(153 days)
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No
The summary describes a simple mechanical device (suture wire) and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is a surgical suture wire used for mechanical approximation and fixation of tissues and bones. It does not provide any therapeutic effect but rather aids in the physical repair process.
No
Explanation: The device, described as a "Stainless Steel Soft Suture Wire," is intended for surgical procedures like bone fracture fixation and soft tissue approximation (e.g., abdominal wound closure, hernia repair). Its purpose is to repair or support tissues, not to diagnose a condition.
No
The device description clearly states "Suture Wire," which is a physical, hardware component used in surgery. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for surgical procedures like bone fixation and soft tissue approximation.
- Device Description: The device is a "Suture Wire," which is a surgical implant.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is clearly intended for use inside the body during surgery.
N/A
Intended Use / Indications for Use
The Stainless Steel Soft Suture Wire is intended for general orthopedic purposes for cerclage in or with bones, and for surgery such as Sternulli Closure, patella fracture fixation. The device is also intended for soft tissue approximation such as abdominal wound closure and hernia repair.
Product codes
LRN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bones, soft tissue (abdominal, patella)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 consists of a stylized eagle with three horizontal lines representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is facing to the right, and the text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 JUL
Dr. Assem Hedayat President Bregma International Trading Company, Ltd. 214-111 Research Drive Saskatoon, Saskatchewan Canada S7N 3R2
Re: K990355
Trade Name: Stainless Steel Soft Suture Wire Regulatory Class: II Product Code: LRN Dated: June 7, 1999 Received: June 11, 1999
Dear Dr. Hedayat:
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 (OS) 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.
1
Page 2 -- Dr. Assem Hedayat
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) 594-4595. 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,
Celia 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
Page of of
510(k) Number (if known):__ K990355
Device Name:_Suture Wire (87 LRN)
Indications For Use:
The Stainless Steel Soft Suture Wire is intended for general orthopedic
ones and The Stainless Steel Solt Suture Mic 15 meetigs in or bones, and surgery such as Sternulli Closure, nature is also intended for soft tissue
patella fracture fixation. The device is also intended for soft tissue patella fracture fixation. "The device is also more
approximation such as abdominal wound closure and hernia repair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Jise_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use-
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Re
Division of General Restorative Devices
510(k) Number
i