Dear Mr. Ahn:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section JTQ(s) prematially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and nave delemined the devices medicate devices marketed in interstate for use stated in the enclosure) to regally mancede provide interest of the Federal Food. Drug commerce prior to May 28, 1970, the charteries and the provisions of the Federal Food, Drug, devices that have been reculted in accordance whiles proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act . The and Cosmetic Act (Act) that to not require approval of the general controls provisions of the Act. The You may, therefore, market the device, but jeet to tires.
general controls provisions of the Act include requirements mightending and general controls provisions of the Feet mentals requirements of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into e. Existing major regulations affecting your device
it may be subject to such additional controls. Existing major regulation it may be subject to such additional controls: "Little" 21, "arts 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title Saderal Register can be found in the Code of Pederal Regarming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualles of a substant equirements of the requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmanon that your as reed by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21 comply with all the Act 3 requirements, mere manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing of if caplicable, the el CFR Part 807), labeling (21 CFR Fart 800); good manager (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000) (21 CFR 1000 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Saeyoung Ahn
This letter will allow you to begin marketing your device as described in your Section 510(k)
The States of the many of the only hat at the smivalence of your device to a leg This letter will allow you to begin makemig your artise of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA Intuing of substantial of a more of the more of 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
rs the regulation of 10 10 10 10 10 100 - Alge masses note the regulation e If you desire specific advice for your uc vice on van accesse note the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . Also, please note the regulat contact the Office of Comphalice at (240) 270 v 1400 person - 1200.97). You may obtain
"Misbranding by reference to premarket notification" (210) - 11 at the Division of Sm "Misbranding by reference to premarket nothlication (cr on the Division of Small)
other general information on your responsibilities under the Act from the 1800) 638-200 other general information on your responsionings and its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Assistance at 10 001 Mindustry/support/index.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/suppo
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
SOLCO 4CIS® General Plate System Device Name:
Indications for Use:
The SOLCO 4CIS® General Plate System is used for adult or pediatric patients as inclicated
Contraction of the Same of any for the disations for use include fractures of The SOLCO 4CIS * General Piate System is associons for use include fractures of
for pelvic, small, and long bone fracture fixations for use include fractures of for pelvic, small, and long bone fracture fractor. metators 10-1
the tibia, fibula, femur, pelvis, metacarpals, metatarsals, humerus, ulna, radius, hand and middle foot bones.
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)
Styt Purda
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Namber_________________________________________________________________________________________________________________________________________________________________
Solco Biomedical Co.,Ltd SOLCO 4CIS™ General Plate System 510(k) Submission