(15 days)
No
The 510(k) summary describes a mechanical delivery system with no mention of AI or ML capabilities. The changes are material and configuration based.
No
The device is a delivery system for introducing other devices (balloon catheters or leads) into the heart; it does not itself provide a therapeutic effect.
No
The device is described as a delivery system for introducing catheters or leads, indicating its function is interventional rather than diagnostic. It facilitates procedures, but does not diagnose conditions.
No
The device description explicitly lists multiple hardware components (guide wires, valves, catheters, dilator, slitters, clip) and describes physical changes to the guide catheter material and system configuration.
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 or left heart vessels. This is a surgical/interventional procedure performed directly on a patient's body.
- Device Description: The components described (guide wires, catheters, dilators, slitters, valves) are all tools used for accessing and navigating within the cardiovascular system during a procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis of specimens.
Therefore, the Attain™ Access 6218A Left-heart delivery system is a medical device used for a surgical/interventional procedure, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Medtronic Attain Access 6218A Left-heart delivery system is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Product codes
DQY
Device Description
The left-heart delivery system features two guide wires to facilitate venous access, adjustable hemostasis valves to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.
The Attain Access 6218A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.
The key changes being made to the system are the addition of Tungsten Carbidefilled polyether block amide material to the guide catheter distal tip segment and the addition of extra slitters and adjustable hemostasis valves in a revised system configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left heart, coronary sinus
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)
In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain Access 6218A meets all of its 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
MAY 3 0 2002
CONFIDENTIAL
May not be reproduced without written permission from Medtronic, Inc.
510(K) Summary of Substantial Equivalence
Date prepared Submitter:
Submission Correspondent:
Telephone: Fax:
E-Mail:
Proprietary Name:
Common Name: Device Classification: Product Code:
May 13, 2002
Medtronic, Inc. Parkmore Business Park West Galway, Ireland.
Karen Reidt, RAC Sr. Product Regulation Manager 7000 Central Avenue N.E. Minneapolis. MN 55432
(763) 514-3914
(763) 514-6424
Attain™ Access 6218A Left-heart delivery system
Catheter, Percutaneous
Class II, 21 CFR § 870.1250
74 DQY
Performance Standard
Performance standards do not currently exist for these devices. None established under Section 514.
Device Description
The left-heart delivery system features two guide wires to facilitate venous access, adjustable hemostasis valves to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.
The Attain Access 6218A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.
The key changes being made to the system are the addition of Tungsten Carbidefilled polyether block amide material to the guide catheter distal tip segment and
1
CONFIDENTIAL
May not be reproduced without written permission from Medtronic, Inc.
the addition of extra slitters and adjustable hemostasis valves in a revised system configuration.
Indications for Use
The intended use of the Medtronic Attain Access 6218A Left-heart delivery system is for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus
Substantially Equivalent Device
| Attain Access
6218A Left-heart
Delivery System
| Device | Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|---|---|---|---|
| 45 cm and 50 cm | |||
| Guide Catheters | Medtronic Attain Access | ||
| 6218 Left-heart Delivery | |||
| System | Medtronic, Inc. | ||
| Minneapolis, MN 55432 | K012083 | ||
| Guide Catheter | |||
| Dilator | Medtronic Attain Access | ||
| 6218 Left-heart Delivery | |||
| System | Medtronic, Inc. | ||
| Minneapolis, MN 55432 | K012083 | ||
| Adjustable | |||
| Hemostasis Valve | Medtronic Attain Access | ||
| 6218 Left-heart Delivery | |||
| System | Medtronic, Inc. | ||
| Minneapolis, MN 55432 | K012083 | ||
| 120 cm Guide | |||
| Wires | Medtronic Attain Access | ||
| 6218 Left-heart Delivery | |||
| System | Medtronic, Inc. | ||
| Minneapolis, MN 55432 | K012083 | ||
| 4 Fr and 6 Fr | |||
| Guide Catheter | |||
| Slitters | Medtronic Attain Access | ||
| 6218 Left-heart Delivery | |||
| System | Medtronic, Inc. | ||
| Minneapolis, MN 55432 | K012083 | ||
| Guide Wire Clip | Class I device, exempt from premarket notification |
Attain Access 6218A Left-heart Delivery System Predicate Device
Summary of Studies
In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain Access 6218A meets all of its design and performance requirements.
Biocompatibility Information
Biocompatibility testing was performed on representative samples of Attain product. Complete testing according to ISO 10993-1 was conducted and all materials were found to be biocompatible.
2
Sterilization Validation
The Attain Access 6218A Left-heart delivery system is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Appropriate processes for sterilizing the devices were validated.
Conclusion (Statement of Equivalence)
Through the data and information presented, as well as similarities to a legally Through the data and microniation the Attain Access 6218A Left-heart marketed device, medically equivalent to the previously discussed legally marketed predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2002
Ms. Karen Reidt Principal Regulatory Affairs Specialist Cardiac Rhythm Management Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432
Re: K021589
Trade Name: Attain™ Access 6218A Left-Heart Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 13, 2002 Received: May 15, 2002
Dear Ms. Reidt:
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.
4
Page 2 - Ms. Karen Reidt
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at 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,
Reala Well
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CONFIDENTIAL May not be reproduced without written permission from Medtronic, Inc.
Indications for Use Statement
NA KO21589 510(k) Number (if known): Attain™ Access 6218A Left-heart delivery system Device Name:
Indications For Use:
The Attain™ Access 6218A Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
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)
Over-The-Counter Use_
Division of Cardiovascular & Respiratory Devices
510(k) Number K021589
OR
Special 510(k): Device Modification Premarket Notification Attain™ Access 6218A Left-heart delivery system