(34 days)
Not Found
No
The document describes a mechanical catheter delivery system and does not mention any AI or ML components or functionalities.
No
The device is described as a delivery system intended to provide a pathway for other diagnostic and therapeutic devices, rather than being therapeutic itself. It facilitates the introduction of other devices into the heart.
No
The device is described as a delivery system intended to provide a pathway for diagnostic AND therapeutic devices, but it is not itself a diagnostic device. It facilitates the introduction of other devices, rather than performing a diagnostic function itself.
No
The device description clearly outlines multiple physical components (catheter, dilator, loader, etc.) and performance studies focus on physical characteristics like integrity and strength, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing a pathway for introducing diagnostic and therapeutic transvenous devices within the body (chambers and coronary vasculature of the heart). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: The description details a catheter system designed for insertion into the body. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the AMPLATZER® Reliant™ Catheter Delivery System is a medical device used for delivering other devices within the body, not an IVD.
N/A
Intended Use / Indications for Use
The AMPLATZER® Reliant™ Catheter Delivery System is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart.
Product codes
DQY
Device Description
The AMPLATZER® Reliant™ Catheter Delivery System is a sterile, single-use device designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 6-12 French (2.0-4.0 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components: Delivery Catheter, Dilator, Loader, Delivery Wire, Vise, Hemostasis Valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers and coronary vasculature of the heart
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
Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Reliant™ Catheter Delivery System are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 2 8 2007
510(k) SUMMARY of Safety and Effectiveness
Applicant Information: l.
| Date Prepared:
Submitter: | January 19, 2007
AGA Medical Corporation |
|-----------------------------------|----------------------------------------------------------|
| Address: | 5050 Nathan Lane North
Plymouth, MN 55442 |
| Establishment
Registration No. | 2135147 |
| Contact Person: | David D. Cox, Ph.D.
Senior Regulatory Affairs Manager |
| Telephone Number:
Fax Number: | (763) 531-3064
(763) 647-5932 |
II. Device Information:
| Trade Name: | AMPLATZER® Reliant™ Catheter Delivery System |
|---|---|
| Common Name: | Catheter Delivery System |
| Classification Name: | Catheter, Percutaneous |
|---|---|
| Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
-
Medtronic® SelectSite® Deflectable Catheter Delivery System Predicate Device: 510(k) No. K033989, Reg. No. 870.1250; Product Code: DQY
Predicate Device Intended Use: The deflectable catheter system is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. -
The AMPLATZER® Reliant™ Catheter Delivery System is a sterile. Device Description: single-use device designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart.
The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 6-12 French (2.0-4.0 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components:
1
- Delivery Catheter used to deliver transvenous devices � Dilator - used within the Delivery Catheter to dilate the vessel . and to help direct the Delivery Catheter during placement Loader- used to help introduce the selected implantable . device into the delivery catheter Delivery Wire - attaches to the implantable device and . facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.] Vise – a handle that is attached to the Delivery Wire by means . of a set screw Hemostasis Valve- used on the proximal end of the Loader to . minimize bleeding from the Delivery Catheter and for flushing air from the system The AMPLATZER® Reliant™ Catheter Delivery System is intended Intended Use: to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart. Comparison to The AMPLATZER® Reliant™ Catheter Delivery System is Predicate Device: substantially equivalent to the predicate device cleared by K033989. The two systems are both handheld catheter systems designed to facilitate access and placement of specified implantable devices within the chambers and coronary vasculature of the heart. Both delivery catheters are single lumen design with a hemostasis valve and an included dilator and introducer. Verification and validation testing confirms that the functional Test Data: characteristics of the AMPLATZER® Reliant" Catheter Delivery System are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.
- Based on the technical information, intended use, laboratory Summary: verification tests and in vitro performance information provided. the AMPLATZER® Reliant™ Catheter Delivery System is substantially equivalent to the currently marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AGA Medical Corporation c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
FEB 2 8 2007
Re: K070238
Amplatzer Reliant Catheter Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: February 6, 2006 Received: February 7, 2006
Dear Mr. Job:
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.
3
Page 2 - Mr. Mark Job
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,
Bram D. Zuckerman, M.D. Directof Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
16070238 510(k) Number:
Device Name: AMPLATZER® Reliant® Catheter Delivery System
Indications for use:
The AMPLATZER® Reliant™ Catheter Delivery System is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart.
Prescription Use X (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDE! D
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Syn-om
vascular m
DIVISION
ko 70238
AMPLATZER® Reliant™ Catheter Delivery System 510(k) Premarket Notification
Section 4 - Page 1