SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H

K060655 · Biotronik, Inc. · DQY · Apr 4, 2006 · Cardiovascular

Device Facts

• Record ID: K060655
• Device Name: SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
• Applicant: Biotronik, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 4, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.

Device Story

ScoutPro 8F is a coronary sinus lead delivery system used to facilitate access to the coronary sinus venous system and introduce leads into left heart vessels. The system includes guiding catheters (various shapes: Blo, Hook, Multi-Purpose Hook, Amplatz 6.0), hemostatic valve, dilators, peel-away sheath, guide wire, needle, syringe, and slitter tools. Operated by physicians in a clinical setting, the device assists in the mechanical navigation and placement of cardiac leads. It is a modified version of the predicate ScoutPro (K033320), featuring updated accessory components including modified hemostatic valve markings, a larger syringe, and different materials for the slitter tool blade and body. The device provides the physical pathway for lead delivery, aiding in the treatment of patients requiring cardiac rhythm management devices.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous catheter delivery system. Components include guiding catheters, hemostatic valve, dilators, peel-away sheath, guide wire, needle, syringe, and slitter tools. Materials include unspecified plastics and steel for slitter blades. System is non-powered, mechanical. No software or electronic components.

Indications for Use

Indicated for patients requiring lead placement into left heart vessels via the coronary sinus.

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

• ScoutPro (K033320)

Submission Summary (Full Text)

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K 060655

March 10, 2006

# ScoutPro 8F Special 510(k) Premarket Notification

APR

## 1. 510(k) SUMMARY

Name and Address of Sponsor:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035

4 2006

Establishment Registration Number:

1028232

Device Name:

Proprietary Name: Classification: Classification Name: Product Code:

ScoutPro 8F Class II (21 CFR 870.1250; 870.1310; 870.1330) Catheters, Percutaneous DQY, DRE, DQX

## General Description:

ScoutPro 8F is a special delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left heart via the coronary sinus. It facilitates access to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's currently legally marketed predicate device, ScoutPro (K033320, 11-19-2003). The following ScoutPro 8F accessories are subject to this 510(k)

The basic set ScoutPro 8F contains the following components:

1 hemostatic valve

- 2 guiding catheters Blo I and Blo 2
- 1 dilator for the guiding catheter
- 1 peel-away sheath 11F with dilator
- 1 guide wire
- 1 needle
- 1 syringe

2 slitter tools 4.9 F and 6.3 F for different lead sizes

ScoutPro 8F Sheath "Hook" contains the following components:

1 quiding catheter "Hook"

1 dilator for the guiding catheter

ScoutPro 8F Sheath "Multi-Purpose Hook" contains the following components:

1 guiding catheter "Multi-Purpose Hook"

1 dilator for the guiding catheter

ScoutPro 8F Sheath "Amplatz 6.0" contains the following components:

1 guiding catheter "Amplatz 6.0"

1 dilator for the guiding catheter

Additionally, the hemostatic valve and the slitter tools are available separately. These accessories have been cleared with the legally marketed predicate device ScoutPro (K033320, 11-19-2003).

#### Device Modification:

The main difference between the predicate device ScoutPro and the ScoutPro 8F described in this documentation are some modifications with the accessories included in the system. The changes to the accessories include the markings on the hemostatic valve, a bigger scaled syringe and a different plastic material and a different steel blade for slitter tools.

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## Predicate Device:

BIOTRONIK proposes the following delivery system cleared through 510(k) notification as a predicate device for the ScoutPro 8F:

- BIOTRONIK's ScoutPro (#K033320, 11-19-2003) .
### Indication for Use:

The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.

| Name and Address of Manufacturer: | BIOTRONIK GmbH & Co. KG (reg. no. 9610139)<br>Woermannkehre 1,<br>12359 Berlin, Germany |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | 011-49-30-689-05-1210 |
| Name and Address of Contract Manufacturer: | BIOTRONIK AG (reg. no. 8043892)<br>Ackerstrasse 6<br>8180 Bülach,<br>Switzerland 011-41-44-864-5169 |
| Contact Person(s) and Phone Number: | Jon Brumbaugh<br>Director, Regulatory Affairs and Compliance<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and four human figures. The logo is encircled by the words "U.S. Department of Health and Human Services".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2006 APR

Biotronik, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035

Re: K060655

Trade Name: ScoutPro 8F Coronary Sinus Lead Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 10, 2006 Received: March 13, 2006

Dear Mr. Brumbaugh:

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 - Mr. Jon Brumbaugh

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 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 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/industry/support/index.html.

Sincerely yours,

Bhimmon for

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: ScoutPro 8F

Indications for Use:

The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Slan-Off

Division of Cardlovascular Devices 5100

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