(24 days)
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 sinus.
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.
The provided text is a 510(k) summary for the Medtronic Attain LDS 6216A Left Heart Delivery System and Attain Access 6218A Left Heart Delivery System. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The "Summary of Studies" section explicitly states: "The modified Attain 6216A and 6218A Product Family met all specified design and performance requirements." However, the specific acceptance criteria and the details of the studies conducted to meet these requirements are not provided in this document.
Furthermore, the "Summary of Clinical Data" explicitly states: "No clinical investigation has been performed for this device." This confirms that there was no clinical study involving human patients to assess the device's performance in a clinical setting.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only generally states that "design and performance requirements" were met.
- Sample size used for the test set and the data provenance: Not available, as specific studies for performance are not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external "ground truth" establishment is mentioned for performance studies.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no clinical or AI-assisted study is described.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The studies mentioned are related to design and performance requirements (likely bench and lab testing) and biocompatibility (consistent with ISO10993-1:2003). The conclusion of the submission relies on the device's substantial equivalence to previously cleared predicate devices, meaning it shares similar technological characteristics, intended use, function, materials, and method of operation.
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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 |
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| Common Name: | Attain 6216A Left Heart Delivery SystemAttain 6218A Left Heart Delivery SystemAttain 6216A and 6218A Guide Catheters for Left Heart Delivery |
|---|---|
| Device Classification Name: | Catheter, PercutaneousClass II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Description: | The modified Attain 6216A and 6218A Left Heart DeliverySystems contain one or two guide catheters, one guide catheterdilator, one guidewire, one valve and one slitter. They are designedto access the coronary sinus and the chambers of the heart usingthe guidewire to access the vein, the valve to reduce blood lossduring the implant procedure, the guide catheter to introduce atransvenous device, the guide catheter dilator to facilitate catheterpassage and the slitter to remove the guide catheter.The modified Attain 6216A and 6218A Left Heart DeliverySystems are available in two models:Attain LDS 6216A Left Heart Delivery SystemAttain Access 6218A Left Heart Delivery SystemAll components with the exception of the guide catheter (shape,length and quantity) and dilator (length) are identical in bothmodels.The modified Attain 6216A/6218A Guide Catheters for Left HeartDelivery are individual packs, each containing one guide catheterand one guide catheter dilator. They are also designed to access thecoronary sinus and the chambers of the heart using the guidecatheter to introduce a transvenous device and the guide catheterdilator to facilitate catheter passage.The modified Attain 6216A and 6218A Guide Catheters areavailable 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 andlength and the dilator length. | |
| Indications For Use: | The modified Attain 6216A/6218A Product Family is intended forintroducing balloon catheters into the coronary sinus or leads intovessels of the left heart via the coronary sinus. |
| Substantially EquivalentDevices: | The modified Attain 6216A/6218A Product Family uses similartechnology and has similar intended uses, function, materials andmethod of operation to the following predicate devices: |
| • Attain Access 6218A Left Heart Delivery System (510(k)K021589). Also commercialized under this 510(k) numberis the Attain 6218A-45S, 6218A-50S, 6218A-57S and6218A-EH Guide Catheters for Left-Heart Deliveryindividual packs. | |
| • Attain LDS 6216A Left Heart Delivery System (510(k)K021587). Also commercialized under this 510(k) numberis the Attain™ 6216A-MB2 Guide Catheter for Left-HeartDelivery. | |
| • 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 andGuide Catheters for Left Heart Delivery (510(k) K090659). | |
| Summary of TechnologicalCharacteristics: | The modified Attain 6216A and 6218A guide catheters for leftheart delivery consist of an inner liner, and an outer jacket, with awire braid encapsulated between the inner liner and outer layers.The distal tip is radiopaque to facilitate imaging under fluoroscopyand the hub at the proximal end of the shaft allows interfacing ofthe catheter with other devices used during the procedure. Thecatheter is packaged with a dilator. Additionally, the Attain 6216Aand 6218A left heart delivery systems contain a valve to reduceblood loss and slitters to remove the guide catheter. Thetechnological characteristics of the modified Attain 6216A and6218A Product Family are identical to the predicate Attain 6216Aand 6218A Product Family (510(k) K024032, K024035, K021587and K021589) and the Attain Command Product Family(K090659). |
| Summary of Studies: | The modified Attain 6216A and 6218A Product Family met allspecified design and performance requirements. |
| Summary of Clinical Data: | No clinical investigation has been performed for this device. |
| BiocompatibilityInformation: | The biocompatibility evaluation completed verifies that themodified Attain 6216A/6218A Left Heart Delivery Systems andthe modified Attain 6216A/6218A Guide Catheters for Left HeartDelivery are biocompatible.The testing which supports the biocompatibility of the modifiedAttain 6216A/6218A Product Family is consistent withInternational Standard ISO10993-1:2003, "Biological Evaluationof Medical devices- Part 1: Evaluation and Testing." Whenclassified according to this standard, the catheter and dilatorincluded in the modified Attain 6216A/6218A Product Family arecategorized as external communicating devices with limitedexposure i.e. whose contact with circulating blood is (less than) <24hours. |
| Sterilization Validation: | The modified Attain 6216A and 6218A Product Family will besterilized using a validated Ethylene Oxide (EtO) sterilizationprocess. |
| Conclusion: | Through the data and information presented, Medtronic Irelandconsiders the modified Attain 6216A and 6218A Product Family tobe substantially equivalent to the predicate devices. |
.
CONFIDENTIAL May not be reproduced without written permission from Medtronic treland
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CONFIDENTIAL May not be reproduced without written permission from Medtronic Ireland
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Confidential May not be reproduced without written permission from MedIronic Ireland ા ર
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The text is in all caps and arranged to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT 2 7 2011
Medtronic, Inc. c/o Ms. Deborah Kidder Regulatory Affairs Specialist 8200 Coral Sea Street Mounds View, MN 55112
Re: K112917
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.
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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
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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
§ 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).