(80 days)
The steerable catheter set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cm Steerable catheter, one guidewire, one Y-connector with valve, one extension set, 3-way stopcock, one guidewire clip and two guidewire torque tools.
Here's a breakdown of the requested information based on the provided 510(k) summary for the Medtronic Attain Prevail™ 6228CTH80 Steerable Catheter Set:
This submission is for a medical device (catheter), not an AI/ML-driven diagnostic or image analysis system. Therefore, many of the typical acceptance criteria and study components related to ML models (like statistical performance metrics, ground truth experts, MRMC studies, or training/test sets) are not applicable in this context. The evaluation focuses on device integrity, biocompatibility, and sterility as compared to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not contain specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML device. Instead, acceptance is based on meeting design and performance requirements through various engineering and biological tests, demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Bench Testing | The Attain Prevail™ 6228CTH80 Steerable Catheter Set met all specified design and performance requirements. (Details on specific tests and their outcomes are not provided in this summary but were part of the full 510(k) submission). |
| Sterilization Validation | The device will continue to be sterilized using a validated Ethylene Oxide (EtO) sterilization process. |
| Biocompatibility Evaluation | The device is verified to be biocompatible, consistent with ISO 10993-1:2003 ("Biological Evaluation of Medical devices- Part 1: Evaluation and Testing"). Classified as an external communicating device with < 24 hours contact with circulating blood. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" referred to here is engineering and biological validation on device prototypes or manufactured units. The sample sizes for these specific tests (e.g., number of catheters tested for tensile strength, torque, steerability, etc.) are not detailed in this summary.
- Data Provenance: Not applicable. The "data" comes from physical testing of the device and its components, not from patient data or imaging.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. There is no concept of "ground truth experts" for establishing diagnostic accuracy in this type of device submission. The "ground truth" for device performance is defined by engineering specifications and international standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not applicable. Adjudication methods are used to resolve disagreements among human readers or experts in diagnostic studies, which is not relevant for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
- MRMC Study: No. This is a medical catheter and not an AI/ML diagnostic or image analysis system. An MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No. This is a medical catheter and not an AI/ML algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For a medical device like this catheter, the "ground truth" for performance is based on engineering specifications, international standards (e.g., ISO 10993-1 for biocompatibility), and established test methodologies to evaluate physical properties, functionality, sterility, and material safety. There is no diagnostic "ground truth" from patient data or pathology.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not involve machine learning and therefore has no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. This device does not involve machine learning and therefore has no "training set" or associated ground truth.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image contains the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, sans-serif font on the right. The circular symbol appears to depict a stylized representation of the human body.
:
DEC 0 4 2008
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | September 12, 2008 |
|---|---|
| Applicant: | Medtronic IrelandParkmore Business Park WestGalwayIreland |
| Submission Correspondent: | Beth ClaasSenior Regulatory Affairs SpecialistMedtronic, Inc.8200 Coral Sea StreetMS MVS11Mounds View MN 55112USA |
| Telephone: | (+1-763) 526-2384 |
| Fax: | (+1-651) -367-0603 |
| E-Mail: | beth.a.claas@medtronic.com |
| Proprietary Name: | Attain Prevail™ 6228CTH80 Steerable Catheter Set |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |
| Device Description: | The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cmSteerable catheter, one guidewire, one Y-connector with valve, one extension set,3-way stopcock, one guidewire clip and two guidewire torque tools. |
| Indications For Use: | The steerable catheter set is indicated to provide a pathway for delivery oftransvenous devices to the coronary sinus and coronary vasculature of the heart. |
| Substantially Equivalent Devices: | The Attain Prevail™ 6228CTH80 Steerable Catheter Set uses similar technologyand has similar intended uses, function, materials and method of operation to thefollowing predicate devices:- Attain Prevail™ 6228CTH Steerable Catheter Set (510(k) K031211). Alsocommercialized under this 510(k) number is the current Attain Prevail™6228CTH80 Steerable Catheter Set.- Attain Prevail™ 6228SYS Left-Heart Delivery System, 80 cm Prevail catheter(510(k) K032622). |
| Summary of Studies: | Device integrity testing was performed to support the equivalency of the AttainPrevail™ 6228CTH80 Steerable Catheter Set to the predicate devices. Testingincluded bench, sterilisation and biocompatibility testing. The Attain Prevail™6228CTH80 Steerable Catheter Set met all specified design and performancerequirements. |
{1}------------------------------------------------
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, sans-serif font on the right. The circular symbol contains a stylized representation of a human figure within a circle.
Biocompatibility Information:
The biocompatibility evaluation completed for the Attain Prevail™ 6228CTH80 Steerable Catheter Set verifies that this device is biocompatible.
The testing which supports the biocompatibility of the Attain Prevail™ 6228CTH80 Steerable Catheter Set is consistent with International Standard ISO10993-1:2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing."
When classified according to this standard, this device is categorized as external communicating devices with limited exposure i.e. whose contact with circulating blood is (less than) < 24 hours
Sterilization Validation:
The Attain Prevail™ 6228CTH80 Steerable Catheter Set will continue to be sterilized using a validated Ethylene Oxide (EtO) sterilization process.
Conclusion:
Through the data and information presented, Medtronic Ireland considers the Attain Prevail™ 6228CTH80 Steerable Catheter Set to be substantially equivalent to legally marketed predicate devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2008
Medtronic, Inc. c/o Ms. Beth Claas Senior Regulatory Affairs Specialist 8200 Coral Sea Street MS MVS11 Mounds View, MN 55112
Re: K082670
Roo2070
Trade/Device Name: Attain Prevail™ 6228CTH80 Steerable Catheter Set Common Name: Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DQY Dated: November 5, 2008 Received: November 7, 2008
Dear Ms. Claas:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regary the enactment date of the Medical Device Ameridaents, or to Commerce prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices mat have been require approval of a premarket approval application (PMA). allu Costietle Act (110t) that to hovice, subject to the general controls provisions of the Act. The 1 ou may, utcrefore, market the Act include requirements for annual registration, listing of general condois provisions of associety, 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 If your device is chassined (600 above) als. Existing major regulations affecting your device can thay be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 of any I cach sunntes and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Ms. Beth Class
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. 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.
Duma R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATION FOR USE
510(k) Number (if known):_KOBILIO
Device Name: Attain Prevail™ 6228CTH80 Steerable Catheter Set
The steerable catheter set is indicated to provide a pathway for delivery of Indications For Use: transvenous devices to the coronary sinus and coronary vasculature of the heart.
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)
Duane R. Holmes
(Division Sign-Off)
Division of Cardrovascular Devices
510(k) Number_K082670
§ 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).