(43 days)
No
The device description and intended use focus on a physical balloon catheter for contrast infusion and imaging, with no mention of AI/ML in the device's function or analysis of the resulting images.
No.
The device is used for imaging (infusing contrast solutions for venogram imaging) and facilitating lead placement, not for treating a disease or condition.
No
Explanation: The device is described as a catheter used for infusing contrast solutions for venogram imaging, which is a method of acquiring images, not diagnosing a condition. Its purpose is to facilitate image acquisition rather than interpreting images or physiological signals to make a diagnosis.
No
The device description clearly outlines physical components like polymeric tubing, lumens, a syringe, a luer lock, a stopcock, and a latex balloon, 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 is for infusing contrast solutions into the coronary vasculature for venogram imaging. This is a procedure performed in vivo (within the living body) to visualize blood vessels.
- Device Description: The device is a balloon catheter designed for use within the coronary sinus. It's a physical tool used during a medical procedure.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status. This device does not perform any analysis of biological samples.
The device is a medical device used for a diagnostic imaging procedure performed on a patient.
N/A
Intended Use / Indications for Use
The Attain™ 6215 Venogram balloon catheter is intended for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.
Product codes
74 DYG
Device Description
The Medtronic Attain 6215 Venogram balloon catheter is designed for use within the coronary sinus for infusing contrast solutions for venogram imaging. It consists of extruded polymeric tubing with two lumens (inflation and infusion) in the main body of the catheter and a 1.25 cc controlled stroke volume syringe. The inflation lumen features a luer lock and stopcock at the proximal hub. Its distal end opens into a latex balloon, which is located near the catheter tip. The infusion lumen has a luer lock at its proximal hub.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus, coronary 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
Compatibility testing and incoming inspection of final packaged device was performed to support substantial equivalence to the predicate device. The Attain 6215 Venogram balloon catheter passed all of the in vitro specified requirements, and ensures that the Attain 6215 Venogram balloon catheter meets all of its design and performance requirements.
The Attain 6215 Venogram balloon catheter has been used in two Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain 6215 Venogram balloon catheter has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
510(K) Summary of Substantial Equivalence
| Date prepared | July 13, 2001 | |
|---|---|---|
| Submitter: | Medtronic, Inc. | |
| 7000 Central Avenue N.E. | ||
| Minneapolis, MN 55432 | ||
| Contact: | Karen Reidt, RAC | |
| Sr. Product Regulation Manager | ||
| Telephone: | (763) 514-3914 | |
| Fax: | (763) 514-6424 | |
| E-Mail: | karen.reidt@medtronic.com | |
| Proprietary Name: | Attain™ 6215 Venogram Balloon Catheter | |
| Common Name: | Catheter, Flow Directed | |
| Device Classification: | Class II, 21 CFR § 870.1240 | |
| Product Code: | 74 DYG |
Device Description
The Medtronic Attain 6215 Venogram balloon catheter is designed for use within the coronary sinus for infusing contrast solutions for venogram imaging. It consists of extruded polymeric tubing with two lumens (inflation and infusion) in the main body of the catheter and a 1.25 cc controlled stroke volume syringe. The inflation lumen features a luer lock and stopcock at the proximal hub. Its distal end opens into a latex balloon, which is located near the catheter tip. The infusion lumen has a luer lock at its proximal hub.
Indications for Use
The Attain™ 6215 Venogram balloon catheter is intended for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.
Medtronic COMMERCIAL
1
Substantially Equivalent Device
The predicate device for the Attain™ 6215 Venogram balloon catheter is outlined in the following table.
| Predicate Device | Predicate Device
Manufacturer | Predicate 510(k) |
|----------------------------------------------------------------|------------------------------------------------|-----------------------------|
| Balloon Wedge Pressure, Angiographic | B. Braun Medical, Inc.*
Allentown, PA 18103 | K822806
cleared 11/1/82 |
| Accent DG ™ Balloon Angioplasty
Catheter | Cook, Inc
Bloomington, IN 47402 | K900677
cleared 02/22/91 |
| Vueport ™ Coronary Sinus Balloon
Occlusion Guiding Catheter | Cardima, Inc
Freemont, CA 94538 | K973298
cleared 06/26/98 |
Summary of Studies
Compatibility testing and incoming inspection of final packaged device was performed to support substantial equivalence to the predicate device. The Attain 6215 Venogram balloon catheter passed all of the in vitro specified requirements, and ensures that the Attain 6215 Venogram balloon catheter meets all of its design and performance requirements.
Clinical Use Experience
The Attain 6215 Venogram balloon catheter has been used in two Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain 6215 Venogram balloon catheter has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus.
Biocompatibility Information
Because there are no new materials or material composition changes made to the Attain 6215 Venogram balloon catheter from those used in the predicate Model WP balloon catheter manufactured by B. Braun Medical, Inc., biocompatibility testing was not repeated for the Attain 6215 Venogram balloon catheter.
Sterilization Validation
The Attain 6215 Venogram balloon catheter is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Processes appropriate for sterilizing the devices were validated.
2
Conclusion
Through the data and information presented, as well as similarities to legally marketed devices, Medtronic Inc, considers the Attain 6215 Venogram balloon catheter to be substantially equivalent to the previously discussed legally marketed predicate devices.
Medtronic CONFIDENTIAL
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2001
Ms. Karen Reidt Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576
Re: K012225
Trade Name: Attain 6215 Venogram Balloon Catheter Regulation Number: 21 CFR 870.1240 Regulatory Class: Class II (two) Product Code: 74 DYG Dated: July 13, 2001 Received: July 16, 2001
Dear Ms. Reidt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
4
Page 2 - Ms. Karen Reidt
response to your premarket notification submission does not affect any obligation you might It spoulse to your promations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premater notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The I Dri imanig of easing 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 and If you desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, (201) 594-4640. Raditionally, For quice at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation 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,
Dak Tiller
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | N/A K012225 |
|---|---|
| Device Name: | Medtronic® Attain™ 6215 Venogram balloon catheter |
| Indications For Use: | The Attain 6215 Venogram balloon catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012225
CONNOCHTAL