(43 days)
No
The summary describes a mechanical system for embolic protection and aspiration, with no mention of AI or ML in its function or description.
Yes
The device is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material in saphenous vein coronary bypass grafts during percutaneous transluminal coronary angioplasty and/or stenting procedures, which is a therapeutic function. It also controls the flow of fluids and aids in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
No
The Proxis System is an embolic protection system designed to prevent and remove embolic material during interventional procedures, not to diagnose medical conditions.
No
The device description explicitly lists physical components such as a catheter, inflation device, syringe, lip seal, and strainer basket, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (percutaneous transluminal coronary angioplasty and/or stenting) to physically protect against and remove embolic material from blood vessels. This is an interventional device, not a diagnostic one.
- Device Description: The description details a system of catheters, syringes, and other components designed for physical manipulation within the body (preventing flow, aspirating material). This aligns with an interventional device.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, tissue, etc.) in vitro to provide diagnostic information about a patient's condition. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens from the human body in vitro to provide information for diagnostic, monitoring, or compatibility purposes. The Proxis System does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm - 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.
The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction. The device is not intended to be used as a thrombectomy system.
Product codes
NFA
Device Description
The Proxis System (Proxis Embolic Protection System) is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. 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.
In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. Upon completion of the interventional device procedure, fluid and particles from the procedure may be aspirated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to aspirate fluid and particles from the treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous vein coronary bypass graft(s), 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 K060651. Previously reviewed test results (K060651 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 proposed Proxis System, no additional animal or clinical data was deemed necessary.
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 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
Section 5. 510(k) Summary
Applicant Information 5.1
| Submitted by: | St. Jude Medical |
|---|---|
| 6550 Wedgwood Rd. N., Suite 150 | |
| Maple Grove, MN 55311 |
1 31
| Contact Person: | Linh Pham |
|---|---|
| Telephone: | 763-383-2586 |
| Fax: | 763-383-2776 |
| Date Prepared: | 17 December, 2007 |
5.2 Device Information
| Trade Name: | Proxis System |
|---|---|
| Common Name: | Proximal Embolic Protection Device |
| Classification Name: | Device, coronary saphenous vein bypass graft, temporary, for |
| embolization protection | |
| Classification: | Class II per 21 CFR 870.1250 |
| Product Code: | NFA |
Device Description 5.3
The Proxis System (Proxis Embolic Protection System) is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), Inflation device, Aspiration syringe, Lip Seal and Strainer
1
In addition, an optional accessory called the Proxis Infusion Catheter (packaged basket. separately) may be used with Proxis System.
In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. Upon completion of the interventional device procedure, fluid and particles from the procedure may be aspirated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to aspirate fluid and particles from the treatment site.
5.4 Intended Use
There is no change to the intended use of the modified Proxis System as it is identical to the predicate Proxis System, K052523-Sept. 7, 2006.
The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm -- 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.
The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction. The device is not intended to be used as a thrombectomy system.
2
K073563
Predicate Device Comparison/Technological Characteristics 5.5
The Proxis System included in this Special 510(k) submission shares the same intended use as the predicate Proxis System (K052523, Sept. 7, 2006), which is indicated for embolic protection, control of flow of fluids, and aid in the removal of fresh soft thrombi and emboli. The modified Proxis System is physically identical to the cleared Proxis System (K060651, Sept. 13, 2006)), with the exception of a non-significant change in material for the occluding balloon. In addition, a precaution statement was added to the Instructions for Use to alert users of the risk of applying excessive pressure to the Proxis System.
The modifications to the Proxis System do not affect the intended use of the system and there is no alteration in the fundamental scientific technology of the device. The Proxis System covered by this Special 510(k) submission is identical in function, technological characteristics, mechanism of action and intended use as the market cleared predicated devices, Proxis System (K060651 & K052523 ).
Test Summary 5.6
The Proxis System passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests as cleared in K060651. Previously reviewed test results (K060651 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 proposed Proxis System, no additional animal or clinical data was deemed necessary.
3
5.7 Substantial Equivalence
The Proxis System covered by this submission is substantially equivalent to the previously cleared Proxis Systems, K060651 and K052523, given identical technological characteristics, principles of operation and intended use.
5.8 Conclusion
The Proxis System in this submission has the same indications for use (K052523), principles of operation (K052523 & K060651), and technological characteristics (K060651) 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.
4
Public Health Service
Image /page/4/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 three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 31 2008
St. Jude Medical c/o Ms. Linh Pham Regulatory Affairs Specialist 6500 Wedgwood Road North Maple Grove, MN 55311
Re: K073563
Trade Name: Proxis 1M System Regulation Number: 21 CFR 870.1250 Regulation Name: Proximal Emblic Protection Device Regulatory Class: Class II Product Code: NFA Dated: January 25, 2008 Received: January 28, 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
5
Page 2 - Ms. Linh Pham
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 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) 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. Vorliner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Section 4. Indication For Use
510(k) Number: _ KO73563
Device Name: Proxis System
Indication for Use:
The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm - 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.
The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction. 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)
Duna R. Volmer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko73563
Confidential