(14 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™ 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
The provided document is a 510(k) summary for the Medtronic Attain Command™ 6250 Left Heart Delivery Systems and Guide Catheters. This document details the substantial equivalence of minor modifications to an existing device rather than presenting a study for a new device's performance against specific acceptance criteria in a clinical setting.
Therefore, much of the requested information regarding acceptance criteria and a study proving a device meets them (especially in the context of AI/standalone algorithm performance, multi-reader studies, and ground truth establishment) is not applicable to this particular 510(k) submission.
However, I can extract information related to the device integrity testing that was performed to support equivalency.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "The modified Attain Command™ 6250 product family met all specified design and performance requirements." It does not provide a specific table of quantitative acceptance criteria or detailed numerical performance metrics.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Device Integrity | Met all specified design and performance requirements. |
| Biocompatibility | Biocompatible, consistent with ISO10993-1:2003. |
| Sterilization | Sterilized using a validated Ethylene Oxide (EtO) process. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Device integrity testing was performed" but does not specify the sample size for this testing. It also does not specify data provenance in terms of country of origin or whether it was retrospective/prospective, as this was not a clinical study involving patient data. This testing would have been conducted on prototypes or production samples of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable. The "ground truth" for device integrity testing refers to engineering specifications and performance benchmarks, not clinical outcomes interpreted by experts.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical data interpretation, not for evaluating engineering device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for evaluating diagnostic or interpretive AI systems, not for a medical device such as a catheter delivery system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth for this submission was based on engineering design specifications, performance requirements, and established industry standards (e.g., ISO10993-1:2003 for biocompatibility).
8. The Sample Size for the Training Set:
This is not applicable. There is no "training set" in the context of establishing substantial equivalence for a physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a modified medical device to a predicate device, primarily through engineering and biocompatibility testing, rather than a clinical study evaluating the performance of an AI or diagnostic tool against specific acceptance criteria.
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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" 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 IrelandParkmore Business Park WestGalwayIreland |
MAR 2 6 2009
| Primary Correspondent: | Christine FazentieuxRegulatory Affairs SpecialistMedtronic IrelandParkmore Business Park WestGalwayIrelandPhone: (011-353-91) 708958Fax: (011-353-91) 708672Email: christine.fazentieux@medtronic.com |
|---|---|
| Alternate Correspondent: | Bruce BacklundSenior Regulatory Affairs SpecialistCardiac Rhythm Disease Management8200 Coral Sea StreetMS MVS11Mounds View MN 55112USAPhone: (+1-763) 526-2357Fax: (+1-651) -367-0603Email: bruce.j.backlund@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™ 6250 Left Heart Delivery Systems containtwo guide catheters, one guide catheter dilator, one guide wire, onevalve and one slitter. It is designed to access the coronary sinus andthe chambers of the heart using the guidewire to access the vein, thevalve to reduce blood loss during the implant procedure, the guidecatheter to introduce a transvenous device, the guide catheter dilatorto facilitate catheter passage and the slitter to remove the guidecatheter. |
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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:
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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) < 24 lhours
The Attain Command" 6250 Left Heart Delivery Systems and the Sterilization Validation: Attain Command" 6250 Guide Catheters for Left Heart Delivery will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.
Through the data and information presented, Medtronic Ireland considers the modified Attain Command™ 6250 product family to be substantially equivalent to the predicate devices.
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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.
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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
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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
§ 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).