(199 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical components and lumens.
Yes
The device is intended for the infusion of diagnostic and/or therapeutic agents, which indicates a therapeutic purpose.
No
The device is a catheter used for infusion of diagnostic and/or therapeutic agents and controlling blood flow, not for diagnosing conditions itself.
No
The device description clearly describes a physical catheter with lumens, shafts, and a balloon, indicating it is a hardware device, not software-only.
Based on the provided information, the DuoFlo™ Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- The DuoFlo™ Catheter is a medical device intended for intravascular use within the patient's body. Its purpose is to facilitate the delivery of substances or control blood flow in vivo.
The description clearly states its use in the peripheral vasculature for infusion and blood flow control, which are procedures performed directly on the patient, not on a sample outside the body.
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 Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.
The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.
Product codes
DQO, MJN, DXC
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 in arteries 3.5 mm and larger.
Contraindicated for use in the coronary and intracranial arteries.
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 ' ' bloghour banderials in accordance with the standards outlined in ISO 10993-1. Physical te : ing was performed to assure catheter integrity including verification of catheter body and balioon burst pressure.
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
2080700
SEP 2 6 2008
ThermopeutiX, Inc. September 25, 2008
510 (k) SUMMARY
Applicant
ThermopeutiX, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717
Manufacturer
ThermopeutiX, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: (858) 549-1760 Fax: (858) 549-1717
Contact Person
Thomas Schroeder, Director, RA/QA
- Temporary Intravascular Occluding Catheter Common Names: Diagnostic Intravascular Catheter Classification Names: Devices of this type are classified as Class II under 21 CFR Part 870.1200, Diagnostic Intravascular Catheter (Product Code DQO) and 21 CFR Part 870.4450, Vascular Clamp (Product Codes MJN and DXC). DuoFlo™ Catheter Proprietary name:
Predicate Devices
The ThermopeutiX DuoFlo™ is substantially equivalent in general indications and design and features to temporary occluding catheters, perfusion catheters and diagnostic intravascular catheters; these devices are:
-
- OriGen Dual Lumen Catheter (K003288) DQO
-
- Coaxia FloControl™ Catheter (K023914) MJN
-
- Couxia Remote Access Perfusion Catheter (K990573) DXC
1
510 (k) SUMMARY
Indications for Use
Indications for use: The DuoFlo™ Catheter is intended for general intravascular use in the perioheral 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 Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.
The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.
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.
Tecnnological Characteristics Comparison
Th a catheter is equivalent in design and construction to currently marketed temporary occluding catheters and intravascular continuous flush catheters. The construction materials used have an established history of safe use in similar medical devices.
Primance and Safety
The biological safety of the device has been demonstrated through biocompatibility studies of n : ' bloghour banderials in accordance with the standards outlined in ISO 10993-1. Physical te : ing was performed to assure catheter integrity including verification of catheter body and balioon burst pressure.
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 the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ThermopeutiX, Inc. c/o Ms. Dawn Tibodeau Project Coordinator TUV SUD America Inc. 1775 Old Hwy 8 NW, Stc 104 New Brighton, MN 55112-1891
Re: K080700
Trade/Device Name: DuoFlo™ Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 9, 2008 Received: September 10, 2008
Dear Ms. Tibodeau:
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.
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, 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 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); good manufacturing practice requirements as set forth in the quality
3
Page 2 - Ms. Dawn Tibodeau
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) promarket 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 Biometrics' (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.
Sincercly yours,
R. Vochines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
KO80700
Device Name: DuoFlo™ Catheter
Indications for use: The DuoFlo™ Catheter is intended for general intravascular use in Indications for assulature in arteries 3.5 mm and larger. Once placed in the selected the porferer rater face intelled of diagnostic and/or therapeutic agents, and region, the bathleter connected 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 Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.
The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.
Prescription Use: _ X (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)
Duna R. Sochares
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko80700