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).

AI/ML Overview

This document is a 510(k) Premarket Notification for the ScoutPro 8F, a medical device for introducing leads into the heart. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the context of an AI/algorithm-driven device.

Therefore, the information requested for AI device studies, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, cannot be found in this document.

This document is a regulatory submission for a physical medical device (a catheter delivery system), not an AI/software as a medical device (SaMD). The regulatory pathway and the type of evidence required are different.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) because this is a 510(k) for a physical device, not an AI/diagnostic algorithm. The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
Reported Device Performance: The document describes the device and its modifications but does not report specific performance data (e.g., success rates, complication rates from clinical trials directly in this summary). The basis for demonstrating substantial equivalence often relies on:
- Bench testing: To ensure modifications maintain material integrity, functional dimensions, and performance characteristics.
- Biocompatibility testing: To ensure materials are safe for human contact.
- Sterilization validation: To ensure the device can be consistently sterilized.
- Software validation (if applicable, though minimal for this device): To ensure any embedded software functions correctly.
- Comparison to predicate device's known performance: The assumption is that if the new device is substantially equivalent, it will perform similarly to the predicate.
The document states: "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." The implicit performance claim is that these modifications do not negatively impact the core function (introducing leads into vessels of the left heart) or safety compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable for this type of submission. This document does not describe a clinical study with a test set of patient data as one would for an AI algorithm. Substantial equivalence for this kind of physical device is typically demonstrated through engineering testing, material testing, and comparison of design features.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. There is no "ground truth" establishment in the context of an AI product review. The "truth" in this submission relies on engineering principles, established medical device standards, and the predicate device's safety and effectiveness history.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is described, as there isn't a test set of cases needing expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant here.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

Not applicable in the AI sense. For a physical device like this, the "ground truth" for proving substantial equivalence lies in:
- Functional Testing: Does the device perform its intended mechanical functions?
- Material Compatibility: Are the materials safe and effective?
- Biocompatibility: Is it safe for the human body?
- Sterility Validation: Is it demonstrably sterile?
- Predicate Device Performance: The predicate device (BIOTRONIK's ScoutPro #K033320) serves as the benchmark against which the new device is compared in terms of safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. There is no AI training set involved in this 510(k) submission.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no AI training set involved.

Summary of what's provided related to the request (if the device were an AI/SaMD):

Predicate Device: BIOTRONIK's ScoutPro (#K033320, 11-19-2003) is identified. For an AI/SaMD, this would be a predicate AI/SaMD or a conventional diagnostic method that the new AI algorithm aims to be substantially equivalent to.
Intended Use: "The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus." This is crucial for any device, including AI, as it defines the scope of its application.

This document clearly outlines the regulatory path for a physical medical device. The framework for evaluating an AI/SaMD is distinctly different, requiring evidence related to algorithm performance on diverse datasets, expert evaluation of ground truth, and often clinical utility studies.

Summary

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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:

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)Woermannkehre 1,12359 Berlin, Germany
	011-49-30-689-05-1210
Name and Address of Contract Manufacturer:	BIOTRONIK AG (reg. no. 8043892)Ackerstrasse 68180 Bülach,Switzerland 011-41-44-864-5169
Contact Person(s) and Phone Number:	Jon BrumbaughDirector, Regulatory Affairs and CompliancePhone (888) 345-0374Fax (503) 635-9936jon.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 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

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).