The ScoutPro 7F delivery system is a modified version of the BIOTRONIK's current legally marketed ScoutPro delivery system (K03320, dated 11-19-2003). The ScoutPro 7F functions similarly to that of a standard introducer for pacemaker leads. It contains catheters with various distal arcs to facilitate and support the implantation of left-ventricular polyurethane leads up to 6.6 F in the coronary venous system.

For implantation of left ventricular pacing leads, the subclavian or the cephalic vein is used as a point of entry into the venous system. After gaining access to the vein, one of the braided, peel-away guiding catheters (long sheaths) used in combination with the dilator and hemostatic valve is introduced into the vein using a guide wire initially positioned in the atrium. Selection of a guiding catheter with a suitable curve (arc) allows the distal tip of the catheter to probe the coronary sinus and facilitates implantation of the lead into the coronary veins. A side access in the hemostatic valve enables the injection of irrigation solutions and contrast dyes to facilitate gaining access to the coronary sinus.

After successful placement of the hemostatic valve and the guiding catheter are removed over the lead. In this process, the pre-slitted peel-away grip, which is glued to the proximal end of the guiding catheter, is broken off. The catheter is opened along the pre-slit portion (2 cm). Then, using the slitter tool, the guiding catheter is slit from proximal to distal end.

The main difference between the predicate device ScoutPro and the ScoutPro 7F described in this documentation is the inner diameter of the guiding catheters included in the system. Most coronary sinus leads to be implanted have a smaller diameter, for which a 7F introducer system is sufficient.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called ScoutPro 7F. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than exhaustive new clinical studies proving performance against absolute acceptance criteria.

Therefore, the document does not contain the kind of detailed information requested in the prompt regarding acceptance criteria, study performance, sample sizes, expert involvement, and ground truth establishment as would be found in a study designed to prove device performance from the ground up (e.g., for a PMA submission or a novel device).

Here's an breakdown based on the information provided, highlighting what is implicitly or explicitly stated and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for a 510(k) submission is typically showing substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as the predicate, often through comparisons of technological characteristics and intended use.
Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, accuracy, sensitivity, specificity) are reported in a quantifiable manner for the ScoutPro 7F. The submission focuses on describing the device and its modifications relative to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided: The document does not describe a clinical "test set" in the sense of a study testing the device's performance in patients. This is a 510(k) submission, not a clinical trial report. Data provenance, if any, for non-clinical testing is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided: As there's no described clinical "test set" with ground truth to be established, this information is not present.

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

Not applicable / Not provided: No clinical test set means no adjudication method.

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 / Not provided: This device is a delivery system (catheter, guide wires, etc.) for coronary sinus leads, not an imaging or AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this product submission.

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

Not applicable / Not provided: This refers to AI/algorithm performance. The ScoutPro 7F is a mechanical device, not an algorithm.

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

Not applicable / Not provided: No clinical "ground truth" data is referenced in this submission. The basis for substantial equivalence is primarily comparison of technological characteristics and intended use to a previously cleared device.

8. The sample size for the training set

Not applicable / Not provided: There is no "training set" in the context of device performance data for this submission. This term relates to machine learning models.

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

Not applicable / Not provided: No training set or ground truth for it.

Summary based on the document:

This 510(k) submission for the ScoutPro 7F is based on demonstrating substantial equivalence to the predicate device, BIOTRONIK's ScoutPro (K033320). The modifications described are primarily the inner diameter of the guiding catheters and some accessory changes. The implicit "acceptance criteria" for this type of submission is satisfying the FDA that these modifications do not raise new questions of safety or effectiveness and that the device remains substantially equivalent to the predicate.

The document does not detail specific performance studies with quantitative data, sample sizes, or expert ground truth as would be required for novel device approval or other types of regulatory pathways.

Summary

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K060807 page 1

March 23, 2006

ScoutPro 7F Special 510(k) Premarket Notification

APR 24 4000

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 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 7F is a special delivery system for coronary sinus leads. It is clesigned to assist with introducing leads into the vessels of the left side of the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's current legally marketed predicate device ScoutPro (K033320, 11-19-2003). The following ScoutPro 7F accessories are subject to this Special 510 (k)

1028232

The basic set ScoutPro 7F contains the following components:

1 hemostatic valve
· 2 guiding catheters MPEP and BIO 2
· 1 dilator for the guiding catheter
1 peel-away sheath 10F with dilator
· 1 guide wire
1 needle
· 1 syringe
· 2 slitter tools 4.9 F and 6.3 F for different lead sizes

ScoutPro 7F Sheath "Hook" contains the following components:

· 1 guiding catheter "Hook"
· 1 dilator for the guiding catheter

ScoutPro 7F Sheath "Multi-Purpose Hook" contains the following components:

· 1 guiding catheter "Multi-Purpose Hook"
· 1 dilator for the guiding catheter

ScoutPro 7F Sheath "Amplatz 6.0" contains the following components:

· 1 guiding catheter "Amplatz 6.0"
· 1 dilator for the guiding catheter

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BIOTRONIK, ScoutPro 7F, Special 510(k)

... March 23, 2006

Additionally, the hemostatic valve and the slitter tools are available separately. The hemostatic valve and slitter tool 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 7F described in this documentation is the inner diameter of the guiding catheters included in the system. Some other modifications include changes to the accessories like the markings on the hemostatic valve, a larger scaled syringe and a different plastic material for slitter tools.

Predicate Device:

BIOTRONIK proposes the following delivery system cleared through 510(k) notification as a predicate device for the ScoutPro 7F:

BIOTRONK's ScoutPro (#K033320, 11-19-2003) .

Indication for Use:

The intended use of the ScoutPro 7F 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, Germany011-49-30-689-05-1210
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) 635-9936

jon.brumbaugh@biotronik.com

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K060807 Page 3

March 23, 2006

2. INDICATIONS FOR USE

The intended use of the ScoutPro 7F is for introducing leads into the vessels of the left heart via the coronary sinus.

See Appendix 1 for the 510(k) Indications for Use Form.

3. CONTRAINDICATIONS

The ScoutPro 7F is contraindicated for:

· Patients with known or possible obstructed coronary sinus vasculature or inadequate coronary sinus anatomy.
· Patients with active systemic infection.

4. DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE PRODUCTS

4.1 DEVICE DESCRIPTION

The basic set ScoutPro 7F (Figure 1) contains the following components with changes (if any) listed in Table 1.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2006

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

Re: K060807

Trade/Device Name: ScoutPro 7F Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 23, 2006 Received: March 24, 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.

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

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Page 2 - Mr. Jon Brumbaugh

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,

B.Bimmerman 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 7F

Indications for Use:

The intended use of the ScoutPro 7F is for introducing leads into the vessels of the left 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, Office of Device Evaluation (ODE)

Page 1 of 1

Blummo

issen Slon-Off Division of Cardlov scular De 510/2) Number

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).