(14 days)
Not Found
No
The description focuses on the physical components and intended use for delivering devices and leads, with no mention of AI or ML capabilities.
No.
The device is intended for introducing transvenous devices and leads into vessels, acting as a delivery system rather than providing a therapeutic effect itself.
No
Explanation: The device is described as a delivery system intended for introducing transvenous devices and leads into the heart. Its components facilitate access and implantation, not the diagnosis of a condition.
No
The device description explicitly lists multiple physical components (guide catheters, dilator, guidewire, valve, slitter) and describes their physical functions in a medical procedure. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "introducing transvenous devices and leads into vessels of the left heart via the coronary sinus." This describes a surgical or interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device components (guide catheters, dilator, guidewire, valve, slitter) are all tools used to facilitate the delivery of other devices within the body. They are not designed to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, tissue, or other bodily fluids for diagnostic information.
Therefore, the Medtronic Attain Command" 6250 Left Heart Delivery Systems and Guide Catheters are considered medical devices used for interventional procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medtronic Attain Command™ 6250 Left Heart Delivery Systems and the Medtronic Attain Command™ 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Attain Command™ 6250 Left Heart Delivery Systems contain two guide catheters, one guide catheter dilator, one guide wire, one valve and one slitter. It is 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 Attain Command™ 6250 Left Heart Delivery Systems arc available in two models:
- Attain Command™ 6250C Left Heart Delivery System
- Attain Command™ 6250S Left Heart Delivery System.
All components with the exception of the two guide catheters are identical in both models. The guide catheters are different in each model with respect to the guide catheter shape and length.
The Attain Command™ 6250 Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. It is 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 Attain Command" 6250 Guide Catheters for Left Heart Delivery are available in eleven models as follows:
- Attain Command" 6250-45S Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-50S Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-57S Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-AM Guide Catheter for Left Heart Delivery
- Attain Command" 6250 Fin Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-EHXL Guide Catheter for Left Heart Delivery
- Atlain Command™ 6250-MB2 Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-MB2X Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-MP Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-MPR Guide Catheter for Left Heart Delivery
- Attain Command™ 6250-MPX Guide Catheter for Left Heart Delivery
Each model is different with respect to the guide catheter shape and length and the dilator length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus and the chambers of the heart, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Device integrity testing was performed to support the equivalency of the Attain Command™ 6250 product family to the predicate. The modified Attain Command™ 6250 product family met all specified design and performance requirements.
The biocompatibility evaluation completed verifies that the Attain Command™ 6250 Left Heart Delivery Systems and the Attain Command™ 6250 Guide Catheters for Left Heart Delivery are biocompatible.
The testing which supports the biocompatibility of the Attain Command™ 6250 product family is consistent with International Standard ISO10993-1:2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing."
The Attain Command™ 6250 Left Heart Delivery Systems and the Attain Command™ 6250 Guide Catheters for Left Heart Delivery will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" on the right. The circular graphic appears to be an abstract representation of a flower or a globe. The word "Medtronic" is written in a bold, sans-serif font.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | Monday, March 09, 2009 |
|---|---|
| Applicant: | Medtronic Ireland |
| Parkmore Business Park West | |
| Galway | |
| Ireland |
MAR 2 6 2009
| Primary Correspondent: | Christine Fazentieux
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 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternate Correspondent: | Bruce Backlund
Senior Regulatory Affairs Specialist
Cardiac Rhythm Disease Management
8200 Coral Sea Street
MS MVS11
Mounds View MN 55112
USA
Phone: (+1-763) 526-2357
Fax: (+1-651) -367-0603
Email: bruce.j.backlund@medtronic.com |
| Proprietary Name: | Attain Command™ 6250 Left Heart Delivery Systems
Attain Command™ 6250 Guide Catheters for Left Heart Delivery |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Description: | The Attain Command™ 6250 Left Heart Delivery Systems contain
two guide catheters, one guide catheter dilator, one guide wire, one
valve and one slitter. It is 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. |
1
Image /page/1/Picture/0 description: The image contains the Medtronic logo. The logo consists of a stylized, abstract circular design on the left, resembling a globe or a complex network. To the right of the circular design is the word "Medtronic" in a sans-serif font. The text is in a dark color, providing contrast against the background.
The Attain Command™ 6250 Left Heart Delivery Systems arc available in two models:
- · Attain Command™ 6250C Left Heart Delivery System
- · Attain Command™ 6250S Left Heart Delivery System.
All components with the exception of the two guide catheters are identical in both models. The guide catheters are different in each model with respect to the guide catheter shape and length.
The Attain Command™ 6250 Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. It is 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 Attain Command" 6250 Guide Catheters for Left Heart Delivery are available in eleven models as follows:
- Attain Command" 6250-45S Guide Catheter for Left Heart Delivery
Attain Command™ 6250-50S Guide Catheter for Left Heart Delivery - · Attain Command™ 6250-57S Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-AM Guide Catheter for Left Heart Delivery
- · Attain Command" 6250 Fin Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-EHXL Guide Catheter for Left Heart Delivery
- · Atlain Command™ 6250-MB2 Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MB2X Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MP Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MPR Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MPX Guide Catheter for Left Heart Delivery
Each model is different with respect to the guide catheter shape and length and the dilator length
The Attain Command™ 6250 Left Heart Delivery Systems and the Attain Command" 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus. .
The modified Attain Command™ 6250 product family uses similar technology and has similar intended uses, function, materials and method of operation to the predicate Attain Command"" 6250 product family (510(k) cleared K080428)
Indications For Use:
Substantially Equivalent Devices:
2
Image /page/2/Picture/0 description: The image shows the Medtronic logo. On the left is a circular graphic with abstract lines and shapes, possibly representing a globe or a network. To the right of the graphic is the word "Medtronic" in a bold, sans-serif font. The overall impression is that of a corporate logo for a company involved in technology or global operations.
Device integrity testing was performed to support the equivalency of Summary of Studies: the Attain Command" 6250 product family to the predicate. The modified Attain Command™ 6250 product family met all specified design and performance requirements.
Biocompatibility Information:
Conclusion:
The biocompatibility evaluation completed verifies that the Attain Command"* 6250 Left Heart Delivery Systems and the Attain Command™ 6250 Guide Catheters for Left Heart Delivery are biocompatible.
The testing which supports the biocompatibility of the Attain Command" 6250 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 Attain Command" 6250 product family are categorized as external communicating devices with limited exposure i.e. whose contact with circulating blood is (less than) Through the data and information presented, Medtronic Ireland considers the modified Attain Command™ 6250 product family to be substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. c/o Ms. Christine Fazentieux Regulatory Affairs Specialist CRDM - Medtronic Ireland Parkmore Business Park West Galway Ireland
MAR 2 6 2009
Re: K090659
Medtronic Attain Command™ 6250 Left Heart Delivery Systems; Medtronic Attain Command TM 6250 Guide Catheters for Left Heart Delivery Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: March 09, 2009 Received: March 12, 2009
Dear Ms. Fazentieux:
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. Christine Fazentieux
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
· Sincerely yours,
R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE
K19059 510(k) Number (if known):
Device Name: Attain Command™ 6250 Left Heart Delivery Systems and Attain Command™ 6250 Guide Catheters for Left Heart Delivery
The Medtronic Attain Command" 6250 Left Heart Delivery Systems and the Indications For Use: Medtronic Attain Command™ 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus
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)
Donna R. Jenkins
(Division Sign-Off) Division of Cardiovascular Devices
510(k) number K090659