(24 days)
No
The device description focuses on physical components and their function in delivering catheters and leads. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a "Left Heart Delivery System" and "Guide Catheter" whose intended use is "for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart". It is designed to deliver other devices, not to provide therapeutic treatment itself.
No
The device is described as a delivery system for introducing balloon catheters or leads, and its components facilitate access and introduction of other transvenous devices. It does not perform diagnostic functions.
No
The device description explicitly details multiple physical components including guide catheters, a guide catheter dilator, a guidewire, a valve, and a slitter. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for introducing balloon catheters or leads into the coronary sinus and left heart vessels. This is a procedural device used in vivo (within the body) for delivering other medical devices.
- Device Description: The description details components like guide catheters, dilators, guidewires, valves, and slitters, all designed for accessing and navigating within the cardiovascular system. These are tools for a medical procedure, not for analyzing biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The modified Attain 6216A/6218A Product Family is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sınus.
Product codes
DQY
Device Description
The modified Attain 6216A and 6218A Left Heart Delivery Systems contain one or two guide catheters, one guide catheter dilator, one guidewire, one valve and one slitter. They are designed to access the coronary sinus and the chambers of the heart using the guidewire to access the vein, the valve to reduce blood loss during the implant procedure, the guide catheter to introduce a transvenous device, the guide catheter dilator to facilitate catheter passage and the slitter to remove the guide catheter.
The modified Attain 6216A and 6218A Left Heart Delivery Systems are available in two models: Attain LDS 6216A Left Heart Delivery System Attain Access 6218A Left Heart Delivery System All components with the exception of the guide catheter (shape, length and quantity) and dilator (length) are identical in both models.
The modified Attain 6216A/6218A Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. They are also designed to access the coronary sinus and the chambers of the heart using the guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.
The modified Attain 6216A and 6218A Guide Catheters are available in seven models as follows: Attain 6216A-MB2 Guide Catheter for Left Heart Delivery Attain 6216A-MP Guide Catheter for Left Heart Delivery
• Attain 6218A-AM Guide Catheter for Left Heart Delivery
• Attain 6218A-45S Guide Catheter for Left Heart Delivery
• Attain 6218A-EH Guide Catheter for Left Heart Delivery
• Attain 6218A-50S Guide Catheter for Left Heart Delivery
• Attain 6218A-57S Guide Catheter for Left Heart Delivery
Each model is different with respect to guide catheter shape and length and the dilator length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy (to facilitate imaging)
Anatomical Site
Coronary sinus, vessels of the left 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
The modified Attain 6216A and 6218A Product Family met all specified design and performance requirements.
Key Metrics
Not Found
Predicate Device(s)
K021589, K021587, K024035, K024032, K090659
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
K112917
OCT 2 7 2011
CONFIDENTIAL May not be reproduced without written permission from Medtronic Ireland
4.0 510(k) Summary
| Date Prepared: | September 29th, 2011 |
|---|---|
| Applicant: | Medtronic Ireland |
| Parkmore Business Park West | |
| Galway | |
| Ireland | |
| Primary Correspondent: | Aoife Kerans |
| Regulatory Affairs Specialist | |
| Medtronic Ireland | |
| Parkmore Business Park West | |
| Galway | |
| Ireland | |
| Phone: (011-353-91) 708858 | |
| Fax: (011-353-91) 708672 | |
| Email: aoife.kerans@medtronic.com | |
| Alternate Correspondent: | Deborah Kidder |
| Principal Regulatory Affairs Specialist | |
| Cardiac Rhythm Disease Management | |
| 8200 Coral Sea Street | |
| MS MVS11 | |
| Mounds View MN 55112 | |
| USA | |
| Phone: (763) 526-3561 | |
| Fax: (651) 367-0603 | |
| Email: deborah.a.kidder@medtronic.com | |
| Proprietary Name: | Attain LDS 6216A Left Heart Delivery System |
| Attain Access 6218A Left Heart Delivery System | |
| Attain 6216A and 6218A Guide Catheters for Left Heart Delivery |
12
1
| Common Name: | Attain 6216A Left Heart Delivery System
Attain 6218A Left Heart Delivery System
Attain 6216A and 6218A Guide Catheters for Left Heart Delivery |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name: | Catheter, Percutaneous
Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Description: | The modified Attain 6216A and 6218A Left Heart Delivery
Systems contain one or two guide catheters, one guide catheter
dilator, one guidewire, one valve and one slitter. They are designed
to access the coronary sinus and the chambers of the heart using
the guidewire to access the vein, the valve to reduce blood loss
during the implant procedure, the guide catheter to introduce a
transvenous device, the guide catheter dilator to facilitate catheter
passage and the slitter to remove the guide catheter.
The modified Attain 6216A and 6218A Left Heart Delivery
Systems are available in two models:
Attain LDS 6216A Left Heart Delivery SystemAttain Access 6218A Left Heart Delivery System
All components with the exception of the guide catheter (shape,
length and quantity) and dilator (length) are identical in both
models.
The modified Attain 6216A/6218A Guide Catheters for Left Heart
Delivery are individual packs, each containing one guide catheter
and one guide catheter dilator. They are also designed to access the
coronary sinus and the chambers of the heart using the guide
catheter to introduce a transvenous device and the guide catheter
dilator to facilitate catheter passage.
The modified Attain 6216A and 6218A Guide Catheters are
available in seven models as follows:
Attain 6216A-MB2 Guide Catheter for Left Heart DeliveryAttain 6216A-MP Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-AM Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-45S Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-EH Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-50S Guide Catheter for Left Heart Delivery |
| | • Attain 6218A-57S Guide Catheter for Left Heart Delivery |
| | Each model is different with respect to guide catheter shape and
length and the dilator length. |
| Indications For Use: | The modified Attain 6216A/6218A Product Family is intended for
introducing balloon catheters into the coronary sinus or leads into
vessels of the left heart via the coronary sinus. |
| Substantially Equivalent
Devices: | The modified Attain 6216A/6218A Product Family uses similar
technology and has similar intended uses, function, materials and
method of operation to the following predicate devices: |
| | • Attain Access 6218A Left Heart Delivery System (510(k)
K021589). Also commercialized under this 510(k) number
is the Attain 6218A-45S, 6218A-50S, 6218A-57S and
6218A-EH Guide Catheters for Left-Heart Delivery
individual packs. |
| | • Attain LDS 6216A Left Heart Delivery System (510(k)
K021587). Also commercialized under this 510(k) number
is the Attain™ 6216A-MB2 Guide Catheter for Left-Heart
Delivery. |
| | • Attain 6218A-AM Guide Catheter for Left-Heart Delivery
(510(k) K024035). Also commercialized under this 510(k)
number is the Attain™ 6218A-EH Guide Catheter for Left-
Heart Delivery individual pack. |
| | • Attain 6216A-MP Guide Catheter for Left-Heart Delivery
(510(k) K024032) |
| | • Attain Command 6250 Left Heart Delivery Systems and
Guide Catheters for Left Heart Delivery (510(k) K090659). |
| | |
| Summary of Technological
Characteristics: | The modified Attain 6216A and 6218A guide catheters for left
heart delivery consist of an inner liner, and an outer jacket, with a
wire braid encapsulated between the inner liner and outer layers.
The distal tip is radiopaque to facilitate imaging under fluoroscopy
and the hub at the proximal end of the shaft allows interfacing of
the catheter with other devices used during the procedure. The
catheter is packaged with a dilator. Additionally, the Attain 6216A
and 6218A left heart delivery systems contain a valve to reduce
blood loss and slitters to remove the guide catheter. The
technological characteristics of the modified Attain 6216A and
6218A Product Family are identical to the predicate Attain 6216A
and 6218A Product Family (510(k) K024032, K024035, K021587
and K021589) and the Attain Command Product Family
(K090659). |
| Summary of Studies: | The modified Attain 6216A and 6218A Product Family met all
specified design and performance requirements. |
| Summary of Clinical Data: | No clinical investigation has been performed for this device. |
| Biocompatibility
Information: | The biocompatibility evaluation completed verifies that the
modified Attain 6216A/6218A Left Heart Delivery Systems and
the modified Attain 6216A/6218A Guide Catheters for Left Heart
Delivery are biocompatible.
The testing which supports the biocompatibility of the modified
Attain 6216A/6218A Product Family is consistent with
International Standard ISO10993-1:2003, "Biological Evaluation
of Medical devices- Part 1: Evaluation and Testing." When
classified according to this standard, the catheter and dilator
included in the modified Attain 6216A/6218A Product Family are
categorized as external communicating devices with limited
exposure i.e. whose contact with circulating blood is (less than) Trade/Device Name: Attain Catheter Product Family models 6216A and 6218A Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: September 30, 2011 Received: October 3, 2011.
Dear Ms. Kidder:
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.
5
Page 2 – Ms. Deborah Kidder
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
ICC
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
Device Name: Attain 6216A and 6218A Product Family
Indications For Use: The Attain 6216A/6218A Product Family is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sınus.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K112917