The ScoutPro Slitter Tool Advanced is used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

Device Description

The ScoutPro family of introducer systems and accessories is specifically used for the placement of 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 ScoutPro Slitter Tool Advanced represents further development of the ScoutPro Slitter Tool, which is part of the ScoutPro family of coronary sinus lead delivery systems. The main difference between the modified Slitter Tool Advanced and its predecessor is a more ergonomic design of the grip in order to optimize the handling and to enable a smooth removal of the delivery system. The optimized design is achieved by fabricating the entire device out of stainless steel. The Slitter Tool Advanced can be used with all BIOTRONIK coronary sinus leads with diameters 4.1F to 7.2F. Thus the optimized Slitter Tool Advanced covers the same lead diameter range as the two preceding Slitter Tools combined. The usage of the Slitter Tool remains unchanged and the product characteristics such as indications, contraindications, and function of the Slitter Tool Advanced are identical to the previous Slitter Tool. The ScoutPro Slitter Tool Advanced is a separately sold accessory that can be used in conjunction with the ScoutPro family of coronary sinus lead introducer systems.

AI/ML Overview

This looks like a Special 510(k) for a modified medical device, the ScoutPro Slitter Tool Advanced. Special 510(k)s are primarily used for minor modifications to a manufacturer's own legally marketed device, where the modifications do not significantly alter the device's fundamental scientific technology or safety and effectiveness.

For such submissions, the focus of the testing and acceptance criteria is often on demonstrating that the changes to the device do not adversely affect its performance compared to the predicate, rather than establishing entirely new performance criteria. Therefore, the details you're asking for, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies, are typically not part of a Special 510(k) and are not present in the provided text.

The document states: "The usage of the Slitter Tool remains unchanged and the product characteristics such as indications, contraindications, and function of the Slitter Tool Advanced are identical to the previous Slitter Tool." This indicates that the core functionality is assumed to be equivalent to the predicate, and the focus of the submission is on the design change (more ergonomic grip, stainless steel fabrication, covering a wider lead diameter range).

Here's an analysis based on the information provided, highlighting why many of your questions cannot be answered from this specific document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in quantitative terms or report specific performance metrics for the ScoutPro Slitter Tool Advanced beyond the physical characteristics changed. Instead, the submission relies on demonstrating substantial equivalence to its predicate device, the BIOTRONIK's ScoutPro 7F (#K060807, 04-24-2006).

The key "performance" aspect mentioned is the ability to work with a range of lead diameters:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Lead Diameter Compatibility	Compatible with 4.1F to 7.2F lead diameters, same as the two preceding Slitter Tools combined.	Compatible with 4.1F to 7.2F lead diameters.
Ergonomics/Handling	Optimized handling and smooth removal of the delivery system for the user.	Optimized design achieved by fabricating the entire device out of stainless steel, for more ergonomic grip and smooth removal.
Functionality	Functions identically to the previous Slitter Tool.	Function is identical to the previous Slitter Tool.
Indications for Use	Same as the previous Slitter Tool.	Same as the previous Slitter Tool.

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

Not explicitly stated in the provided text. For a Special 510(k) focused on design changes and substantial equivalence, the testing often involves bench testing (e.g., mechanical strength, material compatibility, dimensional analysis) to ensure the changes don't introduce new risks or degrade performance. The specific test quantities and data provenance for such tests are not detailed here.

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

Not applicable/Not stated. This type of information is typically reserved for studies involving subjective human assessment (like image interpretation or clinical outcomes) or establishing a complex diagnostic ground truth. For a mechanical device modification, expert "ground truth" for performance would likely be based on engineering specifications and bench test results, often reviewed by in-house experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not stated. Adjudication methods are usually relevant to studies with multiple readers or assessments that require conflict resolution regarding a 'ground truth'. For physical device testing, adjudication is less common.

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:

No, an MRMC study was not done. This is a medical device (a slitter tool), not an AI/software device that assists human readers with interpretation. Therefore, MRMC studies are not relevant to this submission.

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

No, a standalone algorithm performance study was not done. This is a mechanical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this type of device modification, the "ground truth" would be established through engineering specifications, material science standards, and the performance characteristics of the predicate device. Testing would likely confirm that the new design meets these established engineering and safety benchmarks, and that the material change (stainless steel) is appropriate.

8. The sample size for the training set:

Not applicable/Not stated. There is no "training set" in the context of this mechanical device modification. Training sets are relevant for machine learning or AI models.

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

Not applicable/Not stated. As there is no training set, this question is not relevant.

Summary based on the Provided Text:

The Special 510(k) for the ScoutPro Slitter Tool Advanced is based on demonstrating substantial equivalence to its predicate by showing that:

The device's function, indications for use, and contraindications are identical to the previous version.
The design modifications (more ergonomic grip, stainless steel fabrication) improve handling and allow for compatibility with the combined lead diameter range of the previous two tools, without introducing new safety or effectiveness concerns.
The primary "study" supporting this would be a comparison of the modified device to the predicate device through bench testing and potentially design verification/validation activities (e.g., material testing, dimensional checks, simulated use testing) to ensure the new design performs as intended and does not compromise safety or efficacy. The specific details of these tests (e.g., number of units tested, specific parameters measured) are not included in this high-level summary but would be part of the full 510(k) submission.

Summary

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BIOTRONIK, ScoutPro Slitter Tool Advanced, Special 510(k)

K071665

June 15, 2007

ScoutPro Slitter Tool Advanced Special 510(k) Premarket Notification

JUL 1 8 2007

1. 510(k) SUMMARY

Name and Address of Sponsor:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
Establishment Registration Number:	1028232
Device Name:
Proprietary Name:	ScoutPro Slitter Tool Advanced
Classification:	Class II (21 CFR 870.1250; 870.1310; 870.1330)
Classification Name:	Wire, Guide, Catheters, Percutaneous
Product Code:	DQY, DRE, DQX
General Description:

· ScoutPro Slitter Tool Advanced

Device Modifications:

The ScoutPro Slitter Tool Advanced represents further development of the ScoutPro Slitter Tool, which is part of the ScoutPro family of coronary sinus lead delivery systems. The main difference between the modified Slitter Tool Advanced and its predecessor is a more ergonomic design of the grip in order to optimize the handling and to enable a smooth removal of the delivery system. The optimized design is achieved by fabricating the entire device out of stainless steel. The Slitter Tool Advanced can be used with all BIOTRONIK coronary sinus leads with diameters 4.1F to 7.2F. Thus the optimized Slitter Tool Advanced covers the same lead diameter range as the two preceding Slitter Tools combined. The usage of the Slitter Tool remains unchanged and the product characteristics such as indications, contraindications, and function of the Slitter Tool Advanced are identical to the previous Slitter Tool.

The ScoutPro Slitter Tool Advanced is a separately sold accessory that can be used in conjunction with the ScoutPro family of coronary sinus lead introducer systems.

Predicate Devices:

BIOTRONIK proposes the following delivery system cleared through 510(k) notification as the predicate device for the ScoutPro Slitter Tool Advanced described in this Special 510(k):

. BIOTRONIK's ScoutPro 7F (#K060807, 04-24-2006)

Indication for Use:

The ScoutPro Slitter Tool Advanced is used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

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Name and Address of Manufacturer:	BIOTRONIK GmbH & Co. KGWoermannkehre 1,12359 Berlin, Germany011-49-30-689-05-1210
Manufacturer's Registration Number:	9610139
Name and Address of Contract Manufacturer:	BIOTRONIK AGAckerstraße 68180 Bülach, Switzerland011-41-44-864-5169
Contract Manufacturer's Registration Number:	8043892
Contact Person(s) and Phone Number:	Jon Brumbaugh

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

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2007

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

Re: K071665

ScoutPro Slitter Tool Advanced Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: June 15, 2007 Received: June 18, 2007

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 (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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bfummima for

Bram B. 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):

Device Name: ScoutPro Slitter Tool Advanced

Indications for Use:

The ScoutPro Slitter Tool Advanced is used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

Prescription Use イ (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)

Blummo

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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).