(155 days)
Not Found
No
The summary describes a mechanical system for controlling fluid flow and does not mention any computational or algorithmic components related to AI or ML.
No.
The device's primary function is to control fluid flow and create a stagnant column for visualization or temporary delivery of therapeutic solutions, not to provide therapy itself. It facilitates the delivery of other therapeutic devices or solutions.
No
The device is described as a flow control system that occludes vessels to aid in visualization or local delivery of therapeutic solutions. Its primary function is to manipulate fluid flow, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components: Evacuation Sheath Catheter, Inflation System, Infusion Catheter, Lip Seal, and an Aspiration syringe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control the flow of fluids in the coronary and peripheral vasculature for purposes like visualization and local delivery of therapeutic solutions. This is a direct intervention on the patient's body.
- Device Description: The device components (catheter, balloon, syringe, etc.) are designed for physical manipulation within the blood vessels.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. The Proxis Flow Control System is a therapeutic/interventional device used directly within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Proxis Flow Control system controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Proxis System has five major components: the Evacuation Sheath Catheter, Inflation System, Infusion Catheter, Lip Seal, and an Aspiration syringe.
The Evacuation Sheath Catheter has one proximal low-pressure compliant sealing balloon that is inflated to occlude the arterial vessel. A radiopaque marker at the balloon site facilitation and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has a sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloon is inflated using the Inflation System.
Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloon is inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the evacuation sheath catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.
Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the evacuation sheath catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.
The Aspiration syringe is provided for the removal of stagnated fluid during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal of stagnated fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and 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 Proxis Flow Control System passed all verification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy. Given the scope of the modifications incorporated to create the Proxis Flow Control System no additional animal or clinical data was deemed necessary.
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.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
99 ST. Jude MEDICAL
510(k) Summary
Applicant Information
| Submitted by: | St. Jude Medical |
|---|---|
| 6550 Wedgwood Rd. N. | |
| Suite 150 | |
| Maple Grove, MN 55311 |
MAY 1 1 2007
| Contact Person: | Shannon Springer |
|---|---|
| Telephone: | 763-383-0900 |
| Fax: | 763-322-8808 |
| Date Prepared: | 06 December, 2006 |
Device Information
| Trade Name: | |
|---|---|
| Common Name: | |
| Classification Name: | |
| Classification: | |
| Product Code: |
Proxis Flow Control System Percutaneous Catheter Catheter, Percutaneous Class II per 21 CFR 870.1250 DQY
Device Description
The Proxis System has five major components: the Evacuation Sheath Catheter, Inflation System, Infusion Catheter, Lip Seal, and an Aspiration syringe.
The Evacuation Sheath Catheter has one proximal low-pressure compliant sealing balloon that is inflated to occlude the arterial vessel. A radiopaque marker at the balloon site facilitation and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has a sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloon is inflated using the Inflation System.
Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloon is inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the evacuation sheath catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.
Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the evacuation sheath catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.
1
The Aspiration syringe is provided for the removal of stagnated fluid during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal of stagnated fluid.
Intended Use
The Proxis Flow Control System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.
Predicate Device Comparison / Technological Characteristics
The Proxis Flow Control System, a modification of the current over-the-wire Proxis System (K060651), was created by decreasing the diameter of the catheter and sealing balloon. The Proxis Flow Control System device covered by this submission is identical in function, mechanism of action and intended use as the market cleared rapid-exchange Proxis System (K042117). In addition, the technological characteristics and ability to control fluid flow are identical to the over-the-wire Proxis System (K060651). Although the device may be similar in design to the device cleared under K060651, the Proxis Flow Control System is not intended for embolic protection.
Test Summary
The Proxis Flow Control System passed all verification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy. Given the scope of the modifications incorporated to create the Proxis Flow Control System no additional animal or clinical data was deemed necessary.
Substantial Equivalence
The Proxis Flow Control System has the same indications for use, technical characteristics and principles of operation as the market cleared rapid exchange Proxis System (K042117). In addition, the Proxis Flow Control System has the same technological characteristics and flow control indication as the over-the-wire Proxis System (K06065/). Although the device may be similar in design to the device cleared under K060651, the Proxis Flow Control System is not intended for embolic protection. The differences between this device and its predicate devices do not raise new questions of safety or efficacy. Therefore, the Proxis Flow Control System is substantially equivalent to the predicate devices.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 2007
St. Jude Medical c/o Ms. Shannon Springer Sr. Regulatory Affairs Specialist 6550 Wedgewood Rd. N. Maple Grove, MN 55311
Re: K063638 Proxis Flow Control System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: April 26, 2007 Received: April 27, 2007
Dear Ms. Springer:
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. Iisting 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.
3
Page 2 - Ms. Shannon Springer
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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Duma R. Vochner
ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K063638
Device Name: Proxis Flow Control System
Indications for Use:
The Proxis Flow Control system controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. bechmer
Division Sign-Off
(Division Sign-Off)
(Division of Cardiovascular Devices
510(k) Number