(94 days)
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Not Found
No
The summary describes a physical medical device (introducer) and does not mention any software, algorithms, or AI/ML terms.
No.
The device is an introducer for catheters and other devices, not a device that directly treats a medical condition itself.
No
The device is described as an introducer to guide catheters and devices, not to diagnose a condition or disease.
No
The device description clearly indicates a physical, balloon-expandable introducer intended for percutaneous insertion into the femoral artery. This is a hardware device, not software.
Based on the provided information, the SoloPath™ Balloon Expandable TransFemoral Introducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that is inserted into the body (percutaneously into the femoral artery) to facilitate the introduction of other devices. This is an in vivo procedure, meaning it takes place within a living organism.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The SoloPath™ device does not perform any such testing on samples.
Therefore, the SoloPath™ Balloon Expandable TransFemoral Introducer is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.
Product codes
DYB
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
femoral artery, femoral iliac arteries
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
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.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Onset Medical Corporation c/o Mr. Mark Job 1394 25th St. NW Buffalo, MN 55313
OCT - 8 2009
Re: K092014
SoloPath™ Balloon Expandable TransFemoral Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 22, 2009 Received: September 23, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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, de noos that have been require approval of a premarket approval application (PMA). and Costhede Fror (110) the device, subject to the general controls provisions of the Act. The I ou may, diorolore, mains of the Act include requirements for annual registration, listing of general controls proficturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (so acols, Existing major regulations affecting your device can be . found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Dr over intimation that your device complies with other requirements of the Act that I DIT has made a cond regulations administered by other Federal agencies. You must of uny I occurrents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY at 007), laborning (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overlis) (2) Canadon (21 CFR Part 820); and if applicable, the electronic forth in the quality of every of ections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Mark Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R. bohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4. Indications for Use
510(k) Number (if known):_ ko 9 ZO | 4
Device Name: SoloPath™ Balloon Expandable TransFemoral Introducer
Indications for Use:
The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
suma R. Vahnes
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_ 109 201