(91 days)
Not Found
No
The device description focuses on mechanical and functional aspects of a steerable catheter and accessories, with no mention of AI or ML capabilities. Performance studies are limited to device integrity testing.
No.
The device is described as providing a "pathway for delivery of transvenous devices," indicating it is a delivery tool rather than a device that directly performs a therapeutic action.
No
The device is described as providing a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart, indicating a therapeutic or interventional function rather than a diagnostic one.
No
The device description clearly details a physical catheter, guide wire, and other hardware components used for delivering devices to the coronary sinus and vasculature. It is not solely software.
Based on the provided information, the Attain™ Prevail® Steerable Catheter Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart." This describes a device used in vivo (within the body) for delivering other medical devices.
- Device Description: The description details a catheter with a lumen for device passage or contrast injection, a steerable distal section, and accessories like a guidewire and fluid management components. These are all characteristics of devices used for interventional procedures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or compatibility testing.
In summary, the Attain™ Prevail® Steerable Catheter Set is a device used for facilitating the delivery of other devices within the cardiovascular system, which is an in vivo application, not an in vitro diagnostic application.
N/A
Intended Use / Indications for Use
The Attain™ Prevail® Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Product codes (comma separated list FDA assigned to the subject device)
74DOY, DQY
Device Description
The Medtronic Attain™ Prevail® Steerable Catheter Set features a steerable catheter and accessories to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The Prevail Steerable Catheter has a single lumen for passage of devices up to 0.035" (0.89 mm) diameter or injection of contrast solutions. Transvenous devices with an inner diameter of 7 French (2.3 mm) or larger can be loaded on and delivered with the Prevail catheter. The catheter features a steerable distal section controlled by the catheter handle. The catheter is radiopaque for visibility under fluoroscopy.
The Prevail Steerable Catheter Set features a guide wire and guide wire torque tool to assist in cannulating the coronary sinus ostium and coronary vasculature. Fluid management components include a Y-connector with an adjustable hemostasis valve. extension tube and 3-way stopcock. The adjustable hemostasis valve is used to reduce blood loss during the procedure. The Y-connector with side port and stopcock are used to aspirate air or inject solutions during the procedure.
The Prevail Steerable Catheter Set is provided STERILE and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus and coronary vasculature of the 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 Prevail Steerable Catheter Set to the predicate devices. Testing included mechanical, functional, and packaging testing. The Attain Prevail Steerable Catheter Set met all specified design and performance requirements.
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.
K013517, K021587, K021589, K931794, K974683, Approved 10/7/86 with P790017/S8 prior to down-classing of PTCA guide wires., K945461, K895580, K760385, Pre-amendment device., K921702 (Accessory to Guide Wire)
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
510(k) Attachments JUL 17 2003 Attain™ Prevail® Steerable Catheter Set
510(k) Summary of Substantial Equivalence
| Date Prepared: | April 14, 2003 |
|---|---|
| Submitter: | Medtronic, Inc. |
| 7000 Central Avenue N.E. | |
| Minneapolis, MN 55432 | |
| Contact: | Lynn Jensen |
| Sr. Regulatory Affairs Specialist | |
| Telephone: | (763) 514-4459 |
| Fax: | (763) 514-6424 |
| E-Mail: | lynn.a.jensen@medtronic.com |
| Proprietary Name: | Attain™ Prevail® Steerable Catheter Set |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR § 870.1250 |
| Product Code: | 74DOY |
Device Description
The Medtronic Attain™ Prevail® Steerable Catheter Set features a steerable catheter and accessories to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The Prevail Steerable Catheter has a single lumen for passage of devices up to 0.035" (0.89 mm) diameter or injection of contrast solutions. Transvenous devices with an inner diameter of 7 French (2.3 mm) or larger can be loaded on and delivered with the Prevail catheter. The catheter features a steerable distal section controlled by the catheter handle. The catheter is radiopaque for visibility under fluoroscopy.
The Prevail Steerable Catheter Set features a guide wire and guide wire torque tool to assist in cannulating the coronary sinus ostium and coronary vasculature. Fluid management components include a Y-connector with an adjustable hemostasis valve. extension tube and 3-way stopcock. The adjustable hemostasis valve is used to reduce blood loss during the procedure. The Y-connector with side port and stopcock are used to aspirate air or inject solutions during the procedure.
Image /page/0/Picture/9 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" on the right. The circular symbol contains a stylized figure of a person inside a circle. The word "Medtronic" is written in a bold, sans-serif font.
1
510(k) Attachments
The Prevail Steerable Catheter Set is provided STERILE and is intended for single use only.
Indications for Use
The Attain Prevail Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
| Substantially Equivalent Devices | |||
|---|---|---|---|
| Predicate Device | Predicate Device | ||
| Manufacturer | Predicate 510(k) | ||
| Percutaneous Catheter | Medtronic Model | ||
| 10600 Deflectable | |||
| Catheter System | Medtronic | K013517 | |
| Medtronic Attain LDS | |||
| Model 6216A Left- | |||
| Heart Delivery | |||
| System | Medtronic | K021587 | |
| Medtronic Attain | |||
| Access Model 6218A | |||
| Left-Heart Delivery | |||
| System | Medtronic | K021589 | |
| Medtronic Marinr | |||
| Series EP Diagnostic | |||
| Catheters | Medtronic | K931794 | |
| Cardima Naviport | |||
| Deflectable Guiding | |||
| Catheter | Cardima Inc. | K974683 | |
| Stainless Steel | |||
| Guidewire | Medtronic AVE | ||
| Steerable Guidewires | Medtronic AVE | Approved 10/7/86 | |
| with P790017/S8 | |||
| prior to down- | |||
| classing of PTCA | |||
| guide wires. | |||
| Y Connector with | |||
| Adjustable | |||
| Hemostasis Valve | Interventional Vascular | ||
| Y-Adapter | Medtronic AVE | K945461 | |
| Angeion Y-Adaptor | |||
| with Touhy-Borst | |||
| Valve | Angeion | K895580 | |
| Extension Tubing | Smallbore Extension | ||
| Set | B Braun | K760385 | |
| Stopcock | Medex Stopcock and | ||
| Luer Lock Plug | |||
| Model MX531-1L | Medex, Inc. | Pre-amendment | |
| device. | |||
| Guide Wire Torque Tool | Pinvise / Torque Tool | Merit Medical | K921702 (Accessory to |
| Guide Wire) | |||
| Guide Wire Clip | Class I device, exempt from premarket notification. |
Substantially Equivalent Devices
Image /page/1/Picture/8 description: The image shows the Medtronic logo. The logo consists of a stylized human figure inside a circle on the left, and the word "Medtronic" in bold, sans-serif font on the right. The human figure appears to be in motion, possibly running or dancing, and the circle around it suggests a global or holistic concept.
2
510(k) Attachments
The Attain Prevail Steerable Catheter Set uses similar technology and has similar intended uses, materials and dimensional characteristics to the predicate devices.
Summary of Studies
Device integrity testing was performed to support the equivalency of the Attain Prevail Steerable Catheter Set to the predicate devices. Testing included mechanical, functional, and packaging testing. The Attain Prevail Steerable Catheter Set met all specified design and performance requirements.
Biocompatibility Information
Biocompatibility was performed on all blood and tissue contacting materials of the Prevail catheter. Testing performed was consistent with ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". All specified biocompatibility requirements were met.
Sterilization Validation
The Attain Prevail Steerable Catheter Set will be sterilized using a validated Ethylene Oxide (EtO) sterilization process.
Conclusion
Through the data and information presented, Medtronic, Inc. considers the Attain Prevail Steerable Catheter Set to be substantially equivalent to legally marketed predicate devices.
Image /page/2/Picture/12 description: The image shows the Medtronic logo. The logo consists of a stylized human figure within a circle on the left, followed by the word "Medtronic" in a bold, sans-serif font. The logo is black and white.
3
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 consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
Medtronic, Inc. c/o Lynn Jensen Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576
Re: K031211
Attain Prevail Steerable Catheter Set, Model 6228CTH Regulation Number: 870.1250 Regulation Name: Catheter Percutaneous Regulatory Class: Class II Product Code: DQY Dated: May 14, 2003 Received: May 15, 2003
Dear Ms. Jensen:
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 - Lynn Jensen
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 (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 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) you may obtain. 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,
Bram D/ Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
510(k) Indications for Use Attain™ Prevail® Steerable Catheter Set
INDICATIONS FOR USE
Page I of 1
510(k) Number (if known): _ _ KU31211
Device Name: Attain™ Prevail® Steerable Catheter Set
Indications for Use: The Attain™ Prevail® Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
(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)
OR
Over-the Counter Use
(Optional Format 1-2-96)
510(K
Image /page/5/Picture/15 description: The image shows the Medtronic logo. The logo consists of a stylized symbol on the left and the word "Medtronic" on the right. The symbol appears to be a stylized representation of a human figure within a circle. The word "Medtronic" is written in a bold, sans-serif font.