(252 days)
Not Found
No
The summary describes a mechanical catheter for infusion and flow control, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device itself is not a therapeutic device. It is intended for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow, which are functions that support therapy but do not constitute therapy directly. The therapeutic agents are separate from the catheter.
Yes
The "Intended Use / Indications for Use" section explicitly states that "the catheter can be used for infusion of diagnostic and/or therapeutic agents."
No
The device description clearly outlines a physical catheter with lumens, connectors, and a guidewire channel, indicating it is a hardware medical device.
Based on the provided information, the DuoFlo™ Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- DuoFlo™ Catheter Function: The description clearly states the DuoFlo™ Catheter is intended for intravascular use in the peripheral vasculature. It is used inside the body for infusion of agents and controlling blood flow.
- Lack of Specimen Testing: There is no mention of the DuoFlo™ Catheter being used to collect or test specimens from the body. Its function is directly related to interacting with the blood vessels themselves.
Therefore, the DuoFlo™ Catheter is a medical device used in vivo (inside the body), not an IVD.
N/A
Intended Use / Indications for Use
The DuoFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
The DuoFlo™ Catheter is contraindicated for use in the coronary and intracranial arteries.
The DuoFlo™ Catheter is not intended for embolic protection or as an aspiration catheter.
Product codes
MJN
Device Description
The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the standards outlined in ISO 10993-1.
The device is supplied sterility conforms to a Sterility Assurance Level (SAL) of 10-6. The supplied instructions for use provide the user with the applicable warnings and cautions during use. There are no new safety or effectiveness issues related to this device
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
ThermopeutiX, Inc. Special 510(k) Premarket Notification December11, 2009
510 (k) SUMMARY
Applicant
AUG 25 2010
ThermopeutiX, Inc. 9925B Businesspark Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717
Manufacturer
ThermopeutiX, Inc. 9925B Businesspark Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717
Contact Person
Thomas Schroeder, Director, RA/QA
| Common Names: | Temporary Intravascular Occluding Catheter |
|---|---|
| --------------- | -------------------------------------------- |
- Classification Name: Devices of this type are classified as Class II under 21 CFR Part CFR Part 870.4450, Vascular Clamp (Product Code MJN).
- DuoFlo™ Catheter (Heparin Coated) Proprietary Name:
Predicate Devices
The ThermopeutiX DuoFlo™ Catheter (Heparin Coated) is substantially equivalent in indications, design, construction and features to the ThermopeutiX DuoFlo™ catheter cleared under 510k K080700 with the exception that bound heparin has been included in the catheter's hydrophilic coating ..
1
Indications for Use
There is no change in the indications for use for the DuoFlo™ Catheter (Heparin Coated). The existing DuoFlo™ catheter indications statement remains unchanged.
Device Description
The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.
Technological Characteristics Comparison
The DuoFlo™ Catheter identical in design and construction to the currently marketed DuoFlo™ catheter with the exception that bound heparin has been included in the catheter coating. The heparin in the coating helps to minimize thrombus formation on the catheter surfaces.
Performance and Safety
The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the standards outlined in ISO 10993-1.
The device is supplied sterility conforms to a Sterility Assurance Level (SAL) of 10°. The supplied instructions for use provide the user with the applicable warnings and cautions during use. There are no new safety or effectiveness issues related to this device
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH &" is visible along the left side of the logo, oriented vertically.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ThermopeutiX, Inc c/o Mr. Thomas Schroeder Director, RA/QA 9925B Businesspark Avenue San Diego, CA 92131
AUG 2 5 2010
Re: K093847
Trade/Device Name: DuoFlo Catheter (Heparin Coated) Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: MJN Dated: July 22, 2010 Received: July 26, 2010
Dear Mr. Schroeder:
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Thomas Schroeder
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 of 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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.htm 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,
W.M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Device Name: DuoFlo™ Catheter and DuoFlo™ Catheter (Heparin Coated)
Indications for use: The DuoFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
The DuoFlo™ Catheter is contraindicated for use in the coronary and intracranial arteries.
The DuoFlo™ Catheter is not intended for embolic protection or as an aspiration catheter.
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)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Cardiovascular Devices
| 510(k) Number | 2093847 |
|---|---|
| --------------- | --------- |
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