(155 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a balloon catheter for venogram imaging, with no mention of AI or ML capabilities.
No.
The device is used for infusing contrast solutions for imaging, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for "infusing contrast solutions into the coronary vasculature for occlusive venogram imaging," which is a diagnostic imaging procedure to visualize the coronary vasculature.
No
The device description clearly outlines physical components such as a balloon catheter, stopcock, and syringe, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Attain Clarity™ 6225 Venogram Balloon Catheter is a medical device used within the body (in vivo) to facilitate imaging. It is used to infuse contrast solutions into the coronary vasculature for occlusive venogram imaging. This is a procedural device used during a medical imaging procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "infusing contrast solutions into the coronary vasculature for occlusive venogram imaging." This describes a procedure, not a diagnostic test performed on a sample.
Therefore, the Attain Clarity™ 6225 Venogram Balloon Catheter is a medical device used in vivo for imaging purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Attain Clarity™ 6225 Venogram Balloon Catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging.
Product codes
DQY
Device Description
The Attain Clarity™ 6225 Venogram Balloon Catheter contains one non-latex occlusion balloon catheter, one stopcock and one controlled stroke syringe. It is indicated for use within the coronary sinus and is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging. This device is available in one model, the Attain Clarity™ 6225 Venogram Balloon Catheter.
The Attain Clarity™ 6225 Venogram Balloon Catheter is a non-latex occlusion balloon catheter designed for use within the coronary sinus for infusing contrast solution for occlusive venogram imaging. The balloon catheter consists of polymeric tubing with an infusion port and an inflation port in the main body of the catheter. The inflation port features a luer lock at the proximal end. Inflation is achieved through the use of a controlled stroke fixed volume syringe attached to a stopcock. The stopcock is manually attached to the balloon catheter. Both the stopcock and the syringe are supplied with the device. A silicone balloon is located near the distal end; a marker band is located proximally to the balloon to help with visualizing the location of the balloon under fluoroscopy. The infusion port has a luer lock at the proximal end.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Device integrity testing was performed to support the equivalency of the Attain Clarity™ 6225 Venogram Balloon Catheter to the predicates. The following in-vitro bench tests were completed on the device: Dimensional testing, Balloon safety & performance testing, Catheter safety & performance testing, Compatibility testing, Packaging testing. The Attain Clarity™ 6225 Venogram Balloon Catheter met all specified design and performance requirements.
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
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
5 2012
510(k) Summary
Date Prepared:
April 20, 2012
Applicant:
Medtronic Ireland Parkmore Business Park West Galway Ireland
Official Correspondent:
Christine Fazentieux Senior Regulatory Affairs Specialist Medtronic Ireland Parkmore Business Park West . Galway Ireland Phone: (011-353-91) 708958 Fax: (011-353-91) 708672 Email: christine.fazentieux(@medtronic.com
Proprietary Name:
Medtronic Attain Clarity™ Venogram Balloon Catheter
Model:
6225
Device Classification Name: Product Code:
DQY
Catheter, Percutaneous
Class II, 21 CFR 870.1250
Device Description:
The Attain Clarity™ 6225 Venogram Balloon Catheter contains one non-latex occlusion balloon catheter, one stopcock and one controlled stroke syringe. It is indicated for use within the coronary sinus and is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging. This device is available in one model, the Attain Clarity™ 6225 Venogram Balloon Catheter.
1
KI2I2I9
| Indications For Use: | The Attain Clarity™ 6225 Venogram Balloon Catheter is
indicated for use within the coronary sinus; it is intended for
infusing contrast solutions into the coronary vasculature for
occlusive venogram imaging. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantially Equivalent
Devices: | The Attain Clarity™ 6225 Venogram Balloon Catheter is
similar to the following predicates with respect to intended
use, design and technology:
Attain™ 6215 Venogram Balloon Catheter (K012225,
cleared August 28, 2001) Oscor Occlusion Balloon Catheter, Model Venos™
(K081052, cleared June 18, 2008) |
| Summary of Technological
Characteristics: | The Attain Clarity™ 6225 Venogram Balloon Catheter is a
non-latex occlusion balloon catheter designed for use within
the coronary sinus for infusing contrast solution for occlusive
venogram imaging.
The balloon catheter consists of polymeric tubing with an
infusion port and an inflation port in the main body of the
catheter.
The inflation port features a luer lock at the proximal end.
Inflation is achieved through the use of a controlled stroke
fixed volume syringe attached to a stopcock. The stopcock is
manually attached to the balloon catheter. Both the stopcock
and the syringe are supplied with the device.
A silicone balloon is located near the distal end; a marker
band is located proximally to the balloon to help with
visualizing the location of the balloon under fluoroscopy.
The infusion port has a luer lock at the proximal end. |
| Summary of Studies: | Device integrity testing was performed to support the
equivalency of the Attain Clarity™ 6225 Venogram Balloon
Catheter to the predicates.
The following in-vitro bench tests were completed on the
device:
Dimensional testing Balloon safety & performance testing Catheter safety & performance testing Compatibility testing Packaging testing The Attain Clarity™ 6225 Venogram Balloon Catheter met
all specified design and performance requirements. |
:
.
2
Summary of Clinical Data:
No clinical investigation has been performed for this device.
Biocompatibility Information:
Biocompatibility testing for the Attain Clarity™ 6225 Venogram Balloon Catheter has been completed in accordance with the International Standard ISO10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing" for an external communicating devices with limited exposure i.e. whose contact with circulating blood is ≤ 24 hours.
The following Biocompatibility tests were performed:
- Cytotoxicity Study using ISO MEM Elution method: .
- ISO Maximisation Sensitisation Study .
- . ISO Acute Intracutaneous Reactivity
- ISO Acute Systemic Toxicity ●
- USP Material Mediated Pyrogen Study in Rabbits .
- ASTM In-vitro Hemolysis ●
- ASTM Partial Thromboplastin Time (PTT) . Coagulation Testing
- C3a Complement Activation Assay Study .
- SC5b-9Complement Activation Assay Study .
- In Vivo Thromboresistance Study in the Dog, Jugular . Vein
- . USP Physicochemical Tests for Plastic (Aqueous)
The biocompatibility evaluation completed verifies that the Attain Clarity™ 6225 Venogram Balloon Catheter is biocompatible.
The Attain Clarity™ 6225 Venogram Balloon Catheter will be sterilized using a validated Ethylene Oxide (EtO) to a minimum Sterility Assurance Level of 10-6 in compliance with ANSI/AAMI/ISO 11135-1.
Through the data and information presented, Medtronic Ireland considers the Attain Clarity™ 6225 Venogram Balloon Catheter to be substantially equivalent to the predicate devices.
Sterilization Validation:
Conclusion:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP
25 2012
Wendy A. Saunders Medtronic, Inc CRDM 8200 Coral Sea Street, MS MVS11 Mounds View, MN 55112
Re: K121219
Attain Clarity 6225 Venogram Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: September 14, 2012 Received: September 17, 2012
Dear Ms. Saunders:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram Zuckerman, MD
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known):
Medtronic Attain Clarity™ 6225 Venogram Balloon Catheter Device Name:
The Attain Clarity™ 6225 Venogram Balloon Catheter is indicated for Indications for Use: use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging.
Prescription Use
AND/OR
(Part 21 CFR 801 Subpart D)
X
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
മ്യേടിon Sign-Only
Division of Cardiovascular Devices
. 510(k) Number K12121