ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH

K031211 · Medtronic Vascular · DQY · Jul 17, 2003 · Cardiovascular

Device Facts

• Record ID: K031211
• Device Name: ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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.

Device Story

Attain Prevail Steerable Catheter Set provides pathway for delivery of transvenous devices to coronary sinus and coronary vasculature. System includes steerable catheter with single lumen for device passage (up to 0.035" diameter) or contrast injection; catheter features steerable distal section controlled by handle; radiopaque for fluoroscopic visualization. Set includes guide wire, guide wire torque tool, Y-connector with adjustable hemostasis valve, extension tube, and 3-way stopcock. Used in clinical setting by physicians to assist in cannulating coronary sinus ostium and coronary vasculature. Hemostasis valve reduces blood loss; Y-connector/stopcock allow aspiration or solution injection. Device is sterile, single-use.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes mechanical, functional, and packaging integrity testing, and biocompatibility testing per ISO-10993.

Technological Characteristics

Steerable catheter with single lumen; radiopaque; includes guide wire, torque tool, Y-connector with hemostasis valve, extension tubing, and stopcock. Materials are biocompatible per ISO-10993. Sterilization via Ethylene Oxide (EtO).

Indications for Use

Indicated for patients requiring transvenous device delivery to the coronary sinus and coronary vasculature of the heart.

Regulatory Classification

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.

Predicate Devices

• Medtronic Model 10600 Deflectable Catheter System (K013517)
• Medtronic Attain LDS Model 6216A Left-Heart Delivery System (K021587)
• Medtronic Attain Access Model 6218A Left-Heart Delivery System (K021589)
• Medtronic Marinr Series EP Diagnostic Catheters (K931794)
• Cardima Naviport Deflectable Guiding Catheter (K974683)
• Medtronic AVE Steerable Guidewires (P790017/S8)
• Interventional Vascular Y-Adapter (K945461)
• Angeion Y-Adaptor with Touhy-Borst Valve (K895580)
• Smallbore Extension Set (K760385)
• Medex Stopcock and Luer Lock Plug Model MX531-1L (Pre-amendment)
• Pinvise / Torque Tool (K921702)

Submission Summary (Full Text)

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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.<br>7000 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Contact: | Lynn Jensen<br>Sr. Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| 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.

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#### 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<br>Manufacturer | Predicate 510(k) |
| Percutaneous Catheter | Medtronic Model<br>10600 Deflectable<br>Catheter System | Medtronic | K013517 |
| | Medtronic Attain LDS<br>Model 6216A Left-<br>Heart Delivery<br>System | Medtronic | K021587 |
| | Medtronic Attain<br>Access Model 6218A<br>Left-Heart Delivery<br>System | Medtronic | K021589 |
| | Medtronic Marinr<br>Series EP Diagnostic<br>Catheters | Medtronic | K931794 |
| | Cardima Naviport<br>Deflectable Guiding<br>Catheter | Cardima Inc. | K974683 |
| Stainless Steel<br>Guidewire | Medtronic AVE<br>Steerable Guidewires | Medtronic AVE | Approved 10/7/86<br>with P790017/S8<br>prior to down-<br>classing of PTCA<br>guide wires. |
| Y Connector with<br>Adjustable<br>Hemostasis Valve | Interventional Vascular<br>Y-Adapter | Medtronic AVE | K945461 |
| | Angeion Y-Adaptor<br>with Touhy-Borst<br>Valve | Angeion | K895580 |
| Extension Tubing | Smallbore Extension<br>Set | B Braun | K760385 |
| Stopcock | Medex Stopcock and<br>Luer Lock Plug<br>Model MX531-1L | Medex, Inc. | Pre-amendment<br>device. |
| Guide Wire Torque Tool | Pinvise / Torque Tool | Merit Medical | K921702 (Accessory to<br>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.

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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.

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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.

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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.