(402 days)
No
The description focuses solely on the mechanical and fluid delivery aspects of a catheter and does not mention any computational or analytical capabilities that would suggest AI/ML.
No.
The device is an infusion catheter designed to deliver fluids and isolate a region, but it is not described as directly providing therapy itself. Its function is to facilitate the delivery of physician-specified fluids, which may contain therapeutic agents, or to allow for other procedures, but it does not perform a therapeutic function on its own.
No
The device is described as an "Infusion Catheter" designed to "isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region." Its function is to deliver fluids and isolate regions, which are therapeutic actions, not diagnostic ones. While it mentions "fluoroscopy guidance" for positioning, the device itself is not performing a diagnostic function; the imaging modality is used to guide its therapeutic application.
No
The device description clearly details a physical catheter with multiple lumens, balloons, a hydrophilic coating, radiopaque markers, and connections for fluids and guide wires. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IsoFlow™ Infusion Catheter is a physical device designed to be inserted into the body (specifically, the vascular system) to isolate a region and deliver fluids directly to that region. It is used for therapeutic or diagnostic procedures performed within the body, not for testing samples outside the body.
- Intended Use: The intended use describes isolating a region and infusing fluids, which is an interventional procedure, not an in vitro diagnostic test.
- Device Description: The description details the physical components of a catheter designed for insertion and manipulation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on samples, or providing diagnostic information based on sample analysis.
Therefore, the IsoFlow™ Infusion Catheter is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.
The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.
Product codes
DQY, KRA
Device Description
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region. The exterior surface of the distal 120cm catheter length is treated with a hydrophilic coating.
The 2.4F IsoFlow™ Infusion Catheter System is intended to be used with guide catheters 4F (0.050") and larger, along with a 0.010" guide wire for positioning the catheter in the desired region. A standard Y-adaptor RHV provides for guide wire entry and saline flush into the main guide wire / bypass lumen of the catheter. Radiopaque markers at the distal tip and between the two balloons allow for final position adjustment under fluoroscopy guidance.
The two compliant balloons are inflated simultaneously using radiopaque fluid delivered via a single inflation lumen.
Physician specified infusion fluid through either the labeled infusion lumen or the labeled guidewire lumen is delivered via the 1-way stopcock connection. The mixture of infusion and radiopaque agents is delivered directly to the target region between the balloons, or out the distal tip respectively.
For infusion out of the sideport holes, retracting the guide wire to the radiopaque marker band proximal to both balloons allows blood to bypass the isolated tarqet region via holes connecting the guide wire / bypass lumen with the catheter exterior. Complete removal of the guidewire allows delivery from the distal tip.
All components of the catheter system are provided sterile. Each device is intended for single use. Do not reuse or attempt to resterilize any component of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
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5. 510(k) Summary
VascularDesigns™
MAY 2 9 2009
Kosjitt
Submitter's name: Address:
Vascular Designs Inc 5655 Silver Creek Valley Road #512 San Jose, CA 95138
Phone: Fax number: 408-230-5560 408-416-4116
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 Email: grace@regulatoryspecialists.com
Date the summary was prepared: April 16, 2008
| Name of the device: | IsoFlow |
|---|---|
| Trade or proprietary name: | IsoFlow |
| Common or usual name: | Infusion catheter |
| Classification name: | Catheter, percutaneous |
| Continuous flush catheter | |
| CFR Classification Reference | 870.1250 |
| 870.1210 | |
| Class | Class II (two) |
| Product Code | DQY |
| KRA |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
| Predicate Device Name | Submitted By | 510k
Reference # |
|-----------------------------------------|------------------------------|---------------------|
| DISPATCH™ Coronary Infusion
Catheter | SCIMED | K932616 |
| ISOLATE™ Infusion Catheter System | Lake Region Mfg. Co.
Inc. | K913517 |
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Description of the device:
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region. The exterior surface of the distal 120cm catheter length is treated with a hydrophilic coating.
The 2.4F IsoFlow™ Infusion Catheter System is intended to be used with guide catheters 4F (0.050") and larger, along with a 0.010" guide wire for positioning the catheter in the desired region. A standard Y-adaptor RHV provides for guide wire entry and saline flush into the main guide wire / bypass lumen of the catheter. Radiopaque markers at the distal tip and between the two balloons allow for final position adjustment under fluoroscopy guidance.
The two compliant balloons are inflated simultaneously using radiopaque fluid delivered via a single inflation lumen.
Physician specified infusion fluid through either the labeled infusion lumen or the labeled guidewire lumen is delivered via the 1-way stopcock connection. The mixture of infusion and radiopaque agents is delivered directly to the target region between the balloons, or out the distal tip respectively.
For infusion out of the sideport holes, retracting the guide wire to the radiopaque marker band proximal to both balloons allows blood to bypass the isolated tarqet region via holes connecting the guide wire / bypass lumen with the catheter exterior. Complete removal of the guidewire allows delivery from the distal tip.
All components of the catheter system are provided sterile. Each device is intended for single use. Do not reuse or attempt to resterilize any component of the system.
Indications:
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.
The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.
2
Summary of characteristics of our device compared to the predicate device:
| ISO Flow Catheter versus predicate devices | ||
|---|---|---|
| DISPATCH™ Coronary | ||
| Infusion Catheter | ISOLATE™ Infusion | |
| Catheter System | ||
| Parameter | K932616 | K913517 |
| Intended Use | Substantially Equivalent | Substantially Equivalent |
| Physical Description | Substantially Equivalent | Substantially Equivalent |
| Anatomical Sites | Substantially Equivalent | Substantially Equivalent |
| Design | Substantially Equivalent | Substantially Equivalent |
| Materials | Substantially Equivalent | Substantially Equivalent |
| IsoFlow Catheter versus predicate devices | |||
|---|---|---|---|
| ------------------------------------------- | -- | -- | -- |
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Image /page/3/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 an abstract symbol that resembles an eagle or bird in flight.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Designs C/O Regulatory Specialists, Inc. Ms. Grace Holland Regulatory Consultant 3722 Ave: Sausalito Irvine, CA 92606
MAY 2 9 2009
Re: K081147
Trade/Device Name: IsoFlow Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: May 4, 2009 Received: May 6, 2009
Dear Ms. Holland:
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 intestate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, IDA 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 that FDA has made a determination that your device complies with other requirements nf the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Directory Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use Statement Indications for Use
510(k) Number (if known): Koogli47
Device Name: IsoFlow
Indications for Use:
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.
The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.
Prescription Use V (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)
h
(Division/Sign-C Dill rdiovascular Devices
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