SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117

K020821 · Biotronik, Inc. · DQX · Jun 3, 2002 · Cardiovascular

Device Facts

• Record ID: K020821
• Device Name: SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
• Applicant: Biotronik, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.

Device Story

SCOUT Accessories are a set of procedural tools used to facilitate the implantation of cardiac leads into the left heart via the coronary sinus. The kit includes a hemostatic valve, guiding catheters (peel-away long sheaths), a dilator, an 11F peel-away introducer, a guidewire, a cannula, a syringe body, and a peel tool. These components are used by clinicians in a clinical setting to provide a delivery pathway for leads. The device functions as a mechanical delivery system; it does not involve electronic processing, software, or automated decision-making. The system is designed to be functionally equivalent to existing delivery systems, assisting the physician in navigating the coronary sinus to ensure proper lead placement, which benefits the patient by enabling effective cardiac pacing or defibrillation therapy.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

The device consists of a kit of mechanical accessories including catheters, sheaths, dilators, and guidewires. Materials and design are similar to predicate delivery systems. The device is non-electronic, standalone, and does not contain software or algorithms.

Indications for Use

Indicated for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Medtronic LDS 6216 Left-Heart Delivery System (K012130)

Submission Summary (Full Text)

{0}------------------------------------------------

JUN 0 3 2002

K020821

page 1 of 2

BIOTRONIK, Inc., SCOUT Accessories for Implanting in the Coronary Sinus, K020821 May 20, 2002

# SCOUT Accessories for Implanting in the Coronary Sinus 510(k) K020821

#### 510(K) SUMMARY 1.

Name and Address of Sponsor: BIOTRONIK, Inc.

6024 Jean Road Lake Oswego, OR 97035 1028232

Establishment Registration Number:

Device Name:

Proprietary Name: Classification: Classification Name: Product Code:

SCOUT Class II (21 CFR 870.1330; 21 CFR 870.1380) Wire, Guide, Catheter; Stylet, Catheters DQX, DRB

#### General Description:

The SCOUT Accessories for Implanting in the Coronary Sinus are for introducing legally marketed leads into the vessels of the left heart via the coronary sinus. The following SCOUT Accessories for Implanting in the Coronary Sinus are the subject of this 510(k):

- 1 Hemostatic Valve .
- 2 Guiding Catheters Peel-Away (Long Sheaths) ●
- 1 Dilator (for Long Sheath) ●
- 1 Introducer Peel-Away 11F .
- . 1 - Guidewire
- 1 Cannula .
- . 1 - Syringe Body
- 1 Peel Tool ●

The SCOUT Accessories for Implanting in the Coronary Sinus are functionally equivalent to marketreleased delivery systems. In specific, the materials used and design are similar to Medtronic's LDS 6216 Left-Heart Delivery System (K012130, cleared 08-28-01).

#### Indication for Use:

The intended use of the SCOUT Accessories for Implantation in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.

#### Name and Address of Manufacturer:

BIOTRONIK GmbH & Co. (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304

## Contact Person(s) and Phone Number:

Jon Brumbaugh Director, Requlatory Affairs Phone [phone] ´ Fax [phone]

#### Name and Address of Contract Manufacturing Site:

BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169

{1}------------------------------------------------

K020821
Page 2 of 2

May 20, 2002

## 2. INDICATIONS FOR USE

The intended use of the SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.

See Appendix 1 for the 510(k) Indications for Use Form. Device description and substantial

#### 3. PROPOSED LABELING

#### 3.1 TECHNICAL MANUAL

The Technical Manual for the SCOUT Accessories is provided in Appendix 2.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 3 2002

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

Re: K020821

Trade Name: SCOUT Regulation Number: 21 CFR 870.1330, 870.1380, and 870.1250 Regulation Name: Wire, Guide, Catheter; Stylet, Catheter; Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQX, DRB, and DQY Dated: March 8, 2002 Received: March 13, 2002

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.

{3}------------------------------------------------

## 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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), 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.

Denise Tell

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

| 510(k) Number (if known): | K020821 |
|---------------------------|---------|
| Device Name: | SCOUT |

Page ¹ of ¹

K020821

page 1 of 1

Indications For Use:

The SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketedleads into the vessels of the left heart via the coronary sinus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020821

(Optional Format 3-10-98)

Prescription Use X