(62 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of the infusion system and introducer sheath, with no mention of AI or ML capabilities.
Yes
The device is intended for "Infusion of physician-specified agents in the peripheral vasculature" and "selectively delivering physician-specified agents directly to the peripheral vasculature," which falls under the definition of a therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states: "The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature." Additionally, the "Device Description" mentions that the Introducer Sheath allows for "the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure."
No
The device description clearly outlines physical components: a catheter and an introducer sheath, made of polymer and metal. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Infusion of physician-specified agents in the peripheral vasculature" and to "facilitate the entry of interventional and diagnostic devices into the human vasculature." This describes a device used within the body for therapeutic or procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter and introducer sheath designed for delivering substances and introducing other devices into blood vessels. This is consistent with an interventional or therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the FlowMedica Bifurcated Infusion System is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlowMedica Bifurcated Infusion System is intended for the infusion of physicianspecified agents in the peripheral vasculature including but not limited to the renal arteries.
The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRA; DYB
Device Description
The FlowMedica Bifurcated Infusion System consists of the FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas.
The Bifurcated Infusion Catheter functions by selectively delivering physician-specified agents directly to the peripheral vasculature. The Bifurcated Infusion Catheter contains a 77cm working length shaft/infusion lumen. It is bifurcated at the distal end, which is comprised of two identical metal-supported and braided polymer branches.
The Introducer Sheath provides for the introduction of two interventional devices through a single vessel access site, allowing for the introduction of the Bifurcated Infusion Catheter and the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure. The Introducer Sheath, available in four lengths, is a polymer and metal coil reinforced sheath with two insertion ports in its integral Y hub assembly. The ports contain a hemostasis valve, designed for a 6Fr diagnostic or guiding catheter, and Touhy Borst valve used for the Bifurcated Infusion Catheter. A vessel diffator is supplied with the Introducer Sheath.
The FlowMedica Bifurcated Infusion Catheter is designed for use only with the FlowMedica Introducer Sheath. Each component is packaged separately and may be ordered and shipped separately; however, the Instructions for Use included with the Bifurcated Infusion Catheter specify exclusive usage with the FlowMedica Introducer Sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature including but not limited to the renal 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)
- . Design Verification Testing
- . Biocompatibility Testing
- Animal Testing
- Predicate Device Comparative Testing .
The results of the testing demonstrate that the FlowMedica, Inc. Bifurcated Infusion System performs as designed, is suitable for its intended use, and that it is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K904788, K955525, K030637, K883880, K897152, K924607, K970229, K012854
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
510(k) Summary
FlowMedica, Inc.
Bifurcated Infusion System
510(k) Notification K_033569 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
GENERAL INFORMATION
Manufacturer:
| FlowMedica, Inc. | |
|---|---|
| 46563 Fremont Boulevard | P: (510) 252-9500 |
| Fremont, CA 94538 | F: (510) 252-9515 |
Contact Person:
Jeff Elkins Vice President of R&D and COO
Date Prepared:
November 07, 2003
DEVICE DESCRIPTION
The FlowMedica Bifurcated Infusion System consists of the FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath.
Classification:
Continuous Flush Catheter, 21 CFR Sec. 870.1210, Class II
Introducer, Catheter, 21 CFR Sec. 870.1340, Class II
Trade Name:
FlowMedica Bifurcated Infusion System:
FlowMedica Bifurcated Infusion Catheter
FlowMedica Introducer Sheath
Generic/Common Name:
Continuous Flush Catheter
1
Introducer, Catheter
PREDICATE DEVICES
FlowMedica Bifurcated Infusion Catheter:
Boston Scientific Mewissen™ Catheter (K904788) Interventional Innovations Flower™ Infusion Catheter (K955525) EKOS Peripheral Infusion System (K030637) Boston Scientific Katzen™ Thrombolysis Wire (K883880) Boston Scientific Cragg FX™ Wire (K897152).
FlowMedica Introducer Sheath:
Cook Check-Flo® Performer® Introducer (unable to determine 510[k] reference) Cook Shuttle® SL Flexor® Tuohy-Borst Side Arm Introducer Set (unable to determine 510[k] reference)
Super Arrow-Flex® Percutaneous Sheath Introducer Set (K924607, K970229) Terumo Pinnacle™ Destination™ Renal Guiding Sheath (K012854)
INTENDED USE
The FlowMedica Bifurcated Infusion System is intended for the infusion of physicianspecified agents in the peripheral vasculature including but not limited to the renal arteries.
The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.
PRODUCT DESCRIPTION
The FlowMedica Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas.
The Bifurcated Infusion Catheter functions by selectively delivering physician-specified agents directly to the peripheral vasculature. The Bifurcated Infusion Catheter contains a 77cm working length shaft/infusion lumen. It is bifurcated at the distal end, which is comprised of two identical metal-supported and braided polymer branches.
The Introducer Sheath provides for the introduction of two interventional devices through a single vessel access site, allowing for the introduction of the Bifurcated Infusion Catheter and the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure. The Introducer Sheath, available in four lengths, is a polymer and metal coil reinforced sheath with two insertion ports in its integral Y hub assembly. The ports contain a hemostasis valve, designed for a 6Fr diagnostic or guiding catheter, and Touhy Borst valve used for the Bifurcated Infusion Catheter. A vessel diffator is supplied with the Introducer Sheath.
2
The FlowMedica Bifurcated Infusion Catheter is designed for use only with the FlowMedica Introducer Sheath. Each component is packaged separately and may be ordered and shipped separately; however, the Instructions for Use included with the Bifurcated Infusion Catheter specify exclusive usage with the FlowMedica Introducer Sheath.
SUBSTANTIAL EQUIVALENCE
The FlowMedica, Inc. Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath.
The FlowMedica Bifurcated Infusion Catheter has substantially equivalent indications for use, and/or technological characteristics as the Boston Scientific Mewissen™ Catheter (K904788), the Interventional Innovations Flower™ Infusion Catheter (K955525), the EKOS Peripheral Infusion System (K030637), the Boston Scientific Katzen™ Thrombolysis Wire (K883880), and the Boston Scientific Cragg FX™ Wire (K897152). Any differences in the technological characteristics do not raise any new issues of safety or efficacy. Comparative bench testing demonstrates that the performance and safety of the FlowMedica Bifurcated Infusion Catheter is equivalent to that of the predicate devices. Thus, it is substantially equivalent to the predicate devices.
The FlowMedica Introducer Sheath has substantially equivalent indications for use and and/or technological characteristics as the Cook Check-Flo® Performer® Introducer (unable to determine 510[k] reference), the Cook Shuttle® SL Flexor® Tuohy-Borst Side Arm Introducer Set (unable to determine 510[k] reference), the Super Arrow-Flex® Percutaneous Sheath Introducer Set (K924607 and K970229), and the Terumo Pinnacle™ Destination™ Renal Guiding Sheath (K012854). Any differences in the technological characteristics do not raise any new issues of safety or efficacy. Comparative bench testing demonstrates that the performance and safety of the FlowMedica Introducer Sheath is equivalent to that of the predicate devices. Thus, it is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
The following testing has been conducted. The results of the testing demonstrate that the FlowMedica, Inc. Bifurcated Infusion System performs as designed, is suitable for its intended use, and that it is substantially equivalent to the predicate devices:
- . Design Verification Testing
- . Biocompatibility Testing
- Animal Testing
- Predicate Device Comparative Testing .
SUMMARY
The FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath (the Bifurcated Infusion System) are substantially equivalent to the predicate devices.
3
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 stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 1 3 2004
FlowMedica, Inc. c/o Mr. Jeff Elkins Vice President R&D and COO 46563 Fremont Boulevard Fremont, CA 94538
Re: K033569
K033569
Trade/Device Name: FlowMedica Bifurcated Infusion System
Trade/Device Name: Flow Medica 1850, 21 CED 870, 1340 Trade/Device Name: 116w.hours: 21 CFR 870.1250; 21 CFR 870.1340 Regulation Numbers. 21 CFR 8707259, 2017
Regulation Names: Continuous Flush Catheter; Catheter Introducer Regulatory Class: Class II Product Codes: KRA; DYB Dated: November 11, 2003 Received: November 12, 2003
Dear Mr. Elkins:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premaise is substantially equivalent (for the indications
referenced above and have determined the device is substantierted in interstat referenced above and have delemined the devices marketed in interstate for use stated in the enclosure) to the enatment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the provision of the Federal Fo commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance was archarded application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require apptoval or a pel. controls provisions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject or the gential vannual registration, listing of
general controls provisions of the Act include requirements for amount misbrand general controls provisions of the Act Include requirements of the management 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 (see above) mio crime on regulations affecting your device can
may be subject to such additional controls. Existing major regulations alle addit may be subject to such additions: Entrois: Existing includes In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition, be found in the Code of Pederal Regalations, our device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a substitution with other requirements of the Act
that FDA has made a determination that your device also also as a concies. You m that FDA has made a determination that your are root by other Federal agencies. You must or any Federal statutes and regulations and mits of on timited to: registration and listing (21
comply with all the Act's requirements, including, but not one seguirements as comply with all the Act s requirements, meridanty, careforming practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement
4
Page 2 - Mr. Jeff Elkins
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 100-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1 product radiation control provisions (Declons over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your This letter will anow you to oegin manoling of substantial equivalence of your deversite way day premarket notheation. The PDA mining of casification 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 If you desire specific advice for your ac not 60 % 0.0 % 0.0 % as note the regulation entitled, contact the Office of Comphalled as (Set notification" (21CFR Part 807.97). You may obtain " Misoranding by reference to premantonities under the Act from the Division of Small
on 1900 of Shall information on your responsibilities under the Act from the 1900 Call o other general information on your responsibility and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ashley B Braun
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K033569
Device Name: FlowMedica Bifurcated Infusion System
Indications For Use: Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries.
The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adeline B. Brown
Page 1 of
(Division Sign Division of Cardiovascular D
510(K) Number