(276 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid control mechanisms, with no mention of AI or ML technologies.
Yes
The device is described as aiding in the "local and temporary delivery of therapeutic solutions" and the "removal of fresh, soft emboli and thrombi," which are therapeutic actions.
No
The device is designed for fluid control, therapeutic solution delivery, and removal of emboli/thrombi. While it can aid in visualization of a lesion, its primary functions do not involve diagnosing a condition or disease.
No
The device description explicitly lists multiple hardware components including a catheter, inflation device, aspiration syringe, lip seal, and strainer basket.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The 6F Proxis System is a medical device used within the body (in vivo) to control fluid flow, aid visualization, deliver therapeutic solutions, and remove emboli/thrombi directly in the coronary and peripheral vasculature.
- Lack of Specimen Testing: The description does not mention the device being used to test or analyze any biological specimens. Its function is entirely focused on interacting with the patient's circulatory system directly.
Therefore, the 6F Proxis System is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 6F Proxis 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 solutions.
The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The 6F Proxis System (Proxis System) is a proximal flow control system used in conjunction with other interventional devices. The Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporarily occluding the vessel which holds the column of fluid stagnant. The stagnant column can be used to aid in the visualization of the lesion and for the delivery of therapeutic solution(s).
The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), inflation device. aspiration syringe, lip seal, and strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.
The Proxis Catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion. To minimize the occlusion time, the interventional devices are advanced through the Proxis Catheter and positioned near the distal tip. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented.
While the vessel is occluded, therapeutic solutions may be infused through the Proxis 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 and/or fresh, soft thrombi and emboli during aspiration. Additionally, if there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to infuse saline to augment the retrograde flow of fluid and 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 System passed all verification specification criteria for dimensional, strength. functional, packaging, sterilization, biocompatibility, and shelf life tests as cleared in K063638. Previously reviewed test results (K063638 and K052523) 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 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
510(k) Summary Section 5.
Applicant Information 5.1
| Submitted by: | St. Jude Medical
6550 Wedgwood Rd. N, Suite 150
Maple Grove, MN 55311 | OCT-2 2008 |
| --------------- | ----------------------------------------------------------------------------- | ------------ |
|---|
| Contact Person: | Linh Pham |
|---|---|
| Telephone: | 763-383-0900 |
| Fax: | 763-383-2776 |
| Date Prepared: | 28 December, 2007 |
Device Information 5.2
| Trade Name: | 6F Proxis™ System |
|---|---|
| Classification Name: | Percutaneous Catheter |
| Classification: | Class II per 21 CFR 870.1250 |
| Product Code: | DQY |
Device Description 5.3
The 6F Proxis System (Proxis System) is a proximal flow control system used in conjunction with other interventional devices. The Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporarily occluding the vessel which holds the column of fluid stagnant. The stagnant column can be used to aid in the visualization of the lesion and for the delivery of therapeutic solution(s).
St. Jude Medical Proxis System Special 510k
1
The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), inflation device. aspiration syringe, lip seal, and strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.
The Proxis Catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion. To minimize the occlusion time, the interventional devices are advanced through the Proxis Catheter and positioned near the distal tip. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented.
While the vessel is occluded, therapeutic solutions may be infused through the Proxis 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 and/or fresh, soft thrombi and emboli during aspiration. Additionally, if there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to infuse saline to augment the retrograde flow of fluid and removal of stagnated fluid.
5.4 Intended Use
The 6F Proxis 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 solutions.
'The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.
2
5.5 Test Summary
The Proxis System passed all verification specification criteria for dimensional, strength. functional, packaging, sterilization, biocompatibility, and shelf life tests as cleared in K063638. Previously reviewed test results (K063638 and K052523) 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 System, no additional animal or clinical data was deemed necessary.
Substantial Equivalence 5.6
The Proxis System covered by this submission is substantially equivalent to the previously cleared Proxis System (K063638) and Proxis Flow Control System (K052523) given identical technological characteristics and principles of operation and similar intended uses (control of flow of fluids and aid in fresh, soft thrombus removal).
5.7 Conclusion
The Proxis System in this submission has similar indications for use-control of flow of fluids and aid in soft thrombus removal----(K052523), identical principles of operation (K063638) and technological characteristics (K063638) as the previously cleared predicate devices.
As a result, the differences between this device and its predicate devices do not raise new questions of safety or efficacy. Therefore, the Proxis System is substantially equivalent to its predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical c/o Ms. Linh Pham Regulatory Affairs Specialist 6500 Wedgwood Rd. N. Maple Grove, MN 55311
OCT - 2
Re: K073700
Trade/Device Name: 6F Proxis™ System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2008 Received: October 1, 2008
Dear Ms. Pham:
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
4
Page 2 -- Ms. Linh Pham
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 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.
Sincerely yours,
R. Barnes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication For Use Section 4.
510(k) Number: (073700 __
Device Name: 6F Proxis™ System
Indication for Use:
The 6F Proxis 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 solutions.
The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and efficacy of this device as an embolic protection system has not been established. The 6f Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dames D. Schuner
(Division Sign-Off) (Division Oigh Sin, Sin, Devices
510(k) Number_Ko737000
St. Jude Medical Proxis System Special 510k