The ScoutPro CS lead introducer system and its separately available accessories are used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Device Description

ScoutPro 7F is a delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The system contains guiding catheters with seven distal arc shapes and accessories to facilitate the lead implantation. This Special 510(k) introduces additional catheters as shown below, which have the same distal arc shapes but are 5 cm longer in length: ScoutPro 7F Sheath Hook L, ScoutPro 7F Sheath Multipurpose Hook L, ScoutPro 7F Sheath Amplatz 6.0 L, ScoutPro 7F Sheath BIO2 L, ScoutPro 7F Sheath MPEP L, ScoutPro 7F Sheath Extended Hook L, ScoutPro 7F Sheath Extended Hook Right L. Each of these catheters is separately available from the ScoutPro 7F kit and contains the following components: 1 guiding catheter, 1 (long) dilator for the guiding catheter. The main difference between the predicate device ScoutPro 7F catheters and the ScoutPro 7F long catheters described in this documentation is the long catheters also utilize a modified X-ray marker which is described in this document; however the patient contacting materials remain identical to the predicate. Additionally, a new dilator which is identical to the predicate but differs in length is also described.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device, specifically the ScoutPro 7F Long Catheters by BIOTRONIK. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way an AI diagnostic device would.

Therefore, much of the requested information (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) is not applicable to this type of device and submission. The document focuses on modifications to existing predicate devices (primarily length of catheters and a modified X-ray marker) and their substantial equivalence.

Here's what can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance
Material Composition	Patient contacting materials remain identical to the predicate device.
Functional Design	Same distal arc shapes as predicate devices, but 5 cm longer.
Radiographic Visibility	Utilizes a modified X-ray marker.
Accessory Compatibility	Connects with a new dilator, identical to the predicate's but differing in length.
Intended Use	Used in conjunction with the ScoutPro 7F CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus. (Identical to predicate's indication).
Safety and Effectiveness	Deemed substantially equivalent to predicate devices (K060807, K072329), implying similar safety and effectiveness profile.

2. Sample size used for the test set and the data provenance:

Not applicable. This submission is based on engineering design, material equivalence, and functional equivalence to predicate devices, not on a clinical test set with human subjects as would be used for an AI diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission does not involve "ground truth" derived from expert interpretation of data. Substantial equivalence for this type of device relies on engineering specifications and comparison to existing, cleared devices.

4. Adjudication method for the test set:

Not applicable. No test set or expert adjudication process described.

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:

Not applicable. This device is a guiding catheter, not an AI diagnostic device. No human reader studies or AI assistance are involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device (catheter), not an algorithm.

7. The type of ground truth used:

Not applicable. The concept of "ground truth" as it applies to diagnostic accuracy studies is not relevant here. The "truth" for this submission revolves around demonstrating that the modified device maintains the same safety and effectiveness profile as its predicate, primarily through engineering and material comparisons.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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5093303

BIOTRONIK, ScoutPro 7F Long Catheters, Special 510(k)

October 20, 2009

ScoutPro 7F Long Guiding Catheters Special 510(k) Premarket Notification

1028232

NOV 2 0 2009

1. 510(k) SUMMARY

Name and Address of Sponsor:

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

Establishment Registration Number:

Device Name:

Proprietary Name:

ScoutPro 7F Sheath Multipurpose Hook L

ScoutPro 7F Sheath Amplatz 6.0 L

... ScoutPro 7F Sheath BIO2 L

ScoutPro 7F Sheath MPEP L

ScoutPro 7F Sheath Hook L

ScoutPro 7F Sheath Extended Hook L

ScoutPro 7F Sheath Extended Hook Right L

Class II (21 CFR 870.1250; 870.1310; 870.1330) Classification: Guide, Catheters, Percutaneous Classification Name: DQY, DRE Product Code:

General Description:

ScoutPro 7F Sheath Hook L

ScoutPro 7F Sheath Multipurpose Hook L

ScoutPro 7F Sheath Amplatz 6.0 L

ScoutPro 7F Sheath BIO2 L

ScoutPro 7F Sheath MPEP L

ScoutPro 7F Sheath Extended Hook L

ScoutPro 7F Sheath Extended Hook Right L

Each of these catheters is separately available from the ScoutPro 7F kit and contains the following components:

· 1 quiding catheter
• 1 (long) dilator for the guiding catheter

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Device Modification: .

The main difference between the predicate device ScoutPro 7F catheters and the ScoutPro 7F long catheters described in this documentation is the long catheters also utilize a modified X-ray marker which is described in this document; however the patient contacting materials remain identical to the predicate. Additionally, a new dilator which is identical to the predicate but differs in length is also described.

Predicate Device:

BIOTRONK's ScoutPro 7F (#K060807, 24-Apr-2006)

ScoutPro 7F Sheath Amplatz 6.0 .
ScoutPro 7F Sheath Hook .
ScoutPro 7F Sheath Multipurpose Hook .

BIOTRONIK's ScoutPro 7F (#K072329, 25-Mar-2008)

ScoutPro 7F Sheath BIO2 .
. ScoutPro 7F Sheath Extended Hook
ScoutPro 7F Sheath Extended Hook Right .
ScoutPro 7F Sheath MPEP | i .

Indication for Use:

The ScoutPro 7F long catheters are used in coniunction with the ScoutPro 7F CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus.

Name and Address of Manufacturer:

BIOTRONIK SE & Co. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-1210

Name and Address of Contract Manufacturer: BIOTRONIK AG (reg. no. 8043892)

Contact Person(s) and Phone Number:

Ackerstrasse 6 8180 Bülach, Switzerland 011-41-44-864-5169

Jon Brumbaugh VP, Regulatory Affairs and Compliance Phone (888) 345-0374 Fax (503) 635-9936 jon brumbaugh@biotronik.com

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

NOV 2 0 2009

Re: K093303

Trade/Device Name: ScoutPro 7F Long Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY, DRE Dated: October 20, 2009 Received: October 21, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. 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):

K093303

Device Name:

ScoutPro 7F Long Catheters

Indications For Use:

The ScoutPro CS lead introducer system and its separately available accessories are used to facilitate lead implantation in the left side of the heart via the coronary sinus.

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 e of Device Evaluation (ODE)

W.M.

on Sian-Off Division of Cardiovascular Devices

510(k) Number K093303

Page 1 of 1

Regulation Number and Section

§ 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).