(294 days)
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
The Attain Command™ 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™ Left Heart Delivery Systems are 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™ 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™ 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-EH Guide Catheter for Left Heart Delivery
- TH 6250-EHXL Guide Catheter for Left Heart Delivery · Attain Command
- ти 6250-MB2 Guide Catheter for Left Heart Delivery · Attain Command
- · Attain Command ™ 6250-MB2X Guide Catheter for Left Heart Delivery
- 6250-MP Guide Catheter for Left Heart Delivery · Attain Command T
- · 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
This 510(k) summary describes a medical device submission for the Medtronic Attain Command™ 6250 Left Heart Delivery Systems and Attain Command™ 6250 Guide Catheters for Left Heart Delivery. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical, functional, and biocompatibility testing.
Here's an breakdown of the requested information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity | Met all specified design and performance requirements. |
| Functional performance | Met all specified design and performance requirements. |
| Biocompatibility | Verified, consistent with ISO 10993-1:2003 for external communicating devices with <24 hours contact with circulating blood. |
| Sterilization | Validated using Ethylene Oxide (EtO) sterilization process. |
Note: The document specifies that the device "met all specified design and performance requirements" in summary of studies but does not explicitly list the quantitative acceptance criteria for each test. The acceptance criteria are implied to be the successful demonstration of equivalency in mechanical, functional, and biocompatibility aspects.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of the number of devices or components tested. It broadly refers to "device integrity testing" and "biocompatibility evaluation."
- Data Provenance: The studies were performed by Medtronic Ireland as part of their 510(k) submission. The nature of the tests (mechanical, functional, biocompatibility) suggests they are laboratory-based studies rather than clinical trials with patient data. Thus, terms like "country of origin of the data" or "retrospective/prospective" in the context of patient data are not directly applicable here. The testing would have been conducted in a controlled lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical catheter system, and the studies described are engineering and biological validations, not clinical studies requiring expert interpretation of diagnostic images or patient outcomes to establish ground truth. "Ground truth" in this context would refer to established engineering specifications and biological safety standards.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are technical evaluations (mechanical, functional, biocompatibility) against predetermined specifications, not clinical assessments that would require adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. The submitted device is a physical medical instrument (catheter system), not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. The device is a physical catheter system, not a software algorithm.
7. The Type of Ground Truth Used
For the studies described (mechanical, functional, biocompatibility), the "ground truth" would be the established engineering specifications, material standards, and biological safety standards (e.g., ISO 10993-1:2003 for biocompatibility). The device's performance was compared against these predefined criteria to determine if it "met all specified design and performance requirements."
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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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" in bold, sans-serif font on the right. The graphic appears to depict a human figure within a circle. The text is in black.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | February 14, 2008 |
|---|---|
| Applicant: | Medtronic IrelandParkmore Business Park WestGalwayIreland |
| Submission Correspondent: | Marlene PetersonPrincipal Regulatory Affairs SpecialistMedtronic, Inc.8200 Coral Sea StreetMS MVS11Mounds View MN 55112USA |
| Telephone: | (763) 526 2355 |
| Fax: | (651) 367 0603 |
| E-Mail: | marlene.v.peterson@medtronic.com |
| Proprietary Name: | Attain Command™ 6250 Left Heart Delivery SystemsAttain 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™ Left Heart Delivery Systems contain two guidecatheters, one guide catheter dilator, one guide wire, one valve and one slitter. It isdesigned to access the coronary sinus and the chambers of the heart using theguidewire to access the vein, the valve to reduce blood loss during the implantprocedure, the guide catheter to introduce a transvenous device, the guide catheterdilator to facilitate catheter passage and the slitter to remove the guide catheter.The Attain Command™ Left Heart Delivery Systems are 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 bothmodels. The guide catheters are different in each model with respect to the guidecatheter shape and length.The Attain Command™ Guide Catheters for Left Heart Delivery are individualpacks, each containing one guide catheter and one guide catheter dilator. It is alsodesigned to access the coronary sinus and the chambers of the heart using the |
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Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, black letters on the right. The circular symbol appears to depict a stylized human figure within a circle.
guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.
The Attain Command™ 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-EH Guide Catheter for Left Heart Delivery
- TH 6250-EHXL Guide Catheter for Left Heart Delivery · Attain Command
- ти 6250-MB2 Guide Catheter for Left Heart Delivery · Attain Command
- · Attain Command ™ 6250-MB2X Guide Catheter for Left Heart Delivery
- 6250-MP Guide Catheter for Left Heart Delivery · Attain Command T
- · 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 Medtronic Indications For Use: 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
Substantially Equivalent Devices:
Attain Command™ 6250 Left Heart Delivery Systems and the Attain Command™ 6250 Guide Catheters for Left Heart Delivery uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices:
- · Attain Select™ II 6248DEL Delivery Catheter System (510(k) K053431).
- · 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™ 6218A-MP Guide Catheter for Left-Heart Delivery (510(k) K024032)
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Image /page/2/Picture/0 description: The image shows the Medtronic logo. On the left is a circular symbol with a stylized human figure inside. To the right of the symbol is the word "Medtronic" in a bold, sans-serif font.
| Summary of Studies: | Device integrity testing was performed to support the equivalency of the Attain Command™ product family to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Command™ product family met all specified design and performance requirements. |
|---|---|
| Biocompatibility Information: | The biocompatibility evaluation completed for the Attain Command™ product family verifies that the Attain Command™ Left Heart Delivery Systems and the Attain Command™ Guide Catheters for Left Heart Delivery are biocompatible. |
| The testing which supports the biocompatibility of the Attain Command™ Left Heart Delivery Systems and the Attain Command™ Guide Catheters for Left Heart Delivery 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™ product family are categorized as external communicating devices with limited exposure i.e. whose contact with circulating blood is (less than) < 24 hours | |
| Sterilization Validation: | The Attain Command™ Left Heart Delivery Systems and the Attain Command™ Guide Catheters for Left Heart Delivery will be sterilized using a validated Ethylene Oxide (EtO) sterilization process. |
| Conclusion: | Through the data and information presented, Medtronic Ireland considers the Attain Command™ Left Heart Delivery Systems and the Attain Command™ Guide Catheters for Left Heart Delivery to be substantially equivalent to legally marketed predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9
Medtronic, Inc. c/o Ms. Marlene Peterson 8200 Coral Street NE Mounds View, MN 55112
Re: K080428
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: DQY Dated: November 27, 2008 Received: December 01, 2008
Dear Ms. Peterson:
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.
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Page 2 - Ms. Marlene Peterson
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,
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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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CONFIDENTIAL May not be reproduced without written permission from Medtronic, Inc.
INDICATION FOR USE
510(k) Number (if known): KOSD4 28
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)
f Cardiovascular Devices
510(k) Number
Medtronic Ireland Attain Command" Left Heart Delivery Systems and Attain Command" Guide Catheters for Left Heart Delive Traditional 510(k)
§ 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).