(199 days)
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.
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.
The provided text is a 510(k) summary for the ThermopeutiX DuoFlo™ Catheter, and it does not contain the level of detail typically found in a study report for an AI/ML-based medical device. Therefore, I cannot extract all the requested information. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and basic performance/safety validation for a physical medical device (a catheter), not a software algorithm.
However, I can provide information based on what is available in the document regarding the performance and safety aspects of the physical device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions Performance and Safety validation but does not provide specific quantitative acceptance criteria or detailed reported performance in a tabular format as would be expected for an AI/ML study. It generally states that the device meets safety and integrity requirements.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated through biocompatibility studies of materials in accordance with ISO 10993-1. |
| Physical Integrity | Physical testing was performed to assure catheter integrity, including verification of catheter body and balloon burst pressure. |
| Sterility | Device is supplied sterile with a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Safety/Effectiveness | There are no new safety or effectiveness issues related to this device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the document describes validation for a physical catheter through biocompatibility and physical integrity testing, not a clinical study on a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The validation described does not involve establishing ground truth by human experts for a test set, as it's not a diagnostic or AI/ML device requiring such evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the same reasons as item 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The device is a physical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. There is no algorithm for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The "ground truth" for a physical device like a catheter would be its physical properties, material safety, and functional performance metrics, not clinical outcomes derived from expert assessment or pathology.
8. The sample size for the training set
This information is not applicable/provided. There is no training set for a physical catheter.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no training set for a physical catheter.
Summary of Study (Based on available information):
The "study" described in the 510(k) summary is primarily comprised of:
- Biocompatibility studies: Conducted on the raw materials in accordance with ISO 10993-1 to demonstrate the safety of materials in contact with the body.
- Physical testing: Performed to assure the integrity of the catheter, including verification of catheter body and balloon burst pressure. The document states that these tests were done to "assure catheter integrity."
- Sterility validation: The device is supplied with a Sterility Assurance Level (SAL) of 10⁻⁶.
The overall approach for this device relies on demonstrating substantial equivalence to already legally marketed predicate devices in terms of general indications, design, features, construction materials, and safety profile. The validation tests (biocompatibility, physical integrity, sterility) confirm that the DuoFlo™ Catheter meets established safety and performance standards for its type.
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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
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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.
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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
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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
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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
§ 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).