The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left side 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. This submission is in regard to a modification in a hemostatic valve, which is an accessory component of the ScoutPro family. The hemostatic valve is included with the ScoutPro 7F kit and is also separately available. The hemostatic valve will be modified to include a 2-way spigot instead of a 3-way spigot, from a new supplier, Qosina.

AI/ML Overview

This document describes a Special 510(k) for a modification to the BIOTRONIK ScoutPro Hemostatic Valve. Special 510(k)s often refer back to previously cleared predicate devices and generally focus on modifications that do not significantly alter the device's fundamental scientific technology or indications for use. Therefore, the information typically found in a full de novo 510(k) about extensive clinical studies and detailed acceptance criteria may not be present in this type of submission.

Based on the provided text, the device in question is a modified hemostatic valve, which is an accessory component of the ScoutPro 7F kit. The modification involves changing from a 3-way spigot to a 2-way spigot and sourcing the new spigot from a new supplier (Qosina). The manufacturer explicitly states that "No changes have been made to the functionality of the hemostatic valve or any other accessories included within the kit." and that "The usage of the ScoutPro hemostatic valve and ScoutPro 7F kit remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories in submission #K060807."

This indicates that the acceptance criteria for this Special 510(k) are primarily related to ensuring the modified component does not negatively impact the previously established performance of the overall device and retains substantial equivalence to the predicate device. The primary evidence presented for meeting these criteria is biocompatibility testing and the assertion of no functional changes.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit for Special 510(k))	Reported Device Performance
Material Safety	Biocompatibility of new components	"All patient contacting materials have already been used in other US legally marketed devices and the modified hemostatic valves have successfully undergone a full battery of biocompatibility testing."
Functional Equivalence	No change in functionality	"No changes have been made to the functionality of the hemostatic valve or any other accessories included within the kit."
Indications for Use	Retain original indications	"The product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories."
Substantial Equivalence	Demonstrates equivalence to predicate device	"Therefore, the previously cleared versions will serve as predicate devices for the modified products included in this Special 510(k)."

2. Sample Size for Test Set and Data Provenance

The document mentions "a full battery of biocompatibility testing" for the modified hemostatic valves. However, it does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective nature). Given that it's a Special 510(k) for a component modification, the "test set" likely refers to the samples used for this specific biocompatibility testing and potentially functional verification tests in a lab, rather than a clinical study with human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information (experts for ground truth determination) is typically associated with studies involving diagnostic accuracy or efficacy in clinical settings. Since this submission is for a component modification based on maintaining substantial equivalence and successful biocompatibility testing, no information is provided regarding experts establishing ground truth for a test set. The "ground truth" here would be defined by established material safety standards (for biocompatibility) and engineering specifications (for functional equivalence).

4. Adjudication Method for the Test Set

Similarly, adjudication methods (like 2+1, 3+1) are common in clinical trials or diagnostic accuracy studies where human interpretation of results is involved. For a component modification involving biocompatibility and functional equivalence, no adjudication method is described in the provided text. The assessment would rely on standardized laboratory test results against predefined acceptance limits.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or is mentioned. This type of study is relevant for evaluating the impact of AI or assisted technologies on human reader performance, which is not applicable to a modification of a mechanical hemostatic valve.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study was done or is mentioned. This section is also related to AI or diagnostic imaging devices, which is not relevant to this medical device modification.

7. Type of Ground Truth Used

For the reported performance related to the modification, the ground truth is established through:

Biocompatibility Standards: The "full battery of biocompatibility testing" implies adherence to recognized standards (e.g., ISO 10993 series) for material safety.
Engineering Specifications/Functional Requirements: The statement "No changes have been made to the functionality" suggests that the modified valve meets the original functional specifications of the predicate device.

8. Sample Size for the Training Set

No training set is applicable or mentioned. This concept is primarily relevant to machine learning or AI models, not a mechanical component modification.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set involved.

Summary

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BIOTRONIK, Inc., ScoutPro Hemostatic Valve, Additional Information for Special 510(k) #K 101282 - June 18, 2010

Modifications to theScoutPro Hemostatic Valve Special 510(k) Premarket Notification

1. 510(K) SUMMARY

Name and Address of Applicant:

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

JUL 2 1 2010

Establishment Registration Number:

1028232

Device Name:

Proprietary Name: Classification:

Classification Name: Product Code:

June 18, 2010

ScoutPro 7F Class II (21 CFR 870.1250; 870.1310; 870.1330) Wire, Guide, Catheters, Percutaneous DQY, DRE, DQX

Date Prepared:

General 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. This submission is in regard to a modification in a hemostatic valve, which is an accessory component of the ScoutPro family. The following ScoutPro 7F kit contains the hemostatic valve which is the subject of this Special 510(k):

The ScoulPro 7F kit (with accessories) were cleared under 510(k) #K060807 on April 24, 2006:

The basic set ScoutPro 7F contains the following components:

. 1 hemostatic valve (which is also separately available)
2 guiding catheters "MPEP" and "BIO2" .
1 dilator for the guiding catheter .
1 peel-away sheath 10F with dilator .
. 1 quide wire
1 needle .
. 1 syringe
2 slitter tools 4.9 F and 6.3 F for different lead sizes .

Device Modification:

The hemostatic valve is included with the ScoutPro 7F kit and is also separately available. The hemostatic valve will be modified to include a 2-way spigot instead of a 3-way spigot, from a new supplier, Qosina. All patient contacting materials have already been used in other US legally marketed devices and the modified hemostatic valves have successfully undergone a full battery of biocompatibility testing. As a result of these modifications, updates will be made to the labeling. No changes have been made to the functionality of the hemostatic valve or any other accessories included within the kit. The change is being made to ensure continued supply of the hemostatic valves.

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BIOTRONIK, Inc., ScoutPro Hemostatic Valve, Additional Information for Special 510(k) #K101282 June 18, 2010

The usage of the ScoutPro hemostatic valve and ScoutPro 7F kit remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories in submission #K060807, cleared on April 24, 2006. Therefore, the previously cleared versions will serve as predicate devices for the modified products included in this Special 510(k).

Predicate Device:

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

Indications for Use:

The ScoutPro CS Lead Introducer System facilitates lead implantation in the left of the heart via the coronary sinus.

The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

Name and Address of Manufacturing Site:

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

Name and Address of Manufacturing Site:

BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-44-864-5169

510(k) Contact Person and Phone Number:

Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone (888) 345-0374 Fax (503) 635-9936

jon.brumbauqh@biotronik.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

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

JUL 2 1 2010

Re: K101282

Trade/Device Name: ScoutPro Hemostatic Valve Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: June 18, 2010 Received: June 21, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Page 2 - Mr. Jon Brumbaugh

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.

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/ReportaProblem/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): TBD

Device Name: ScoutPro Hemostatic Valve (Part of the ScoutPro 7F Kit) Indications for Use:

The ScoutPro CS Lead Introducer System facilitates lead implantation in the heart via the coronary sinus.

The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus.

Prescription Use V (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)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number

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).