(179 days)
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No
The 510(k) summary describes a standard medical device (coronary guiding catheter) and its physical characteristics and performance through bench testing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device is described as a "Coronary Guiding Catheter" used for introducing other medical instruments, monitoring, and injecting contrast medium. Its intended use is to guide and facilitate other interventions, not to directly treat a medical condition itself.
No
The device is a coronary guiding catheter used for introducing medical instruments and for procedures like injecting contrast medium, pressure monitoring, and passing interventional devices. It is not described as detecting or identifying a disease or condition.
No
The device description clearly outlines a physical catheter made of plastic, stainless steel braid, and teflon, designed for intravascular introduction of medical instruments. The performance studies are bench tests on the physical properties of the catheter. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Medi-Dyne, Inc. Coronary Guiding Catheter is a physical instrument used within the body (intravascularly) to facilitate medical procedures like injecting contrast medium, monitoring pressure, and delivering other devices. It does not analyze samples taken from the body.
The description clearly indicates its use as a tool for interventional procedures within the cardiovascular system, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents.
The Medi-Dyne, Inc. Coronary Guiding Catheter is designed to be used for the intravascular introduction of medical instruments.
Product codes
74 DQY
Device Description
The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents.
The Medi-Dyne device is similar in construction and materials when compared to the predicate devices. For example, both the Medi-Dyne and predicate device is manufactured with a plastic luer, radiopacifier loaded plastic shaft (jacket), a radiopacifier loaded soft tip, a teflon lined lumen, and an encapsulated layer of stainless steel braid between the inner teflon/liner and the outer plastic jacket. In addition, the lumens are similar in size, the distal ends are nontapered and sideholes are available.
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
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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
The following nonclinical tests were performed:
- Tensile strength of catheter body
- Tensile strength of catheter body to luer attachment
- Catheter stiffness
- Catheter tip (distal) attachment strength
- Catheter elongation
- Leakage at hub
- Catheter burst test (positive internal pressure)
- Catheter collapse (negative internal pressure)
- Catheter flexural fatigue tolerance
- Curve retention
- Frequency response
Based on the above bench testing, it was determined that the Medi-Dyne catheter is safe and effective and is substantially equivalent to predicate devices noted above. The Medi-Dyne equivalence equaled or exceeded values obtained on competitive products (1 thru 11). Review of competitive literature suggested no differences in indicated use or performance claims.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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Section 1 General Information
C. 510 (k) Summary
Summary of safety and effectiveness for the Medi-Dyne Powerback Coronary Guiding Catheter
Medi-Dyne, Inc. Submitter: 604 Queensbury Avenue AUG - 1 1997 Queensbury, New York 12804 518-792-2183 Phone : Fax: 518-792-2184
- Norman L. Hall Contact: Manager, QA/Reg. Affairs
Date Prepared: January 30, 1997
| Device Name: | Trade Name | Medi-Dyne Powerback Coronary
Guiding Catheter |
|--------------|----------------|--------------------------------------------------|
| | Common Name | Coronary Guiding Catheter |
| | Classification | Percutaneous Catheter (per
870.1250) |
SE to Marketed Device:
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The Medi-Dyne Powerback Coronary Guiding Catheter is comparable to the Cordis Corporation Coronary Guiding Catheter (Petite Brite Tip™ and Vista Brite Tip™ models) and to the SCIMED Life Systems, Inc. Coronary Guiding Catheter (Triguide™ - Elite model).
Description and Intended Use:
The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents.
Technological Characteristics Comparison:
The Medi-Dyne device is similar in construction and materials when compared to the predicate devices. For example, both the Medi-Dyne and predicate device is manufactured with a plastic luer, radiopacifier loaded plastic shaft (jacket), a radiopacifier loaded soft tip, a teflon lined lumen, and an encapsulated layer of stainless steel braid between the inner teflon/liner and the outer plastic jacket. In addition, the lumens are similar in size, the distal ends are nontapered and sideholes are available.
1
General Information Section 1
- 510(k) Summary {Continued} C.
Assessment of Performance Data (Bench Tests):
The following nonclinical tests were performed:
- Tensile strength of catheter body 1.
- Tensile strength of catheter body to luer 2. attachment
-
- Catheter stiffness
- Catheter tip (distal) attachment strength র :
বাংলাদেশে প্রায় করে বাংলাদেশ করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে -
- Catheter elongation
-
- Leakage at hub
- Catheter burst test (positive internal pressure) 7 . .
- Catheter collapse (negative internal pressure)
- Catheter flexural fatigue tolerance 9.
-
- Curve retention
대표 대책위원회 대회 대학교 1000 1000 1000 1000 1000 1
- Frequency response 11.
Based on the above bench testing, it was determined that the Medi-Dyne catheter is safe and effective and is substantially equivalent to predicate devices noted above. The Medi-Dyne equivalence equaled or exceeded values obtained on competitive oxoducts (1 thru 11). Review of competitive literature suggested po differences in indicated use or performance claims.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
AUG | 1997
Mr. Norman Hall Medi-Dyne, Inc. 604 Queensbury Avenue Queensbury, New York 12804
Re: K970401 Coronary Guiding Catheter Regulatory Class: II (two) Product Code: 74 DQY Dated: May 27, 1997 Received: May 29, 1997
Dear Mr. Hall:
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 aqainst 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 requlations.
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Page 2 - Mr. Norman Hall
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) 594-4639. 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,
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
The Medi-Dyne, Inc. Coronary Guiding Catheter is designed to
r and the consideration dusting of medical instruments The Medi-Dyne, Inc. Coronaly Gulding Catheror and Corporation
be used for the intravascular introduction of medical instruments
on the intravaluation response be used for the incravablar system.
Tana A-Rys
(Division Sign-Off)
Director Sign-Off)
Direstin of Cardiovascular, Res and Neurological Devices 5 1 O(k) Number -